For further information about SUPRAX® (cefixime):
You may also write to:
Lupine Pharmaceuticals, Inc.
111 S. Calvert Street, 21st Floor
Baltimore, MD 21202
Call your doctor for medical advice on side effects. You are encouraged to report suspected side effects of prescription drugs to FDA at www.fda.gov/medwatch also at 1-800-FDA-1088.
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- SUPRAX® (cefixime) is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria: Uncomplicated Urinary Tract Infections; Otitis Media; Pharyngitis and Tonsillitis; Acute Exacerbations of Chronic Bronchitis; Uncomplicated Gonorrhea (cervical/urethral).
IMPORTANT SAFETY INFORMATION
SUPRAX should only be used to treat infections that are proven or strongly suspected to be caused by bacteria.
- SUPRAX (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins.
WARNINGS AND PRECAUTIONS
- Hypersensitivity reaction: Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime. Before therapy with SUPRAX is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Discontinue use if a reaction occurs.
- Clostridium difficile associated diarrhea: Evaluate if diarrhea occurs.
- Dose Adjustment in Renal Impairment: The dose of SUPRAX should be adjusted in patients with renal impairment and those undergoing continuous ambulatory peritoneal dialysis and hemodialysis.
- Coagulation Effects: Cephalosporins, including SUPRAX, may be associated with a fall in prothrombin activity. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
- Phenylketonurics: SUPRAX Chewable Tablets contain aspartame, a source of phenylalanine.
- Most common adverse reactions are gastrointestinal such as diarrhea (16%), loose or frequent stools (6%), abdominal pain (3%), nausea (7%), dyspepsia (3%), and flatulence (4%).
- Adverse reactions during postmarketing experience occurred at rates of less than 2%. Some serious adverse reactions included: pseudomembranous colitis, hypersensitivity reactions including Stevens-Johnson syndrome and serum sickness, acute renal failure, seizures, agranulocytosis, and toxic epidermal necrolysis.
- Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly.
- Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly with warfarin and anticoagulants.
- A false positive reaction for ketones and glucose in urine may occur with certain test kits. A false positive direct Coombs test has also been reported.
USE IN SPECIAL POPULATIONS
- Efficacy and safety in infants aged less than six months have not been established.
- Cefixime should be used during pregnancy only if clearly needed.
- Consideration should be given to discontinuing nursing temporarily during treatment with cefixime.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561.