"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
(erythromycin ethylsuccinate and sulfisoxazole acetyl)
- Patient Information:
Details with Side Effects
Pediazole (erythromycin and sulfisoxazole) is a combination of erythromycin ethylsuccinate, USP, and sulfisoxazole acetyl, USP. When reconstituted with water as directed on the label, the granules form a white, strawberry-banana flavor suspension that provides the equivalent of 200 mg erythromycin activity and the equivalent of 600 mg of sulfisoxazole activity per teaspoonful (5 mL).
Erythromycin is produced by a strain of Saccaropolyspora erythraea and belongs to the macrolide group of antibiotics. It is basic and readily forms salts and esters. Erythromycin ethylsuccinate is the 2'-ethylsuccinyl ester of erythromycin. It is essentially a tasteless form of the antibiotic suitable for oral administration, particularly in suspension dosage forms. The chemical name is erythromycin 2'-(ethyl succinate).
Sulfisoxazole acetyl or N 1 -acetyl sulfisoxazole is an ester of sulfisoxazole. Chemically, sulfisoxazole is N-(3,4-Dimethyl-5-isoxazolyl)-N-sulfanilylacetamide.
What are the possible side effects of erythromycin and sulfisoxazole (Pediazole)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- dizziness, fainting, fast or pounding heartbeat;
- diarrhea that is watery or bloody;
- confusion, hallucinations;
- muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
- white patches or sores inside your mouth or on your lips;
- fever, sore throat, and...
What are the precautions when taking erythromycin and sulfisoxazole (Pediazole)?
Before taking erythromycin with sulfisoxazole, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (e.g., azithromycin, clarithromycin) or 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe allergies, asthma, blood disorders, decreased bone marrow function (bone marrow suppression), diabetes, a certain genetic condition (glucose-6-phosphate dehydrogenase/G6PD deficiency), kidney disease, liver disease, a certain type of muscle disease (myasthenia gravis).
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Pediazole Information
Pediazole - User Reviews
Pediazole User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.