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Spectracef (Cefditoren Pivoxil) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug Interactions

Oral Contraceptives

Multiple doses of cefditoren pivoxil had no effect on the pharmacokinetics of ethinyl estradiol, the estrogenic component in most oral contraceptives.

OVERDOSAGE

Information on cefditoren pivoxil overdosage in humans is not available. However, with other ß-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of cefditoren from the body, particularly if renal function is compromised (30% reduction of plasma concentrations following 4 hours of hemodialysis). Treat overdosage symptomatically and institute supportive measures as required.

In acute animal toxicity studies, cefditoren pivoxil when tested at the limit oral doses of 5100 mg/kg in rats and up to 2000 mg/kg in dogs did not exhibit any health effects of concern. Certain effects, such as diarrhea and soft stool lasting for a few days were observed in some animals as expected with most oral antibiotics due to inhibition of intestinal microflora.

CONTRAINDICATIONS

SPECTRACEF® is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components.

SPECTRACEF® is contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency, because use of SPECTRACEF® causes renal excretion of carnitine. (See PRECAUTIONS, General.)

SPECTRACEF® tablets contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered SPECTRACEF®.

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically – Fifth Edition; Approved Standard, NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January, 2000.

Rx Only

Manufactured by:

Tedec-Meiji Farma, S.A

Madrid, Spain

Distributed by:

Vansen Pharma Inc.

Westmount, QC H3Z 3C1

U.S. Patent No. 5,958,915

©2003, 2005, 2007, 2009, 2011 Vansen Pharma Inc.

CTS-001-1211-01

A233070-201207/04

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