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Cefdiren

Cefditoren Pivoxil INN

NAME STRENGTH PACK SIZE DOSAGE FORM
Cefdiren-200 200 mg 8's Tablet
Cefdiren-400 400 mg 8's Tablet

Composition

Cefdiren 200 Tablet: Each tablet contains Cefditoren Pivoxil INN 245 mg Eqv. to Cefditoren 200 mg. Cefdiren 400 Tablet: Each tablet contains Cefditoren Pivoxil INN 490 mg Eqv. to Cefditoren 400 mg.

Acute Bacterial Exacerbations of Chronic Bronchitis, Community-Acquired Pneumonia (CAP), Pharyngitis/Tonsillitis, Uncomplicated Skin and Skin-Structure Infections.

Uncomplicated Skin and Skin Structure InfectionsPharyngitis/TonsillitisAcute Bacterial Exacerbation of Chronic Bronchitis*Should be taken with meals200 mg BID1014Duration (Days)400 mg BID400 mg BIDCommunity-Acquired PneumoniaDosageType of Infection Use in Renal impaired patient: 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. Use in Hepatically impaired patient: No dose adjustments are necessary for patients with mild or moderate hepatic impairment. The pharmacokinetics of Cefditoren have not been studied in patients with severe hepatic impairment.

The most common side effects are mild and self-limiting include diarrhea, nausea, vaginal moniliasis and headache.

Cefditoren is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its ingredients.

Cefditoren should be prescribed with caution in individuals with a history of gastrointestinal colitis.

Pregnancy: Cefditoren pivoxil has been assigned to pregnancy category B by the FDA. Lactation: There are no data on the excretion of Cefditoren pivoxil into human milk. Cefditoren is excreted into the milk of rats. So caution is recommended when Cefditoren pivoxil is given to nursing women.

Co-administration of a single dose of an antacid and H2 receptor antagonists may reduce the oral absorption of Cefditoren pivoxil. As with other beta-lactam antibiotics, co-administration of probenecid with cefditoren pivoxil resulted in an increase in the plasma exposure of Cefditoren.

Store in a cool (20º- 25º C) and dry place, keep it away from light and moisture.

Cefdiren 200 Tablet: Each box contains 8 tablets in Alu-Alu blister pack. Cefdiren 400 Tablet: Each box contains 8 tablets in Alu-Alu blister pack.