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)
1DOSAGE FORMS AND STRENGTHS
Cefixime Capsules are available for oral administration in the following dosage strength:
- Capsules provide 400 mg of cefixime as trihydrate. These are off white to yellow colour granular powder filled in size ''0''' hard gelatin capsules, pink opaque cap imprinted ''CFX'' with black ink and pink opaque body imprinted ''400'' with black ink.
2CONTRAINDICATIONS
Cefixime capsules are contraindicated in patients with known allergy to cefixime or other cephalosporins.
3OVERDOSAGE
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.
4DESCRIPTION
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:
- I nactive ingredients contained in cefixime capsules 400 mg are: colloidal silicon dioxide, croscarmellose sodium, low substituted hydroxypropyl cellulose, magnesium stearate and mannitol. The capsule shell contains the following inactive ingredients: black iron oxide, butyl alcohol, dehydrated alcohol, gelatin, iron oxide red, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulphate, strong ammonia solution and titanium dioxide.
5HOW SUPPLIED/STORAGE AND HANDLING
Cefixime Capsules 400 mg
Off white to yellow color granular powder filled in size “0” hard gelatin capsules, pink opaque cap imprinted “CFX” with black ink and pink opaque body imprinted “400” with black ink.
NDC: 70518-2749-00
NDC: 70518-2749-01
NDC: 70518-2749-02
NDC: 70518-2749-03
NDC: 70518-2749-04
NDC: 70518-2749-05
PACKAGING: 10 in 1 BOTTLE PLASTIC
PACKAGING: 1 in 1 BOTTLE PLASTIC
PACKAGING: 2 in 1 BOTTLE PLASTIC
PACKAGING: 2 in 1 BOX
PACKAGING: 1 in 1 POUCH
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762