Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)
PharmPak, Inc.
ORAL
PRESCRIPTION DRUG
SUPRAX 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 . SUPRAX 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)]. SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isol
SUPRAX ® is available for oral administration in following dosage forms, strengths and packages listed in the table below:
Abbreviated New Drug Application
SUPRAX- CEFIXIME CAPSULE PHARMPAK, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SUPRAX® SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUPRAX®. SUPRAX® (CEFIXIME) TABLETS, FOR ORAL USE SUPRAX® (CEFIXIME) CAPSULES, FOR ORAL USE SUPRAX® (CEFIXIME) CHEWABLE TABLETS, FOR ORAL USE SUPRAX® (CEFIXIME) FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 1986 RECENT MAJOR CHANGES Warnings and Precautions, Risk in Patients with Phenylketonuria ( 5.6) 03/2017 INDICATIONS AND USAGE SUPRAX (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 SUPRAX and other antibacterial drugs, SUPRAX 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 Film-coated, scored Tablets: 400 mg ( 3) Capsules: 400 mg ( 3) Chewable Tablets: 100 mg, 150 mg and 200 mg ( 3) Oral Suspension: 100 mg/5 mL, 200 mg/5 mL and 500 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 SUPRAX chewable tablets in a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including SUPRAX chewable ta read_full_document