Pediazole

Last updated on RxList: 6/28/2022

What is Pediazole and how is it used?

Pediazole is a prescription medicine used in children to treat the symptoms of H. influenzae Acute Otitis Media. Pediazole may be used alone or with other medications.

Pediazole belongs to a class of drugs called Sulfonamides.

It is not known if Pediazole is safe and effective in children younger than 2 months of age.

What are the possible side effects of Pediazole?

Pediazole may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • sun sensitivity (sunburn),
  • muscle weakness,
  • slurred speech,
  • blurred vision,
  • drooping eyelids,
  • eye redness,
  • hearing loss,
  • joint pain or aches,
  • new lump or growth in the neck (goiter),
  • change in the amount of urine,
  • painful urination,
  • pink or bloody urination,
  • mental or mood changes,
  • confusion,
  • numbness or tingling in the hands or feet,
  • anemia,
  • easy bruising,
  • unusual bleeding,
  • unusual tiredness,
  • pale skin,
  • fever,
  • chills,
  • persistent sore throat,
  • persistent diarrhea (may occur during treatment or weeks to months after treatment has stopped),
  • abdominal pain or cramping,
  • blood or mucus in the stool,
  • white patches in the mouth,
  • change in vaginal discharge,
  • severe dizziness,
  • fainting,
  • fast or irregular heartbeat,
  • persistent cough,
  • seizures,
  • blue lips or skin,
  • persistent nausea or vomiting,
  • yellowing of the skin or eyes (jaundice),
  • dark urine,
  • severe stomach pain,
  • rash, and
  • itching

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Pediazole include:

  • nausea,
  • vomiting,
  • diarrhea,
  • stomach pain or cramping,
  • loss of appetite,
  • headache, and
  • dizziness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Pediazole. For more information, ask your doctor or pharmacist.

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

DESCRIPTION

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.

Inactive Ingredients:   Citric acid, magnesium aluminum silicate, poloxamer, sodium carboxymethylcellulose, sodium citrate, sucrose and artificial flavoring.