CEFIXIME

CEFIXIME

Manufacturer: Lupin Pharmaceuticals, Inc.

Score: 142.0

Quick Summary

SUPRAX (cefixime) is a cephalosporin antibacterial drug used to treat various infections, including uncomplicated urinary tract infections, otitis media, pharyngitis and tonsillitis, acute exacerbations of chronic bronchitis, and uncomplicated gonorrhea. The recommended dose for adults is 400 mg daily, while pediatric patients (6 months and older) should receive 8 mg/kg/day. The drug has several important safety considerations, including contraindications in patients with known allergy to cefixime or other cephalosporins, and potential interactions with other medications such as carbamazepine and warfarin. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Uncomplicated Urinary Tract Infections
Otitis Media
Pharyngitis and Tonsillitis
Acute Exacerbations of Chronic Bronchitis
Uncomplicated Gonorrhea (cervical/urethral)

Important Safety Information

Warning

Contraindicated in patients with known allergy to cefixime or other cephalosporins

Contraindications

Known allergy to cefixime or other cephalosporins

Adverse Reactions

Diarrhea
Nausea
Loose stools
Abdominal pain
Dyspepsia
Vomiting

Dosing Recommendations

General Guidance

Dose adjustments are required for patients with renal impairment

Uncomplicated Urinary Tract Infections

Adult Dose

400 mg daily

Pediatric Dose

8 mg/kg/day

Otitis Media

Adult Dose

400 mg daily

Pediatric Dose

8 mg/kg/day

Pharyngitis and Tonsillitis

Adult Dose

400 mg daily

Pediatric Dose

8 mg/kg/day

Acute Exacerbations of Chronic Bronchitis

Adult Dose

400 mg daily

Pediatric Dose

8 mg/kg/day

Uncomplicated Gonorrhea (cervical/urethral)

Adult Dose

400 mg single dose

Pediatric Dose

Not recommended

Special Population Considerations

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

Nursing Mothers

It is not known whether cefixime is excreted in human milk
Consideration should be given to discontinuing nursing temporarily during treatment with this drug

Pediatric Use

Safety and effectiveness of cefixime in children aged less than six months old have not been established
The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets

Geriatric Use

Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects
A pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters, but these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly

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