Sulfatrim

Generic Name: sulfamethoxazole/trimethoprim (Oral route)

sul-fa-meth-OX-a-zole, trye-METH-oh-prim

Commonly used brand name(s)

In the U.S.

• Bactrim


• Bactrim DS


• Septra


• Septra DS


• Sulfatrim


• Sulfatrim Pediatric

In Canada

• Apo-Sulfatrim


• Novo-Trimel


• Nu-Cotrimox


• Septa Pediatric


• Septra Pediatric Suspension

Available Dosage Forms:

• Tablet


• Suspension

Therapeutic Class: Sulfonamide Combination

Pharmacologic Class: Folic Acid Antagonist

Chemical Class: Sulfonamide

Uses For Sulfatrim

Sulfamethoxazole and trimethoprim combination is used to treat infections such as urinary tract infections, middle ear infections (otitis media), bronchitis, traveler's diarrhea, and shigellosis (bacillary dysentery). This medicine is also used to prevent or treat Pneumocystis carinii pneumonia (PCP), a very serious kind of pneumonia. This type of pneumonia occurs more commonly in patients whose immune systems are not working normally, such as cancer patients, transplant patients, and patients with acquired immune deficiency syndrome (AIDS).

Sulfamethoxazole and trimethoprim combination is an antibiotic. It works by eliminating the bacteria that cause many kinds of infections. This medicine will not work for colds, flu, or other virus infections.

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

Before Using Sulfatrim

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 sulfamethoxazole and trimethoprim combination in children and infants 2 months of age and older. Because of the toxicity of the combination of sulfamethoxazole and trimethoprim, use in infants younger than 2 months of age is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in the elderly. However, elderly patients are more likely to have a folate deficiency, age-related kidney or liver problems, and may be more likely to experience unwanted side effects (e.g., severe skin rash, increased potassium in the body, or problems with blood clotting or the immune system). There may be a dose adjustment for elderly patients receiving sulfamethoxazole and trimethoprim combination.

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

Sulfamethoxazole

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.

Trimethoprim

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.

• Bepridil


• Cisapride


• Dofetilide


• Levomethadyl


• Mesoridazine


• Pimozide


• Terfenadine


• Thioridazine

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.

• Acecainide


• Acenocoumarol


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Arsenic Trioxide


• Astemizole


• Azimilide


• Bretylium


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Clarithromycin


• Desipramine


• Dibenzepin


• Disopyramide


• Dolasetron


• Doxepin


• Droperidol


• Eltrombopag


• Enflurane


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gemifloxacin


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Imipramine


• Isoflurane


• Isradipine


• Lidoflazine


• Lorcainide


• Mefloquine


• Methotrexate


• Nortriptyline


• Octreotide


• Pentamidine


• Pirmenol


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Pyrimethamine


• Quetiapine


• Quinidine


• Risperidone


• Sematilide


• Sertindole


• Sotalol


• Spiramycin


• Sultopride


• Tedisamil


• Telithromycin


• Trifluoperazine


• Trimipramine


• Vasopressin


• Warfarin


• Zotepine

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.

• Acetohexamide


• Anisindione


• Chlorpropamide


• Didanosine


• Digoxin


• Enalaprilat


• Enalapril Maleate


• Fosphenytoin


• Glipizide


• Glyburide


• Phenytoin


• Quinapril


• Repaglinide


• Rifabutin


• Rosiglitazone


• Tolazamide


• Tolbutamide

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:

• Alcohol abuse, history of or


• Folate (vitamin B9) deficiency or


• HIV or AIDS or


• Kidney disease or


• Liver disease or


• Malabsorption syndrome (difficulty of absorbing food in the body) or


• Malnutrition state (nutrition disorder)—Use with caution. May have an increased chance of serious side effects.

• Anemia, megaloblastic (caused by not enough folic acid) or


• Drug-induced thrombocytopenia (low platelets in the blood) after using this medicine or


• Kidney disease, severe or


• Liver disease, severe—Should not be used in patients with these conditions.

• Asthma or


• Diabetes or


• Hyperkalemia (high potassium in the blood) or


• Porphyria (enzyme problem) or


• Severe allergies or


• Thyroid problems—Use with caution. May make these conditions worse.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (blood disorder) in patients with this condition.

• Streptococcal infection (group A β-hemolytic)—Sulfonamides should not be used in patients with this condition.

Proper Use of trimethoprim and sulfamethoxazole

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

Take this medicine exactly 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. To do so may increase the chance of side effects.

Sulfamethoxazole and trimethoprim combination is best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects. .

For patients taking the oral liquid, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

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 forms (liquid or tablets):
  
  • For treatment of bacterial infections:
    
    • Adults and children weighing 40 kilograms (kg) or more—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours. Your doctor may adjust this dose if needed.
    
    
    • Children and infants 2 months of age and older, and weighing up to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 40 milligrams (mg) of sulfamethoxazole and 8 milligrams (mg) of trimethoprim per kilogram of body weight, given in two divided doses every 12 hours.
    
    
    • Infants younger than 2 months of age—Use is not recommended.
    
    
  
  
  • For chronic bronchitis:
    
    • Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours. Your doctor may adjust this dose if needed.
    
    
    • Children and infants 2 months of age and older—Use and dose must be determined by your doctor.
    
    
    • Infants younger than 2 months of age—Use is not recommended.
    
    
  
  
  • For treatment of Pneumocystis carinii pneumonia (PCP):
    
    • Adults and children 2 months of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 75 to 100 milligrams (mg) of sulfamethoxazole and 15 to 20 milligrams (mg) of trimethoprim per kilogram of body weight each day, given in equally divided doses every 6 hours.
    
    
    • Infants younger than 2 months of age—Use is not recommended.
    
    
  
  
  • For prevention of Pneumocystis carinii pneumonia (PCP):
    
    • Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim once a day. Your doctor may adjust this dose if needed.
    
    
    • Children and infants 2 months of age and older—Dose is based on body size and must be determined by your doctor. The dose is 750 mg of sulfamethoxazole and 150 mg of trimethoprim per square meter (m[2]) of body surface each day. This is given in equally divided doses two times a day for 3 days a week on consecutive days (e.g., Monday, Tuesday, Wednesday).
    
    
    • Infants younger than 2 months of age—Use is not recommended.
    
    
  
  
  • For traveler's diarrhea:
    
    • Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours. Your doctor may adjust this dose if needed.
    
    
    • Children and infants 2 months of age and older—Use and dose must be determined by your doctor.
    
    
    • Infants younger than 2 months of age—Use is not recommended.
    
    
  
  

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.

Precautions While Using Sulfatrim

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Very rarely, this medicine has caused severe side effects. If you or your child start to have a skin rash, or if you think you are having a severe skin reaction, stop taking this medicine and call your doctor right away. Symptoms of a severe reaction may include a skin rash, skin color that is very pale or yellow, or skin with purple spots, along with a sore throat, fever, muscle pain, cough, and trouble with breathing.

This medicine, especially if you are receiving high doses or for a long period of time, may lower the number of platelets in your body, which are necessary for proper blood clotting. Because of this, you may bleed or get infections more easily. Talk with your doctor if you have concerns about this.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Check with your doctor right away if you or your child have abdominal or stomach cramps; bloating; watery and severe diarrhea, which may also be bloody; nausea or vomiting; or unusual tiredness or weakness. These may be symptoms of a serious intestinal infection.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; shortness of breath; or chest pain after you use the medicine.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Patients receiving anticonvulsant therapy (medicines to prevent seizures) may be at risk for a folate (vitamin B9) deficiency, which may increase the risk for side effects. Talk with your doctor if you have concerns about this.

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.

Sulfatrim 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:

Rare

• Abdominal or stomach pain


• black, tarry stools


• blistering, peeling, or loosening of the skin


• changes in skin color


• chest pain


• chills


• cough or hoarseness


• dark urine


• diarrhea


• dizziness


• fever with or without chills


• general feeling of tiredness or weakness


• headache


• itching


• joint or muscle pain


• light-colored stools


• loss of appetite


• lower back or side pain


• nausea


• pain, tenderness, or swelling of the foot or leg


• painful or difficult urination


• pale skin


• rash


• red irritated eyes


• red skin lesions, often with a purple center


• shortness of breath


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• swollen or painful glands


• tightness in the chest


• unpleasant breath odor


• unusual bleeding or bruising


• vomiting of blood


• wheezing


• yellow eyes or skin

Incidence not known

• Abdominal or stomach tenderness


• back, leg, or stomach pains


• bleeding gums


• blindness or vision changes


• blisters, hives, or itching


• bloating


• blood in the urine or stools


• bluish-colored lips, fingernails, or palms


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


• burning of the face or mouth


• chest pain


• cloudy urine


• confusion


• constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• convulsions


• cracks in the skin


• decreased frequency or amount of urine


• diarrhea, watery and severe, which may also be bloody


• difficulty with breathing


• difficulty with swallowing


• fainting spells


• general body swelling


• general feeling of discomfort or illness


• hair loss


• hearing loss


• hives


• increased blood pressure


• increased thirst


• indigestion


• irregular heartbeat


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


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of heat from the body


• muscle or joint pain


• nosebleeds


• not able to pass urine


• numbness or tingling in the hands, feet, or lips


• pain or burning while urinating


• pinpoint red spots on the skin


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


• raised red swellings on the skin, the buttocks, legs, or ankles


• redness of the white part of the eyes


• redness, swelling, or soreness of the tongue


• sores, ulcers, or white spots on the lips or in the mouth


• soreness of the muscles


• stiff neck or back


• swelling of the face, hands, legs, and feet


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


• unusual weight loss


• weakness in the hands or feet


• weakness or heaviness of the 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

• Passing of gas

Incidence not known

• Discouragement


• feeling of constant movement of self or surroundings


• feeling sad or empty


• increased sensitivity of skin to sunlight


• irritability


• lack of feeling or emotion


• loss of interest or pleasure


• nervousness


• redness or other discoloration of the skin


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


• sensation of spinning


• severe sunburn


• sleeplessness


• trouble concentrating


• trouble sleeping


• unable to sleep


• uncaring


• weight loss

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: Sulfatrim side effects (in more detail)

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More Sulfatrim resources

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

• Sulfatrim Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Bactrim Prescribing Information (FDA)


• Bactrim Consumer Overview


• Bactrim MedFacts Consumer Leaflet (Wolters Kluwer)


• Bactrim DS Prescribing Information (FDA)


• Cotrim Consumer Overview


• Septra Prescribing Information (FDA)


• Septra Consumer Overview

Compare Sulfatrim with other medications

• Acne
• Bacterial Infection
• Bacterial Skin Infection
• Bronchitis
• Diverticulitis
• Epiglottitis
• Granuloma Inguinale
• Infection Prophylaxis
• Kidney Infections
• Melioidosis
• Meningitis
• Nocardiosis
• Otitis Media
• Pneumocystis Pneumonia
• Pneumocystis Pneumonia Prophylaxis
• Pneumonia
• Prevention of Bladder infection
• Prostatitis
• Shigellosis
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• Toxoplasmosis
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Cuprimine

Generic Name: penicillamine (Oral route)

pen-i-SIL-a-meen

Oral route(Capsule;Tablet)

Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special dosage considerations, and therapeutic benefits. Patients should be warned to report promptly any symptoms suggesting toxicity .

Commonly used brand name(s)

In the U.S.

• Cuprimine


• Depen

Available Dosage Forms:

• Capsule


• Tablet

Therapeutic Class: Antirheumatic

Uses For Cuprimine

Penicillamine is used in the treatment of medical problems such as Wilson's disease (too much copper in the body) and rheumatoid arthritis. Also, it is used to prevent kidney stones. Penicillamine may also be used for other conditions as determined by your doctor.

In addition to the helpful effects of this medicine, it has side effects that can be very serious. Before you take penicillamine, be sure that you have discussed the use of it with your doctor.

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

Once a product has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, penicillamine is used in certain patients with the following conditions:

• Felty's syndrome


• Heavy metal toxicity


• Rheumatoid vasculitis

Before Using Cuprimine

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

Although there is no specific information about the use of penicillamine in children, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older. In clinical trials, elderly people may have an increased chance for getting a skin rash.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. 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.

• Aurothioglucose

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.

• Auranofin


• Gold Sodium Thiomalate

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.

• Iron

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.

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:

• Blood disease caused by penicillamine treatment, history of or


• Kidney disease or history of (only for patients with rheumatoid arthritis)—The chance of side effects may be increased

Proper Use of penicillamine

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

Since penicillamine is taken in different ways for different medical problems, it is very important that you understand exactly why you are taking this medicine and how to take it. See below for information on specific medical problems. If you have any questions about this, check with your doctor.

For patients taking this medicine to prevent kidney stones:

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals) and at least 1 hour before or after any other food, milk, or medicine.


• You should drink 2 full glasses (8 ounces each) of water at bedtime and another 2 full glasses (8 ounces each) during the night.


• It is very important that you follow any special instructions from your doctor, such as following a low-methionine diet. If you have any questions about this, check with your doctor.

For patients taking this medicine for rheumatoid arthritis :

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals) and at least 1 hour before or after any other food, milk, or medicine.


• After you begin taking this medicine, 2 to 3 months may pass before you feel its effects. It is very important that you keep taking the medicine, even if you do not feel better, in order to give it time to work.

For patients taking this medicine for Wilson's disease :

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals).


• It is very important that you follow any special instructions from your doctor, such as following a low-copper diet. If you have any questions about this, check with your doctor.


• After you begin taking this medicine, 1 to 3 months may pass before you notice any improvement in your condition.

For patients taking this medicine for lead poisoning :

• Take this medicine on an empty stomach (2 hours before meals or at least 3 hours after meals).

For all patients:

• Take this medicine regularly as directed. Do not stop taking it without first checking with your doctor, since stopping the medicine and then restarting it may increase the possibility of side effects.

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 forms (capsules or tablets):
  
  • For Wilson's disease (too much copper in the body):
    
    • Adults and teenagers—At first, 250 milligrams (mg) four times a day. After a while your doctor may need to increase the dose, depending on the amount of copper in your urine. Most people do not need more than 2000 mg a day (two 250-mg capsules or tablets four times a day).
    
    
    • Children (older than 6 months of age)—At first, 250 mg a day. After a while your doctor may need to increase the dose, depending on the amount of copper in your urine. Older children may need the same dose as adults.
    
    
  
  
  • For rheumatoid arthritis:
    
    • Adults—At first, 125 or 250 mg once a day. Your doctor may increase the dose after a few months, depending on how well the medicine is working and whether it causes any side effects. The largest dose is not more than 1500 mg a day (two 250-mg capsules or tablets three times a day).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For preventing kidney stones:
    
    • Adults—At first, 500 mg (two 250-mg capsules or tablets) four times a day. After a while your doctor may need to change the dose, depending on the results of your urine tests. Some people may need as much as 4000 mg a day (four 250-mg capsules or tablets four times a day).
    
    
    • Children—The dose is based on body weight and must be determined by your doctor. At first, 7.5 mg per kilogram (kg) (about 3.5 mg per pound) of body weight four times a day. After a while your doctor may need to change the dose, depending on the results of your urine tests.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Cuprimine

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

Before having any kind of surgery (including dental surgery), tell the medical doctor or dentist in charge that you are taking this medicine.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Do not take iron preparations or vitamin preparations containing iron without checking with your healthcare provider. If your doctor tells you to take iron preparations, or vitamin preparations containing iron, do not take them within 2 hours of the time you take this medicine. Taking the two medicines too close together may keep the penicillamine from working properly.

Tell your doctor right away if you get a fever, sore throat, chills, bruising, or bleeding. These may be symptoms of a serious blood problem.

Tell your doctor right away if you have trouble breathing, noisy breathing, or an unexplained cough. These may be symptoms of a serious lung problem.

Cuprimine 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 as soon as possible if any of the following side effects occur:

More common

• Fever


• joint pain


• lesions on the face, neck, scalp, and/or trunk


• skin rash, hives, or itching


• swollen and/or painful glands


• ulcers, sores, or white spots on lips or in mouth

Less common

• Bloody or cloudy urine


• shortness of breath, troubled breathing, tightness in chest, or wheezing


• sore throat and fever with or without chills


• swelling of face, feet, or lower legs


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight gain

Rare

• Abdominal or stomach pain (severe)


• blisters on skin


• bloody or black, tarry stools


• chest pain


• coughing or hoarseness


• dark urine


• difficulty in breathing, chewing, talking, or swallowing


• eye pain, blurred or double vision, or any change in vision


• general feeling of discomfort or illness or weakness


• lower back or side pain


• muscle weakness


• painful or difficult urination


• pale stools


• pinpoint red spots on skin


• redness, tenderness, itching, burning, or peeling of skin


• red or irritated eyes


• red, thick, or scaly skin


• ringing or buzzing in the ears


• spitting blood


• yellow eyes or skin

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

• Diarrhea


• lessening or loss of sense of taste


• loss of appetite


• nausea or vomiting


• stomach pain (mild)

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: Cuprimine 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 Cuprimine resources

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

• Cuprimine Prescribing Information (FDA)


• Cuprimine MedFacts Consumer Leaflet (Wolters Kluwer)


• Cuprimine Concise Consumer Information (Cerner Multum)


• Penicillamine Professional Patient Advice (Wolters Kluwer)


• Penicillamine Monograph (AHFS DI)


• Depen Prescribing Information (FDA)

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Activase

Pronunciation: AL-teh-PLACE
Generic Name: Alteplase
Brand Name: Activase

Activase is used for:

Treating blood clots in the lungs and improving heart function and survival following a heart attack. Activase may also be used to improve recovery and reduce disability in certain patients who have had a stroke. It may also be used for other conditions as determined by your doctor.

Activase is a tissue plasminogen activator (tPA). It works by helping to break down unwanted blood clots.

Do NOT use Activase if:

• you are allergic to any ingredient in Activase


• you have active internal bleeding, history of stroke, recent brain or spinal surgery (within 3 months), a growth in the brain, abnormal formation of blood vessels, or a certain type of bulging blood vessel (aneurysm)


• you have a heart attack or blood clot in the lung and you also have had recent brain or spinal injury, a history of bleeding problems, or severe uncontrolled high blood pressure


• you have a stroke and you also have known or suspected bleeding in the head or brain, a history of bleeding in the brain, a recent serious head injury, uncontrolled high blood pressure, low platelet count, high international normalized ratio (INR) or prothrombin time (PT), or a history of bleeding problems, or if you had a seizure at the onset of the stroke


• you have a stroke and you are taking warfarin, or you have used heparin within the past 48 hours and you currently have a high activated partial thromboplastin time (aPTT)

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

Before using Activase:

Tell your health care provider 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 had recent major surgery or have recently undergone childbirth


• if you have a disease of the blood vessels in your brain; recent bleeding of the stomach, bowel, genitals, or urinary tract; a recent injury; high blood pressure; inflammation around the heart; inflammation inside the heart due to an infection; blood problems (including blood clotting problems); moderate to severe liver disease; severe kidney disease; bleeding in the eye due to diabetes or other problems; a serious infection; or blood vessel inflammation


• if you have an increased risk of a blood clot in your heart


• if you are older than 75 years of age

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

• Abciximab, anticoagulants (eg, warfarin, heparin), aspirin, or dipyridamole because the risk of serious side effects, such as bleeding, may be increased


• Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril) because the risk of serious side effects, such as severe swelling or trouble breathing, may be increased


• Nitrates (eg, nitroglycerin, isosorbide dinitrate) because the effectiveness of Activase may be decreased

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

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

• Activase is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Activase at home, carefully follow the injection procedures taught to you by your health care provider.


• If Activase contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Mix Activase by swirling gently. Do not shake.


• Throw away any unused medicine left in the vial.


• Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.


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

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

Important safety information:

• Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Activase. Using Activase alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Activase may reduce the number of cells in your blood that help your blood clot (platelets). To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• If serious bleeding occurs while you are using Activase, contact your doctor immediately.


• LAB TESTS, including electrocardiogram (ECG), blood coagulation, and blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


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


• Use Activase with extreme caution in CHILDREN. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY AND BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this product during pregnancy. It is unknown if Activase is excreted in breast milk. If you are or will be breast-feeding while you are using Activase, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Activase:

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; bloody vomit; change in color of your fingers or toes; changes in vision; chills; coughing up blood; decreased amount of urine produced; difficulty breathing or sudden shortness of breath; difficulty swallowing; fast, slow, or irregular heartbeat; fever; hoarseness; numbness in arm or leg; one-sided weakness; pain, redness, or swelling at the injection site; purple skin color; rectal bleeding; seizures; severe bleeding; severe muscle aches or pain; severe stomach pain; sharp or crushing chest pain; speech problems or changes; sudden arm or leg pain; sudden dizziness, fainting, severe headache, or vomiting; unusual or easy bleeding or bruising.

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: Activase 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 severe bleeding.

Proper storage of Activase:

Store Activase at room temperature, below 86 degrees F (30 degrees C), or under refrigeration, between 36 and 46 degrees F (2 and 8 degrees C). Store away from heat, moisture, and light. Keep Activase, as well as syringes and needles, out of the reach of children and away from pets.

General information:

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


• Activase 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 Activase. 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 Activase resources

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

• Activase Advanced Consumer (Micromedex) - Includes Dosage Information


• Alteplase Monograph (AHFS DI)

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Sonahist DM Pediatric Drops

Pronunciation: KLOR-fen-IR-a-meen/DEX-troe-meth-OR-fan/FEN-il-EF-rin
Generic Name: Chlorpheniramine/Dextromethorphan/Phenylephrine
Brand Name: Examples include AccuHist PDX Drops, Bronkids, and Sonahist DM Pediatric Drops

Sonahist DM Pediatric Drops is used for:

Relieving sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory tract infections, and allergies. It may also be used for other conditions as determined by your doctor.

Sonahist DM Pediatric Drops is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Sonahist DM Pediatric Drops if:

• you are allergic to any ingredient in Sonahist DM Pediatric Drops


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking droxidopa, sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Sonahist DM Pediatric Drops:

Some medical conditions may interact with Sonahist DM Pediatric Drops. 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 adrenal gland problems (eg, an adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, or thyroid problems


• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea) or chronic obstructive pulmonary disease (COPD), or if your cough produces large amounts of mucus


• if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; an enlarged prostate or other prostate problems; or trouble urinating

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

• Digoxin or droxidopa because the risk of irregular heartbeat or a heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Sonahist DM Pediatric Drops's side effects


• Barbiturates (eg, phenobarbital), bromocriptine, or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Sonahist DM Pediatric Drops


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Sonahist DM Pediatric Drops

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

Use Sonahist DM Pediatric Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sonahist DM Pediatric Drops by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use the dropper that comes with Sonahist DM Pediatric Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Sonahist DM Pediatric Drops and you are taking it regularly, 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 Sonahist DM Pediatric Drops.

Important safety information:

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


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


• Do not take diet or appetite control medicines while you are taking Sonahist DM Pediatric Drops without checking with your doctor.


• Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Sonahist DM Pediatric Drops for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Do NOT exceed the recommended dose or take Sonahist DM Pediatric Drops for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days, if they get worse, if they are accompanied by fever, or if your cough is accompanied by rash or persistent headache, check with your doctor.


• Sonahist DM Pediatric Drops may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sonahist DM Pediatric Drops. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Sonahist DM Pediatric Drops may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Sonahist DM Pediatric Drops for a few days before the tests.


• Tell your doctor or dentist that you take Sonahist DM Pediatric Drops before you receive any medical or dental care, emergency care, or surgery.


• Use Sonahist DM Pediatric Drops with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, nervousness, sleeplessness, and trouble urinating.


• Caution is advised when using Sonahist DM Pediatric Drops in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Different brands of Sonahist DM Pediatric Drops may have different dosing instructions for CHILDREN. They may also be indicated for different age ranges of children. Follow the dosing instructions that your doctor has given you. If you are unsure of the dose to give to your child or if you are unsure if Sonahist DM Pediatric Drops is appropriate for your child, check with your doctor or pharmacist.


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

Possible side effects of Sonahist DM Pediatric Drops:

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

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth; excitability; headache; heartburn; loss of appetite; nausea; nervousness; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; increased urination; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent 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: Sonahist DM Pediatric 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 (http://www.aapcc.org ), or emergency room immediately. Symptoms may include blurred vision; confusion; decreased coordination; excitability; fever; flushing; hallucinations; mental or mood changes; muscle spasms; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Sonahist DM Pediatric Drops:

Store Sonahist DM Pediatric Drops between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sonahist DM Pediatric Drops out of the reach of children and away from pets.

General information:

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


• Sonahist DM Pediatric Drops 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 Sonahist DM Pediatric Drops. 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 Sonahist DM Pediatric resources

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

Compare Sonahist DM Pediatric with other medications

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Acuvail

ketorolac tromethamine

Dosage Form: ophthalmic solution
FULL PRESCRIBING INFORMATION

Indications and Usage for Acuvail

Acuvail® ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery.

Acuvail Dosage and Administration

Recommended Dosing

Patient Dosing

One drop of Acuvail® should be applied to the affected eye twice daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of the postoperative period.

Use With Other Topical Ophthalmic Medications

Acuvail® ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

Dosage Forms and Strengths

4.5 mg/mL ketorolac tromethamine solution (0.45%) in a single-use vial.

Contraindications

Acuvail® solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

Warnings and Precautions

Delayed Healing

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Potential for Cross-Sensitivity

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Increased Bleeding Time

With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

It is recommended that Acuvail® ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.

Corneal Effects

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.

Contact Lens Wear

Acuvail® should not be administered while wearing contact lenses.

Adverse Reactions

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Studies

The most common adverse events were reported in 1-6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred. Some of these events may be the consequence of the cataract surgical procedure.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects.

Pregnancy Category C: Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 600 times and 1700 times higher respectively than the typical human topical ophthalmic daily dose of 0.35 mg (4.5 mg/mL x 0.04 mL/drop, BID) to an affected eye on a mg/kg basis. Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 300 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Acuvail® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Acuvail® solution during late pregnancy should be avoided.

Nursing Mothers

Because many drugs are excreted in human milk, caution should be exercised when Acuvail® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Acuvail Description

Acuvail® (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and its molecular weight is 376.40. Its molecular formula is C19H24N2O6. Its chemical structure is:

Acuvail® solution is supplied as a sterile isotonic aqueous 0.45% preservative-free solution, with a pH of approximately 6.8. Acuvail® solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The osmolality of Acuvail® solution is approximately 285 mOsml/kg.

Contains: Active: ketorolac tromethamine 0.45%. Inactives: carboxymethylcellulose sodium; sodium chloride; sodium citrate dihydrate; and purified water with sodium hydroxide and/or hydrochloric acid to adjust pH.

Acuvail - Clinical Pharmacology

Mechanism of Action

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.

Pharmacokinetics

The pharmacokinetics of ketorolac tromethamine ophthalmic solution 0.45% have not been assessed in humans.

Two drops of 0.5% ketorolac tromethamine ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in the aqueous humor of 8 of 9 eyes tested (range 40 to 170 ng/mL).

One drop of 0.5% ketorolac tromethamine ophthalmic solution was instilled into 1 eye and 1 drop of vehicle into the other eye TID in 26 normal subjects. Five (5) of 26 subjects had detectable concentrations of ketorolac in their plasma (range 11 to 22 ng/mL) at Day 10 during topical ocular treatment. The range of concentrations following TID dosing of 0.5% ketorolac tromethamine ophthalmic solution are approximately 4 to 8% of the steady state mean minimum plasma concentration observed following four times daily oral administration of 10 mg ketorolac in humans (0.29 ± 0.07 μg/mL).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ketorolac tromethamine was not carcinogenic in either rats given up to 5 mg/kg/day orally for 24 months or in mice given 2 mg/kg/day orally for 18 months. These doses are approximately 900 times and 300 times higher respectively than the typical human topical ophthalmic daily dose given as BID to an affected eye on a mg/kg basis.

Ketorolac tromethamine was not mutagenic in vitro in the Ames assay or in forward mutation assays. Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or an in vivo increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.

Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 9 mg/kg/day and 16 mg/kg/day, respectively. These doses are respectively 1500 and 2700 times higher than the typical human topical ophthalmic daily dose.

Clinical Studies

Two multicenter, randomized, double-masked, parallel group comparison studies including approximately 500 patients were conducted to evaluate the effects of Acuvail® on anterior chamber cell and flare, and ocular pain relief following cataract extraction with posterior chamber intraocular lens (IOL) implantation. Results of these studies indicated that patients receiving Acuvail® had a significantly higher incidence of clearing of anterior chamber inflammation 53% (167/318) vs. patients receiving vehicle 26% (41/155) at day 14.

Acuvail® was also significantly superior to vehicle in resolving ocular pain. On Day 1 post cataract surgery, 72% (233/322) of patients in the Acuvail® group were pain free compared to 40% (62/156) of patients in the vehicle group.

Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

How Supplied/Storage and Handling

Acuvail® (ketorolac tromethamine ophthalmic solution) 0.45% is available as a sterile solution supplied in clear, LDPE, single-use vials packaged in 6 foil pouches, 5 vials per pouch:

30 Single-Use Vials 0.4 mL each: NDC 0023-3507-30

Storage: Acuvail® should be stored at 15°-30° C (59°-86° F). Store the vials in the pouch, protected from light. Fold pouch ends closed.

Patient Counseling Information

Slow or Delayed Healing

Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

Avoiding Contamination of the Product

Patients should be instructed that the solution from one individual single-use vial is to be used immediately after opening for administration to the affected eye. The remaining contents should be discarded immediately after administration. Avoid allowing the tip of the vial to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Store the vials in the pouch, protected from light. Fold pouch ends closed.

Contact Lens Wear

Acuvail® solution should not be administered while wearing contact lenses.

Intercurrent Ocular Conditions

Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of Acuvail®.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.

Rx Only

© 2011 Allergan, Inc., Irvine, CA 92612, U.S.A.

® marks owned by Allergan, Inc.

U.S. Patent 7,842,714

Made in the U.S.A.

72220US12C

Acuvail®

(ketorolac tromethamine

ophthalmic solution) 0.45%

Allergan, Inc.

NDC 0023-3507-30

5 Single-Use Vials

0.4 mL Each

Preservative-Free

Sterile

Acuvail®

(ketorolac tromethamine

ophthalmic solution) 0.45%

FOR SINGLE-USE ONLY

Store the vials in the pouch, protected

from light. Fold pouch ends closed.

Rx only   ALLERGAN

ALLERGAN NDC 0023-3507-30

Acuvail®

(ketorolac tromethamine

ophthalmic solution) 0.45%

Preservative-Free

FOR SINGLE-USE ONLY

Rx only

sterile

30 Single-Use Vials 0.4 mL Each

Acuvail  ketorolac tromethamine  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0023-3507 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ketorolac tromethamine (ketorolac tromethamine) ketorolac tromethamine 4.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength carboxymethylcellulose sodium   sodium chloride   trisodium citrate dihydrate   water   sodium hydroxide   hydrochloric acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0023-3507-05 5 VIAL In 1 CARTON contains a VIAL, SINGLE-USE 1 0.4 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (0023-3507-05) 2 0023-3507-30 30 VIAL In 1 CARTON contains a VIAL, SINGLE-USE 2 0.4 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (0023-3507-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022427	08/01/2009

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Allergan, Inc.		362898611	MANUFACTURE

Revised: 04/2011Allergan, Inc.

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

• Acuvail Advanced Consumer (Micromedex) - Includes Dosage Information


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Compare Acuvail with other medications

• Postoperative Ocular Inflammation

methylprednisolone Injection

meth-il-pred-NIS-oh-lone

Commonly used brand name(s)

In the U.S.

• A-Methapred


• Depo-Medrol


• Solu-Medrol

Available Dosage Forms:

• Powder for Solution


• Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For methylprednisolone

Methylprednisolone injection provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, eye or vision problems, lupus, skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Methylprednisolone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

methylprednisolone is available only with your doctor's prescription.

Before Using methylprednisolone

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 methylprednisolone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methylprednisolone 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 methylprednisolone injection in children. However, pediatric patients are more likely to have slower growth and bone problems if methylprednisolone injection is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Depo-Medrol® and some strengths of Solu-Medrol® injection should not be used in premature infants. Both brands of methylprednisolone injection contain benzyl alcohol, which may cause serious unwanted effects in premature infants.

Geriatric

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

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 receiving methylprednisolone, 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 methylprednisolone 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.

• Rotavirus Vaccine, Live

Using methylprednisolone 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.

• Aldesleukin


• Bupropion


• Fluindione


• Quetiapine


• Telaprevir

Using methylprednisolone 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.

• Acenocoumarol


• Alatrofloxacin


• Alcuronium


• Aprepitant


• Aspirin


• Atracurium


• Balofloxacin


• Carbamazepine


• Cinoxacin


• Ciprofloxacin


• Clarithromycin


• Clinafloxacin


• Cyclosporine


• Dalfopristin


• Diltiazem


• Enoxacin


• Erythromycin


• Fleroxacin


• Fluindione


• Flumequine


• Fosphenytoin


• Gallamine


• Gemifloxacin


• Grepafloxacin


• Hexafluorenium


• Itraconazole


• Ketoconazole


• Levofloxacin


• Licorice


• Lomefloxacin


• Metocurine


• Mibefradil


• Moxifloxacin


• Nefazodone


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Phenobarbital


• Primidone


• Prulifloxacin


• Quinupristin


• Rifampin


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Troleandomycin


• Trovafloxacin Mesylate


• Warfarin

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 methylprednisolone. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain injury, traumatic or


• Cerebral malaria or


• Fungal infections, systemic or


• Herpes simplex eye infection, active or


• Idiopathic thrombocytopenic purpura (low platelet count)—Should not be given to patients with these conditions.

• Cataracts or


• Cirrhosis (liver problem) or


• Congestive heart failure or


• Cushing's syndrome (adrenal gland problem) or


• Depression or


• Diabetes or


• Emotional problems or


• Eye infection or


• Glaucoma or


• Heart attack, recent or


• Heart disease or


• Hyperglycemia (high blood sugar) or


• Hypertension (high blood pressure) or


• Mental illness or


• Myasthenia gravis (severe muscle weakness) or


• Osteoporosis (weak bones) or


• Stomach or bowel problems (e.g., diverticulitis, ulcers, ulcerative colitis) or


• Thyroid problems or


• Tuberculosis, inactive—Use with caution. May make these conditions worse.

• Infection (bacteria, virus, fungus, parasite, or protozoa)—May decrease your body's ability to fight infection.

Proper Use of methylprednisolone

A nurse or other trained health professional will give you methylprednisolone. methylprednisolone may be given through a needle placed in one of your veins, as a shot into a muscle or joint, or as a shot into a lesion on your skin.

Your doctor may give you a few doses of methylprednisolone until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using methylprednisolone

Your doctor will check your progress closely while you are receiving methylprednisolone. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood or urine tests may be needed to check for unwanted effects.

Using methylprednisolone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using methylprednisolone, tell your doctor right away.

If you are using methylprednisolone for a long time, the skin at the injection site may become slightly depressed or wrinkled. Talk to your doctor if you notice any of these changes at the injection site: depressed or indented skin; or pain, redness, or sloughing (peeling) of the skin.

If you are using methylprednisolone for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of methylprednisolone might need to be changed for a short time while you have extra stress.

Using too much of methylprednisolone or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using methylprednisolone: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

methylprednisolone may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

Tell your doctor if you or your child have recently spent time in a tropical climate or have unexplained diarrhea before receiving methylprednisolone.

While you are being treated with methylprednisone injection, do not have any immunizations (vaccines) without your doctor's approval. Methylprednisone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

methylprednisolone might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using methylprednisolone, tell the doctor if you think your child is not growing properly.

methylprednisolone may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while using methylprednisolone.

Make sure any doctor or dentist who treats you knows that you are using methylprednisolone. methylprednisolone may affect the results of certain skin tests.

Do not stop using methylprednisolone without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

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.

methylprednisolone 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 or nurse immediately if any of the following side effects occur:

More common

• Aggression


• agitation


• anxiety


• blurred vision


• decrease in the amount of urine


• dizziness


• fast, slow, pounding, or irregular heartbeat or pulse


• headache


• irritability


• mental depression


• mood changes


• nervousness


• noisy, rattling breathing


• numbness or tingling in the arms or legs


• pounding in the ears


• shortness of breath


• swelling of the fingers, hands, feet, or lower legs


• trouble thinking, speaking, or walking


• troubled breathing at rest


• weight gain

Incidence not known

• Abdominal cramping and/or burning (severe)


• abdominal pain


• backache


• bloody, black, or tarry stools


• cough or hoarseness


• darkening of skin


• decrease in height


• decreased vision


• diarrhea


• dry mouth


• eye pain


• eye tearing


• facial hair growth in females


• fainting


• fatigue


• fever or chills


• flushed, dry skin


• fractures


• fruit-like breath odor


• full or round face, neck, or trunk


• heartburn and/or indigestion (severe and continuous)


• increased hunger


• increased thirst


• increased urination


• loss of appetite


• loss of sexual desire or ability


• lower back or side pain


• menstrual irregularities


• muscle pain or tenderness


• muscle wasting or weakness


• nausea


• pain in back, ribs, arms, or legs


• painful or difficult urination


• skin rash


• sleeplessness


• sweating


• trouble healing


• trouble sleeping


• unexplained weight loss


• unusual tiredness or weakness


• vision changes


• vomiting


• vomiting of material that looks like coffee grounds

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

• Increased appetite

Incidence not known

• Abnormal fat deposits on the face, neck, and trunk


• acne


• dry scalp


• lightening of normal skin color


• pain, redness, or hard skin at the injection site


• pitting or depression of the skin at the injection site


• red face


• reddish purple lines on the arms, face, legs, trunk, or groin


• swelling of the stomach area


• thinning of the scalp hair

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.

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