IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ERYTHROMYCIN WITH SULFISOXAZOLE - ORAL

(eh-rith-row-MY-sin WITH sull-fih-SOX-uh-zole)

COMMON BRAND NAME(S): Eryzole, Pediazole

USES: This antibiotic is used to treat middle ear infections (otitis media) especially in children.

HOW TO USE: This medication may be taken with food or milk if stomach upset occurs. Shake the liquid suspension form of this medicine well before using. It is recommended to drink plenty of fluids while taking this medication unless your doctor directs you otherwise. Antibiotics work best when the amount of medicine in your body is kept at a constant level. Do this by taking the medication at evenly spaced intervals throughout the day and night. Continue to take this medication until the full prescribed amount is finished even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow resulting in a relapse of the infection.

SIDE EFFECTS: This medication may cause stomach upset, diarrhea, nausea, headache or vomiting during the first few days as your body adjusts to the medication. If these symptoms persist or become severe, inform your doctor. This medication may increase sensitivity to sunlight. Avoid prolonged exposure. Wear protective clothing and a sunscreen. Rarely, this medication can cause serious, even fatal, side effects such as a severe peeling skin rash known as Stevens- Johnson syndrome, blood disorders (e.g., agranulocytosis, aplastic anemia), or liver damage. Seek immediate medical attention if you develop any of the following symptoms: skin rash or blisters, unusual fatigue, persistent sore throat or fever, yellowing eyes or skin, dark urine, abdominal pain. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: liver disease/jaundice, kidney disease, blood disorders, allergies (especially drug allergies). Use of this medication for prolonged or repeated periods may result in a secondary infection (e.g., oral, bladder or vaginal yeast infection). Caution is advised when this drug is used in infants. Though very unlikely to happen, a stomach problem called IHPS (infantile hypertrophic pyloric stenosis) has been noted. Contact your child's doctor immediately if the child has persistent vomiting or increased irritability. This drug should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug passes into breast milk. The sulfisoxazole in this combination product has caused undesirable effects in some nursing infants. Breast-feeding is not recommended. Consult your doctor.

DRUG INTERACTIONS: Tell your doctor of all the drugs you may use, (prescription and nonprescription) especially of the following: carbamazepine, cyclosporine, theophylline, certain benzodiazepines (e.g., midazolam, triazolam), warfarin, felodipine (a calcium channel blocker), cisapride, corticosteroids (e.g., prednisone), digoxin, ergotamine-containing medications, sildenafil, certain live vaccines, disopyramide, phenytoin, all other antibiotics, oral PABA (may be in vitamins), methotrexate, oral drugs used for diabetes, certain drugs used to treat high cholesterol (e.g., lovastatin). Other drugs besides erythromycin which may affect the heart rhythm (QTc prolongation in the EKG) include dofetilide, pimozide, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize the risk of this effect. This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include loss of appetite, nausea, vomiting, dizziness, drowsiness, and headache.

NOTES: This medication has been prescribed for your current condition only. Do not use it later for another infection or give it to someone else. A different medication may be necessary.

MISSED DOSE: If you should miss a dose, take it as soon as remembered unless it is almost time for the next dose. If it is nearly time for the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose.

STORAGE: Store in the refrigerator. Check the expiration date and discard any unused portion after 14 days.

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Copyright 2004 by First DataBank, Inc.