Gantrisin Pediatric

They will not work for colds, flu, or other virus infections.

Sulfonamides are available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet


• Capsule


• Tablet, Enteric Coated


• Suspension


• Capsule, Extended Release


• Syrup

Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Sulfonamides should not be given to infants under 2 months of age unless directed by the child`s doctor, because they may cause unwanted effects.

Geriatric

Elderly people are especially sensitive to the effects of sulfonamides. Severe skin problems and blood problems may be more likely to occur in the elderly. These problems may also be more likely to occur in patients who are taking diuretics (water pills) along with this medicine.

Pregnancy

Studies have not been done in pregnant women. However, studies in mice, rats, and rabbits have shown that some sulfonamides cause birth defects, including cleft palate and bone problems . Sulfonamides are not recommended for use at the time of labor and delivery. These medicines may cause unwanted effects in the baby .

Breastfeeding

Sulfonamides pass into the breast milk. This medicine is not recommended for use during breast-feeding. It may cause liver problems, anemia, and other unwanted effects in nursing babies, especially those with glucose-6-phosphate dehydrogenase (G6PD) deficiency .

Drug Interactions

Using medicines in this class with any of the following medicines is not recommended . Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Bepridil


• Cisapride


• Dofetilide


• Levomethadyl


• Mesoridazine


• Pimozide


• Terfenadine


• Thioridazine

Using medicines in this class 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


• Digitalis


• Disopyramide


• Dolasetron


• Doxepin


• Droperidol


• Enflurane


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gemifloxacin


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Imipramine


• Isoflurane


• Isradipine


• Levomethadyl


• Lidoflazine


• Lorcainide


• Mefloquine


• Methotrexate


• Nortriptyline


• Octreotide


• Pentamidine


• Pirmenol


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Proscillaridin


• Pyrimethamine


• Quetiapine


• Quinidine


• Riluzole


• Risperidone


• Sematilide


• Sertindole


• Sotalol


• Spiramycin


• Sultopride


• Tedisamil


• Telithromycin


• Trifluoperazine


• Trimipramine


• Vasopressin


• Warfarin


• Zotepine

Other Interactions

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 medicines in this class 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 your 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or other blood problems or


• Glucose-6-phosphate dehydrogenase (G6PD) deficiencya€”Patients with these problems may have an increase in side effects affecting the blood .

• Kidney disease or


• Liver diseasea€”Patients with kidney and/or liver disease may have an increased chance of side effects.

• Porphyriaa€”This medicine may bring on an attack of porphyria.

Proper Use

Sulfonamides should not be given to infants less than 2 months of age unless directed by the patient`s doctor because sulfonamides may cause serious unwanted effects.

Sulfonamides are 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 of sulfonamides.

For patients taking the oral liquid form of this medicine:

• 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 taking 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.

This medicine works best when there is a constant amount in the blood or urine . To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night . If you need help in planning the best times to take your medicine, check with your health care professional .

Dosing

The dose medicines in this class 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 these medicines. 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 sulfadiazine

• For oral dosage form (tablet):
  
  
  
  • For bacterial or protozoal infections:
    
    
    
    • Adults and teenagersa€”2 to 4 grams for the first dose, then 1 gram every four to six hours.
    
    
    • Children 2 months of age and oldera€”Dose is based on body weight . The usual dose is 75 milligrams (mg) per kilogram (kg) (34 mg per pound) of body weight for the first dose, then 37.5 mg per kg (17 mg per pound) of body weight every six hours, or 25 mg per kg (11.4 mg per pound) of body weight every four hours.
    
    
    • Children up to 2 months of agea€”Use is not recommended .
    
    
    
    
  
  
  
  

For sulfamethizole

• For oral dosage form (tablets):
  
  
  
  • For bacterial infections:
    
    
    
    • Adults and teenagersa€”500 milligrams (mg) to 1 gram every six to eight hours.
    
    
    • Children 2 months of age and oldera€”Dose is based on body weight . The usual dose is 7.5 to 11.25 mg per kilogram (kg) (3.4 to 5.1 mg per pound) of body weight every six hours.
    
    
    • Children up to 2 months of agea€”Use is not recommended .
    
    
    
    
  
  
  
  

For sulfamethoxazole

• For oral dosage form (tablets):
  
  
  
  • For bacterial or protozoal infections:
    
    
    
    • Adults and teenagersa€”2 to 4 grams for the first dose, then 1 to 2 grams every eight to twelve hours.
    
    
    • Children 2 months of age and oldera€”Dose is based on body weight . The usual dose is 50 to 60 milligrams (mg) per kilogram (kg) (22.7 to 27.3 mg per pound) of body weight for the first dose, then 25 to 30 mg per kg (11.4 to 13.6 mg per pound) of body weight every twelve hours.
    
    
    • Children up to 2 months of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

For sulfisoxazole

• For oral dosage forms (suspension, syrup, or tablets):
  
  
  
  • 
    
    
    
    • Adults and teenagersa€”2 to 4 grams for the first dose, then 750 milligrams (mg) to 1.5 grams every four hours; or 1 to 2 grams every six hours.
    
    
    • Children 2 months of age and oldera€”Dose is based on body weight . The usual dose is 75 mg per kilogram (kg) (34 mg per pound) of body weight for the first dose, then 25 mg per kg (11.4 mg per pound) of body weight every four hours, or 37.5 mg per kg (17 mg per pound) of body weight every six hours.
    
    
    • Children up to 2 months of agea€”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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is very important that your doctor check your progress at regular visits. This medicine may cause blood problems, especially if it is taken for a long time.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor .

Sulfonamides may cause blood problems . These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal . Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment .

Sulfonamides may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional .


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor .

This medicine may also cause some people to become dizzy. 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 are not alert. If this reaction is especially bothersome, check with your doctor .

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

• Itching


• Skin rash

Less common

• Aching of joints and muscles


• Difficulty in swallowing


• Pale skin


• Redness, blistering, peeling, or loosening of skin


• Sore throat and fever


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Yellow eyes or skin

Rare

• Abdominal or stomach cramps and pain (severe)


• Abdominal tenderness


• Blood in urine


• Diarrhea (watery and severe), which may also be bloody


• Greatly increased or decreased frequency of urination or amount of urine


• Increased thirst


• Lower back pain


• Mood or mental changes


• Pain or burning while urinating


• Swelling of front part of neck

Some of the above side effects (severe abdominal or stomach cramps and pain, and watery and severe diarrhea, which may also be bloody) may also occur up to several weeks after you stop taking any of these medicines.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Increased sensitivity of skin to sunlight

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


• Dizziness


• Headache


• Loss of appetite


• Nausea or vomiting


• Tiredness

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.