Cefixime is a medicine sold in the U.S. under 2 brand and generic names, for bronchitis, escherichia coli infections and gonorrhea. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Cefixime (application ANDA206358). Other cefixime products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Adults: 400 mg daily ( 2.1 ) Children: weighing more than 45 kg or older than 12 years should be treated with recommended adults dose ( 2.2 ) 2.1 Adults The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The tablet may be administered without regard to food. In the treatment of infections due to Streptococcus pyogenes , a therapeutic dosage of cefixime should be administered for at least 10 days. 2.2 Pediatric Patients (weighing more than 45 kg or older than 12 years) Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the tablet should not be substituted for the chewable tablets or suspension in the treatment of otitis media [ see Clinical Pharmacology (12.3)] In the treatment of infections due to Streptococcus pyogenes , a therapeutic dosage of cefixime should be administered for at least 10 days. 2.3 Renal Impairment Cefixime may be administered in the…
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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most commonly seen adverse reactions in U.S. trials of the tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the twice daily or the once daily regimen. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions. Individual adverse reactions included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. 6.2 Post-marketing Experience The following adverse reactions have been reported following the post-approval use of cefixime. Incidence rates were less than 1 in 50 (less than 2%). Gastrointestinal Several cases of documented pseudomembranous colitis were identified in clinical trials. The onset of pseudomembranous…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | Generic | $10 | View → | |
| 2 | Not yet rated | Prescription | Suspension | Generic | $10 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| F;400 | 400 mg | white | capsule | — |
| LU;U43 | 400 mg | pink, pink | capsule | — |
| CMI;400 | 400 mg | pink | capsule | — |
| CFX;400 | 400 mg | pink | capsule | — |
| CFX;400 | 400 mg | pink | capsule | — |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Cefixime for Oral Suspension USP
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Lupin Pharmaceuticals Inc. · Aug 21, 2024
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size)
Failed Content Uniformity Specifications
Lupin Pharmaceuticals Inc. · May 30, 2024
Cefixime for Oral Suspension 100mg/5mL
Failed Impurities/Degradation Specifications
Lupin Pharmaceuticals Inc. · Jan 3, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Contraindicated in patients with known allergy to cefixime or other cephalosporins. ( 4 ) Cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins.
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 ) 7.1 Carbamazepine Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations. 7.2 Warfarin and Anticoagulants Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly. 7.3 Drug/Laboratory Test Interactions A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide. The administration of cefixime may result in a false-positive reaction for glucose in the urine using Clinitest ® **, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix ® ** or TesTape ® **) be used. A false-positive direct Coombs test has been reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug. **Clinitest ® and Clinistix ® are registered…