Pronunciation:

sul-fi-SOX-a-zole

Brand Names:

• Gantrisin Pediatric
• Truxazole

Classifications:

Chemical—

Sulfonamide

Uses of This Medicine:

Sulfisoxazole is used to treat or prevent infections in many different parts of the body. It belongs to the group of medicines known as sulfonamide antibiotics. It works by preventing the growth of bacteria. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using This Medicine:

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.

Children—

Because of sulfisoxazole's toxicity, use in infants younger than 2 months of age is not recommended.

Older adults—

No information is available on the relationship of age to the effects of sulfisoxazole in geriatric patients. However, elderly patients are more likely to have age-related kidney and liver problems, which may require caution in patients receiving sulfadiazine.

Breast-feeding—

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

Other 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.

• Methenamine

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

• Methotrexate
• Porfimer
• Warfarin

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
• Aminolevulinic Acid

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Asthma or
• Blood problems (e.g., agranulocytosis, aplastic anemia) or
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem) or
• Kidney disease or
• Liver disease—Use with caution. May have an increased chance of side effects.

Proper Use of This Medicine:

This medicine should not be given to infants younger than 2 months of age unless directed by your child's doctor. Sulfisoxazole may cause serious unwanted effects in this age group.

Take this medicine with a full glass (8 ounces) of water. Several additional glasses of water should be taken during the day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects.

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 during the day. If you need help in planning the best times to take your medicine, check with your doctor.

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

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

Dosing—

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

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

• For oral dosage form (suspension, tablets):
  • For treatment of infections:
    • Adults—4000 to 8000 milligrams (mg) per day, divided and given in 4 to 6 doses per day.
    • Children and infants 2 months of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 75 milligrams (mg) per kilogram (kg) of body weight per day (mg/kg/day), divided and given in 4 to 6 doses per day. Your doctor may increase your dose to 150 mg/kg/day, but the total dose is usually not more than 6000 mg per day.
    • 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 This Medicine:

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

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have any of the following symptoms: a skin rash; blistering, peeling, or loosening of the skin; cough; diarrhea; itching; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Check with your doctor right away if you have fever; chills; joint or muscle pain; pale skin; pinpoint red or purple spots on the skin; shortness of breath; sore throat; pain in the upper stomach; or yellow eyes or skin. These may be symptoms of a serious blood problem.

Sulfisoxazole may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without checking first with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If mild diarrhea continues or gets worse, check with your doctor.

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.

Side Effects of This Medicine:

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

Anxiety

blurred vision

changes in menstrual periods

chills

cold sweats

coma

confusion

cool, pale skin

decreased sexual ability in males

depression

dizziness

dry, puffy skin

fast heartbeat

feeling cold

headache

increased hunger

nausea

nervousness

nightmares

seizures

shakiness

slurred speech

swelling of the front part of the neck

unusual tiredness or weakness

weight gain

Incidence not known

Abdominal or stomach pain, cramps, or tenderness

agitation

back, leg, or stomach pains

bleeding gums

bleeding under the skin

blindness or vision changes

blistering, peeling, or loosening of the skin

bloating

bloody or cloudy urine

bloody, black, or tarry stools

bluish color of the fingernails, lips, skin, palms, or nail beds

burning of the face or mouth

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

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

chest pain

chills

clay-colored stools

clumsiness or unsteadiness

constipation

continuing ringing or buzzing or other unexplained noise in the ears

cough or hoarseness

cracks in the skin

dark urine

decrease in frequency of urination

decrease in the amount of urine

diarrhea

diarrhea, watery and severe, which may also be bloody

difficult or painful urination

difficulty in passing urine (dribbling)

difficulty with breathing

difficulty with swallowing

dizziness or lightheadedness

drowsiness

enlarged salivary glands

fainting

fast, pounding, or irregular heartbeat or pulse

feeling of discomfort

feeling unusually cold

fever with or without chills

general body swelling

general feeling of discomfort or illness

general feeling of tiredness or weakness

hair loss

headache

hearing loss

hives or welts

hostility

increased sensitivity of the skin to sunlight

increased thirst

indigestion

inflammation of the joints

irritability

itching

joint or muscle pain

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

lethargy

light-colored stools

loss of appetite and weight

loss of heat from the body

loss of strength or energy

lower back or side pain

muscle aches

muscle pain or weakness

muscle twitching

nosebleeds

not able to pass urine

pain

pain or burning while urinating

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

pale skin

pinpoint red or purple spots on the skin

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

rapid heart rate

rapid weight gain

rash

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

redness of the white part of the eyes

redness, soreness or itching skin

scaly skin

severe sunburn

shakiness and unsteady walk

shivering

shortness of breath

skin rash

sore throat

soreness of the muscles

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

sores, welting, or blisters

stupor

swelling around the eyes

swelling of face, ankles, hands, feet, or lower legs

swelling or inflammation of the mouth

swollen lymph glands

swollen or painful glands

thickening of bronchial secretions

tightness in the chest

troubled breathing

troubled breathing with exertion

unpleasant breath odor

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

unusual bleeding or bruising

unusual weak feeling

unusual weight gain

unusual weight loss

upper right abdominal pain

vomiting

vomiting of blood or material that looks like coffee grounds

weakness in the hands or feet

weight loss

wheezing

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:

Incidence not known

Confusion about identity, place, and time

difficulty with moving

excess air or gas in the stomach or intestines

fear

feeling of constant movement of self or surroundings

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

full feeling

lack of feeling or emotion

passing gas

redness, swelling, or soreness of the tongue

sensation of spinning

severe mood or mental changes

sleeplessness

trouble with sleeping

unable to sleep

uncaring

unusual behavior

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.