These highlights do not include all the information needed to use SUPRAX safely and effectively. See full prescribing information for SUPRAX.
Suprax (cefixime) Tablets USP, 400 mg
Suprax (cefixime) Capsules, 400 mg
Suprax (cefixime) Chewable Tablets, 100 mg, 150 mg and 200 mg
Suprax (cefixime) for Oral Suspension USP, 100 mg/5 mL
Suprax (cefixime) for Oral Suspension USP, 200 mg/5 mL
Suprax (cefixime) for Oral Suspension USP, 500 mg/5 mL
For oral administration
Initial U.S. Approval:1986
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.
INDICATIONS AND USAGE
Suprax (cefixime) is a cephalosporin antibacterial drug indicated for
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Uncomplicated Urinary Tract Infections (1.1)
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Otitis Media (1.2)
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Pharyngitis and Tonsillitis (1.3)
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Acute Exacerbations of Chronic Bronchitis (1.4)
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Uncomplicated Gonorrhea (cervical/urethral) (1.5)
DOSAGE AND ADMINISTRATION
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Adults: 400 mg daily (2.1)
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Children: 8 mg/kg/day (2.2)
DOSAGE FORMS AND STRENGTHS
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Film-coated, scored Tablets: 400 mg (3)
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Capsules: 400 mg (3)
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Chewable Tablets: 100 mg, 150 mg and 200 mg (3)
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Oral Suspension: 100 mg/5 mL, 200 mg/5 mL and 500 mg/5 mL (3)
CONTRAINDICATIONS
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Contraindicated in patients with known allergy to cefixime or other cephalosporins. (4)
WARNINGS AND PRECAUTIONS
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Hypersensitivity reactions including shock and fatalities have been reported with cefixime. Discontinue use if a reaction occurs. (5.1)
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Clostridium difficile associated diarrhea: eva luate 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 Pharma at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. (7.1)
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Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly with warfarin and anticoagulants. (7.2)
USE IN SPECIFIC POPULATIONS
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Pregnancy: Cefixime should be used during pregnancy only if clearly needed. (8.1)
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Nursing Mothers: Consideration should be given to discontinuing nursing temporarily during treatment with cefixime. (8.3)
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Children: Efficacy and safety in infants aged less than six months have not been established. (8.4)
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Geriatric Use: Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. (8.5)
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Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Dose adjustment is required in patients whose creatinine clearance is less than 60 mL/min. (8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2014
