Kadian

Generic Name: morphine (Oral route)

MOR-feen

Oral route(Capsule, Extended Release)

Kadian(R): Capsule contains morphine sulfate, an opioid agonist and Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Kadian(R) is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The 100-mg and 200-mg capsules are for use in opioid-tolerant patients only. Kadian(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule pellets due to the risk of rapid release and absorption of a potentially fatal dose of morphine .

Oral route(Capsule, Extended Release, 24 HR)

Avinza(R): Capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. Avinza(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule beads due to the risk of rapid release and absorption of a potentially fatal dose of morphine. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in the rapid release and absorption of a potentially fatal dose of morphine .

Oral route(Solution)

Morphine oral solution is available in 10 mg/5 mL, 20 mg/5 mL and 100 mg/5 mL (20 mg/mL) concentrations. The 100 mg/5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only. Take care to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Keep morphine oral solution out of the reach of children .

Oral route(Tablet, Extended Release)

MS Contin(R): 100 mg and 200 mg tablets are for use in opioid-tolerant patients only. MS Contin(R) tablets are a controlled-release formulation, should be swallowed whole and are not to be broken, chewed, dissolved, or crushed due to the risk of rapid release and absorption of a potentially fatal dose of morphine . Oramorph(R) SR: This is a sustained-release dosage form. Swallow the tablet whole; the tablet should not be broken in half, nor should it be crushed or chewed .

Commonly used brand name(s)

In the U.S.

• Avinza


• Kadian


• Kadian ER


• MS Contin


• MSIR


• Oramorph SR


• Roxanol


• Roxanol-T

Available Dosage Forms:

• Capsule, Extended Release


• Capsule, Extended Release, 24 HR


• Tablet, Extended Release


• Capsule


• Tablet


• Powder for Suspension, Extended Release


• Solution


• Capsule, Delayed Release


• Syrup

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Kadian

Morphine is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Morphine acts on the central nervous system (CNS) to relieve pain.

When morphine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using Kadian

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

Appropriate studies have not been performed on the relationship of age to the effects of morphine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of morphine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving morphine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Naltrexone


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

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.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Cimetidine


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenobarbital


• Prazepam


• Prochlorperazine


• Promazine


• Promethazine


• Propoxyphene


• Quazepam


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiethylperazine


• Thiopental


• Thioridazine


• Triazolam


• Trifluoperazine

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.

• Cyclosporine


• Esmolol


• Gabapentin


• Rifampin


• Somatostatin


• Yohimbine

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, or history of or


• Chronic obstructive pulmonary disease (COPD) or


• Cor pulmonale (serious heart condition) or


• Drug dependence, especially with narcotics, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Gallbladder disease or gallstones or


• Head injuries, history of or


• Heart disease or


• Hypothyroidism (an underactive thyroid) or


• Hypovolemia (low blood volume) or


• Kyphoscoliosis (curvature of the spine with breathing problems) or


• Pancreatitis (inflammation of the pancreas) or


• Problems with passing urine or


• Swallowing problems—Use with caution. May increase risk for more serious side effects.

• Asthma, severe or


• Breathing problems, severe (e.g., hypoxia) or


• Paralytic ileus (intestine stops working and may be blocked) or


• Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or


• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of morphine

This section provides information on the proper use of a number of products that contain morphine. It may not be specific to Kadian. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

You may take this medicine with or without food.

Morphine extended-release capsules and tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Swallow the extended-release capsules and tablets whole. Do not break, crush, dissolve, or chew them. Do not use extended-release tablets that are broken.

If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing.

While taking the extended-release tablet, part of the tablet may pass into your stool. This is normal and nothing to worry about.

Morphine extended-release capsules or tablets work differently from the regular morphine oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

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 (extended-release capsules):
  
  • For moderate to severe pain:
    
    • Patients switching from regular morphine forms:
      
      • Adults—The capsule is given once a day. The initial dose in milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • Patients who are not taking narcotic medicines:
      
      • Adults—At first, 30 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
  
  


• For oral dosage form (extended-release tablets):
  
  • For moderate to severe pain:
    
    • Patients switching from regular morphine forms:
      
      • Adults—The tablet is given every 8 hours or every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. The total amount per day will be divided and given as 2 or 3 doses during the day. Your doctor may adjust your dose if needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
  
  


• For oral dosage form (solution):
  
  • For moderate to severe pain:
    
    • Adults—10 to 20 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (tablets):
  
  • For moderate to severe pain:
    
    • Adults—15 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Morphine can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush the unused capsules, liquid, and tablets down the toilet.

Precautions While Using Kadian

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Kadian 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:

Less common

• Abdominal or stomach pain


• blurred vision


• bulging soft spot on the head of an infant


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in the ability to see colors, especially blue or yellow


• chest pain or discomfort


• chills


• confusion


• cough


• decreased urination


• difficulty with breathing


• difficulty with swallowing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast, pounding, or irregular heartbeat or pulse


• headache


• hives


• increased sweating


• insomnia


• itching


• loss of appetite


• nausea


• nervousness


• noisy breathing


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• severe constipation


• severe vomiting


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• skin rash


• slow or irregular heartbeat


• sweating


• swelling


• tightness in the chest


• trembling or shaking of the hands or feet


• trouble with breathing


• trouble with urinating


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• bluish lips or skin


• change in consciousness


• chest pain or discomfort


• cold, clammy skin


• convulsions


• decrease in the amount of urine


• decrease in the frequency of urination


• difficulty in passing urine (dribbling)


• extremely shallow or slow breathing


• fast, weak pulse


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• irregular, fast or slow, or shallow breathing


• lightheadedness


• loss of consciousness


• low blood pressure or pulse


• nervousness


• painful urination


• pale or blue lips, fingernails, or skin


• pale skin


• pinpoint red spots on the skin


• pounding in the ears


• shakiness and unsteady walk


• troubled breathing with exertion


• unconsciousness


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• very slow breathing


• very slow heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bloody urine


• constricted, pinpoint, or small pupils (black part of the eye)


• dark-colored urine


• decreased awareness or responsiveness


• extreme drowsiness


• fever


• increased blood pressure


• increased thirst


• lower back or side pain


• muscle cramps or spasms


• muscle pain or stiffness


• no muscle tone or movement


• severe sleepiness


• swelling of the face, fingers, or lower legs


• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Cramps


• diarrhea


• difficulty having a bowel movement (stool)


• drowsiness


• false or unusual sense of well-being


• relaxed and calm feeling


• sleepiness or unusual drowsiness


• weight loss

Less common

• Absent, missed, or irregular menstrual periods


• acid or sour stomach


• agitation


• bad, unusual, or unpleasant (after) taste


• belching


• blurred or loss of vision


• change in taste


• decreased interest in sexual intercourse


• depression


• disturbed color perception


• double vision


• dry mouth


• face is warm or hot to touch


• fear


• floating feeling


• halos around lights


• heartburn


• inability to have or keep an erection


• indigestion


• loss in sexual ability, desire, drive, or performance


• muscle stiffness or tightness


• nervousness


• night blindness


• overbright appearance of lights


• problems with muscle control


• redness of the skin


• seeing double


• skin rash


• sleeplessness


• stomach discomfort, upset, or pain


• stopping of menstrual bleeding


• trouble sleeping


• tunnel vision


• unable to sleep


• uncontrolled eye movements


• upper abdominal or stomach pain


• weakness

Incidence not known

• Abnormal dreams


• belching


• burning while urinating


• change in vision


• change in walking and balance


• change or problem with discharge of semen


• clumsiness or unsteadiness


• confusion as to time, place, or person


• delusions


• dementia


• dry skin


• eye pain


• feeling of constant movement of self or surroundings


• general feeling of discomfort or illness


• hiccup


• holding false beliefs that cannot be changed by fact


• impaired vision


• indigestion


• loss of memory


• problems with memory


• seeing, hearing, or feeling things that are not there


• sensation of spinning


• thirst


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• unusual excitement, nervousness, or restlessness

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: Kadian side effects (in more detail)

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More Kadian resources

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

• Kadian Prescribing Information (FDA)


• Kadian Consumer Overview


• Kadian Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Morphine Concentrate MedFacts Consumer Leaflet (Wolters Kluwer)


• Astramorph PF Prescribing Information (FDA)


• Astramorph PF Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Avinza Prescribing Information (FDA)


• Avinza Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Avinza Consumer Overview


• Infumorph Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• MS Contin Consumer Overview


• MS Contin Prescribing Information (FDA)


• MS Contin Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Morphine Sulfate Monograph (AHFS DI)


• Oramorph SR Prescribing Information (FDA)


• RMS Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Kadian with other medications

• Pain

Saizen Subcutaneous, Injection

Generic Name: somatropin, e-coli derived (Subcutaneous route, Injection route)

soe-ma-TROE-pin, E-KOH-lye dee-rived

Commonly used brand name(s)

In the U.S.

• Accretropin


• Genotropin


• Genotropin Miniquick


• Humatrope


• Norditropin


• Norditropin Flexpro


• Nutropin


• Nutropin AQ NuSpin 10


• Nutropin AQ NuSpin 5


• Nutropin AQ Pen


• Omnitrope


• Tev-Tropin

In Canada

• Nutropin Aq


• Saizen

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatropin

Uses For Saizen

Somatropin is a man-made version of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in adults or children who have certain conditions that prevent normal growth. These conditions include growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), Noonan syndrome, Turner syndrome, short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age.

This medicine is available only with your doctor's prescription.

Before Using Saizen

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatropin in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin in the elderly. However, elderly patients are more sensitive to the effects of somatropin, which may require a dose adjustment in patients receiving somatropin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Brain tumor or


• Cancer, active or


• Closed epiphyses (normal bone growth stopped) in children or


• Diabetic retinopathy (eye condition) or


• Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems or


• Severe illness after surgery or major medical emergency (e.g., open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.

• Cancer, history of or


• Hypopituitarism (pituitary gland produces low hormone levels) or


• Hypothyroidism (underactive thyroid gland) or


• Otitis media (ear infection) in children, history of or


• Scoliosis (abnormally curved spine)—Use with caution. May make these conditions worse.

• Diabetes, or a family history of—Use with caution. May prevent insulin or other drugs for diabetes from working properly.

• Turner syndrome—Use with caution. May increase risk of having serious problems (e.g., pancreas, thyroid, or heart and blood vessel problems; ear or hearing disorders; diabetes; increased pressure in the head; and bone problems such as dislocation in the hip bone or scoliosis).

Proper Use of somatropin, e-coli derived

This section provides information on the proper use of a number of products that contain somatropin, e-coli derived. It may not be specific to Saizen. Please read with care.

This medicine is given as a shot under your skin. Somatropin may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

There are many different forms (e.g., vial, cartridge, injection device) available for this medicine. Read all instructions carefully to be sure you know how to use your device.

Each time you get your medicine, check to be sure you have received the proper device. Talk to your pharmacist if you have questions about the device that you were given.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Use a new needle, unopened vial, or syringe each time you inject your medicine.

You might not use all of the medicine in each vial (glass container) or prefilled syringe. Use each vial or syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 injection dosage form:
  
  • For all indications:
    
    • Adults—Dose is usually based on body weight (depending on the brand of somatropin you are using) and dose must be determined by your doctor. Your doctor will adjust your dose as needed.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. Your doctor will adjust your child's dose as needed.
    
    
  
  

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store this medicine in the refrigerator, away from direct light. Do not freeze or shake.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Saizen

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause a serious allergic reaction that requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, or throat; trouble with breathing; or chest pain after you receive the medicine.

This medicine may cause a dislocation in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you or your child has a limp or pain in the hip or knee.

This medicine may affect blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests or if you have any questions.

This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause fluid retention (extra water in the body). Tell your doctor if you have burning, numbness, pain, or tingling in all fingers except the smallest finger; swelling of the hands and feet; or pain, swelling, or stiffness of the muscles. Your doctor may adjust your dose to reduce these side effects.

Pancreatitis has occurred rarely in some patients receiving somatropin. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Before you have any medical tests, tell the medical doctor in charge that you are using this certain brand of somatropin (Humatrope®). The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Saizen 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:

More common

• Bleeding gums


• bloating or swelling of the face, arms, hands, ankles, lower legs, or feet


• burning, numbness, pain, or tingling in all fingers except smallest finger


• coughing up blood


• difficulty with breathing or swallowing


• difficulty with moving


• dizziness


• increased menstrual flow or vaginal bleeding


• muscle pain or stiffness


• nosebleeds


• not able to move


• pain, swelling, or redness in joints


• prolonged bleeding from cuts


• rapid weight gain


• red or black, tarry stools


• red or dark brown urine


• tingling of the hands or feet


• unusual weight gain or loss

Rare

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• blurred vision


• bone pain


• change in ability to see colors, especially blue or yellow


• change in personality


• changes in vision


• chills


• confusion


• constipation


• curved spine


• darkened urine


• dry mouth


• fast heartbeat


• fever


• flushed, dry skin


• fracture


• fruit-like breath odor


• headache


• increased hunger


• increased thirst


• increased urination


• indigestion


• limp pain in the hip or knee


• loss of appetite


• loss of consciousness


• nausea


• pains in the stomach, side, or abdomen, possibly radiating to the back


• problems with walking or talking


• seizures


• stomachache


• sweating


• troubled breathing


• tumor


• unusual tiredness or weakness


• vomiting


• weakness


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Backache


• excessive sweating


• extreme weakness


• increase in hands and feet size


• increased volume of pale, diluted urine


• pain in extremities


• stop in menstruation

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Large, flat, blue, or purplish patches in the skin


• unusually warm skin

Rare

• Increased growth of skin lesions


• swelling of the breasts or breast soreness in both females and males

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: Saizen Subcutaneous, Injection 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Saizen Subcutaneous, Injection resources

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

Compare Saizen Subcutaneous, Injection with other medications

• Adult Human Growth Hormone Deficiency
• Pediatric Growth Hormone Deficiency
• Short Stature for Age

Triveen-CF NAC

Pronunciation: meth-ill-FOE-late/meth-ill-koe-BAL-a-min/a-se-teel-SIS-teen
Generic Name: L-Methylfolate/Methylcobalamin/N-Acetylcysteine
Brand Name: Examples include Cerefolin with NAC and Triveen-CF NAC

Triveen-CF NAC is used for:

Supplying nutritional requirements of certain patients with neurovascular oxidative stress or high blood levels of homocysteine. It may also be used for other conditions as determined by your doctor.

Triveen-CF NAC is a nutritional supplement. It works by providing the body with folate, vitamin B₁₂, and a form of antioxidant, which helps to reduce or eliminate oxidative stress and lower homocysteine levels.

Do NOT use Triveen-CF NAC if:

• you are allergic to any ingredient in Triveen-CF NAC


• you are very ill

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

Before using Triveen-CF NAC:

Some medical conditions may interact with Triveen-CF NAC. 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 anemia, liver problems, kidney stones, or a history of ulcers

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

• Antibiotics (eg, penicillin, cephalexin, ciprofloxacin), cholestyramine, colchicine, colestipol, metformin, nitrous oxide, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), para-aminosalicylic acid, potassium chloride, or sulfasalazine because they may decrease the effectiveness of Triveen-CF NAC


• Fluorouracil or nitrates (eg, nitroglycerin) because their side effects may be increased


• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), primidone, pyrimethamine, or valproic acid because their effectiveness may be decreased by Triveen-CF NAC

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triveen-CF NAC 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 Triveen-CF NAC:

Use Triveen-CF NAC as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Triveen-CF NAC may be taken with or without food.


• If you miss a dose of Triveen-CF NAC, 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 Triveen-CF NAC.

Important safety information:

• Diabetes patients - Triveen-CF NAC may cause incorrect test results with some ketone tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.


• Triveen-CF NAC is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Triveen-CF NAC, discuss with your doctor the benefits and risks of using Triveen-CF NAC during pregnancy. Triveen-CF NAC is excreted in breast milk. Do not breastfeed while you are taking Triveen-CF NAC.

Possible side effects of Triveen-CF NAC:

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:

Bloated feeling; headache; itching; mild diarrhea; mild fever; nausea; vomiting.

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

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

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 Triveen-CF NAC:

Store Triveen-CF NAC at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, light, and moisture. Keep Triveen-CF NAC out of the reach of children and away from pets.

General information:

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


• Triveen-CF NAC 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 Triveen-CF NAC. 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 Triveen-CF NAC resources

• Triveen-CF NAC Use in Pregnancy & Breastfeeding
• Triveen-CF NAC Drug Interactions
• Triveen-CF NAC Support Group
• 4 Reviews for Triveen-CF NAC - Add your own review/rating

Compare Triveen-CF NAC with other medications

• Dietary Supplementation
• Hyperhomocysteinemia

Silver Sulfadiazine Cream

SSD™ (1% Silver Sulfadiazine Cream)

SSD AF™ (1% Silver Sulfadiazine Cream)

Silver Sulfadiazine Cream Description

SSD (1% Silver Sulfadiazine) Cream and SSD AF (1% Silver Sulfadiazine) Cream are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base.

Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine

Inactive Ingredients: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative.

Silver sulfadiazine has an emprical formula of C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown:

Silver Sulfadiazine Cream - Clinical Pharmacology

Silver sulfadiazine has broad antimicrobial activity. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast.  Results from in vitro testing are listed below. Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine.

Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell wall to produce its bactericidal effect.

Results of In Vitro Testing 1% Concentration of Silver SulfadiazineNumber of Sensitive Strains / Total Number of Strains Tested

Genus and Species	50 ug/mL	100 ug/mL
Pseudomonas aeruginosa	130/130	130/130
Pseudomonas maltophilia	7/7	7/7
Enterobacter species	48/50	50/50
Enterobacter cloacae	24/24	24/24
Klebsiella species	53/54	54/54
Escherichia coli	63/63	63/63
Serratia species	27/28	28/28
Proteus mirabilis	53/53	53/53
Morganella morganii	10/10	10/10
Providencia rettgeri	2/2	2/2
Proteus vulgaris	2/2	2/2
Providencia species	1/1	1/1
Citrobacter species	10/10	10/10
Acinetobacter calcoaceticus	10/11	11/11
Stahylococcus aureus	100/101	101/101
Staphylococcus epidermidis	51/51	51/51
B-Hemolytic Streptococcus	4/4	4/4
Enterococcus species	52/53	53/53
Corynebacterium diphtheriae	2/2	2/2
Clostridium perfringens	0/2	2/2
Candida albicans	43/50	50/50

Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

Indications and Usage for Silver Sulfadiazine Cream

Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.

Contraindications

Silver Sulfadiazine Cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation.

Because sulfonamide therapy is known to increase the possibility of kernicterus, Silver Sulfadiazine Cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.

Warnings

There is potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction.

Fungal proliferation in and below the eschar may occur. However, the incidence of clinically reported fungal superinfection is low.

The use of Silver Sulfadiazine Cream in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

Precautions

General: If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur and discontinuation of Silver Sulfadiazine Cream should be weighed against the therapeutic benefit being achieved.

In considering the use of topical proteolytic enzymes in conjunction with Silver Sulfadiazine Cream, the possibility should be noted that silver may inactivate such enzymes.

Laboratory Tests: In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 to 12mg %). Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals.

Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Long-term dermal toxicity studies of 24 months duration in rats and 18 months in mice with concentrations of silver sulfadiazine three to ten times the concentration in Silver Sulfadiazine Cream revealed no evidence of carcinogenicity.

Pregnancy: Pregnancy Category B. A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in Silver Sulfadiazine Cream and has revealed no evidence of harm to the fetus due to silver sulfadiazine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. (See CONTRAINDICATIONS)

Nursing Mothers

It is not known whether Silver Sulfadiazine Cream is excreted in human milk. However, sulfonamides are known to be excreted in human milk, and all sulfonamides derivatives are known to increase the possibility of kernicterus. Because of the possibility for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established. (See CONTRAINDICATIONS)

Adverse Reactions

Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within two to four days of initiation of therapy. Rebound to normal leukocyte levels follows onset within two to three days. Recovery is not influenced by continuation of silver sulfadiazine therapy. The incidence of leukopenia in various reports averages about 20%. A higher incidence has been seen in patients treated concurrently with cimetidine.

Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis.

Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias, including agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia and hemolytic anemia, dermatologic and and allergic reactions, including Stevens-Johnson syndrome and exfoliative dermatitis, gastrointestinal reactions, hepatitis and hepatocellular necrosis, CNS reactions, and toxic nephrosis.

Silver Sulfadiazine Cream Dosage and Administration

FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE:

Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided; and Silver Sulfadiazine Cream is applied under sterile conditions. The burn areas should be covered with Silver Sulfadiazine Cream at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity. Administration may be accomplished in minimal time because dressings are not required. However, if individual patient requirements make dressings necessary, they may be used.

Reapply immediately after hydrotherapy.

Treatment with Silver Sulfadiazine Cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

How is Silver Sulfadiazine Cream Supplied

SSD™ (1% Silver Sulfadiazine) Cream: white to off-white cream.

50 gram jar
400 gram jar
25 gram tube
50 gram tube
85 gram tube

SSD AF™ (1% Silver Sulfadiazine) Cream: white to off-white cream.

50 gram jar
400 gram jar

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

SSD is a trademark of Dr. Reddy's Laboratories Louisiana, LLC

Manufactured for

Par Pharmaceutical Companies, Inc.

Spring Valley, NY 10977

Manufactured by

Dr. Reddy's Laboratories Louisiana, LLC

Shreveport, LA 71106

Repacked by

H.J. Harkins Company, Inc.

Nipomo, CA 93444

Aug 2011

PRINCIPAL DISPLAY PANEL – 50 GRAM TUBE

SILVER SULFADIAZINE  silver sulfadiazine  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52959-635 (49884-600) Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER SULFADIAZINE (SILVER SULFADIAZINE) SILVER SULFADIAZINE 10 g  in 1000 g

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL   ISOPROPYL MYRISTATE   METHYLPARABEN 0.3 mg  in 1 g PETROLATUM   POLYOXYL 40 STEARATE   PROPYLENE GLYCOL   SORBITAN MONOOLEATE   STEARYL ALCOHOL   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52959-635-00 400 g In 1 VIAL None 2 52959-635-25 25 g In 1 VIAL None 3 52959-635-50 50 g In 1 VIAL None 4 52959-635-85 85 g In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018578	09/18/1997

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - Dr. Reddy's Laboratories Inc. DBA Dr. Reddy's Laboratories Louisiana, LLC (830397282)

Establishment
Name	Address	ID/FEI	Operations
Dr. Reddy's Laboratories Inc. DBA Dr. Reddy's Laboratories Louisiana, LLC		830397282	manufacture

Revised: 11/2011H.J. Harkins Company, Inc.

More Silver Sulfadiazine Cream resources

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

Compare Silver Sulfadiazine Cream with other medications

• Burns, External

Neurontin

Pronunciation: GAB-a-PEN-tin
Generic Name: Gabapentin
Brand Name: Neurontin

Neurontin is used for:

Treating certain types of seizures associated with epilepsy when used along with other medicines. It may also be used for treating nerve pain associated with herpes zoster (shingles) infection (postherpetic neuralgia). It may also be used for other conditions as determined by your doctor.

Neurontin is an anticonvulsant. Exactly how it works to prevent seizures and treat nerve pain is not known.

Do NOT use Neurontin if:

• you are allergic to any ingredient in Neurontin

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

Before using Neurontin:

Some medical conditions may interact with Neurontin. 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 problems, including if you are on dialysis


• if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions

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

• Morphine because it may increase the risk of Neurontin's side effects, including drowsiness

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

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

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


• Take Neurontin by mouth with or without food.


• Do not take an antacid containing aluminum or magnesium within 2 hours before you take Neurontin.


• If you are taking half of a scored tablet as your dose, take the other half of that tablet as your next dose. Throw away any half-tablets not used within several days of breaking a scored tablet.


• Do not suddenly stop taking Neurontin. Patients taking Neurontin to prevent seizures may have an increased risk of seizures if the medicine is suddenly stopped. If you need to stop Neurontin or add a new medicine, your doctor will gradually lower your dose.


• If you miss a dose of Neurontin, 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 Neurontin.

Important safety information:

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


• Do not change your dose of Neurontin without checking with your doctor.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Neurontin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Patients who take Neurontin may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Neurontin closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Neurontin may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body (eg, liver, blood cells). A rash may or may not occur along with this reaction. Contact your doctor right away if you develop symptoms such as rash; red, swollen, blistered, or peeling skin; swollen glands or lymph nodes; swelling of the lip or tongue; yellowing of the skin or eyes; unusual bruising or bleeding; severe tiredness or weakness; unusual muscle pain; or symptoms of infection (eg, fever, chills, sore throat).


• Diabetes patients - Neurontin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Neurontin may interfere with certain lab tests, including a certain urine protein test. Be sure your doctor and lab personnel know you are taking Neurontin.


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


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


• Neurontin may cause emotional or behavioral side effects in CHILDREN 3 to 12 years old. If the following side effects occur, notify your doctor immediately: emotional "swings", hostile or aggressive behavior, problems concentrating, decreased performance at school, an increase in restlessness or hyperactivity.


• Neurontin should be used with extreme caution in CHILDREN younger than 3 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 Neurontin while you are pregnant. Neurontin is found in breast milk. If you are or will be breast-feeding while you use Neurontin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Neurontin:

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:

Clumsiness; constipation; diarrhea; dizziness; drowsiness; dry mouth; nausea; stomach upset; tiredness; vomiting; 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; unusual hoarseness); abnormal thoughts; back and forth eye movements; behavioral problems; change in school performance; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hyperactivity; loss of coordination; memory loss; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); new or worsening seizures; numbness of an arm or leg; one-sided weakness; severe or persistent headache or dizziness; shortness of breath; speech changes or trouble speaking; suicidal thoughts or actions; swelling of the hands, legs, or feet; tremor; trouble concentrating; twitching; vision changes (eg, double or blurred vision).

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: Neurontin 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 diarrhea; double vision; drowsiness; sluggishness; slurred speech.

Proper storage of Neurontin:

Store Neurontin between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Neurontin out of the reach of children and away from pets.

General information:

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


• Neurontin 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 Neurontin. 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.

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Sulfacetamide Sodium

Sulfacetamide Sodium OPHTHALMIC SOLUTION USP, 10%

DESCRIPTION

Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical antibacterial agents for ophthalmic use. The active ingredient is represented by the following structural formula:

C8H9N2Na03S • H2O

MW = 254.24

Chemical Name:

N-Sulfanilylacetamide monosodium salt monohydrate.

Contains:

Active: Sulfacetamide Sodium 10% (100 mg/mL).

Preservative: methylparaben and propylparaben

Inactives: sodium thiosulfate, methylcellulose, and monobasic sodium phosphate

CLINICAL PHARMACOLOGY

Microbiology: The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.

Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

INDICATIONS AND USAGE

Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma:

Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Contraindications

Sulfacetamide Sodium Ophthalmic Solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

WARNINGS

FOR TOPICAL EYE USE ONLY - NOT FOR INJECTION.

FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.

PRECAUTIONS

General

Prolonged use of topical antibacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.

The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.

Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur.

At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (See WARNINGS).

Information for Patients

To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

Drug Interactions

Sulfacetamide preparations are incompatible with silver preparations.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systematically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children below the age of two months have not been established.

ADVERSE REACTIONS

Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations.

The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (See WARNINGS).

DOSAGE AND ADMINISTRATION

For conjunctivitis and other superficial ocular infections:

Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For trachoma:

Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

HOW SUPPLIED

Sulfacetamide Sodium Ophthalmic Solution USP, 10% is supplied sterile in plastic bottles in the following sizes:

15 mL: NDC 61314-701-01

Note: Store between 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded.

Rx Only

Dist. by:

FALCON Pharmaceuticals, Ltd

Fort Worth, Texas 76134

Mfd. by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134

Printed in USA

340192-1102

PRINCIPAL DISPLAY PANEL

NDC 61314-701-01           Rx Only

FALCON PHARMACEUTICALS®

Sulfacetamide

Sodium

Ophthalmic

Solution USP

10%

15 mL STERILE

AFFILIATE OF

ALCON LABORATORIES, INC.

QUALITY RX

Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

Sulfacetamide Sodium  Sulfacetamide Sodium  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52959-117 (61314-701) Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (SULFACETAMIDE) Sulfacetamide Sodium 100 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength METHYLPARABEN   PROPYLPARABEN   SODIUM THIOSULFATE   METHYLCELLULOSE (4000 CPS)   SODIUM PHOSPHATE, MONOBASIC

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52959-117-01 15 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA089560	03/25/2003

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - Falcon Pharmaceuticals, Ltd. (874345820)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 11/2011H.J. Harkins Company, Inc.

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