Brand Name
Cefixime
View Brand InformationFDA approval date: April 14, 2015
Classification: Cephalosporin Antibacterial
Form: Tablet, Powder, Capsule
What is Cefixime?
Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections.
Approved To Treat
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Brand Information
CEFIXIME (CEFIXIME)
1OVERDOSAGE
Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of cefixime did not differ from the profile seen in patients treated at the recommended doses.
2DESCRIPTION
Cefixime is a semisynthetic, cephalosporin antibacterial for oral administration. Chemically, it is (
Molecular weight = 507.50 as the trihydrate. Chemical Formula is C
The structural formula for cefixime is:
Inactive ingredients contained in the cefixime powder for oral suspension USP are colloidal silicon dioxide, sodium benzoate, strawberry flavor, sucrose, and xanthan gum.
Inactive ingredients contained in the cefixime capsules 400 mg are colloidal silicon dioxide, croscarmellose sodium, low substituted hydroxy propyl cellulose, magnesium stearate, and mannitol. The capsule shell contains the following inactive ingredients: ferric oxide black, ferric oxide red, gelatin, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide.
3CLINICAL STUDIES
Comparative clinical trials of otitis media were conducted in nearly 400 pediatric patients between the ages of 6 months to 10 years.
The overall response rate of
In these studies, patients were randomized and treated with either cefixime at dose regimens of 4 mg/kg twice a day or 8 mg/kg once a day, or with a comparator. Sixty-nine to 70% of the patients in each group had resolution of signs and symptoms of otitis media when evaluated 2 to 4 weeks post-treatment, but persistent effusion was found in 15% of the patients. When evaluated at the completion of therapy, 17% of patients receiving cefixime and 14% of patients receiving effective comparative drugs (18% including those patients who had
4REFERENCES
- Halperin-Walega, E. Batra VK, Tonelli AP, Barr A, Yacobi A. 'Disposition of Cefixime in the Pregnant and Lactating Rat. Transfer to the Fetus and Nursing Pup'.
5HOW SUPPLIED/STORAGE AND HANDLING
Cefixime capsules, 400 mg is size "0" capsule with pink opaque cap and pink opaque body, imprinted with "LU" on cap and "U43" on body in black ink, containing white to yellowish white granular powder containing 400 mg of cefixime as the trihydrate and is supplied as follows:
NDC: 70518-3221-00
NDC: 70518-3221-01
NDC: 70518-3221-02
NDC: 70518-3221-03
NDC: 70518-3221-04
NDC: 70518-3221-05
PACKAGING: 2 in 1 BOX
PACKAGING: 1 in 1 POUCH
PACKAGING: 2 in 1 BOX
PACKAGING: 1 in 1 POUCH
PACKAGING: 2 in 1 BOTTLE PLASTIC
PACKAGING: 2 in 1 BOTTLE PLASTIC
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Temperature].
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Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
6PATIENT COUNSELING INFORMATION
Development of Drug Resistance Bacteria
Patients should be counseled that antibacterial drugs, including cefixime, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefixime is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefixime or other antibacterial drugs in the future.
Diarrhea
Advise patients that diarrhea is a common problem caused by antibacterial drugs, including cefixime which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
LUPIN and the
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762