CEFIXIME powder, for suspension CEFIXIME capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

CEFIXIME

Composition:

CEFIXIME ANHYDROUS 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefixime for oral suspension and cefixime capsule 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 and cefixime capsule 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 [see Clinical Studies (14)] . Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of

Product summary:

Cefixime for oral suspension USP, 100 mg/5 mL is an 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 and is supplied as follows: NDC 68180-405-01 - 50 mL Bottle 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. Cefixime for oral suspension USP, 200 mg/5 mL is an off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 200 mg of cefixime as the trihydrate and is supplied as follows: NDC 68180-407-03 - 50 mL Bottle NDC 68180-407-04 - 75 mL Bottle 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. 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 68180-423-08 - Bottle of 50 capsules NDC 68180-423-11 - Unit dose Package of 10 (1 blister of 10 capsules) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFIXIME - CEFIXIME POWDER, FOR SUSPENSION
CEFIXIME - CEFIXIME CAPSULE
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFIXIME SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFIXIME.
CEFIXIME FOR ORAL SUSPENSION, 100 MG/5 ML
CEFIXIME FOR ORAL SUSPENSION, 200 MG/5 ML
CEFIXIME CAPSULES, 400 MG
FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
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 (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 and
other antibacterial drugs, cefixime for oral suspension and cefixime
capsules 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 and 200 mg/5 mL (3)
Capsules: 400mg (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 LUPIN PHARMACEUTICALS,
INC. AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
Elevated carbamazepine level