CEFIXIME powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)

Available from:

Belcher Pharmaceuticals,LLC

INN (International Name):

CEFIXIME

Composition:

CEFIXIME ANHYDROUS 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug resistant bacteria and maintain the effectiveness of Cefixime for oral suspension and other antibacterial drugs, Cefixime for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data,local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria: Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis Otitis media caused by Haemophilus influenzae , Moraxella catarrhalis , and Streptococcus pyogenes . (Efficacy for

Product summary:

Cefixime for oral suspension, USP is available for oral administration in following dosage forms, strengths and packages listed in the table below: Dosage Form Description Package Size Storage Cefixime for Oral Suspension,USP Off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 100 mg of cefixime as the trihydrate. Bottle of 50 mL Prior to reconstitution: Store drug powder at 20 to 25°C (68 to 77 °F) [See USP Controlled Room Temperature] After reconstitution: Store at room temperature or under refrigeration. Keep tightly closed. Bottle of 75 mL Bottle of 100 mL Bottle of 50 mL Bottle of 75 mL

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFIXIME- CEFIXIME POWDER, FOR SUSPENSION
BELCHER PHARMACEUTICALS,LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFIXIME FOR ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CEFIXIME FOR ORAL
SUSPENSION.
CEFIXIMEFOR ORAL SUSPENSION USP, 100 MG/5 ML
CEFIXIMEFOR ORAL SUSPENSION USP, 200 MG/5 ML
FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL:1986
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CEFIXIME FOR ORAL SUSPENSION, USP AND OTHER ANTIBACTERIAL DRUGS,
CEFIXIME FOR ORAL
SUSPENSION, USP SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE
PROVEN OR STRONGLY
SUSPECTED TO BE CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Cefixime for oral suspension, USP is a cephalosporin antibacterial
drug indicated for
• Uncomplicated Urinary Tract Infections ( 1.1)
• Otitis Media ( 1.2)
• Pharyngitis and Tonsillitis ( 1.3)
• Acute Exacerbations of Chronic Bronchitis ( 1.4)
• Uncomplicated Gonorrhea (cervical/urethral)( 1.5)
DOSAGE AND ADMINISTRATION
• Adults: 400 mg daily (2.1)
• Children: 8 mg/kg/day (2.2) (2)
DOSAGE FORMS AND STRENGTHS
Oral Suspension: 100 mg/5 mL, 200 mg/5 mL ( 3)
CONTRAINDICATIONS
Contraindicated in patients with known allergy to cefixime or other
cephalosporins. ( 4)
WARNINGS AND PRECAUTIONS
• Hypersensitivity reactions including shock and fatalities have
been reported with cefixime. Discontinue
use if a reaction occurs. ( 5.1)
• _Clostridium difficile_associated diarrhea: Evaluate if diarrhea
occurs. ( 5.2)
ADVERSE REACTIONS
Most common adverse reactions are gastrointestinal such as diarrhea
(16%), nausea (7%), loose stools
(6%), abdominal pain (3%), dyspepsia (3%), and vomiting. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BELCHER
PHARMACEUTICALS, LLC AT 1-727-
471-0850 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
471-0850 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
Elevated carbamazepine levels have been reported in p