Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)
NorthStar RxLLC
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
CEFIXIME- CEFIXIME POWDER, FOR SUSPENSION NORTHSTAR RXLLC ---------- 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 Прочитать полный документ