Suprax Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
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)
What should I know before taking it?
Pregnancy Category B Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug. Safety and effectiveness of cefixime in children aged less than six months old have not been established. The incidence of.
What important warnings are listed?
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 tablets. ( 5.6)
How is this medication usually taken?
Adults: 400 mg daily ( 2.1) Pediatric patients (6 months and older): 8 mg/kg/day ( 2.2)
What side effects are listed?
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 Pharma at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What interactions are listed?
Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. ( 7.1) Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly with warfarin and anticoagulants. ( 7.2)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.