CEDAX Capsule / Oral suspension (2010)

Βιβλιογραφική αναφορά

Συγγραφείς

Sciele Pharma, Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Description

CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension) contain the active ingredient ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a semisynthetic cephalosporin antibiotic for oral ...

2. Clinical Pharmacology

Pharmacokinetics Absorption CEDAX CAPSULES Ceftibuten is rapidly absorbed after oral administration of CEDAX Capsules. The plasma concentrations and pharmacokinetic parameters of ceftibuten after a single ...

3. Indications and Usage

CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below ...

4. Contraindications

CEDAX (ceftibuten) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

5. Warnings

BEFORE THERAPY WITH THE CEDAX PRODUCT IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTIBUTEN, OTHER CEPHALOSPORINS, ...

6.1. General

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection ...

6.2. Information for Patients

Patients should be informed that: If the patient is diabetic, he/she should be informed that CEDAX Oral Suspension contains 1 gram sucrose per teaspoon of suspension. CEDAX Oral Suspension should be taken ...

6.4. Drug Interactions

Theophylline Twelve healthy male volunteers were administered one 200-mg ceftibuten capsule twice daily for 6 days. With the morning dose of ceftibuten on day 6, each volunteer received a single intravenous ...

6.5. Drug/Laboratory Test Interactions

There have been no chemical or laboratory test interactions with ceftibuten noted to date. False-positive direct Coombs' tests have been reported during treatment with other cephalosporins. Therefore, ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of ceftibuten. No mutagenic effects were seen in the following studies: in vitro chromosome assay in human ...

6.7. Pregnancy

Pregnancy Category B Ceftibuten was not teratogenic in the pregnant rat at oral doses up to 400 mg/kg/day (approximately 8.6 times the human dose based on mg/m²/day). Ceftibuten was not teratogenic in ...

6.9. Nursing Mothers

It is not known whether ceftibuten (at recommended dosages) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ceftibuten is administered to a nursing ...

6.10. Pediatric Use

The safety and efficacy of ceftibuten in infants less than 6 months of age has not been established.

6.11. Geriatric Use

The usual adult dosage recommendation may be followed for patients in this age group. However, these patients should be monitored closely, particularly their renal function, as dosage adjustment may be ...

7. Adverse Reactions

Clinical Trials CEDAX CAPSULES (adult patients) In clinical trials, 1728 adult patients (1092 US and 636 international) were treated with the recommended dose of ceftibuten capsules (400 mg per day). There ...

9. Overdosage

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Ceftibuten is readily dialyzable and significant quantities (65% of plasma concentrations) can be removed from the circulation ...

10. Dosage and Administration

The recommended doses of CEDAX Oral Suspension are presented in the table below. CEDAX Oral Suspension must be administered at least 2 hours before or 1 hour after a meal. Type of infection (as ...

11. How Supplied

CEDAX Capsules, containing 400 mg of ceftibuten (as ceftibuten dihydrate) are white, opaque capsules imprinted with the product name and strength, are available as follows: 20 Capsules/Bottle (NDC 59630-820-20) ...

12. Storage and Handling

Store the capsules between 2° and 25°C (36° and 77°F). Replace cap securely after each opening. CEDAX Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains ...

13. Clinical Studies

0.164 CLINICAL STUDIES Acute Bacterial Exacerbations of Chronic Bronchitis Three clinical trials (two domestic, the third abroad) have been conducted testing ceftibuten in the treatment of acute exacerbations ...

14. References

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Third Edition. Approved Standard NCCLS Document M7-A3, ...