SPECTRACEF Film-coated tablet (2013)

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Συγγραφείς

Vansen Pharma Inc.

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1. Description

SPECTRACEF tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed ...

2. Clinical Pharmacology

Pharmacokinetics Absorption Oral Bioavailability Following oral administration, cefditoren pivoxil is absorbed from the gastrointestinal tract and hydrolyzed to cefditoren by esterases. Maximal plasma ...

3. Indications and Usage

SPECTRACEF (cefditoren pivoxil) is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated ...

4. 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 ...

5. Warnings

BEFORE THERAPY WITH SPECTRACEF (CEFDITOREN PIVOXIL) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDITOREN PIVOXIL, OTHER ...

6.1. General

Prescribing SPECTRACEF in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development ...

6.2. Information for Patients

Patients should be counseled that antibacterial drugs including SPECTRACEF should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When SPECTRACEF ...

6.4. 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. Antacids Co-administration of ...

6.5. Drug/Laboratory Test Interactions

Cephalosporins are known to occasionally induce a positive direct Coombs' test. A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedicts or Fehlings solution ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal carcinogenicity studies have been conducted with cefditoren pivoxil. Cefditoren pivoxil was not mutagenic in the Ames bacterial reverse mutation assay, or in the mouse lymphoma mutation ...

6.7. Pregnancy

Pregnancy Category B. 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 ...

6.8. Labor and Delivery

Cefditoren pivoxil has not been studied for use during labor and delivery.

6.9. Nursing Mothers

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. ...

6.10. Pediatric Use

Use of cefditoren pivoxil is not recommended for pediatric patients less than 12 years of age. The safety and efficacy of cefditoren pivoxil tablets in this population, including any effects of altered ...

6.11. Geriatric Use

Of the 2675 patients in clinical studies who received cefditoren pivoxil 200 mg BID, 308 (12%) were >65 years of age. Of the 2159 patients in clinical studies who received cefditoren pivoxil 400 mg BID, ...

7. Adverse Reactions

Clinical Trials – SPECTRACEF (cefditoren pivoxil) Tablets (Adults and Adolescent Patients ≥12 Years of Age) In clinical trials, 4834 adult and adolescent patients have been treated with the recommended ...

9. Overdosage

Information on cefditoren pivoxil overdosage in humans is not available. However, with other β-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, ...

10. Dosage and Administration

(See INDICATIONS AND USAGE for Indicated Pathogens.) <b>SPECTRACEF (cefditoren pivoxil) Dosage and Administration* Adults and Adolescents (≥12 Years):</b> Type of Infection Dosage Duration (Days) Community-Acquired ...

11. How Supplied

SPECTRACEF (cefditoren pivoxil) tablets containing cefditoren pivoxil equivalent to 200 mg or 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with CBP 200 or CBP ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Healthcare professionals ...

14. References

1. National Committee for Clinical Laboratory Standards. <em>Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically – Fifth Edition</em>; Approved Standard, NCCLS Document ...