ORAPENEM FINE GRANULES 10％ FOR PEDIATRIC USE

Generic name: Tebipenem pivoxil

Manufactured by: Meiji Seika Pharma

Description

This medicine is a carbapenem antibiotic to inhibit bacterial cell wall synthesis, and shows antimicrobial effect.

It is usually used to treat pneumonia, otitis media and sinusitis.

Ingredients and dosage form

yellowish pale red fine granule

Dosing schedule/Directions

Your dosing schedule must be prescribed by your doctor or a healthcare professional.

• For children: In general, take 0.04 gram per kilogram of body weight (g/kg) (4 mg of the active ingredient [titer]/kg) at a time, twice a day, after meals. The dosage may be increased up to 0.06 g/kg (6 mg [titer]/kg) as needed. Strictly follow the instructions.

• Standard duration of administration is for 7 days or less.

• If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.

• If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.

• Do not stop taking this medicine unless your doctor instructs you to do so.

Warnings

Before using this medicine, be sure to tell your doctor and pharmacist

• If you have previously experienced any allergic reactions (itch, rash etc.) to any medicines.

• If you or any of your parents or siblings are prone to allergic symptoms such as bronchial asthma, rash or hives.

• If you are a patient with renal disorder, poor ingestion or parenteral nutrition, or poor general status.

• If you have a history of convulsive diseases such as epilepsy.

• If you are pregnant or breastfeeding.

• If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Possible adverse reactions to this medicine

• The most commonly reported adverse reactions include diarrhea and loose stool. If any of these symptoms occur, consult with your doctor or pharmacist.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

• convulsion, disturbed consciousness [hypoglycemia associated with hypocarnitinemia]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storing Conditions

• Keep out of the reach of children. Store away from direct sunlight, heat and moisture.

• Discard the remainder, do not store.

Product specifications, appearance and package content are subject to change without prior notice.

Description of the medical drugs is not intended for prescribing treatment without the involvement of a physician.