Gantrisin

DRUG DESCRIPTION

Gantrisin (acetyl sulfisoxazole pediatric suspension) (sulfisoxazole) is an antibacterial sulfonamide available as a pediatric suspension for oral administration. Each teaspoonful (5 mL) of the pediatric suspension contains the equivalent of approximately 0.5 gm sulfisoxazole in the form of acetyl sulfisoxazole in a vehicle containing 0.3% alcohol, carboxymethylcellulose (sodium), citric acid, methylcellulose, parabens (methyl and propyl), partial invert sugar, sodium citrate, sorbitan monolaurate, sucrose, flavors and water.

Acetyl sulfisoxazole, the tasteless form of sulfisoxazole, is N1-acetyl sulfisoxazole and must be distinguished from N4-acetyl sulfisoxazole, which is a metabolite of sulfisoxazole. Acetyl sulfisoxazole is a white or slightly yellow, crystalline powder that is slightly soluble in alcohol and practically insoluble in water. Acetyl sulfisoxazole has a molecular weight of 309.34 and the following structural formula:

GANTRISIN®  (sulfisoxazole)  Structural Formula Illustration

What are the possible side effects of sulfisoxazole (Gantrisin Pediatric)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • cough, feeling short of breath, pale skin, joint pain, unusual bruising;
  • fast or pounding heartbeat;
  • blue lips or fingernails, feeling light-headed,...

Read All Potential Side Effects and See Pictures of Gantrisin »

What are the precautions when taking acetyl sulfisoxazole pediatric suspension (Gantrisin)?

Before taking sulfisoxazole, tell your doctor or pharmacist if you are allergic to it; or to sulfa medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain metabolic disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe allergies, asthma, diabetes, blood disorders (e.g., anemia due to folate vitamin deficiency), decreased bone marrow function (bone marrow suppression), a certain...

Read All Potential Precautions of Gantrisin »


Gantrisin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, loss of appetite, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sun sensitivity (sunburn), mental/mood changes (e.g., depression, hallucinations), crystals in the urine, painful urination, change in the amount of urine, lump/growth/swelling in the front of the neck (goiter), signs of low blood sugar (e.g., shaking, dizziness, blurred vision, unusual hunger).

Seek immediate medical attention if any of these rare but very serious side effects occur: confusion, persistent/severe headache, neck stiffness, seizures.

This medication may rarely cause serious (possibly fatal) allergic reactions and other side effects such as a severe peeling skin rash (e.g., Stevens-Johnson syndrome), blood disorders (e.g., agranulocytosis, aplastic anemia), liver damage, or lung injury. Seek immediate medical attention if you notice any of the following: skin rash/blisters, itching/swelling (especially of the face/tongue/throat), severe dizziness, persistent cough, trouble breathing, signs of a new infection (e.g., persistent sore throat, fever), pale skin, easy bleeding/bruising, yellowing eyes/skin, persistent nausea/vomiting, unusual tiredness, dark urine, stomach/abdominal pain, joint pain.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sulfisoxazole, tell your doctor or pharmacist if you are allergic to it; or to sulfa medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain metabolic disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe allergies, asthma, diabetes, blood disorders (e.g., anemia due to folate vitamin deficiency), decreased bone marrow function (bone marrow suppression), a certain other metabolic disorder (G6PD deficiency).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be more sensitive to the side effects of the drug, especially skin reactions and blood disorders.

During pregnancy, this medication should be used only when clearly needed. This medication should not be used near the expected delivery date because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. While there have been no reports of harm to healthy infants, this drug may have undesirable effects on infants who are ill or premature or have certain disorders (jaundice, high blood levels of bilirubin, G6PD deficiency). Therefore, breast-feeding is not recommended in infants with these conditions. Consult your doctor before breast-feeding any infant.


Gantrisin Patient Information Including Side Effects

Brand Names: Gantrisin Pediatric

Generic Name: sulfisoxazole (Pronunciation: sul fi SOX a zole)

  • What is sulfisoxazole (Gantrisin)?
  • What are the possible side effects of sulfisoxazole (Gantrisin)?
  • What is the most important information I should know about sulfisoxazole (Gantrisin)?
  • What should I discuss with my health care provider before taking sulfisoxazole (Gantrisin)?
  • How should I take sulfisoxazole (Gantrisin)?
  • What happens if I miss a dose (Gantrisin)?
  • What happens if I overdose (Gantrisin)?
  • What should I avoid while taking sulfisoxazole (Gantrisin)?
  • What other drugs will affect sulfisoxazole (Gantrisin)?
  • Where can I get more information?

What is sulfisoxazole (Gantrisin)?

Sulfisoxazole is a sulfonamide ("sulfa") antibiotic that helps keep bacteria from growing in your body.

Sulfisoxazole is used to treat or prevent many different types of infections caused by bacteria, such as bladder infections, ear infections, or meningitis.

Sulfisoxazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sulfisoxazole (Gantrisin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • cough, feeling short of breath, pale skin, joint pain, unusual bruising;
  • fast or pounding heartbeat;
  • blue lips or fingernails, feeling light-headed, fainting;
  • swelling around your neck or throat;
  • urinating more or less than usual;
  • severe pain in your side or lower back, blood in your urine;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • agitation, confusion, unusual thoughts or behavior; or
  • seizure (black-out or convulsions).

Less serious side effects may include:

  • mild stomach pain, bloating, gas;
  • headache, dizziness;
  • ringing in your ears; or
  • swollen, black, or "hairy" tongue.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sulfisoxazole (Gantrisin)?

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Sulfisoxazole will not treat a viral infection such as the common cold or flu.

Do not give this medication to another person, even if they have the same symptoms you do.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

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