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Sulfisoxazole (Oral route)

Pronunciation:

sul-fi-SOX-a-zole

Brand Names:

  • Gantrisin Pediatric
  • Truxazole

Dosage Forms:

  • Tablet
  • Syrup
  • Suspension

Classifications:

Therapeutic—

Antibiotic

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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
  • 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

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.


Last Updated: 4/4/2014

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