Pediazole

Pediazole is used for:

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Treating ear infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Pediazole is a macrolide and sulfonamide antibiotic combination. It works by slowing the growth of and killing sensitive bacteria.

Do NOT use Pediazole if:

• you are allergic to any ingredient in Pediazole
• you are pregnant and at term (38 to 42 weeks)
• you are breastfeeding a child younger than 2 months old
• the patient is a child younger than 2 months old
• you have severe kidney problems, bladder blockage, or anemia due to folic acid deficiency
• you are taking astemizole, an azole antifungal (eg, ketoconazole), cisapride, conivaptan, diltiazem, dofetilide, terfenadine, an ergot alkaloid (eg, ergotamine), an HIV protease inhibitor (eg, ritonavir), pimozide, propafenone, a QT-prolonging agent (eg, quinidine, sotalol), a quinolone (eg, ciprofloxacin), a streptogramin (eg, quinupristin/dalfopristin), eletriptan, or verapamil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pediazole :

Some medical conditions may interact with Pediazole . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have diarrhea or throat inflammation
• if you have a history of asthma, blood problems, glucose-6-phosphate dehydrogenase deficiency, kidney or liver problems, heart problems, fast or irregular heartbeat, myasthenia gravis, or the blood disease porphyria

Some MEDICINES MAY INTERACT with Pediazole . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Many prescription and nonprescription medicines (eg, used for breathing problems, irregular heartbeat or other heart problems, blood clotting problems, anxiety, bladder problems, cancer, circulation, diabetes, endocrine problems, infection, gout, immune suppression, impotence, inflammation, sleep, aches and pains, high blood pressure, high cholesterol, seizures) may interact with Pediazole , increasing the risk of side effects
• Astemizole, cisapride, pimozide, or terfenadine because serious, even fatal, heart problems may occur
• Azole antifungals (eg, ketoconazole), diltiazem, dofetilide, HIV protease inhibitors (eg, ritonavir), propafenone, QT-prolonging agents (eg, quinidine, sotalol), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin/dalfopristin), or verapamil because the risk of serious, life-threatening irregular heartbeat be increased
• Conivaptan, eletriptan, or ergot alkaloids (eg, ergotamine) because the risk of their side effects may be increased by Pediazole

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pediazole may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pediazole :

Use Pediazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pediazole by mouth with or without food.
• Drinking extra fluids while you are taking Pediazole is recommended. Check with your doctor for instructions.
• Do not eat grapefruit or drink grapefruit juice while you use Pediazole .
• Pediazole works best if it is taken at the same time each day.
• To clear up your infection completely, take Pediazole for the full course of treatment. Keep taking it even if you feel better in a few days.
• If you miss a dose of Pediazole , take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pediazole .

Important safety information:

• Pediazole may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Pediazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Pediazole only works against bacteria; it does not treat viral infections (eg, the common cold).
• Be sure to use Pediazole for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Pediazole may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Tell your doctor or dentist that you take Pediazole before you receive any medical or dental care, emergency care, or surgery.
• Pediazole may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pediazole . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pediazole may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pediazole .
• Lab tests, including liver function, kidney function, complete blood counts, and urinalysis, may be performed while you use Pediazole . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Pediazole should not be used in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pediazole while you are pregnant. Do not take Pediazole if you pregnant and at term (38 to 42 weeks). Pediazole is found in breast milk. Do not breast-feed while taking Pediazole .

Possible side effects of Pediazole :

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or dark urine; bloody stools; change in the amount of urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hearing changes; mood or mental changes; muscle weakness; numbness or tingling of the hands or feet; pale skin; pale stools; red, swollen, or blistered skin; ringing in the ear; seizures; severe or persistent diarrhea, dizziness, or headache; severe stomach pain or cramps; shortness of breath; sore mouth or tongue; unusual bruising or bleeding; unusual weakness or fatigue; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include severe or persistent loss of appetite, nausea, stomach upset, or vomiting; loss of consciousness; high fever; and blood in the urine.

Store Pediazole in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away any unused medicine after 14 days. Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep Pediazole out of the reach of children and away from pets.

General information:

• If you have any questions about Pediazole , please talk with your doctor, pharmacist, or other health care provider.
• Pediazole is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pediazole . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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