Simethicone Strips

Pronunciation: sye-METH-i-kone
Generic Name: Simethicone
Brand Name: Children's Gas-X Tongue Twisters

Simethicone Strips are used for:

Relieving pressure, bloating, and gas in the digestive tract. It may also be used for other conditions as determined by your doctor.

Simethicone Strips are an antiflatulent. It works by breaking up gas bubbles, which makes gas easier to eliminate.

Do NOT use Simethicone Strips if:

• you are allergic to any ingredient in Simethicone Strips

Contact your doctor or health care provider right away if any of these apply to you.

Before using Simethicone Strips:

Some medical conditions may interact with Simethicone Strips. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Simethicone Strips. However, no specific interactions with Simethicone Strips are known at this time.

Ask your health care provider if Simethicone Strips may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Simethicone Strips:

Use Simethicone Strips as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Use Simethicone Strips as needed after meals and before bedtime, unless otherwise directed by your doctor.


• Do not remove the strip from the pouch until you are ready to use Simethicone Strips. Make sure that your hands are dry when you handle Simethicone Strips.


• Remove the strip from the pouch and place it on the tongue. The strip dissolves quickly and can be swallowed with saliva. Simethicone Strips may be taken with or without water.


• Use the strip immediately after opening the pouch. Do not store the strip for future use.


• Do not use more than 6 strips in 24 hours unless your doctor tells you otherwise.


• If you miss a dose of Simethicone Strips, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Simethicone Strips.

Important safety information:

• Do not exceed the recommended dose without checking with your doctor.


• If your symptoms do not get better or if they get worse, check with your doctor.


• Simethicone Strips should not be used in CHILDREN younger than 2 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Simethicone Strips, contact your doctor. You will need to discuss the benefits and risks of using Simethicone Strips while you are pregnant. It is not known if Simethicone Strips are found in breast milk. If you are or will be breast-feeding while you use Simethicone Strips, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Simethicone Strips:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Simethicone Strips:

Store Simethicone Strips at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Simethicone Strips out of the reach of children and away from pets.

General information:

• If you have any questions about Simethicone Strips, please talk with your doctor, pharmacist, or other health care provider.


• Simethicone Strips are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Simethicone Strips. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Simethicone resources

• Simethicone Use in Pregnancy & Breastfeeding
• Drug Images
• Simethicone Support Group
• 2 Reviews for Simethicone - Add your own review/rating

Compare Simethicone with other medications

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• Functional Gastric Disorder
• Gas
• Postoperative Gas Pains

Salagen

Pronunciation: pye-loe-KAR-peen
Generic Name: Pilocarpine
Brand Name: Salagen

Salagen is used for:

Treating dry mouth associated with radiation treatment for cancer or Sjogren syndrome. It may also be used for other conditions as determined by your doctor.

Salagen is a cholinergic agent. It works by increasing the secretion of saliva from the salivary glands, which helps to relieve dry mouth.

Do NOT use Salagen if:

• you are allergic to any ingredient in Salagen


• you have glaucoma, a severe eye infection, eye inflammation, or uncontrolled asthma

Contact your doctor or health care provider right away if any of these apply to you.

Before using Salagen:

Some medical conditions may interact with Salagen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a detached retina or an eye infection


• if you have heart disease, asthma, chronic bronchitis, chronic obstructive pulmonary disease, kidney or liver disease, gallstones, or gall bladder problems


• if you have a psychiatric disorder

Some MEDICINES MAY INTERACT with Salagen. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Parasympathomimetic agents (eg, bethanecol) because they may increase the risk of Salagen's side effects


• Beta-blockers (eg atenolol) because the risk of heart-related side effects may be increased


• Anticholinergic agents (eg, atropine, ipratropium) because their effectiveness may be decreased by Salagen

This may not be a complete list of all interactions that may occur. Ask your health care provider if Salagen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Salagen:

Use Salagen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Salagen by mouth with or without food.


• Drinking extra fluids while you are taking Salagen is recommended. Check with your doctor for instructions.


• If you miss a dose of Salagen, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Salagen.

Important safety information:

• Salagen may cause blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Salagen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• It may take 12 weeks for Salagen to work.


• Salagen should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Salagen while you are pregnant. It is not known if Salagen is found in breast milk. Do not breast-feed while taking Salagen.

Possible side effects of Salagen:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; dizziness; flushing; frequent urination; nausea; runny nose; sweating; vision changes (eg, blurred vision); weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal pain; breathing problems; change in heart rate; confusion; excessive sweating; excessive tears; headache; shaking; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Salagen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal heartbeat; blood pressure changes; confusion; diarrhea; difficulty breathing; headache; tremors; vision changes; vomiting.

Proper storage of Salagen:

Store Salagen at room temperature, up to 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Salagen out of the reach of children and away from pets.

General information:

• If you have any questions about Salagen, please talk with your doctor, pharmacist, or other health care provider.


• Salagen is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Salagen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Salagen resources

• Salagen Side Effects (in more detail)
• Salagen Dosage
• Salagen Use in Pregnancy & Breastfeeding
• Drug Images
• Salagen Drug Interactions
• Salagen Support Group
• 0 Reviews for Salagen - Add your own review/rating

• Salagen Prescribing Information (FDA)


• Salagen Advanced Consumer (Micromedex) - Includes Dosage Information


• Salagen Concise Consumer Information (Cerner Multum)


• Pilocarpine Monograph (AHFS DI)


• Pilocarpine Prescribing Information (FDA)


• Pilocarpine Professional Patient Advice (Wolters Kluwer)

Compare Salagen with other medications

• Xerostomia

Temozolomide

Pronunciation: TEM-oh-ZOL-oh-mide
Generic Name: Temozolomide
Brand Name: Temodar

Temozolomide is used for:

Treating certain types of brain tumors in certain patients. It may also be used for other conditions as determined by your doctor.

Temozolomide is an antineoplastic agent. It works by stopping cancer cells from growing and reproducing.

Do NOT use Temozolomide if:

• you are allergic to any ingredient in Temozolomide, including if you have developed red, swollen, blistered, or peeling skin after taking a previous dose of Temozolomide or oral temozolomide


• you are allergic to dacarbazine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Temozolomide:

Some medical conditions may interact with Temozolomide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are able to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have pneumonia, kidney, or liver problems


• if you have bone marrow depression, including low white blood cell counts or low blood platelet levels

Some MEDICINES MAY INTERACT with Temozolomide. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Corticosteroids (eg, prednisone) because the risk of severe infection may be increased


• Valproic acid because it may increase the risk of Temozolomide's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Temozolomide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Temozolomide:

Use Temozolomide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Temozolomide. Talk to your pharmacist if you have questions about this information.


• Temozolomide is usually given as an infusion at your doctor's office, hospital, or clinic. If you will be using Temozolomide at home, a health care provider will teach you how to use it. Be sure you understand how to use Temozolomide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Temozolomide if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Temozolomide, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Temozolomide.

Important safety information:

• Temozolomide may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Temozolomide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Nausea, vomiting, and loss of appetite are common with Temozolomide. Ask your doctor or pharmacist for ways to decrease these effects if they occur.


• Temozolomide may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Temozolomide may increase your risk of developing a certain blood problem (myelodysplastic syndrome [MDS]) or a second cancer. Talk to your doctor if you have any questions or concerns.


• Temozolomide may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Tell your doctor or dentist that you take Temozolomide before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including complete blood cell counts, may be performed while you use Temozolomide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Temozolomide with caution in the ELDERLY; they may be more sensitive to its effects.


• Temozolomide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• Men who take Temozolomide should always use a condom when having sex with a woman who is pregnant or may become pregnant. Do this for as long as you take Temozolomide.


• PREGNANCY and BREAST-FEEDING: Temozolomide may cause harm to the fetus. Do not become pregnant while you are using it. Use an effective form of birth control while you are taking Temozolomide. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Temozolomide while you are pregnant. It is not known if Temozolomide is found in breast milk. Do not breast-feed while taking Temozolomide.

Possible side effects of Temozolomide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; back pain; breast pain; constipation; cough; diarrhea; dizziness; drowsiness; dry skin; hair loss; headache; joint pain; loss of appetite; mild stomach pain; mouth or tongue sores; muscle aches; nausea; taste changes; tiredness; trouble sleeping; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; coughing up blood; depression; difficulty swallowing; increased, difficult, or painful urination; fever, chills, or sore throat; loss of bladder control; loss of coordination; memory loss; muscle pain or weakness; numbness, burning, or tingling; pain, irritation, itching, warmth, swelling, or redness at the injection site; paralysis on one side of the body; persistent cough; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache, nausea, or vomiting; severe or persistent tiredness or weakness; shortness of breath; small red or purple spots under the skin; speech changes; sudden or unusual weight gain; swelling of the ankles, feet, or hands; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding; trouble walking; vision changes (eg, blurred vision, double vision).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Temozolomide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fever or severe bruising or bleeding.

Proper storage of Temozolomide:

Temozolomide is usually handled and stored by a health care provider. If you are using Temozolomide at home, store Temozolomide as directed by your pharmacist or health care provider. Keep Temozolomide out of the reach of children and away from pets.

General information:

• If you have any questions about Temozolomide, please talk with your doctor, pharmacist, or other health care provider.


• Temozolomide is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Temozolomide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Temozolomide resources

• Temozolomide Side Effects (in more detail)
• Temozolomide Use in Pregnancy & Breastfeeding
• Temozolomide Drug Interactions
• Temozolomide Support Group
• 4 Reviews for Temozolomide - Add your own review/rating

Compare Temozolomide with other medications

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Kola-Pectin

Generic Name: bismuth subsalicylate (Oral route)

BIZ-muth sub-sa-LIS-i-late

Commonly used brand name(s)

In the U.S.

• Bismatrol


• Diotame


• Kaopectate


• Kapectolin


• Kola-Pectin


• Pepto Bismol

In Canada

• Bismuth Extra Strength


• Bismuth Original Formula


• Pepto-Bismol


• Stomach Relief - Regular Formula

Available Dosage Forms:

• Suspension


• Tablet, Chewable


• Tablet

Therapeutic Class: Antacid, Bismuth Containing

Chemical Class: Salicylate, Non-Aspirin

Uses For Kola-Pectin

Bismuth subsalicylate is used to treat diarrhea in adults and teenagers. It is also used to relieve the symptoms of an upset stomach, such as heartburn, indigestion, and nausea in adults and teenagers.

This medicine is available without a prescription.

Before Using Kola-Pectin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine should not be used in children younger than 12 years of age. The fluid loss caused by diarrhea may result in a severe condition. In older children with diarrhea, medicine for diarrhea may be used, but it is also very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, children are usually more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

The bismuth in this medicine may cause severe constipation in children.

In addition, do not use this medicine to treat nausea or vomiting in children or teenagers who have or are recovering from the flu or chickenpox. If nausea or vomiting is present, check with the child's doctor immediately because this could be an early sign of Reye's syndrome.

Geriatric

The fluid loss caused by diarrhea may result in a severe condition. For this reason, elderly persons with diarrhea should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, the elderly may be more sensitive to the effects of salicylates. This may increase the chance of side effects during treatment. In addition, the bismuth in this medicine may cause severe constipation in the elderly.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methotrexate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Doxycycline


• Probenecid


• Sulfinpyrazone


• Tamarind

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dysentery—This condition may get worse; a different kind of treatment may be needed

• Gout—The salicylate in this medicine may worsen the gout and make the medicines taken for gout less effective

• Hemophilia or other bleeding problems—The salicylate in this medicine may increase the chance of bleeding

• Kidney disease—There is a greater chance of side effects because the body may be unable to get rid of the bismuth subsalicylate

• Stomach ulcer—Use of this medicine may make the ulcer worse

Proper Use of bismuth subsalicylate

This section provides information on the proper use of a number of products that contain bismuth subsalicylate. It may not be specific to Kola-Pectin. Please read with care.

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

For safe and effective use of this medicine:

• Follow your doctor's instructions if this medicine was prescribed.


• Follow the manufacturer's package directions if you are treating yourself.

For patients using this medicine to treat diarrhea:

• It is very important that the fluid lost by the body be replaced and that a proper diet be followed. For the first 24 hours you should drink plenty of clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, broth, and gelatin. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholic beverages may make the diarrhea worse.


• If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs of too much fluid loss occur:
  
  • Decreased urination
  
  
  • Dizziness and lightheadedness
  
  
  • Dryness of mouth
  
  
  • Increased thirst
  
  
  • Wrinkled skin
  
  

If you are taking the oral suspension: Use the dose cup that is included to measure out the right amount of medicine. If you are unsure, contact your doctor or pharmacist.

If you are taking the oral tablets: Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.

If you are taking the chewable tablets: Chew up the tablet or allow it to completely disintegrate in your mouth before swallowing it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension):
  
  • For diarrhea or upset stomach:
    
    • Adults and teenagers—The usual dose is 2 tablespoonfuls every half-hour to one hour if needed. You should not take more than 16 tablespoonfuls of the regular-strength suspension or 8 tablespoonfuls of the concentrate in twenty-four hours.
    
    
    • Children—Should not be used in children younger than 12 years of age.
    
    
  
  


• For oral dosage forms (tablets or chewable tablets):
  
  • For diarrhea or upset stomach:
    
    • Adults and teenagers—The usual dose is 2 tablets every half-hour to one hour. You should not take more than 16 tablets in twenty-four hours.
    
    
    • Children—Should not be used in children younger than 12 years of age.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Kola-Pectin

Check the labels of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any contain aspirin or other salicylates, be especially careful. Using other salicylate-containing products while taking this medicine may lead to overdose. If you have any questions about this, check with your health care professional.

For diabetic patients:

• False urine sugar test results may occur if you are regularly taking large amounts of bismuth subsalicylate or other salicylates.


• Smaller doses or occasional use of bismuth subsalicylate usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
  
  • you are not sure how much salicylate you are taking every day.
  
  
  • you notice any change in your urine sugar test results.
  
  
  • you have any other questions about this possible problem.
  
  

If you think that you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

If you are taking this medicine for diarrhea, check with your doctor:

• if your symptoms do not improve within 2 days or if they become worse.


• if you also have a high fever.

Kola-Pectin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

In some patients bismuth subsalicylate may cause dark tongue and/or grayish black stools. This is only temporary and will go away when you stop taking this medicine.

• Anxiety


• any loss of hearing


• confusion


• constipation (severe)


• diarrhea (severe or continuing)


• difficulty in speaking or slurred speech


• dizziness or lightheadedness


• drowsiness (severe)


• fast or deep breathing


• headache (severe or continuing)


• increased sweating


• increased thirst


• mental depression


• muscle spasms (especially of face, neck, and back)


• muscle weakness


• nausea or vomiting (severe or continuing)


• ringing or buzzing in ears (continuing)


• stomach pain (severe or continuing)


• trembling


• uncontrollable flapping movements of the hands (especially in elderly patients) or other uncontrolled body movements


• vision problems

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Kola-Pectin side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Tetrabenazine

Class: Central Nervous System Agents, Miscellaneous
Chemical Name: cisrac-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one
Molecular Formula: C₁₉H₂₇NO₃
CAS Number: 58-46-8
Brands: Xenazine

• 
  

  Tetrabenazine may increase risk of depression and suicidal thinking and behavior (suicidality) in patients with Huntington's disease; balance this risk with clinical need.¹

  
  


• 
  

  Closely observe all patients initiating tetrabenazine therapy for emergence or clinical worsening of depression, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.¹ (See Risk of Depression and Suicidality under Cautions.)

  
  


• 
  

  Exercise particular caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington's disease.¹

  
  


• 
  

  Tetrabenazine is contraindicated in patients who are actively suicidal and in patients with untreated or inadequately treated depression.¹

  
  

REMS:

FDA approved a REMS for tetrabenazine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of tetrabenazine and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

A monoamine-depleting agent; a benzoquinolizine derivative.¹

Uses for Tetrabenazine

Huntington's Chorea

Symptomatic management of chorea associated with Huntington's disease in adults;^{1 2 17 18 19 20 24 25 38 40 46 48} designated an orphan drug by FDA for this use.^{3 4 18}

Patients receiving tetrabenazine may experience slight worsening of cognition, functional capacity, mood, or rigidity; not known whether these effects persist, worsen, or resolve over time.^{1 47} Periodically reevaluate long-term risks and benefits of the drug for the individual patient.^{1 47}

Other Hyperkinetic Movement Disorders

Has been used with some success for the symptomatic management of other hyperkinetic movement disorders (also called hyperkinesias),^{22 29 30 31 32 33 35 37 38 39 40 42 47 48 53} including hemiballismus†,^{48 53} senile chorea†,^{48 53} Tourette's syndrome (Gilles de la Tourette's syndrome)† (see Pediatric Use under Cautions),^{30 35 38 42 53 54} tic disorder†,^{47 53} and tardive dyskinesia† (including severe and/or refractory cases).^{30 36 37 38 40 47 48 50 51 53 54}

Tetrabenazine Dosage and Administration

General

• 
  

  Observe closely for clinical worsening or emergence of depression, suicidal thoughts or behavior (suicidality), or unusual changes in behavior.^{1 28 47} (See Boxed Warning and see also Risk of Depression and Suicidality under Cautions.)

  
  

REMS Program

• 
  

  FDA has approved a REMS for tetrabenazine.^{4 10 13 18 41}

  
  


• 
  

  The goals are to reduce the risk of treatment-emergent depression and suicidality in patients receiving the drug, to promote informed prescribing and proper dosing of tetrabenazine, and to minimize the risk of drug interactions.^{4 10 13 41}

  
  


• 
  

  The program consists of educational materials for health care professionals, patients, and caregivers, including a medication guide to be dispensed with every tetrabenazine prescription;^{1 4 10 13 18 41} tetrabenazine must be obtained in the US via a specialty pharmacy network.^{13 17} For additional information, contact the Xenazine Information Center at 888-882-6013 or consult the Xenazine website at .^{5 9 13 17 28 43}

  
  

Administration

Oral Administration

Administer orally without regard to meals.^{1 18 24 28}

Do not double the next dose if a dose is missed.¹

Dosage

If used with a potent CYP2D6 inhibitor, dosage adjustment required.¹ (See Interactions.)

Carefully titrate dosage over several weeks to determine an individualized dosage for chronic use that reduces chorea and is well tolerated.^{1 28 48}

May discontinue treatment without tapering the dosage.¹ Retitrate dosage if therapy is resumed following an interruption of >5 days or a treatment interruption due to a change in medical condition or concomitant drug therapy.¹ May resume treatment at the previous maintenance dosage (without titration) following treatment interruption of <5 days.¹

Adults

Huntington's Chorea

Oral

Initially, 12.5 mg given once daily in the morning.¹ Increase dosage after one week to 12.5 mg twice daily.¹ Adjust subsequent dosages in 12.5-mg increments at weekly intervals.¹

Administer daily dosages ≥37.5 mg in 3 divided doses.¹ If daily dosage is ≤50 mg, the maximum recommended single dose is 25 mg.¹

Manufacturer recommends CYP2D6 genotype testing prior to administering dosages >50 mg daily to determine whether patient is poor, intermediate, or extensive metabolizer of CYP2D6 substrates. However, some clinicians prefer to adjust tetrabenazine dosage based on clinical response and tolerability.

Administer dosages >50 mg daily in 3 divided doses and make dosage adjustments in 12.5-mg increments at weekly intervals.¹

Table 1. Maximum Recommended Adult Dosage of Tetrabenazine Based on CYP2D6 Phenotype1

CYP2D6 Phenotype	Maximum Single Dose	Maximum Daily Dosage
Poor metabolizer	25 mg	50 mg
Intermediate or extensive metabolizer	37.5 mg	100 mg

Stop dosage titration and reduce daily dosage if adverse effects (e.g., excessive sedation, akathisia, restlessness, parkinsonism, depression, insomnia, anxiety) occur; consider drug discontinuance or initiation of specific treatment (e.g., antidepressant therapy) if adverse effects do not resolve.¹

Daily dosages >100 mg are not recommended;¹ however, higher dosages have been used in some patients.⁴⁴

Other Hyperkinetic Movement Disorders†

Oral

Initial dosage of 25 mg once or twice daily has been used in clinical studies in patients with various hyperkinesias, and then increased in 25-mg daily increments every 1–3 days until optimal therapeutic response, intolerable adverse effects, or maximum dosage of 100–200 mg daily was achieved.^{38 39 40}

One non-US manufacturer recommends initial dosage of 25 mg given 3 times daily, with titration in 25-mg daily increments every 3 or 4 days until maximum tolerated dosage (not exceeding 200 mg daily) is achieved in patients with hyperkinetic movement disorders other than tardive dyskinesia†.⁴⁸ If no improvement occurs at maximum tolerated dosage within 7 days, drug is unlikely to be effective despite increase in dosage or duration of treatment.⁴⁸

Tardive Dyskinesia†

Oral

One non-US manufacturer recommends initial dosage of 12.5 mg daily, with subsequent dosage titration based on response;⁴⁸ discontinue if no clear benefit or if adverse effects cannot be tolerated.⁴⁸

Tourette's Syndrome†

Oral

Clinical experience is limited; some clinicians recommend initial dosage of 12.5–25 mg given once daily at bedtime or twice daily, with titration to a target dosage of 25 mg given 3 times daily and a maximum dosage of 50 mg given 3 times daily.^{35 42}

Prescribing Limits

Adults

Huntington's Chorea

Oral

100 mg daily.¹

Poor metabolizer phenotype: 50 mg daily.¹

Other Hyperkinetic Movement Disorders†

Oral

100–200 mg daily.^{35 38 39 40 42}

Special Populations

Hepatic Impairment

Contraindicated in hepatic impairment.^{1 18} (See Hepatic Impairment under Cautions; see Absorption: Special Populations, under Pharmacokinetics; and see also Elimination: Special Populations, under Pharmacokinetics.)

Renal Impairment

No dosage adjustment required.^{1 43}

Geriatric Patients

No dosage adjustment required.^{1 43} However, at least one manufacturer recommends reduced initial and maintenance dosages.⁵³

Cautions for Tetrabenazine

Contraindications

• 
  

  Actively suicidal or untreated or inadequately treated depression.^{1 18}

  
  


• 
  

  Hepatic impairment.^{1 18}

  
  


• 
  

  Concomitant therapy with an MAO inhibitor.^{1 17 18} (See Specific Drugs under Interactions.)

  
  


• 
  

  Concomitant therapy with reserpine.^{1 18} (See Specific Drugs under Interactions.)

  
  

Warnings/Precautions

Warnings

Periodic Evaluation of Need for Continued Therapy

Slight worsening in mood, cognition, rigidity, and functional capacity may occur; unknown whether these effects persist, resolve, or worsen with continued treatment.^{1 2}

Periodically reevaluate need for continued therapy by assessing benefits on choreiform movements and possible adverse effects (e.g., depression, cognitive decline, parkinsonism, dysphagia, sedation, somnolence, akathisia, restlessness, disability).^{1 47} Dosage reduction or drug discontinuance may help distinguish between drug-induced adverse effects and disease progression.¹ Underlying chorea may improve over time, thereby possibly decreasing the need for tetrabenazine.¹

Importance of Careful Dosing

Individualize and carefully titrate dosage slowly over several weeks to determine a dosage that reduces chorea and is well tolerated.^{1 19 21 47}

Possible dose-dependent adverse effects (e.g., depression, fatigue, insomnia, sedation or somnolence, parkinsonism, akathisia) may resolve or lessen with dosage adjustment or specific treatment.¹ Consider tetrabenazine discontinuance if adverse effect does not resolve or decrease.¹

Dosages >50 mg daily should not be given without CYP2D6 genotyping.¹ (See Dosage under Dosage and Administration and see also Determining CYP2D6 Metabolizer Status under Cautions.)

Risk of Depression and Suicidality

Increased risk for depression and for suicidal ideation and behavior (suicidality) in patients with Huntington's disease.^{1 2} Tetrabenazine increases such risk which may increase with higher dosages.^{1 18 19 24 49} Depression or worsening of depression reported in 19–35% of tetrabenazine-treated patients; completed suicide, attempted suicide, and suicidal ideation reported.^{1 43} Depression more likely to occur or worsen in patients with history of depression.⁴⁹

Closely observe patients for emergence or worsening of depression, suicidality, or unusual changes in behavior.¹ Inform patients, caregivers, and families of these risks and instruct them to promptly report any behaviors of concern to the treating clinician.¹ Immediately evaluate any patient with Huntington's disease who expresses suicidal ideation.¹

Reduce tetrabenazine dosage if depression or suicidality occurs; consider initiating treatment with, or increasing the dosage of, a concomitant antidepressant.^{1 6} Consider drug discontinuance if depression or suicidality does not resolve.¹

Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation; such patients may be at an increased risk for suicidal behavior.¹

Contraindicated in patients who are actively suicidal or those with untreated or inadequately treated depression.¹

Balance potential risks of depression and suicidality with clinical need for control of choreiform movements.¹

Determining CYP2D6 Metabolizer Status

Testing for CYP2D6 status recommended prior to administering tetrabenazine dosages >50 mg daily.¹ Limit dosage to 50 mg daily for poor metabolizer phenotype.¹ (See Dosage under Dosage and Administration and see also Absorption: Special Populations, under Pharmacokinetics.)

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome characterized by hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability, has been reported with tetrabenazine and other drugs that reduce dopaminergic transmission.^{1 16 17 24 25 26 27}

Immediately discontinue therapy and initiate supportive and symptomatic therapy if NMS occurs.^{1 16 17 24 25 26 27} Careful monitoring required if therapy is reinstituted following recovery; the risk that NMS can recur should be carefully considered.¹

General Precautions

Akathisia

Possibly dose dependent; reported in up to 20% of tetrabenazine-treated patients.¹

Monitor for akathisia and symptoms of restlessness and agitation; reduce tetrabenazine dosage if akathisia develops; drug discontinuance may be necessary in some patients.¹

Parkinsonism

Symptoms suggestive of parkinsonism (e.g., bradykinesia, hypertonia, rigidity) reported in 3–15% of tetrabenazine-treated patients and appear to be dose dependent.¹ May be difficult to distinguish between drug-induced effect and rigidity associated with progression of Huntington's disease.¹ For some patients, drug-induced parkinsonism may result in more functional disability than untreated chorea.¹

If parkinsonism develops, consider dosage reduction; some patients may require drug discontinuance.¹

Dysphagia

Dysphagia, sometimes associated with aspiration pneumonia, reported in 4–10% of tetrabenazine-treated patients.¹ Causal relationship not established, since dysphagia is a manifestation of Huntington's disease and esophageal dysmotility and dysphagia also are reported with drugs that reduce dopaminergic transmission, including tetrabenazine.¹

Use tetrabenazine and other drugs that reduce dopaminergic transmission with caution in patients with Huntington's disease at risk for aspiration pneumonia.¹

Sedation and Somnolence

Reported in 17–57% of patients receiving the drug in clinical studies.¹ Sedation is the most common dose-limiting adverse effect.¹ (See Advice to Patients.)

Prolongation of QT Interval

Small increase in corrected QT (QT_c) interval reported.¹ Avoid use in patients concurrently receiving other drugs known to prolong the QT_c interval and in patients with congenital long QT syndrome or history of cardiac arrhythmias.^{1 18} (See Drugs that Prolong QT Interval under Interactions.)

Factors that may increase the risk of torsades de pointes and/or sudden death in association with drugs that prolong the QT_c interval include bradycardia, hypokalemia or hypomagnesemia, concomitant use of other drugs that prolong the QT_c interval, and presence of congenital QT_c interval prolongation.¹

Hypotension and Orthostatic Hypotension

Postural dizziness and dizziness reported.^{1 2} Consider monitoring orthostatic vital signs in patients who are vulnerable to hypotension.¹

Hyperprolactinemia

Elevated prolactin concentrations reported.¹ Perform appropriate laboratory testing and consider drug discontinuance if symptomatic hyperprolactinemia suspected.¹

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, reported with antipsychotic agents.¹ No clear cases reported with tetrabenazine,^{1 38 47} but other extrapyramidal adverse effects typically associated with antipsychotic agents (e.g., parkinsonism, akathisia) possible.¹

Consider drug discontinuance if signs and symptoms suggestive of tardive dyskinesia appear.¹

Concomitant Illnesses

Experience in patients with certain concomitant diseases limited.¹

Has not been evaluated in patients with recent history of MI or unstable cardiovascular disease.¹ (See Prolongation of QT Interval under Cautions and see also Hypotension and Orthostatic Hypotension under Cautions.)

Use with caution in patients with a history of depression or suicidality or with diseases, conditions, or treatments that may cause depression or increased suicidality.¹

Contraindicated in patients with untreated or inadequately treated depression, those who are actively suicidal, or those with hepatic impairment.^{1 18} (See Contraindications and see also Risk of Depression and Suicidality under Cautions and see also Hepatic Impairment under Cautions.)

Binding to Melanin-containing Tissues

Binds to melanin-containing tissues, possibly resulting in accumulation and toxicity with long-term use; clinical importance unknown.^{1 18} Opthalmologic monitoring in clinical studies was inadequate to exclude possibility of injury after long-term drug exposure.^{1 18}

Specific Populations

Pregnancy

Category C.^{1 18}

Lactation

Not known whether tetrabenazine or its metabolites distribute into milk;^{1 18} however, at least one study suggests that the drug is distributed into human milk.^{53 54 57} Discontinue nursing or the drug.^{1 18}

Pediatric Use

Safety and efficacy not established in pediatric patients.^{1 18 28}

Has been effective in a limited number of pediatric patients with hyperkinetic movement disorders, including Tourette's syndrome† and severe chorea†, to date.^{33 35 42 54 55} May have a similar adverse effect profile in pediatric patients as in adults, possibly with fewer parkinsonian adverse effects.³³

Based on clinical experience, one manufacturer suggests starting tetrabenazine at approximately 50% of the adult dose and titrating the dosage slowly according to tolerance and patient response.^{53 54 55}

Geriatric Use

Pharmacokinetics not evaluated in geriatric individuals.¹ (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Decreased tetrabenazine metabolism in patients with mild to moderate hepatic impairment.¹ Safety and efficacy of increased exposure to the drug and its metabolites unknown; dosage adjustments to ensure safe use are not possible in hepatic impairment.¹ Use contraindicated.¹

Renal Impairment

Pharmacokinetics not evaluated in renal impairment.¹

Common Adverse Effects

Sedation, somnolence, insomnia, fatigue, depression, anxiety, irritability, balance difficulties, extrapyramidal adverse effects (e.g., akathisia, bradykinesia, parkinsonism, hypertonia), nausea, vomiting, ecchymosis, falls, laceration of the head, upper respiratory tract infection.^{1 2 18 21 22 25 38 47}

Interactions for Tetrabenazine

Metabolized by carbonyl reductase to the active metabolites α-dihydrotetrabenazine and β-dihydrotetrabenazine, which are metabolized principally by CYP2D6.¹

Neither tetrabenazine nor its α- and β-dihydrotetrabenazine metabolites are substrates or inhibitors of the P-glycoprotein transport system.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potent CYP2D6 inhibitors: Potential pharmacokinetic interaction (increased exposure to α-dihydrotetrabenazine and β-dihydrotetrabenazine).^{1 7 18} When therapy with a potent CYP2D6 inhibitor is initiated in a patient already stabilized on tetrabenazine, use caution and reduce tetrabenazine dosage by 50%.^{1 17} When tetrabenazine is initiated in a patient already stabilized on a potent CYP2D6 inhibitor, maximum recommended tetrabenazine dosage is 50 mg daily, with maximum single dose of 25 mg.¹ (See Specific Drugs under Interactions.)

Moderate or weak CYP2D6 inhibitors: Effects on pharmacokinetics of tetrabenazine not established.^{1 18}

Inducers or inhibitors of CYP isoenzymes 1A2, 2A6, 2C9, 2C19, or 2E1: Pharmacokinetic interaction unlikely.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP 1A2, 2B6, 2D6, 2C8, 2C9, 2C19, 2E1, 3A, 3A4: Pharmacokinetic interaction unlikely.¹

Drugs Affecting or Affected by P-glycoprotein Transport

Clinically important interactions unlikely.¹

Drugs that Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT-interval prolongation); avoid concomitant use of other drugs known to prolong the QT_c interval.^{1 18} (See Specific Drugs under Interactions and see Prolongation of QT Interval under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Alcohol	Potential worsening of sedation and somnolence1
Antiarrhythmics (class Ia and III; e.g., amiodarone, procainamide, quinidine, sotalol)	Increased risk of QT interval prolongation1 18	Avoid concomitant use1 18
Antipsychotic agents	Possible exaggeration of QTc prolongation, NMS, and/or extrapyramidal reactions1	Avoid concomitant use1
Chlorpromazine	Increased risk of QT interval prolongation1 18	Avoid concomitant use1 18
CNS depressants	Potential worsening of sedation and somnolence1
Desipramine	Possible CNS excitation and hypertension53
Digoxin	Pharmacokinetic interaction unlikely1 7 13
Dopamine antagonists	Possible exaggeration of QTc prolongation, NMS, and/or extrapyramidal reactions1
Fluoxetine	Possible increased exposure to tetrabenazine's active metabolites1 7 18	Patient already stabilized on tetrabenazine: Initiate fluoxetine with caution; reduce tetrabenazine dosage by 50%1 17 Patient already stabilized on fluoxetine: Maximum tetrabenazine dosage of 50 mg daily and 25 mg as single dose1
Levodopa	Possible reduced therapeutic effects of levodopa, exacerbation of Parkinson's disease symptoms; amelioration of tetrabenazine-induced parkinsonism34 43
MAO inhibitors	Possible CNS excitation and hypertension53	Concomitant use contraindicated;1 17 18 use caution when initiating tetrabenazine therapy following MAO inhibitor discontinuance13 15 At least one manufacturer recommends allowing at least 14 days to elapse between discontinuance of tetrabenazine and initiation of MAO inhibitor and vice versa53
Moxifloxacin	Increased risk of QT interval prolongation1 18	Avoid concomitant use1 18
Paroxetine	Increased peak plasma concentrations, AUC, and half-lives of tetrabenazine's active metabolites1 7 18	Patient already stabilized on tetrabenazine: Initiate paroxetine with caution; reduce tetrabenazine dosage by 50%1 17 Patient already stabilized on paroxetine: Maximum tetrabenazine dosage of 50 mg daily and 25 mg as single dose1
Quinidine	Possible increased exposure to tetrabenazine's active metabolites1 7 18	Patient already stabilized on tetrabenazine: Initiate quinidine with caution; reduce tetrabenazine dosage by 50%1 17 Patient already stabilized on quinidine: Maximum tetrabenazine dosage of 50 mg daily and 25 mg as single dose1
Reserpine	Possible serotonin and norepinephrine depletion in the CNS1	Concomitant use contraindicated1 17 Wait for signs of chorea to re-emerge after discontinuing reserpine before initiating tetrabenazine therapy1 Allow at least 20 days to elapse after reserpine discontinuance prior to initiating tetrabenazine therapy1 17 18
Thioridazine	Increased risk of QT interval prolongation1 18	Avoid concomitant use1 18
Ziprasidone	Increased risk of QT interval prolongation1 18	Avoid concomitant use1 18

Tetrabenazine Pharmacokinetics

Absorption

Bioavailability

Following oral administration, ≥75% absorbed.¹

Peak plasma concentrations of active metabolites α-dihydrotetrabenazine and β-dihydrotetrabenazine reached within 1–1.5 hours; peak plasma concentration of O-dealkylated-dihydrotetrabenazine (another major metabolite) is reached approximately 2 hours following a dose.¹

Duration

16–24 hours.⁵³

Food

No effect on mean or peak plasma concentrations or AUC of α-dihydrotetrabenazine and β-dihydrotetrabenazine.¹

Special Populations

Patients with mild to moderate chronic hepatic impairment: Mean peak plasma tetrabenazine concentrations were 7- to 190-fold higher and AUCs of α-dihydrotetrabenazine and β-dihydrotetrabenazine were approximately 30–39% greater compared with values in healthy individuals.¹

Poor CYP2D6 metabolizers: Exposures to α-dihydrotetrabenazine and β-dihydrotetrabenazine were about threefold and ninefold higher, respectively, compared with values in extensive metabolizers.¹

Distribution

Extent

Not known whether the drug or its metabolites are distributed into milk in humans;^{1 18} one study suggests that the drug is distributed into human milk and crosses the placenta.^{53 54 57}

Plasma Protein Binding

Tetrabenazine: 82–85%.¹

α-Dihydrotetrabenazine: 60–68%.¹

β-Dihydrotetrabenazine: 59–63%.¹

Elimination

Metabolism

Rapidly and extensively metabolized mainly in the liver by carbonyl reductase to active metabolites α-dihydrotetrabenazine and β-dihydrotetrabenazine, which are further O-dealkylated, principally by CYP2D6, to O-dealkylated-dihydrotetrabenazine.¹

Elimination Route

Eliminated in urine (about 75%) and feces (7–16%).¹ In urine, <10% eliminated as α-dihydrotetrabenazine or β-dihydrotetrabenazine.¹

Half-life

α-Dihydrotetrabenazine: 4–8 hours.¹

β-Dihydrotetrabenazine: 2–4 hours.¹

Special Populations

Patients with hepatic impairment: Elimination half-lives prolonged to approximately 17.5 hours for tetrabenazine, 10 hours for α-dihydrotetrabenazine, and 8 hours for β-dihydrotetrabenazine.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Actions

• 
  

  Reversibly inhibits uptake of monoamines (e.g., dopamine, norepinephrine, serotonin, histamine) into synaptic vesicles and depletes monoamine stores from nerve terminals.^{1 2 13 17 18 19 20 21 23 24 25}

  
  


• 
  

  Precise mechanism of antichorea effects not established, but appears to be related to drug's ability to reversibly and selectively inhibit vesicular monoamine transporter type 2 (VMAT2) in CNS, thereby decreasing uptake of monoamines into synaptic vesicles and depleting monoamine stores from nerve terminals.^{1 2 7 8 13 17 18 19 20 21 23 24 25}

  
  


• 
  

  Preferentially depletes dopamine; dose required to deplete norepinephrine or serotonin is approximately fivefold higher than that required to deplete dopamine.^{2 7 17 21 23} Preferential depletion of dopamine in striatum may contribute to antichorea effects.^{4 13 18 22}

  
  


• 
  

  Exhibits weak in vitro binding affinity for dopamine type 2 (D₂) receptors.^{1 13 21 23} Does not possess binding affinity for GABA, glutamate, glycine, histamine, or norepinephrine receptors or ion channels.⁷

  
  

Advice to Patients

• 
  

  Tetrabenazine medication guide must be provided to the patient each time the drug is dispensed;^{4 10} importance of patient and caregiver reading the medication guide prior to initiation of tetrabenazine therapy and each time the prescription is refilled.^{1 4 13 28}

  
  


• 
  

  Risk of new or worsening depression and suicidality; importance of patients or their families being alert to and immediately reporting emergence of suicidality, new or worsening depression, or other unusual changes in behavior.^{1 28}

  
  


• 
  

  Importance of informing patients that tetrabenazine is used to treat the involuntary movements (chorea) of Huntington's disease and that the drug does not cure the cause of the involuntary movements and does not treat other symptoms of Huntington's disease (e.g., problems with thinking and emotions).²⁸

  
  


• 
  

  Importance of informing patients and their families that the dosage of tetrabenazine will be gradually increased to reach the optimal dosage.^{1 28} Importance of being alert to possible development of adverse effects (e.g., sedation, akathisia, parkinsonism, depression, difficulty swallowing, fatigue, insomnia) that may require a dosage reduction or tetrabenazine discontinuance.^{1 25 47} Importance of informing patient that a blood test may be needed if a dosage exceeding 50 mg daily is considered.^{1 28}

  
  


• 
  

  Importance of taking tetrabenazine exactly as prescribed at the correct time each day.¹⁰ Importance of informing patients not to take a double dose of the drug if a dose of tetrabenazine is missed.^{1 28}

  
  


• 
  

  Importance of informing patients that involuntary movements may return or worsen within 12–18 hours after the last dose if therapy is discontinued or a dose is missed.²⁸ Importance of patients informing clinicians if tetrabenazine has been discontinued for >5 days and importance of patients not taking additional doses of the drug until they notify their clinician.^{10 28}

  
  


• 
  

  Risk of sedation, somnolence, and psychomotor impairment; importance of exercising caution while operating hazardous machinery, including driving a motor vehicle, until patient is receiving a maintenance dosage of tetrabenazine and has gained experience with the drug's effects.^{1 18 28}

  
  


• 
  

  Importance of informing patients that concomitant use of alcohol or other CNS depressants may worsen the sedative effects of tetrabenazine.^{1 18 28}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses (e.g., liver disease).^{1 28}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 28}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 28} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Distribution of tetrabenazine is restricted.^{4 10 13 17 18 41} (See REMS Program under Dosage and Administration.)

Tetrabenazine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	12.5 mg	Xenazine	Lundbeck
		25 mg	Xenazine (scored)	Lundbeck

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Lundbeck Inc. Xenazine (tetrabenazine) tablets prescribing information. Deerfield, IL.; 2009 Sep.

2. . Tetrabenazine as antichorea therapy in Huntington disease: a randomized controlled trial. Neurology. 2006; 66:366-72.

3. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act

Suprane

desflurane

Dosage Form: volatile liquid for inhalation
Suprane (Desflurane, USP) Liquid for Inhalation 240 mL Bottle

Suprane (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether:

Some physical constants are:

Molecular weight	168.04
Specific gravity at (20oC/4oC)	1.465
Vapor pressure in mm Hg	669 mm Hg @ 20o C 731 mm Hg @ 22o C 757 mm Hg @ 22.8o C (boiling point; 1 atm) 764 mm Hg @ 23o C 798 mm Hg @ 24o C 869 mm Hg @ 26o C

Partition coefficients at 37o C

Blood/Gas	0.424
Olive Oil/Gas	18.7
Brain/Gas	0.54

Mean Component/Gas Partition Coefficients:

Polypropylene (Y piece)	6.7
Polyethylene (circuit tube)	16.2
Latex rubber (bag)	19.3
Latex rubber (bellows)	10.4
Polyvinylchloride (endotracheal tube)	34.7

Desflurane is nonflammable as defined by the requirements of International Electrotechnical Commission 601-2-13.

Desflurane is a colorless, volatile liquid below 22.8°C. Data indicate that desflurane is stable when stored under normal room lighting conditions according to instructions.

Desflurane is chemically stable. The only known degradation reaction is through prolonged direct contact with soda lime producing low levels of fluoroform (CHF3). The amount of CHF3 obtained is similar to that produced with MAC-equivalent doses of isoflurane.

No discernible degradation occurs in the presence of strong acids.

Desflurane does not corrode stainless steel, brass, aluminum, anodized aluminum, nickel plated brass, copper, or beryllium.

Clinical Pharmacology

Suprane (desflurane, USP) is a volatile liquid inhalation anesthetic minimally biotransformed in the liver in humans. Less than 0.02% of the Suprane absorbed can be recovered as urinary metabolites (compared to 0.2% for isoflurane). Minimum alveolar concentration (MAC) of desflurane in oxygen for a 25 year-old adult is 7.3%. The MAC of Suprane (desflurane, USP) decreases with increasing age and with addition of depressants such as opioids or benzodiazepines (see DOSAGE AND ADMINISTRATION for details).

Pharmacokinetics

Due to the volatile nature of desflurane in plasma samples, the washin-washout profile of desflurane was used as a surrogate of plasma pharmacokinetics. Eight healthy male volunteers first breathed 70% N2O/30% O2 for 30 minutes and then a mixture of Suprane (desflurane, USP) 2.0%, isoflurane 0.4%, and halothane 0.2% for another 30 minutes. During this time, inspired and endtidal concentrations (FI and FA) were measured. The FA/FI (washin) value at 30 minutes for desflurane was 0.91, compared to 1.00 for N2O, 0.74 for isoflurane, and 0.58 for halothane (See Figure 1). The washin rates for halothane and isoflurane were similar to literature values. The washin was faster for desflurane than for isoflurane and halothane at all time points. The FA/FAO (washout) value at 5 minutes was 0.12 for desflurane, 0.22 for isoflurane, and 0.25 for halothane (See Figure 2). The washout for Suprane was more rapid than that for isoflurane and halothane at all elimination time points. By 5 days, the FA/FAO for desflurane is 1/20th of that for halothane or isoflurane.

Pharmacodynamics

Changes in the clinical effects of Suprane (desflurane, USP) rapidly follow changes in the inspired concentration. The duration of anesthesia and selected recovery measures for Suprane are given in the following tables: In 178 female outpatients undergoing laparoscopy, premedicated with fentanyl (1.5-2.0 ug/kg), anesthesia was initiated with propofol 2.5 mg/kg, desflurane/N2O 60% in O2 or desflurane/O2 alone. Anesthesia was maintained with either propofol 1.5-9.0 mg/kg/hr, desflurane 2.6-8.4% in N2O 60% in O2, or desflurane 3.1-8.9% in O2. EMERGENCE AND RECOVERY AFTER OUTPATIENT LAPAROSCOPY 178 FEMALES, AGES 20-47 TIMES IN MINUTES: MEAN ± SD (RANGE)

EMERGENCE AND RECOVERY AFTER OUTPATIENT LAPAROSCOPY 178 FEMALES, AGES 20-47 TIMES IN MINUTES

Induction:	Propofol	Propofol	Desflurane/N2O	Desflurane/O2
Maintenance:	Propofol/N2O	Desflurane/N2O	Desflurane/N2O	Desflurane/O2
Number of Pts:	N-48	N=44	N=43	N=43
Median age	30 (20-43)	26 (21-47)	29 (21-42)	30 (20-40)
Anesthetic Time	49 ± 53 (8-336)	45 ± 35 (11-178)	44  29 (14-149)	41 ± 26 (19-126)
Time to open eyes	7 ± 3 (2-19)	5 ± 2* (2-10)	5 ± 2* (2-12)	4 ± 2*
Time to state name	9 ± 4 (4-22)	8 ± 3 (3-18)	7 ± 3* (3-16)	7 ± 3* (2-15)
Time to stand	80 ± 34 (40-200)	86 ± 55 (30-320)	81 ± 38 (35-190)	77 ± 38 (35-200)
Time to walk	110- ± 6 (47-285)	122 ± 85 (37-375)	108 ± 59 (48-220)	108 ± 66 (49-250)
Time to fit for discharge	152 ± 75 (66-375)	157 ± 80 (73-385)	150 ± 66 (68-310)	155 ± 73 (69-325)

*Differences were statistically significant (p less than 0.05) by Dunnett’s procedure comparing all treatments to the propofol-propofol/N2O (induction and maintenance) group. Results for comparisons greater than one hour after anesthesia show no differences between groups and considerable variability within groups.


In 88 unpremedicated outpatients, anesthesia was initiated with thiopental 3-9 mg/kg or desflurane in O2. Anesthesia was maintained with isoflurane 0.7-1.4% in N2O 60%, desflurane 1.8-7.7% in N2O 60%, or desflurane 4.4-11.9% in O2. EMERGENCE AND RECOVERY TIMES IN OUTPATIENT SURGERY 46 MALES, 42 FEMALES, AGES 19-70 TIMES IN MINUTES: MEAN ± SD (RANGE)

Induction:	Thipental	Thiopental	Thiopental	Desflurane/O2
Maintenance:	Isoflurane/N2O	Desflurane/N2O	Desflurane/O2	Desflurane/O2
Number of Pts:	N=23	N=21	N=23	N=21
Median age	43 (20-70)	40 (22-67)	43 (19-70)	41 (21-64)
Anesthetic Time	49 ± 23 (11-94)	50 ± 19 (16-80)	50 ± 27 (16-113)	51 ± 23 (19-117)
Time to open eyes	13 ± 7 (5-33)	9 ± 3* (4-16)	12 ± 8 (4-39)	8 ± 2* (4-13)
Time to state name	17 ± 10 (6-44)	11 ± 4* (6-19)	15 ± 10 (6-46)	9 ± 3* (5-14)
Time to walk	195 ± 67 (124-365)	176 ± 60 (101-315)	168 ± 34 (119-258)	181 ± 42 (92-252)
Time to fit for discharge	205 ± 53 (153-365)	202 ± 41 (144-315)	197 ± 35 (155-280)	194 ± 37 (134-288)

 *Differences were statistically significant (p less than 0.05) by Dunnett’s procedure comparing all treatments to the thiopental-isoflurane/N2O (induction and maintenance) group. Results for comparisons greater than one hour after anesthesia show no differences between groups and considerable variability within groups.


Recovery from anesthesia was assessed at 30, 60, and 90 minutes following 0.5 MAC desflurane (3%) or isoflurane (0.6%) in N2O 60% using subjective and objective tests. At 30 minutes after anesthesia, only 43% of the isoflurane group were able to perform the psychometric tests compared to 76% in the desflurane group (p less than 0.05).

RECOVERY TESTS: PERCENT OF PREOPERATIVE BASELINE VALUES 16 MALES, 22 FEMALES, AGES 20-65 PERCENT: MEAN ± SD

	60 minutes After Anesthesia		90 minutes After Anesthesia
Maintenance:	Desflurane/N2O	Isoflurane/N2O	Desflurane/N2O	Isoflurane/N2O
Confusion **	66 ± 6	47 ± 8	75 ± 7*	56 ± 8
Fatigue**	70 ± 9*	33 ± 6	89 ± 12*	47 ± 8
Drowsiness **	66 ± 5*	36 ± 8	76 ± 7*	49 ± 9
Clumsiness **	65 ± 5	49 ± 8	80 ± 7*	57 ± 9
Comfort **	59 ± 7*	30 ± 6	60 ± 8*	31 ± 7
DSST+score	74 ± 4*	50 ± 9	75 ± 4*	55 ± 7
Trieger Tests ++	67 ± 5	74 ± 6	90 ± 6	83 ± 7

** Visual analog scale (values from 0-100; 100 = baseline)

+ DSST = Digit Symbol Substitution Test

++ Trieger Test = Dot Connecting Test

* Differences were statistically significant (p less than 0.05) using a two-sample t-test


Suprane (desflurane, USP) was studied in twelve volunteers receiving no other drugs. Hemodynamic effects during controlled ventilation (PaCO2 38mm Hg) were:

HEMODYNAMIC EFFECTS OF DESFLURANE DURING CONTROLLED VENTILATION 12 MALE VOLUNTEERS, AGES 16-26 MEAN ± SD (RANGE)

			Heart Rate (beats/min)		Mean Arterial Pressure and (mm Hg)		Cardiac Index (L/min/m2)
Total MAC Equivalent	End-Tidal % Des O2	End-Tidal % Des/N2O	O2	N2O	O2	N2O	O2	N2O
0	0%/21%	0%/0%	64 ± 4 (63-76)	70 ± 6 (62-85)	85 ± 9 (74-102)	85 ± 9 (74-102)	3.7 ± 0.4 (3.0-4.2)	3.7 ± 0.4 (3.0-4.2)
1.8	6%/94%	3%/60%	73 ± 5 (67-80)	77 ± 8 (67-97)	61 ± 5* (55-70)	69 ± 5* (55-50)	3.2 ± 0.5 (2.6-4.0)	3.3 ± 0.5 (2.6-4.1)
1.2	9%/91%	6%/60%	80 ± 5* (72-84)	77 ± 7 (67-90)	59 ± 8* (44-71)	63 ± 8* (47-74)	3.4 ± 0.5 (2.6-4.1)	3.1 ± 0.4*
1.7	12%/88%	9%/60%	94 ± 14* (78-109)	79 ± 9 (61-91)	51 ± 12* (31-66)	59 ± 6* (46-68)	3.5 ± 0.9 (1.7-4.7_	3.0 ± 0.4* (2.4-3.6)

*Differences were statistically significant (p less than 0.05) compared to awake values, Newman-Keul’s method of multiple comparison.


When the same volunteers breathed spontaneously during desflurane anesthesia, systemic vascular resistance and mean arterial blood pressure decreased; cardiac index, heart rate, stroke volume, and central venous pressure (CVP) increased compared to values when the volunteers were conscious. Cardiac index, stroke volume, and CVP were greater during spontaneousventilation than during controlled ventilation.

During spontaneous ventilation in the same volunteers, increasing the concentration of Suprane (desflurane, USP) from 3% to 12% decreased tidal volume and increased arterial carbon dioxide tension and respiratory rate. The combination of N2O 60% with a given concentration of desflurane gave results similar to those with desflurane alone. Respiratory depression produced by desflurane is similar to that produced by other potent inhalation agents. The use of desflurane concentrations higher than 1.5 MAC may produce apnea.

Clinical Trials

Suprane (desflurane, USP) was evaluated in 1,843 patients including ambulatory (N=1,061), cardiovascular (N=277), geriatric (N=103), neurosurgical (N=40), and pediatric (N=235) patients. Clinical experience with these patients and with 1,087 control patients in these studies not receiving desflurane are described below. Although desflurane can be used in adults for the inhalation induction of anesthesia via mask, it produces a high incidence of respiratory irritation (coughing, breathholding, apnea, increased secretions, laryngospasm). For incidence, see ADVERSE REACTIONS. Oxyhemoglobin saturation below 90% occurred in 6% of patients (from pooled data, N = 370 adults).

Ambulatory Surgery

Suprane (desflurane, USP) plus N2O was compared to isoflurane plus N2O in multicenter studies (21 sites) of 792 ASA physical status I, II, or III patients aged 18-76 years (median 32).

Induction

Anesthetic induction begun with thiopental and continued with desflurane was associated with a 7% incidence of oxyhemoglobin saturation of 90% or less (from pooled data, N = 307) compared with 5% in patients in whom anesthesia was induced with thiopental and isoflurane (from pooled data, N = 152).

Maintenance and Recovery

Suprane (desflurane, USP) with or without N2O or other anesthetics was generally well tolerated. There were no differences between desflurane and the other anesthetics studied in the times that patients were judged fit for discharge.

In one outpatient study, patients received a standardized anesthetic consisting of thiopental 4.2-4.4 mg/kg, fentanyl 3.5-4.0 μg/kg, vecuronium 0.05-0.07 mg/kg, and N2O 60% in oxygen with either desflurane 3% or isoflurane 0.6%. Emergence times were significantly different; but times to sit up and discharge were not different (see Table).

RECOVERY PROFILES AFTER DESFLURANE 3% IN N2O 60% vs ISOFLURANE 0.6% IN N2O 60% IN OUTPATIENTS 16 MALES, 22 FEMALES, AGES 20-65 MEAN ± SD

	Isoflurane	Desflurane
Number	21	17
Anesthetic time (min)	127 ± 80	98 ± 55
Recovery time to:
Follow commands (min)	11.1 ± 7.9	6.5 ± 2.3*
Sit up (min)	113 ± 27	95 ± 56
Fit for discharge (min)	231 ± 40	207 ± 54

*Difference was statistically significant from the isoflurane group (p less than 0.05), unadjusted for multiple comparisons.


Cardiovascular Surgery

Desflurane was compared to isoflurane, sufentanil or fentanyl for the anesthetic management of coronary artery bypass graft (CABG), abdominal aortic aneurysm, peripheral vascular and carotid endarterectomy surgery in 7 studies at 15 centers involving a total of 558 patients. In all patients except the desflurane vs sufentanil study, the volatile anesthetics were supplemented with intravenous opioids, usually fentanyl. Blood pressure and heart rate were controlled by changes in concentration of the volatile anesthetics or opioids and cardiovascular drugs if necessary. Oxygen (100%) was the carrier gas in 253 of 277 desflurane cases (24 of 277 received N2O/O2).


CARDIOVASCULAR PATIENTS BY AGENT AND TYPE OF SURGERY 418 MALES, 140 FEMALES, AGES 27-87 (MEDIAN 64)

Type of Surgery	13 Centers		1 Center		1 Center
	Isoflurane	Desflurane	Sufentanil	Desflurane	Fentanyl	Desflurane
CABG	58	57	100	100	25	25
Abd Aorta	29	25	-	-	-	-
Periph Vasc	24	24	-	-	-	-
Carotid Art	45	46	-	-	-	-
Total	156	152	100	100	25	25

No differences were found in cardiovascular outcome (death, myocardial infarction, ventricular tachycardia or fibrillation, heart failure) among desflurane and the other anesthetics.


Induction

Desflurane should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or any patients where increases in heart rate or blood pressure are undesirable. In the desflurane vs sufentanil study, anesthetic induction with desflurane without opioids was associated with new transient ischemia in 14 patients vs 0 in the sufentanil group. In the desflurane group, mean heart rate, arterial pressure, and pulmonary blood pressure increased and stroke volume decreased in contrast to no change in the sufentanil group. Cardiovascular drugs were used frequently in both groups: especially esmolol in the desflurane group (56% vs 0%) and phenylephrine in the sufentanil group (43% vs 27%). When 10 μg/kg of fentanyl was used to supplement induction of anesthesia at one other center, continuous 2-lead ECG analysis showed a low incidence of myocardial ischemia and no difference between desflurane and isoflurane. If desflurane is to be used in patients with coronary artery disease, it should be used in combination with other medications for induction of anesthesia, preferably intravenous opioids and hypnotics.


Maintenance and Recovery

In studies where desflurane or isoflurane anesthesia was supplemented with fentanyl, there were no differences in hemodynamic variables or the incidence of myocardial ischemia in the patients anesthetized with desflurane compared to those anesthetized with isoflurane.During the precardiopulmonary bypass period, in the desflurane vs sufentanil study where the desflurane patients received no intravenous opioid, more desflurane patients required cardiovascular adjuvants to control hemodynamics than the sufentanil patients. During this period, the incidence of ischemia detected by ECG or echocardiography was not statistically different between desflurane (18 of 99) and sufentanil (9 of 98) groups. However, the duration and severity of ECG-detected myocardial ischemia was significantly less in the desflurane group. The incidence of myocardial ischemia after cardiopulmonary bypass and in the ICU did not differ between groups.



Geriatric Surgery

Suprane (desflurane, USP) plus N2O was compared to isoflurane plus N2O in a multicenter study (6 sites) of 203 ASA physical status II or III elderly patients, aged 57-91 years (median 71).


Induction

Most patients were premedicated with fentanyl (mean 2 μg/kg), preoxygenated, and received thiopental (mean 4.3 mg/kg IV) or thiamylal (mean 4 mg/kg IV) followed by succinylcholine (mean 1.4 mg/kg IV) for intubation.


Maintenance and Recovery

Heart rate and arterial blood pressure remained within 20% of preinduction baseline values during administration of Suprane (desflurane, USP) 0.5-7.7% (average 3.6%) with 50-60% N2O. Induction, maintenance, and recovery cardiovascular measurements did not differ from those during isoflurane/N2O administration nor did the postoperative incidence of nausea and vomiting differ. The most common cardiovascular adverse event was hypotension occurring in 8% of the Suprane patients and 6% of the isoflurane patients.


Neurosurgery

Suprane (desflurane, USP) was studied in 38 patients aged 26-76 years (median 48 years), ASA physical status II or III undergoing neurosurgical procedures for intracranial lesions.


Induction

Induction consisted of standard neuroanesthetic techniques including hyperventilation and thiopental.


Maintenance

No change in cerebrospinal fluid pressure (CSFP) was observed in 8 patients who had intracranial tumors when the dose of desflurane was 0.5 MAC in N2O 50%. In another study of 9 patients with intracranial tumors, 0.8 MAC desflurane/air/O2 did not increase CSFP above postinduction baseline values. In a different study of 10 patients receiving 1.1 MAC desflurane/air/O2, CSFP increased 7 mm Hg (range 3-13 mm Hg increase, with final values of 11-26 mm Hg) above the predrug values. All volatile anesthetics may increase intracranial pressure in patients with intracranial space occupying lesions. In such patients, desflurane should be administered at 0.8 MAC or less, and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) in the period before cranial decompression. Appropriate attention must be paid to maintain cerebral perfusion pressure. The use of a lower dose of desflurane and the administration of a barbiturate and mannitol would be predicted to lessen the effect of desflurane on CSFP. Under hypocapnic conditions (PaCO2 27 mm Hg) desflurane 1 and 1.5 MAC did not increase cerebral blood flow (CBF) in 9 patients undergoing craniotomies. CBF reactivity to increasing PaCO2 from 27 to 35 mm Hg was also maintained at 1.25 MAC desflurane/air/

O2.


Pediatric Surgery

Suprane (desflurane, USP) is not recommended for induction of anesthesia in pediatric patients because of the high incidence of moderate to severe upper airway adverse reactions, including laryngospasm, coughing, breathholding, and secretions, seen in studies of induction of anesthesia in pediatric patients. (see WARNINGS and PRECAUTIONS – Pediatric Use).

Suprane is not approved for maintenance of anesthesia in non-intubated pediatric patients due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm and secretions, seen in one study of maintenance of anesthesia in non-intubated pediatric patients. (see WARNINGS and PRECAUTIONS – Pediatric Use).


Maintenance and Recovery in Intubated Pediatric Patients

Suprane (desflurane, USP) is approved for maintenance of anesthesia in infants and children after induction of anesthesia with agents other than Suprane, and tracheal intubation.

Suprane, with or without N2O, and halothane, with or without N2O were studied in three clinical trials of pediatric patients aged 2 weeks to 12 years (median 2 years) and ASA physical status I or II. The concentration of Suprane (desflurane, USP) required for maintenance of general anesthesia is age-dependent (see INDIVIDUALIZATION OF DOSE). Changes in blood pressure during maintenance of and recovery from anesthesia with desflurane/N2O/O2 are similar to those observed with halothane/N2O/O2. Heart rate during maintenance of anesthesia is approximately 10 beats per minute faster with desflurane than with halothane. Patients were judged fit for discharge from post-anesthesia care units within one hour with both desflurane and

halothane. There were no differences in the incidence of nausea and vomiting between patients receiving desflurane or halothane.


INDIVIDUALIZATION OF DOSE

(Also see DOSAGE AND ADMINISTRATION)


Preanesthetic Medication

Issues such as whether or not to premedicate and the choice of premedicant(s) must be individualized. In clinical trials, patients scheduled to be anesthetized with desflurane frequently received IV pre-anesthetic medication, such as opioid and/or benzodiazepine.


Induction

In adults, some premedicated with opioid, a frequent starting concentration was 3% desflurane, increased in 0.5-1.0% increments every 2 to 3 breaths. End-tidal concentrations of 4-11% Suprane (desflurane, USP) with and without N2O, produced anesthesia within 2 to 4 minutes. When desflurane was tested as the primary anesthetic induction agent, the incidence of upper airway irritation (apnea, breathholding, laryngospasm, coughing and secretions) was high (see ADVERSE REACTIONS). During induction in adults, the overall incidence of oxyhemoglobin  desaturation (SpO2 less than 90%) was 6%.


After induction in adults with an intravenous drug such as thiopental or propofol, desflurane can be started at approximately 0.5-1 MAC, whether the carrier gas is O2 or N2O/O2.


Maintenance

Surgical levels of anesthesia in adults may be maintained with concentrations of 2.5-8.5% Suprane (desflurane, USP) with or without the concomitant use of nitrous oxide. In children, surgical levels of anesthesia may be maintained with concentrations of 5.2-10% Suprane with or without the concomitant use of nitrous oxide.


During the maintenance of anesthesia, increasing concentrations of Suprane (desflurane, USP) produce dose-dependent decreases in blood pressure. Excessive decreases in blood pressure may be due to depth of anesthesia and in such instances may be corrected by decreasing the inspired concentration of Suprane.


Concentrations of desflurane exceeding 1 MAC may increase heart rate. Thus with this drug, an increased heart rate may not serve reliably as a sign of inadequate anesthesia. Suprane (desflurane, USP) decreases the doses of neuromuscular blocking agents required (see PRECAUTIONS, Drug Interactions).

Indications and Usage

Suprane (desflurane, USP) is indicated as an inhalation agent for induction and/or maintenance of anesthesia for inpatient and outpatient surgery in adults (see PRECAUTIONS). Suprane (desflurane, USP) is not recommended for induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events (see WARNINGS). After induction of anesthesia with agents other than Suprane, and tracheal intubation, Suprane is indicated for maintenance of anesthesia in infants and children.

Contraindications

Suprane (desflurane, USP) should not be used in patients with a known or suspected genetic susceptibility to malignant hyperthermia.

Known sensitivity to Suprane (desflurane, USP) or to other halogenated agents.

Warnings

Perioperative Hyperkalemia

Use of inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the postoperative period. Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated with most, but not all, of these cases. These patients also experienced significant elevations in serum creatinine kinase levels and, in some cases, changes in urine consistent with myoglobinuria. Despite the similarity in presentation to malignant hyperthermia, none of these patients exhibited signs or symptoms of muscle rigidity or hypermetabolic state. Early and aggressive intervention to treat the hyperkalemia and resistant arrhythmias is recommended, as is subsequent evaluation for latent neuromuscular disease.

Malignant Hyperthermia

In susceptible individuals, potent inhalation anesthetic agents may trigger a skeletal muscle hypermetabolic state leading to high oxygen demand and the clinical syndrome known as malignant hyperthermia. In genetically susceptible pigs, desflurane induced malignant hyperthermia. The clinical syndrome is signalled by hypercapnia, and may include muscle rigidity, tachycardia, tachypnea, cyanosis, arrhythmias, and/or unstable blood pressure. Some of these nonspecific signs may also appear during light anesthesia: acute hypoxia, hypercapnia, and hypovolemia.

Treatment of malignant hyperthermia includes discontinuation of triggering agents, administration of intravenous dantrolene sodium, and application of supportive therapy. (Consult prescribing information for dantrolene sodium intravenous for additional information on patient management.) Renal failure may appear later, and urine flow should be monitored and sustained if possible.

Respiratory Adverse Reactions in Pediatric Patients

Suprane (desflurane, USP) is not recommended for induction of general anesthesia via mask in children due to a high incidence of moderate to severe respiratory adverse reactions seen in clinical studies (see PRECAUTIONS – Pediatric Use). Suprane is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm and secretions (see PRECAUTIONS – Pediatric Use).

Administration of Suprane

Suprane (desflurane, USP) should be administered only by persons trained in the administration of general anesthesia, using a vaporizer specifically designed and designated for use with desflurane. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Hypotension and respiratory depression increase as anesthesia is deepened.

Precautions

During the maintenance of anesthesia, increasing concentrations of Suprane (desflurane, USP) produce dose-dependent decreases in blood pressure. Excessive decreases in blood pressure may be related to depth of anesthesia and in such instances may be corrected by decreasing the inspired concentration of Suprane. Concentrations of desflurane exceeding 1 MAC may increase heart rate. Thus an increased heart rate may not be a sign of inadequate anesthesia. In patients with intracranial space occupying lesions, Suprane (desflurane, USP) should be administered at 0.8 MAC or less, in conjunction with a barbiturate induction and hyperventilation (hypocapnia). Appropriate measures should be taken to maintain cerebral perfusion pressure (see CLINICAL STUDIES, Neurosurgery). In patients with coronary artery disease, maintenance of normal hemodynamics is important to the avoidance of myocardial ischemia. Desflurane should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or patients where increases in heart rate or blood pressure are undesirable. It should be used with other medications, preferably intravenous opioids and hypnotics (see CLINICAL STUDIES, Cardiovascular Surgery). Inspired concentrations of Suprane (desflurane, USP) greater than 12% have been safely administered to patients, particularly during induction of anesthesia. Such concentrations will proportionately dilute the concentration of oxygen; therefore, maintenance of an adequate concentration of oxygen may require a reduction of nitrous oxide or air if these gases are used concurrently. The recovery from general anesthesia should be assessed carefully before patients are discharged from the post anesthesia care unit (PACU). Suprane (desflurane, USP), like some other inhalational anesthetics, can react with desiccated carbon dioxide (CO2) absorbents to produce carbon monoxide which may result in elevated levels of carboxyhemoglobin in some patients. Case reports suggest that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO2 absorber cannister at high flow rates over many hours or days. When a clinician suspects that CO2 absorbent may be desiccated, it should be replaced before the administration of Suprane (desflurane, USP). As with other halogenated anesthetic agents, Suprane (desflurane, USP) may cause sensitivity hepatitis in patients who have been sensitized by previous exposure to halogenated anesthetics (see CONTRAINDICATIONS).

Drug Interactions

No clinically significant adverse interactions with commonly used preanesthetic drugs, or drugs used during anesthesia (muscle relaxants, intravenous agents, and local anesthetic agents) were reported in clinical trials. The effect of desflurane on the disposition of other drugs has not been determined. Like isoflurane, desflurane does not predispose to premature ventricular arrhythmias in the presence of exogenously infused epinephrine in swine.

Benzodiazepines and Opioids (MAC Reduction)

Benzodiazepines (midazolam 25-50 μg/kg) decrease the MAC of desflurane by 16% as do the opioids (fentanyl 3-6 μg/kg) by 50% (see DOSAGE AND ADMINISTRATION).

Neuromuscular Blocking Agents

Anesthetic concentrations of desflurane at equilibrium (administered for 15 or more minutes before testing) reduced the ED95 of succinylcholine by approximately 30% and that of atracurium and pancuronium by approximately 50% compared to N2O/opioid anesthesia. The effect of desflurane on duration of nondepolarizing neuromuscular blockade has not been studied.

DOSAGE OF MUSCLE RELAXANT CAUSING 95% DEPRESSION IN NEUROMUSCULAR BLOCKADE

Desflurane Concentration	Pancuronium	Mean ED95 (ug/kg) Atracurium	Succinylcholine
0.65 MAC 60% N2O/O2	26	123	-
1.25 MAC 60% N2O/O2	18	91	-
1.25 MAC O2	22	120	362

Dosage reduction of neuromuscular blocking agents during induction of anesthesia may result in delayed onset of conditions suitable for endotracheal intubation or inadequate muscle relaxation, because potentiation of neuromuscular blocking agents requires equilibration of muscle with the delivered partial pressure of desflurane.


Among nondepolarizing drugs, only pancuronium and atracurium interactions have been studied. In the absence of specific guidelines:

1. For endotracheal intubation, do not reduce the dose of nondepolarizing muscle relaxants or succinylcholine.

2. During maintenance of anesthesia, the dose of nondepolarizing muscle relaxants is likely to be reduced compared to that during N2O/opioid anesthesia. Administration of supplemental doses of muscle relaxants should be guided by the response to nerve stimulation.


Renal or Hepatic Insufficiency

Nine patients receiving Suprane (desflurane, USP) (N=9) were compared to 9 patients receiving isoflurane, all with chronic renal insufficiency (serum creatinine 1.5-6.9 mg/dL). No differences in hematological or biochemical tests, including renal function evaluation, were seen between the two groups. Similarly, no differences were found in a comparison of patients receiving either Suprane (desflurane, USP) (N=28) or isoflurane (N=30) undergoing renal transplant. Eight patients receiving Suprane (desflurane, USP) were compared to six patients receiving isoflurane, all with chronic hepatic disease (viral hepatitis, alcoholic hepatitis, or cirrhosis). No differences in hematological or biochemical tests, including hepatic enzymes and hepatic function evaluation, were seen.


Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal carcinogenicity studies have not been performed with Suprane (desflurane, USP). In vitro and in vivo genotoxicity studies did not demonstrate mutagenicity or chromosomal damage by Suprane. Tests for genotoxicity included the Ames mutation assay, the metaphase analysis of human lymphocytes, and the mouse micronucleus assay. Fertility was not affected after 1 MAC-Hour per day exposure (cumulative 63 and 14 MAC-Hours for males and females, respectively). At higher doses, parental toxicity (mortalities and reduced weight gain) was observed which could affect fertility.


Pregnancy

Teratogenic Effects

No teratogenic effect was observed at approximately 10 and 13 cumulative MAC-Hour exposures at 1 MAC-Hour per day during organogenesis in rats or rabbits. At higher doses increased incidences of post-implantation loss and maternal toxicity were observed. However, at 10 MAC-Hours cumulative exposure in rats, about 6% decrease in the weight of male pups was observed at preterm caesarean delivery.

Pregnancy Category B

There are no adequate and well-controlled studies in pregnant women. Suprane (desflurane, USP) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rats exposed to desflurane at 1 MAC-Hour per day from gestation day 15 to lactation day 21, did not show signs of dystocia. Body weight of pups delivered by these dams at birth and during lactation were comparable to that of control pups. No treatment related behavioral changes were reported in these pups during lactation.


Labor and Delivery

The safety of desflurane during labor or delivery has not been demonstrated.


Nursing Mothers

The concentrations of desflurane in milk are probably of no clinical importance 24 hours after anesthesia. Because of rapid washout, desflurane concentrations in milk are predicted to be below those found with other volatile potent anesthetics.


Pediatric Use

Suprane (desflurane, USP) is approved for maintenance of anesthesia in infants and children after induction of anesthesia with agents other than Suprane, and tracheal intubation.

Suprane is not recommended for induction of general anesthesia via mask in children because of the high incidence of moderate to severe respiratory adverse reactions, including laryngospasm (50%), coughing (72%), breathholding (68%), increase in secretions (21%) and oxyhemoglobin desaturation (SpO2 less than 90%) (26%) seen in clinical studies. Suprane is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions (see below). In a clinical safety trial conducted in children aged 2 to 16 years (mean 7.4 years), following induction with another agent, Suprane and isoflurane (in N2O/O2) were compared when delivered via face mask or laryngeal mask airway (LMA) for maintenance of anesthesia, after induction with intravenous propofol or inhaled sevoflurane, in order to assess the relative incidence of respiratory adverse events.


MAINTENANCE IN NONINTUBATED PEDIATRIC PATIENTS(FACE MASK OR LMA USED; N=300) All Respiratory Events* (greater than 1% of All Pediatric Patients)

	All Ages (N=300)	2-6 yr (N=150)	7-11 yr (N=81)	12-16 yr (N=69)
Any respiratory events	39%	42%	33%	39%
Airway obstruction	4%	5%	4%	3%
Breath-holding	3%	2%	3%	4%
Coughing	26%	33%	19%	22%
Laryngospasm	13%	16%	7%	13%
Secretion	12%	13%	10%	12%
Non-specific desaturation	2%	2%	1%	1%

*Minor, moderate and severe respiratory events


Suprane was associated with higher rates (compared with isoflurane) of coughing, laryngospasm and secretions with an overall rate of respiratory events of 39%. Of the pediatric patients exposed to desflurane, 5% experienced severe laryngospasm (associated with significant desaturation; i.e. SpO2 of less than 90% for greater than 15 seconds, or requiring succinylcholine), across all ages, 2-16 years old. Individual age group incidences of severe laryngospasm were 9% for 2-6 years old, 1% for 7-11 years old, and 1% for 12-16 years old. Removal of LMA under deep anesthesia (MAC range 0.6 – 2.3 with a mean of 1.12 MAC) was associated with a further increase in frequency of respiratory adverse events as compared to awake LMA removal or LMA removal under deep anesthesia with the comparator. The frequency and severity of non-respiratory adverse events were comparable between the two groups. The incidence of respiratory events under these conditions was highest in children aged 2-6 years. Therefore, similar studies in children under the age of 2 years were not initiated.


Geriatric Use

The average MAC for Suprane (desflurane, USP) in a 70 year old patient is two-thirds the MAC for a 20 year old patient (see DOSAGE AND ADMINISTRATION).


Neurosurgical Use

Suprane (desflurane, USP) may produce a dose-dependent increase in cerebrospinal fluid pressure (CSFP) when administered to patients with intracranial space occupying lesions. Desflurane should be administered at 0.8 MAC or less, and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) until cerebral decompression in patients with known or suspected increases in CSFP. Appropriate attention must be paid to maintain cerebral perfusion pressure (see CLINICAL STUDIES, Neurosurgery).

Adverse Reactions

Adverse event information is derived from controlled clinical trials, the majority of which were conducted in the United States. The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered. Of the 2,143 patients exposed to Suprane (desflurane, USP) in clinical trials, 370 adults and 152 children were induced with desflurane alone and 987 patients were maintained principally with desflurane. The frequencies given reflect the percent of patients with the event. Each patient was counted once for each type of adverse event. They are presented in alphabetical order according to body system.

Frequency of Events Occurring in Greater Than 1% of Clinical Trial Patients (in Reports Deemed “Probably Causally Related”)

Induction (use as a mask inhalation agent)

ADULT PATIENTS (N=370)

Coughing 34%, breathholding 30%, apnea 15%, increased secretions*, laryngospasm*, oxyhemoglobin desaturation (SpO2 less than 90%)*, pharyngitis*.

Maintenance or Recovery

ADULT AND INTUBATED PEDIATRIC PATIENTS (N=687):

Body as a Whole	Headache
Cardiovascular	Bradycardia, hypertension, nodal arrhythmia, tachycardia
Digestive	Nausea 27%, vomiting 16%
Nervous system	Increased salivation
Respiratory	Apnea*, breathholding, cough increased*, laryngospasm*, pharyngitis
Special Senses	Conuunctivitis and (conjunctival hyperemia)

Frequency of Events Occurring in Less Than 1% of Patients (in Reports Deemed “Probably Causally Related”) Reported in 3 or more patients, regardless of severity

Adverse reactions reported only from postmarketing experience or in the literature, not seen in clinical trials, are considered rare and are italicized.

Cardiovascular	Arrhythmia, bigeminy abnormal electrocardiogram, myocardial ischemia, vasodilation
Digestive	Hepatitis
Nervous System	Agitation, dizziness
Respiratory	Asthma, dyspnea, hypoxia

Frequency of Events Occurring in Less Than 1% of Clinical Trial Patients (in Reports Deemed “Causal Relationship Unknown”)

Reported in 3 or more patients, regardless of severity

Body as a Whole	Fever
Cardiovascular	Hemorrhage, myocardial infarct
Metabolic and Nutrition	Increased creatinine phosphokinase
Musculoskeletal System	Myalgia
Skin and Appendages	Pruritus

See WARNINGS for information regarding pediatric use and malignant hyperthermia.


Post Marketing Reports

The following adverse reactions have been identified during post-approval use of Suprane (desflurane, USP). Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.


BLOOD AND LYMPHATIC SYSTEM DISORDERS: Coagulopathy

METABOLISM AND NUTRITION DISORDERS: Hyperkalemia, Hypokalemia, Metabolic acidosis

NERVOUS SYSTEM DISORDERS: Convulsion

EYE DISORDERS: Ocular icterus

CARDIAC DISORDERS: Cardiac arrest, Torsade de pointes, Ventricular failure, Ventricular hypokinesia

VASCULAR DISORDERS: Malignant hypertension, Hemorrhage, Hypotension, Shock

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Respiratory arrest, Respiratory failure, Respiratory distress, Bronchospasm, Hemoptysis

GASTROINTESTINAL DISORDERS: Pancreatitis acute, Abdominal pain

HEPATOBILIARY DISORDERS: Hepatic failure, Hepatic necrosis, Cytolytic hepatitis, Cholestasis, Jaundice, Hepatic function abnormal, Liver disorder

SKIN AND SUBCUTANEOUS TISSUE DISORDER: Urticaria, Erythema,

MUSCULOSKELETAL, CONNECTIVE TISSUE, AND BONE DISORDERS: Rhabdomyolysis

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Hyperthermia malignant, Asthenia, Malaise

INVESTIGATIONS: Tranaminases increased, Alanine aminotransferase increased, Aspartate aminotransferase increased, Coagulation test abnormal, Ammonia increased

INJURY, POISONING, AND PROCEDURAL COMPLICATIONS*: Tachyarrhythmia, Palpitations, Eye burns, Blindness transient, Encephalopathy, Ulcerative keratitis, Ocular hyperemia, Visual acuity reduced, Eye irritation, Eye pain, Dizziness, Migraine, Fatigue, Accidental exposure, Skin burning sensation, Drug administration error

*All of reactions categorized within this SOC were accidental exposures to non-patients.


Laboratory Findings

Transient elevations in glucose and white blood cell count may occur as with use of other anesthetic agents.

Drug Abuse and Dependence

The potential drug abuse liability, and dependence associated with Suprane (desflurane, USP) have not been studied.

Overdosage

In the event of overdosage, or suspected overdosage, take the following actions: discontinue administration of Suprane (desflurane, USP), maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function.

Dosage and Administration

Deliver Suprane (desflurane, USP) from a vaporizer specifically designed and designated for use with desflurane. The administration of general anesthesia must be indiv