BOSDITEN 400

DOSAGE AND ADMINISTRATION

Dosage

Adults and adolescents (12 years and older):

Children under 12 years old:

It is recommended to use another appropriate dosage form to ensure accurate dosing.

Elderly:

No dosage adjustment is necessary in the elderly with normal renal function (for their age).

Patients with Renal Insufficiency

No dose adjustment is necessary for patients with mild renal impairment (CLcr: 50-80 mL/min/1.73 m2). 

It is recommended that not more than 200 mg BID be administered to patients with moderate renal impairment (CLcr: 30-49 mL/min/1.73 m2) and 200 mg QD be administered to patients with severe renal impairment (CLcr: <30 mL/min/1.73 m2). 

The appropriate dose in patients with end-stage renal disease has not been determined.

Patients with Hepatic Disease

No dose adjustments are necessary for patients with mild or moderate hepatic impairment (Child-Pugh Class A or B). 

The pharmacokinetics of cefditoren have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).

Administration

Use orally. The tablet should be swallowed whole with a large amount of water. The medicine should be taken during meals.

CONTRAINDICATIONS

Patients with known allergy to the cephalosporin class of antibiotics or any of its components.

Patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency, because use of efditoren pivoxil causes renal excretion of carnitine

BOSDITEN contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered this product.

FERTILITY, PREGNANCY AND LACTATION

Pregnancy

Cefditoren pivoxil was not teratogenic up to the highest doses tested in rats and rabbits. In rats, this dose was 1000 mg/kg/day, which is approximately 24 times a human dose of 200 mg BID based on mg/m2/day. In rabbits, the highest dose tested was 90 mg/kg/day, which is approximately four times a human dose of 200 mg BID based on mg/m2/day. This dose produced severe maternal toxicity and resulted in fetal toxicity and abortions.

In a postnatal development study in rats, cefditoren pivoxil produced no adverse effects on postnatal survival, physical and behavioral development, learning abilities, and reproductive capability at sexual maturity when tested at doses of up to 750 mg/kg/day, the highest dose tested. This is approximately 18 times a human dose of 200 mg BID based on mg/m2/day.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Lactation

Cefditoren was detected in the breast milk of lactating rats. Because many drugs are excreted in human breast milk, caution should be exercised when cefditoren pivoxil is administered to nursing women.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

No impact.

DUE DATE

36 months (from the date of manufacture), do not use the medicine after its expiration date.

STORAGE CONDITIONS

Store in a dry place, below 30°C, protect from light.

Al/Al blister. Box of 02 blisters x 10 film-coated tablets with leaflet.