Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer

Pronunciation: TER-bin-a-feen/hye-DROX-ee-PROE-pil/KYE-toe-san
Generic Name: Terbinafine Tablets and Hydroxypropyl-Chitosan
Brand Name: Terbinex

Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer is used for:

Treating certain fungal infections of the fingernails or toenails.

Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer is an antifungal agent. It works by killing sensitive fungi.

Do NOT use Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer if:

• you are allergic to any ingredient in Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer


• you have severe kidney problems


• you have liver problems

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

Before using Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer:

Some medical conditions may interact with Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer. 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 history of kidney or liver problems, lupus, psoriasis, cirrhosis, or alcohol abuse or dependence


• if you have a weakened immune system

Some MEDICINES MAY INTERACT with Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, cimetidine, fluconazole, or ketoconazole because they may increase the risk of Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer's side effects


• Rifampin because it may decrease Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer's effectiveness


• Certain antiarrhythmics (eg, flecainide, propafenone), beta-blockers (eg, metoprolol), monoamine oxidase type B (MAO-B) inhibitors (eg, selegiline), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, amitriptyline, desipramine) because the risk of their side effects may be increased by Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer


• Anticoagulants (eg, warfarin) or cyclosporine because their effectiveness may be decreased or the risk of their side effects may be increased by Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer

This may not be a complete list of all interactions that may occur. Ask your health care provider if Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer 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 Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer:

Use Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To use the tablets: Take by mouth with or without food.


• The tablets are usually taken for 6 to 12 weeks, depending on your condition. The full benefit may not be seen for several months after stopping treatment. This includes the time period necessary for healthy nails to grow.


• To use the nail lacquer: Use at bedtime, unless your doctor tells you otherwise. Wash and dry the affected nails, then apply a thin coat of medicine.


• Do not apply the nail lacquer to a wound, or to broken or damaged skin.


• Use the nail lacquer until a new, healthy nail has grown, unless your doctor tells you otherwise. This usually takes 6 to 12 months, depending on your condition.


• To clear up your infection completely, take Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer for the full course of treatment. Keep taking it even if you begin to see improvement before the end of your therapy.


• If you miss a dose of Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer, 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 Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer.

Important safety information:

• Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer only works against fungal infections; it does not treat bacterial or viral infections (eg, the common cold).


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Be sure to use Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate) while you are taking Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer.


• Taste changes (eg, taste loss) have been reported in patients taking Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer. These effects may resolve within several weeks after you stop taking Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer, but may last for a long time (eg, more than one year). Tell your doctor right away if you experience a taste disturbance.


• Rarely, Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer may cause severe or even fatal liver problems. If liver problems occur, they may be more severe in patients who have other active liver problems or a history of long-term liver problems. Discuss any questions or concerns with your doctor.


• The nail lacquer is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.


• You may apply nail polish on top of the nail lacquer.


• Unless you are washing your hands, use gloves while using water or chemical substances to avoid accidentally washing the nail lacquer off. Wearing cotton under the gloves is preferred.


• The nail lacquer is flammable. Do not store or use near an open flame or while smoking.


• Lab tests, including liver function and complete blood cell counts, may be performed while you use Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer if you are pregnant. If you think you may be pregnant, contact your doctor right away. Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer is found in breast milk. Do not breast-feed while taking Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer.

Possible side effects of Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer:

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:

Diarrhea; headache; indigestion.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); mental or mood changes (eg, depression); mouth sores; new or worsening symptoms of lupus (eg, butterfly-shaped rash on the face, joint pain, seizures, skin color changes, unusual sensitivity to the sun); red, blistered, peeling, or swollen skin; severe muscle pain or tenderness; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; stomach pain; unexplained, persistent nausea; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes); taste changes (eg, taste loss); unexpected weight loss; unusual bruising or bleeding; vision changes.

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. Symptoms may include dizziness; frequent urination; nausea; rash; severe or persistent headache; stomach pain; vomiting.

Proper storage of Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer:

Store the tablets at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Store the nail lacquer at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Do not store near an open flame. Keep Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer out of the reach of children and away from pets.

General information:

• If you have any questions about Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer, please talk with your doctor, pharmacist, or other health care provider.


• Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer 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 Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer. 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 Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer resources

• Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer Use in Pregnancy & Breastfeeding
• Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer Drug Interactions
• Terbinafine Tablets and Hydroxypropyl-Chitosan Nail Lacquer Support Group
• 0 Reviews · Be the first to review/rate this drug

Simethicone

Generic Name: simethicone (sye METH i cone)

Brand names: Alka-Seltzer Anti-Gas, Equalize Gas Relief Drops, Gas Aide, Gas Free Extra Strength, Gas-X, Gas-X Extra Strength, Gas-X Infant Drops, Gas-X Maximum Strength, Gas-X Thin Strips Cinnamon, Gas-X Thin Strips Peppermint, Gas-X Tongue Twisters Thin Strips Children's, Gas-X Ultra Softgels, Genasyme, Infantaire Gas Relief, Little Tummys, Maalox Anti-Gas, Maalox Anti-Gas Extra Strength, Mi-Acid Gas Relief, Mylanta Gas, Mylanta Gas Maximum Strength, Mylicon, Mytab Gas, Phazyme, Phazyme Maximum Strength, Phazyme Ultra, Phazyme-125, Phazyme-95, ...show all 45 brand names.Major-Con, Maximum Strength Mylanta Gas, Maximum Strength Phazyme 125 Softgels, Colic Drops, Colicon, Majorcon, Micon-80, Mylaval, Gas-X Liquid Extra Strength, Flatulex Drops, Gas X Extra Strength, Ovol, Gerber Gas Relief, Phazyme Ultra Strength, Gas-X Thin Strips, SimePed, Bicarsim, Bicarsim Forte

What is simethicone?

Simethicone allows gas bubbles in the stomach and intestines to come together more easily, which allows for easier passage of gas.

Simethicone is used to relieve painful pressure caused by excess gas in the stomach and intestines. Simethicone is for use in babies, children, and adults.

Simethicone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about simethicone?

Never use more than the recommended dose of simethicone.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are allergic to any drugs, or if you have any type of serious illness (especially one that affects your stomach or intestines).

Simethicone works best if you take it after meals and at bedtime.

Simethicone may be only part of a complete program of treatment that may also include a special diet or increased exercise. It is very important to follow the diet and exercise plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

There may be other drugs that can interact with simethicone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking simethicone?

You should not use this medication if you are allergic to simethicone.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are allergic to any drugs, or if you have any type of serious illness (especially one that affects your stomach or intestines).

Simethicone is not expected to harm an unborn baby. It is not known whether simethicone passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

The liquid form may contain phenylalanine. Talk to your doctor before using this form of simethicone if you have phenylketonuria (PKU).

How should I take simethicone?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is directed.

Simethicone works best if you take it after meals and at bedtime.

The simethicone chewable tablet must be chewed before swallowing.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one. Clean the medicine dropper after each use. Allow it to air dry.

Simethicone liquid drops can be mixed with water, baby formula, or other liquids to make swallowing easier for an infant or child.

Children should never be given more than the recommended dose of simethicone. Call your doctor if the child's gas symptoms do not improve after treatment with simethicone.

Simethicone may be only part of a complete program of treatment that may also include a special diet or increased exercise. It is very important to follow the diet and exercise plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

Store at room temperature away from moisture, heat, and light. Do not allow the liquid form of this medicine to freeze.

What happens if I miss a dose?

Since simethicone is used on an as needed basis, you are not likely to miss a dose. Do not use more of this medication than is directed.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking simethicone?

Ask a doctor or pharmacist before using any other stomach medicine or antacid. Simethicone is contained in many combination medicines. Taking certain products together can cause you to get too much simethicone.

Simethicone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Simethicone Dosing Information

Usual Adult Dose for Flatulence:

40 to 125 mg orally after meals and at bedtime, not to exceed 500 mg/24 hours.

Usual Adult Dose for Functional Gastric Disorder:

40 to 125 mg orally after meals and at bedtime, not to exceed 500 mg/24 hours.

Usual Adult Dose for Postoperative Gas Pains:

40 to 125 mg orally after meals and at bedtime, not to exceed 500 mg/24 hours.

Usual Adult Dose for Endoscopy or Radiology Premedication:

67 mg as an oral suspension in 2.5 mL of water given shortly before the procedure.

Usual Pediatric Dose for Flatulence:

0 to
2 to 12 years: 40 mg orally 4 times a day. For the 40 mg strips, allow 1 strip to dissolve on the tongue as needed after meals and at bedtime. Do not exceed 6 strips in 24 hours except under the advice and supervision of a physician.


12 to 18 years: 40 to 125 mg orally after meals and at bedtime as needed, not to exceed 500 mg/24 hours.

Usual Pediatric Dose for Endoscopy or Radiology Premedication:

Child >12 years: 67 mg as an oral suspension in 2.5 mL of water given shortly before the procedure.

What other drugs will affect simethicone?

There may be other drugs that can interact with simethicone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More simethicone resources

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

• simethicone Advanced Consumer (Micromedex) - Includes Dosage Information


• Simethicone Professional Patient Advice (Wolters Kluwer)


• Simethicone Monograph (AHFS DI)


• Simethicone MedFacts Consumer Leaflet (Wolters Kluwer)


• Bicarsim MedFacts Consumer Leaflet (Wolters Kluwer)


• Gas-X Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Gas-X Infant Drops Liquid Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Genasyme Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare simethicone with other medications

• Endoscopy or Radiology Premedication
• Functional Gastric Disorder
• Gas
• Postoperative Gas Pains

Where can I get more information?

• Your pharmacist can provide more information about simethicone.

Temovate Solution

Pronunciation: kloe-BAY-ta-sol
Generic Name: Clobetasol
Brand Name: Examples include Embeline and Temovate

Temovate Solution is used for:

Treating inflammation and itching of the scalp due to certain skin conditions. It is also used to treat moderate to severe psoriasis. It may also be used for other conditions as determined by your doctor.

Temovate Solution is a topical adrenocortical steroid. It works by reducing skin inflammation (eg, redness, swelling, itching, irritation) in a way that is not clearly understood.

Do NOT use Temovate Solution if:

• you are allergic to any ingredient in Temovate Solution or to other corticosteroids (eg, prednisone)

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

Before using Temovate Solution:

Some medical conditions may interact with Temovate Solution. 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 any kind of skin infection of the scalp, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Temovate Solution. Because little, if any, of Temovate Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Temovate Solution 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 Temovate Solution:

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

• Wash and completely dry the affected area before applying Temovate Solution.


• Apply a small amount of Temovate Solution to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Temovate Solution.


• If applying to an area with hair, part the hair when applying so that Temovate Solution reaches the skin.


• Do not bandage or cover the treated skin area unless directed by your doctor. Do not wear tight-fitting clothes over the treated area.


• If you miss a dose of Temovate Solution, apply 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 apply 2 doses at once.

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

Important safety information:

• Temovate Solution is for external use only. Do not get Temovate Solution in your eyes, nose, mouth, or on your lips. If contact is made with the eyes, flush them immediately with tap water.


• Use Temovate Solution with extreme caution if treating the face, groin, diaper area, or underarms.


• Do not use Temovate Solution to treat rosacea or conditions around the mouth.


• Do NOT take more than the recommended dose or use for longer than 2 weeks without checking with your doctor.


• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Do not use Temovate Solution to treat large areas of your body without first checking with your doctor.


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


• Check with your doctor before having vaccinations while using Temovate Solution.


• Do not use Temovate Solution for other skin conditions at a later time.


• Temovate Solution has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Temovate Solution is flammable. Do not store or use near an open flame or while smoking.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Temovate Solution.


• Temovate Solution should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these 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 Temovate Solution while you are pregnant. It is not known if Temovate Solution is found in breast milk after topical use. If you are or will be breast-feeding while you use Temovate Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Temovate Solution:

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:

Dryness; itching; mild burning or stinging.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Temovate Solution; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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: Temovate 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Temovate Solution:

Store Temovate Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not refrigerate or freeze. Do not store in the bathroom. Keep Temovate Solution out of the reach of children and away from pets.

General information:

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


• Temovate Solution 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 Temovate Solution. 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 Temovate resources

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

Compare Temovate with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Planus
• Lichen Sclerosus
• Psoriasis

Sitagliptin/Simvastatin

Pronunciation: SYE-ta-GLIP-tin /SIM-va-STAT-in
Generic Name: Sitagliptin/Simvastatin
Brand Name: Juvisync

Sitagliptin/Simvastatin is used for:

Treating type 2 diabetes and lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL, "good") cholesterol levels. It is used along with diet and exercise. It is used in certain patients to reduce the risk of heart attack, stroke, and death due to coronary heart disease. It is also used to reduce the need for medical procedures to open blocked blood vessels. It may also be used for other conditions as determined by your doctor.

Sitagliptin/Simvastatin is a dipeptidyl peptidase-4 (DPP-4) inhibitor and HMG-CoA reductase inhibitor (statin) combination. The DPP-4 inhibitor works by increasing the amount of insulin released by your body and decreasing the amount of sugar made by your body. The statin works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use Sitagliptin/Simvastatin if:

• you are pregnant, may become pregnant, or are breast-feeding


• you are allergic to any ingredient in Sitagliptin/Simvastatin


• you have type 1 diabetes


• you have high blood or urine ketone levels (diabetic ketoacidosis)


• you have moderate or severe kidney problems


• you have liver problems or unexplained abnormal liver function tests


• you take cyclosporine, danazol, gemfibrozil, a hepatitis C virus (HCV) protease inhibitor (eg, boceprevir, telaprevir), an HIV protease inhibitor (eg, ritonavir), itraconazole, ketoconazole, certain macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, nefazodone, posaconazole, or telithromycin


• you take or have taken conivaptan within the past 7 days

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

Before using Sitagliptin/Simvastatin:

Some medical conditions may interact with Sitagliptin/Simvastatin. 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 a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, saxagliptin)


• if you have low blood pressure, kidney problems, low thyroid function, muscle problems or a family history of muscle problems, or serious metabolism, hormonal, or electrolyte problems


• if you drink alcohol or have a history of seizures, liver problems, or alcohol abuse


• if you have a history of inflammation of the pancreas (pancreatitis) or stones in your gallbladder (gallstones)


• if you are scheduled for major surgery, have recently had major surgery or a serious injury, or if you have a serious infection


• if you have had an organ transplant and are taking medicine to suppress a rejection reaction

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

• Amiodarone, amlodipine, azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), colchicine, conivaptan, cyclosporine, danazol, daptomycin, delavirdine, diltiazem, dronedarone, fibrates (eg, gemfibrozil, clofibrate, fenofibrate), fusidic acid, HCV protease inhibitors (eg, boceprevir, telaprevir), HIV protease inhibitors (eg, ritonavir), imatinib, macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, nefazodone, niacin, ranolazine, risperidone, streptogramins (eg, dalfopristin, quinupristin), telithromycin, or verapamil because they may increase the risk of muscle or kidney problems


• Rosiglitazone because the risk of swelling of the hands, legs, or feet may be increased


• Insulin or sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased


• Bosentan, carbamazepine, efavirenz, rifamycins (eg, rifampin), or St. John's wort because they may decrease Sitagliptin/Simvastatin's effectiveness


• Anticoagulants (eg, warfarin), digoxin, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Sitagliptin/Simvastatin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sitagliptin/Simvastatin 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 Sitagliptin/Simvastatin:

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

• Sitagliptin/Simvastatin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sitagliptin/Simvastatin refilled.


• Take Sitagliptin/Simvastatin by mouth with or without food in the evening, unless directed otherwise by your doctor.


• Swallow Sitagliptin/Simvastatin whole. Do not break, crush, or chew before swallowing.


• Eating grapefruit or drinking grapefruit juice may increase the amount of Sitagliptin/Simvastatin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than 1 quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Sitagliptin/Simvastatin.


• Take Sitagliptin/Simvastatin on a regular schedule to get the most benefit from it.


• Continue to take Sitagliptin/Simvastatin even if you feel well. Do not miss any doses.


• If you miss a dose of Sitagliptin/Simvastatin, 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 Sitagliptin/Simvastatin.

Important safety information:

• Sitagliptin/Simvastatin may cause liver problems. Rarely, severe and sometimes fatal liver failure has been reported in patients taking Sitagliptin/Simvastatin. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with Sitagliptin/Simvastatin, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking Sitagliptin/Simvastatin. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).


• Carry an ID card at all times that says you have diabetes.


• Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Sitagliptin/Simvastatin.


• Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Sitagliptin/Simvastatin exactly as prescribed, tell your doctor.


• It may be harder to control your blood sugar during times of stress, such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.


• Tell your doctor or dentist that you take Sitagliptin/Simvastatin before you receive any medical or dental care, emergency care, or surgery. Sitagliptin/Simvastatin may need to be stopped for a few days before certain types of surgery.


• Do NOT take more than the recommended dose without checking with your doctor.


• Muscle problems (myopathy) may occur with Sitagliptin/Simvastatin. The risk of muscle problems may be greater in people who take higher doses of Sitagliptin/Simvastatin, in people older than 64 years old, in women, or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin), especially in Chinese patients. Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort.


• Sitagliptin/Simvastatin usually does not cause low blood sugar. However, low blood sugar may occur when it is used along with certain other medicines for diabetes (eg, insulin, sulfonylureas). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Severe and sometimes fatal inflammation of the pancreas has been reported in patients taking Sitagliptin/Simvastatin. Discuss any questions or concerns with your doctor. Contact your doctor immediately if you develop severe stomach or back pain with or without nausea or vomiting.


• Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Rarely, changes to the skin, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern.


• Lab tests, including blood cholesterol levels, blood glucose, hemoglobin A_1c, liver and kidney function, and creatine phosphokinase (CPK) blood levels, may be performed while you use Sitagliptin/Simvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Sitagliptin/Simvastatin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.


• Sitagliptin/Simvastatin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.


• Women who are able to become pregnant should use effective birth control while taking Sitagliptin/Simvastatin. Check with your doctor if you have questions about using birth control.


• PREGNANCY and BREAST-FEEDING: Do not use Sitagliptin/Simvastatin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Sitagliptin/Simvastatin is found in breast milk. Do not breast-feed while taking Sitagliptin/Simvastatin.

Possible side effects of Sitagliptin/Simvastatin:

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:

Constipation; diarrhea; headache; mild stomach pain; nausea; runny or stuffy nose; sore throat; upper respiratory tract infection.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; dark or red-colored urine; decreased sexual ability; depression; dizziness; fast or irregular heartbeat; fever, chills, or persistent cough or sore throat; joint pain; memory problems; muscle pain, tenderness, or weakness (with or without fever and fatigue); red, swollen, blistered, or peeling skin; shortness of breath; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; 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.

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 Sitagliptin/Simvastatin:

Store Sitagliptin/Simvastatin 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 Sitagliptin/Simvastatin out of the reach of children and away from pets.

General information:

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


• Sitagliptin/Simvastatin 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 Sitagliptin/Simvastatin. 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 Sitagliptin/Simvastatin resources

• Sitagliptin/Simvastatin Dosage
• Sitagliptin/Simvastatin Use in Pregnancy & Breastfeeding
• Sitagliptin/Simvastatin Drug Interactions
• Sitagliptin/Simvastatin Support Group
• 0 Reviews for Sitagliptin/Simvastatin - Add your own review/rating

Compare Sitagliptin/Simvastatin with other medications

• Cardiovascular Risk Reduction
• Diabetes, Type 2
• High Cholesterol
• High Cholesterol, Familial Heterozygous
• High Cholesterol, Familial Homozygous

Sumaxin TS Emulsion

Pronunciation: sul-fa-SEE-ta-mide/SULL-fer
Generic Name: Sulfacetamide/Sulfur
Brand Name: Examples include Plexion TS and Sumaxin TS

Sumaxin TS Emulsion is used for:

Treating acne, rosacea, and seborrhea. It may also be used for other conditions as determined by your doctor.

Sumaxin TS Emulsion is a sulfonamide antibiotic and keratolytic. It works by killing bacteria and shedding the top layer of skin to help treat acne.

Do NOT use Sumaxin TS Emulsion if:

• you are allergic to any ingredient in Sumaxin TS Emulsion


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• you have kidney disease

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

Before using Sumaxin TS Emulsion:

Some medical conditions may interact with Sumaxin TS Emulsion. 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 eczema or a history of lupus

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

• Silver-containing products (eg, silver sulfadiazine) because they may decrease Sumaxin TS Emulsion's effectiveness


• Methenamine because it may increase the risk of Sumaxin TS Emulsion's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sumaxin TS Emulsion 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 Sumaxin TS Emulsion:

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

• Sumaxin TS Emulsion is for use on the skin only. Sumaxin TS Emulsion may stain clothing and the skin if too much is used.


• Wash hands before and after using Sumaxin TS Emulsion.


• Gently wash and dry the affected area. Apply a small amount of Sumaxin TS Emulsion to the affected area. Rub in gently.


• To clear up your infection completely, continue using Sumaxin TS Emulsion for the full course of treatment even if you feel better in a few days.


• Sumaxin TS Emulsion works best if it is used at the same time each day.


• Continue to use Sumaxin TS Emulsion even if you feel well. Do not miss any doses.


• If you miss a dose of Sumaxin TS Emulsion, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sumaxin TS Emulsion.

Important safety information:

• Avoid getting Sumaxin TS Emulsion in your eyes, nose, or mouth. If you get Sumaxin TS Emulsion in your eyes, rinse immediately with cool tap water.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Do not apply Sumaxin TS Emulsion to open wounds or to damaged or burned skin without first checking with your doctor.


• If you use topical products too often, your condition may become worse.


• Sumaxin TS Emulsion only works against bacteria; it does not treat viral infections.


• Be sure to use Sumaxin TS Emulsion for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Sumaxin TS Emulsion may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Sumaxin TS Emulsion should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these 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 Sumaxin TS Emulsion while you are pregnant. It is not known if Sumaxin TS Emulsion is found in breast milk after topical use. If you are or will be breast-feeding while you use Sumaxin TS Emulsion, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sumaxin TS Emulsion:

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:

Mild irritation, stinging, or burning of the skin.

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); cracked or extremely dry skin; fever; joint pain; red, swollen, scaling, or blistered skin; severe diarrhea; sores in the mouth; yellowing of the skin or eyes.

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: Sumaxin TS 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. Sumaxin TS Emulsion may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Sumaxin TS Emulsion:

Store Sumaxin TS Emulsion at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Sumaxin TS Emulsion out of the reach of children and away from pets.

General information:

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


• Sumaxin TS Emulsion 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 Sumaxin TS Emulsion. 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 Sumaxin TS resources

• Sumaxin TS Side Effects (in more detail)
• Sumaxin TS Use in Pregnancy & Breastfeeding
• Sumaxin TS Drug Interactions
• 0 Reviews for Sumaxin TS - Add your own review/rating

Compare Sumaxin TS with other medications

• Acne
• Rosacea
• Seborrheic Dermatitis

Triple Wormer

Dosage Form: FOR ANIMAL USE ONLY
TripleWormer™

(pyrantel pamoate/praziquantel)

FOR PUPPIES AND SMALL DOGS

Durvet Triple Wormer™ Flavored Chewables

Package contents: Blisters of 2 or 12 chewables

DRUG FACTS

Active Ingredients (in each chewable)

Pyrantel Pamoate (30mg) and Praziquantel (30mg)

Purpose

De-wormer for Small Dogs and Puppies Only (6.0 to 25 pounds)

Uses

For the treatment and control of

• Roundworms (Toxocara canis, Toxascaris leonina)


• Hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala)


• Tapeworms (Dipylidium caninum, Taenia pisiformis)

Human Warning

Keep this and all medication out of the reach of children. To obtain product information, including a Material Safety Data Sheet (MSDS), call 1-800-821-5570.

When Using This Product:

• Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.


• Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness.


• Durvet Triple Wormer™ Flavored Chewables are safe for use in puppies12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.

You May Notice

Vomiting, loose stools (with or without blood) and decreased activity following treatment. If you notice these signs, contact a veterinarian.

Directions

Each flavored chewable contains 30 mg of pyrantel pamoate and 30 mg of praziquantel. The dose for each drug is 2.27 mg per pound of body weight (5 mg/kg). Please refer to the following dosing table for help finding the right dose for your dog.

Durvet Triple Wormer™ Flavored Chewables Dosing Table

Dog Weight	Number of Chewables
6.0 to 12.0 pounds	1
12.1 to 25 pounds	2
More than 25 pounds	Use the 114 mg size

• You should weigh your dog to make sure you are giving the right dose.


• Durvet Triple Wormer™ Flavored Chewables are palatable if offered by hand. If your dog does not voluntarily eat the chewable, you can hide the chewable in a small amount of food or place it in the back of the dog's mouth for forced swallowing.


• Make sure that the dog eats the complete dose.


• Watch the dog for a few minutes after dosing to make sure the chewable is not rejected.

OTHER INFORMATION

Recommended De-Worming Schedule

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. De-worming schedules may vary depending on the climate where you live and the activity of your dog.

Re-treatment

Re-treatment of your dog may be necessary as determined by laboratory fecal examination and/or if your dog is living where re-infections are likely to occur. Consult your veterinarian for assistance in the diagnosis and prevention of re-infection. In case of re-infection with tapeworms (Dipylidium caninum), consult your veterinarian for advice on how to remove fleas from the dog and the environment.

Storage

Store at controlled room temperature of 59-86°F (15-30°C).

Questions? Comments?

To report a suspected adverse reaction, call 1-800-821-5570

If you have questions or comments about this product, please write: Durvet, Inc., PO Box 279, Blue Springs, MO 64013

Manufactured for:

Durvet, Inc., 100 S.E. Magellan Drive, Blue Springs, MO 64014

MADE IN USA

NADA141-261, Approved by FDA ACAV P002632-1 06/07

PRINCIPAL DISPLAY PANEL - 30 mg Tablet Carton

NDC 30798-185-61

FOR PUPPIES AND SMALL DOGS

TripleWormer™

(pyrantel pamoate/praziquantel)

2

tablets

CHEWABLE FLAVORED DOG DE-WORMER TABLETS

Broad Spectrum

De-Wormer

For Puppies & Small Dogs

6 lbs. to 25 lbs.

For the treatment and control of:

roundworms (Toxocara canis, Toxascaris leonina);

hookworms (Ancylostoma caninum, Ancylostoma

braziliense, Uncinaria stenocephala);

tapeworms (Dipylidium caninum,Taenia

pisiformis) in dogs and puppies.

Active ingredient: Each flavored chewable contains

30 mg pyrantel pamoate and 30 mg praziquantel.

KEEP OUT OF REACH OF CHILDREN

FOR USE ONLY AS DIRECTED ON PACKAGE INSERT & BACK PANEL

NET CONTENTS: 2 FLAVORED TABLETS

NADA #141-261, APPROVED BY FDA

durvet

Triple Wormer  pyrantel pamoate and praziquantel  tablet, chewable

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 30798-185 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pyrantel pamoate (pyrantel) pyrantel pamoate 30 mg praziquantel (praziquantel) praziquantel 30 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 30798-185-61 2 TABLET In 1 BOX, UNIT-DOSE None 2 30798-185-71 12 TABLET In 1 BOX, UNIT-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141261	03/06/2010

Labeler - Durvet, Inc. (056387798)

Registrant - Virbac AH, Inc. (131568396)

Establishment
Name	Address	ID/FEI	Operations
Virbac Bridgeton		808558100	MANUFACTURE

Revised: 03/2010Durvet, Inc.

TetraVisc

tetracaine hydrochloride

Dosage Form: ophthalmic solution
TetraVisc Hydrochloride Ophthalmic Solution, USP 0.5% Viscous Sterile Rx Only

DESCRIPTON:

Tetracaine Hydrochloride 0.5% is a sterile topical ophthalmic solution useful in producing surface anesthesia of the eye. The

active ingredient is represented by the structural formula:



CH3(CH2)3NH      COOCH2CH2N(CH3)2.HCI

CLINICAL PHARMACOLOGY:

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% acts by decreasing the permeability of the neuronal membrane,

thereby decreasing the flux of sodium, potassium and other ions associated with propagation of the nerve impulse. The onset

of anesthesia usually begins within 30 seconds and lasts a relatively short period of time.

INDICATIONS AND USAGE:

For procedures in which a rapid and short acting topical ophthalmic anesthetic is indicated such as in tonometry, gonioscopy,

removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea or conjunctiva,

other short corneal and conjunctival procedures.

Should not be used by the patient without physician supervision, or in those persons showing hypersensitivity to any component

of this preparation.

For topical ophthalmic use only. Not for parenteral use. Not for injection. Do not use solution if it contains crystals or if it is cloudy

or discolored. Prolonged use results in diminished duration of anesthesia and retarded healing. This may cause the drug to be

used more frequently, creating a "vicious circle". Subsequent corneal infection and/or corneal opacification with accompanying

permanent visual loss or corneal perforation may occur. Prolonged use may also produce severe keratitis.

General:

Do not touch dropper tip to any surface as this may contaminate the solution. As with all anesthetics, continuous and prolonged

use should be avoided. Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of

anesthesia is very important. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should be used cautiously in patients

with known allergy or cardiac disease. If signs of sensitivity develop during the treatment or irritation persists or increases,

patients should be advised to discontinue use and consult prescribing physician.

Keep this and all drugs out of the reach of children . In case of accidental ingestion, seek professional assistance or contact a

Poison Control Center immediately.

After instillation of this product, the surface of the eye is insensitive and can be scratched without your feeling it. Do not rub

eye. Do not instill this product repeatedly because severe eye damage may occur.

No studies have been conducted in animals or in humans to evaluate the potential of these effects.

Pregnancy Category C:

Animal reproduction studies have not been performed with Tetracaine Hydrochloride. It is also not known whether Tetracaine

Hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction. Tetracaine

Hydrochloride Ophthalmic Solution, USP 0.5% should be given to pregnant women only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should

be excercised when Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children have not been established.

ADVERSE REACTIONS:

Transient symptoms (signs) such as stinging, burning, and conjunctival redness may occur. A rare, severe, immediate type

allergic corneal reaction has been reported characterized by acute diffuse epithelial keratitis with filament formation and/or

sloughing of large areas of necrotic epithelium, diffuse stromal edema, descemetitis and iritis.

To report SUSPECTED ADVERSE REACTIONS, contact OCuSOFT, Inc. at (800) 233-5469 www.ocusoft.com.

DOSAGE AND ADMINISTRATION: Dosage:

One to two drops per eye.

For Tonometry And Other Procedures Of Short Duration:

Instill one or two drops just prior to evaluation.

For Minor Surgical Procedures Such As Foreign Body Or Suture Removal:

Instill one or two drops in the eye(s) every five to ten minutes maximum three doses.

For Prolonged Anesthesia As In Cataract Extraction:

Instill one or two drops in the eye(s) every five to ten minutes maximum five doses.

HOW SUPPLIED:

Tetracaine Hydrochloride Ophthalmic Solution , USP 0.5% is supplied in:

5 mL multi-drop plastic container NDC 54799-505-05

0.6 mL single unit dose plastic container NDC 54799-505-01

Storage:

Store at a room temperature, 15°-30°C (59°-86°F).

Keep container tightly closed.

TetraVisc  tetracaine hydrochloride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54799-505 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tetracaine Hydrochloride (Tetracaine) Tetracaine Hydrochloride 25 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength Boric Acid   Edetate Disodium   Hypromelloses   Potassium Chloride   Sodium Borate   Sodium Chloride   Water   Hydrochloric Acid   Sodium Hydroxide   BENZALKONIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54799-505-05 5 mL In 1 BOTTLE, DROPPER None 2 54799-505-01 0.6 mL In 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/02/2005

Labeler - OCuSOFT, Inc. (174939207)

Registrant - OCuSOFT, Inc. (174939207)

Establishment
Name	Address	ID/FEI	Operations
Altaire Pharmaceuticals, Inc.		786790378	manufacture

Revised: 05/2011OCuSOFT, Inc.

More TetraVisc resources

• TetraVisc Side Effects (in more detail)
• TetraVisc Use in Pregnancy & Breastfeeding
• TetraVisc Support Group
• 0 Reviews · Be the first to review/rate this drug

• TetraVisc Advanced Consumer (Micromedex) - Includes Dosage Information


• Altacaine Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Trihexyphenidyl

Dosage Form: tablet
Trihexyphenidyl

HYDROCHLORIDE TABLETS, USP

Rx only

Trihexyphenidyl Description

Trihexyphenidyl HCl is a synthetic antispasmodic. Each tablet for oral administration, contains 2 mg or 5 mg Trihexyphenidyl HCl, each strength also containing as inactive ingredients: magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Trihexyphenidyl HCl is a white or slightly off white, crystalline powder, having not more than a very faint odor.

Trihexyphenidyl HCl is the substituted piperidine salt, 1-piperidinepropanol,α-cyclohexyl-α-phenyl-,hydrochloride,(±)-. The structural formula is:

Trihexyphenidyl - Clinical Pharmacology

Trihexyphenidyl exerts a direct inhibitory effect upon the parasympathetic nervous system. It also has a relaxing effect on smooth musculature; exerted both directly upon the muscle tissue itself and indirectly through an inhibitory effect upon the parasympathetic nervous system. Its therapeutic properties are similar to those of atropine, although undesirable side effects are ordinarily less frequent and severe than with the latter.

Indications and Usage for Trihexyphenidyl

Trihexyphenidyl HCl tablets are indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

Warnings

Patients to be treated with Trihexyphenidyl HCl should have a gonioscope evaluation and close monitoring of intraocular pressures at regular periodic intervals.

Precautions

Although Trihexyphenidyl HCl is not contraindicated for patients with cardiac, liver, or kidney disorders, or with hypertension, such patients should be maintained under close observation.

Since the use of Trihexyphenidyl HCl may, in some cases, continue indefinitely and since it has atropine-like properties, patients should be subjected to constant and careful long-term observation to avoid allergic and other untoward reactions. Inasmuch as Trihexyphenidyl HCl possesses some parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy. Geriatric patients, particularly over the age of 60, frequently develop increased sensitivity to the actions of drugs of this type, and hence, require strict dosage regulation. Incipient glaucoma may be precipitated by parasympatholytic drugs such as Trihexyphenidyl HCl.

Tardive dyskinesia may appear in some patients on long-term therapy with antipsychotic drugs or may occur after therapy with these drugs has been discontinued. Antiparkinsonism agents do not alleviate the symptoms of tardive dyskinesia and, in some instances, may aggravate them. However, parkinsonism and tardive dyskinesia often coexist in patients receiving chronic neuroleptic treatment, and anticholinergic therapy with Trihexyphenidyl HCl may relieve some of these parkinsonism symptoms.

Adverse Reactions

Minor side effects, such as dryness of the mouth, blurring of vision, dizziness, mild nausea or nervousness, will be experienced by 30 to 50 percent of all patients. These sensations, however, are much less troublesome with Trihexyphenidyl HCl than with belladonna alkaloids and are usually less disturbing than unalleviated parkinsonism. Such reactions tend to become less pronounced, and even to disappear, as treatment continues. Even before these reactions have remitted spontaneously, they may often be controlled by careful adjustment of dosage form, amount of drug, or interval between doses.

Isolated instances of suppurative parotitis secondary to excessive dryness at the mouth, skin rashes, dilatation of the colon, paralytic ileus, and certain psychiatric manifestations such as delusions and hallucinations, plus one doubtful case of paranoia all of which may occur with any of the atropine-like drugs, have been reported rarely with Trihexyphenidyl hydrochloride.

Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Such patients should be allowed to develop a tolerance through the initial administration of a small dose and gradual increase in dose until an effective level is reached. If a severe reaction should occur, administration of the drug should be discontinued for a few days and then resumed at a lower dosage. Psychiatric disturbances can result from indiscriminate use (leading to overdosage) to sustain continued euphoria.

Potential side effects associated with the use of any atropine-like drugs include constipation, drowsiness, urinary hesitancy or retention, tachycardia, dilation of the pupil, increased intraocular tension, weakness, vomiting, and headache.

The occurrence of angle-closure glaucoma due to long-term treatment with Trihexyphenidyl has been reported.

Trihexyphenidyl Dosage and Administration

Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether Trihexyphenidyl HCl may best be given before or after meals should be determined by the way the patient reacts. Postencephalitic patients, who are usually more prone to excessive salivation, may prefer to take it after meals and may, in addition, require small amounts of atropine which, under such circumstances, is sometimes an effective adjuvant. If Trihexyphenidyl HCl tends to dry the mouth excessively, it may be better to take it before meals, unless it causes nausea. If taken after meals, the thirst sometimes induced can be allayed by mint candies, chewing gum or water.

Trihexyphenidyl HCl in Idiopathic Parkinsonism

As initial therapy for parkinsonism, 1 mg of Trihexyphenidyl in tablet form may be administered the first day. The dose may then be increased by 2 mg increments at intervals of three to five days, until a total of 6 to 10 mg is given daily. The total daily dose will depend upon what is found to be the optimal level. Many patients derive maximum benefit from this daily total of 6 to 10 mg, but some patients, chiefly those in the postencephalitic group, may require a total daily dose of 12 to 15 mg.

Trihexyphenidyl HCl in Drug-Induced Parkinsonism

The size and frequency of dose of Trihexyphenidyl HCl needed to control extrapyramidal reactions to commonly employed tranquilizers, notably the phenothiazines, thioxanthenes, and butyrophenones, must be determined empirically. The total daily dosage usually ranges between 5 and 15 mg, although, in some cases, these reactions have been satisfactorily controlled on as little as 1 mg daily. It may be advisable to commence therapy with a single 1 mg dose. If the extrapyramidal manifestations are not controlled in a few hours, the subsequent doses may be progressively increased until satisfactory control is achieved. Satisfactory control may sometimes be more rapidly achieved by temporarily reducing the dosage of the tranquilizer on instituting Trihexyphenidyl HCl therapy and then adjusting dosage of both drugs until the desired ataractic effect is retained without onset of extrapyramidal reactions.

It is sometimes possible to maintain the patient on a reduced Trihexyphenidyl HCl dosage after the reactions have remained under control for several days. Instances have been reported in which these reactions have remained in remission for long periods after Trihexyphenidyl HCl therapy was discontinued.

Concomitant Use of Trihexyphenidyl HCl with Levodopa

When Trihexyphenidyl HCl is used concomitantly with levodopa, the usual dose of each may need to be reduced. Careful adjustment is necessary, depending on side effects and degree of symptom control. Trihexyphenidyl HCl dosage of 3 to 6 mg daily, in divided doses, is usually adequate.

Concomitant Use of Trihexyphenidyl HCl with Other Parasympathetic Inhibitors

Trihexyphenidyl HCl may be substituted, in whole or in part, for other parasympathetic inhibitors. The usual technique is partial substitution initially, with progressive reduction in the other medication as the dose of Trihexyphenidyl HCl is increased.

The total daily intake of Trihexyphenidyl HCl tablets is tolerated best if divided into 3 doses and taken at mealtimes. High doses (>10 mg daily) may be divided into 4 parts, with 3 doses administered at mealtimes and the fourth at bedtime.

How is Trihexyphenidyl Supplied

Trihexyphenidyl HCl tablets are available as follows:

2 mg – round, flat, scored, white tablets; debossed "5971" above the score and "V" below the score. Available in bottles of 100, 500 and 1000.

5 mg – round, flat, scored, white tablets; debossed "5972" above the score and "V" below the score. Available in bottles of 100, 500, and 1000.

Dispense in a tight, light-resistant container as defined in the USP.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8181446

R2/08-R2

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Trihexyphenidyl HYDROCHLORIDE  Trihexyphenidyl hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0603-6240 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trihexyphenidyl HYDROCHLORIDE (Trihexyphenidyl) Trihexyphenidyl HYDROCHLORIDE 2 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 5971;V Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-6240-21 100 TABLET In 1 BOTTLE, PLASTIC None 2 0603-6240-28 500 TABLET In 1 BOTTLE, PLASTIC None 3 0603-6240-32 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040254	12/24/1998

Trihexyphenidyl HYDROCHLORIDE  Trihexyphenidyl hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0603-6241 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trihexyphenidyl HYDROCHLORIDE (Trihexyphenidyl) Trihexyphenidyl HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 5972;V Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-6241-21 100 TABLET In 1 BOTTLE, PLASTIC None 2 0603-6241-28 500 TABLET In 1 BOTTLE, PLASTIC None 3 0603-6241-32 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040254	12/24/1998

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Charlotte		151228897	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE

Revised: 06/2011Qualitest Pharmaceuticals

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