Pediazole: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PEDIAZOLE^® is used to treat your child’s ear infection.

What it does:

PEDIAZOLE^® treats infection by preventing bacteria from multiplying.

When it should not be used:

PEDIAZOLE^® should not be taken by patients who are:

• allergic to any ingredient in the medication (see What the

  important nonmedicianl ingredients are).

• allergic to sulfonamides (Sulfa drugs)
• allergic to erythromycin or other macrolides
• less than 2 months of age

• taking the following drugs: astemizole*, terfenadine*,

  cisapride*, pimozide, and ergotamine or dihydroergotamine.

• pregnant or nursing as sulfonamides are passed to the

  developing fetus through the placenta, and are passed to the infant through breastmilk

• patients with certain metabolic disorders, including

  porphyria, uremia (urinary constituents in the blood)

• patients with a history of blood, kidney or liver problems

* no longer marketed in Canada

What are the medicinal ingredients:

Erythromycin ethylsuccinate and sulfisoxazole acetyl.

What the important nonmedicinal ingredients are:

Ammonium glycerrhinate, citric acid, magnesium aluminum silicate, poloxamer, sodium carboxymethylcellulose, sodium citrate, sucrose, and artificial flavoring.

What dosage forms it comes in:

PEDIAZOLE^® is available in 105 mL, 150 mL and 200 mL bottles in the form of granules to be reconstituted with water. The suspension provides 200 mg erythromycin (as erythromycin ethylsuccinate) and 600 mg sulfisoxazole (as sulfisoxazole acetyl) per teaspoonful (5 mL).

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

$ Severe allergic reactions, including fatalities, have occurred with sulfonamides, with liver damage, blood problems and serious skin reactions (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM)

$ PEDIAZOLE^® should be discontinued at the first appearance of skin rash or any sign of skin-related reaction.

BEFORE using PEDIAZOLE^® talk to your doctor or pharmacist if the patient has:

$ any allergies to this drug or its ingredients or components of the container

$ any metabolic disorders (e.g. porphyria)

$ any blood disorders (e.g. deficiency in G6P DH) $ impaired kidney or liver function

$ bronchial asthma

$ diabetes (drug interactions with hypoglycaemic drugs) $ convulsions (drug interaction with anticonvulsive) $ myasthenia gravis (muscle weakness)

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with PEDIAZOLE^® include:

• Theophylline;
• Lincomycin, Clindamycin, Chloramphenicol;

• Carbamazepine, Cyclosporin, Hexobarbital, Phenytoin,

  Alfentanil, Disopyramide, Bromocriptine, Valproate, Tacrolimus, Quinidine, Methylprednisolone, Cilostazole, Vinblastine, Sildenafil, Terfenadine, Astemizole;

• Oral anticoagulants;
• Triazolobenzodiazepines (such as triazolam and alprazolam) and related benzodiazepines;
• Ergotamine, Dihydroergotamine;
• Digoxin;
• HMG-CoA Reductase Inhibitors (e.g., lovastatin and simvastatin);
• Colchicine;
• Terfenadine;
• Astemizole;
• Cisapride, Pimozide;
• Zopiclone.

The most important interactions of the sulfonamides involve those with the oral anticoagulants (e.g. warfarin), the sulfonylurea hypoglycemic agents, and the hydantoin anticonvulsants. There are also interactions with thiopental and methotrexate.

PROPER USE OF THIS MEDICATION

Usual dose:

It is important for your child to take PEDIAZOLE^® exactly as instructed by your child’s doctor. It may be taken with or without food, but it is best to take a dose immediately after a meal.

Overdose:

Should an overdose occur, your child should stop taking PEDIAZOLE^® and you should contact your doctor or nearest hospital emergency. Symptoms of overdose include: abdominal discomfort, nausea, diarrhea, loss of appetite, dizziness, headache, drowsiness, unconsciousness, fever.

Missed Dose:

If a dose of this medication is missed, it should be taken as soon as possible. This will help to keep a constant amount of medication in the blood. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Common side effects include headache, fatigue, and nausea.

This is not a complete list of side effects. For any unexpected effects while taking PEDIAZOLE^®, contact your doctor or pharmacist.

HOW TO STORE IT

PEDIAZOLE^® should be stored between 15 and 25°C.

Once reconstituted with water, the suspension should be refrigerated and used within 14 days. Unused portion should be discarded after 14 days. Shake well before use.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at: www.methapharm.com or by contacting the Canadian distributor, Methapharm Inc., at: 1-800-287-7686.

Last revised: June 3, 2009