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:

NorthStar RxLLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis . Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of  Haemophilus influenzae , Moraxella catarrhalis , and Streptococcus pyogenes . (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) Note: For patients with otitis media caused by Streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator. [ s ee C

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 50 mL Bottle of 75 mL

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFIXIME- CEFIXIME POWDER, FOR SUSPENSION
NORTHSTAR RXLLC
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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.
CEFIXIME FOR ORAL SUSPENSION USP, 100 MG/5 ML
CEFIXIME FOR ORAL SUSPENSION USP, 200 MG/5 ML
INITIAL U.S. APPROVAL:1986
RECENT MAJOR CHANGES
Warnings and Precautions, Risk in Patients with Phenylketonuria ( 5.6)
03/2017
INDICATIONS AND USAGE
Cefixime for oral suspension, USP 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 ( 1.1)
• Otitis Media ( 1.2)
• Pharyngitis and Tonsillitis ( 1.3)
• Acute Exacerbations of Chronic Bronchitis ( 1.4)
• Uncomplicated Gonorrhea (cervical/urethral)( 1.5)
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.( 1.6)
DOSAGE AND ADMINISTRATION
• Adults: 400 mg daily ( 2.1)
• Pediatric patients (6 months and older): 8 mg/kg/day ( 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)
Risk in Patients with Phenylketonuria (PKU): Before prescribing
Cefixime chewable tablets in a patient
with PKU, consider the combined daily amount of phenylalanine from all
sources, including Cefixime
chewable tablets. ( 5.6)
ADVERSE REACTIONS
Most common adv