Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)
Lupin Pharmaceuticals, Inc.
CEFIXIME
CEFIXIME ANHYDROUS 100 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
CEFIXIME - CEFIXIME POWDER, FOR SUSPENSION CEFIXIME - CEFIXIME CAPSULE LUPIN PHARMACEUTICALS, INC. ---------- 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 Lire le document complet