CEFIXIME capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis . Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of Haemophilus influenzae , Moraxella catarrhalis , and Streptococcus pyogenes . (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) Note: For patients with otitis media caused by Streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see Clinical Studies ( 14)] . Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime for oral suspension and cefixime capsule is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime for oral suspension and cefixime capsule in the subsequent prevention of rheumatic fever is not available.) Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae . Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension and cefixime capsule should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins. 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. Cefixime has not been studied for use during labor and delivery. Treatment should only be given 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 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. 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. A pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see Clinical Pharmacology ( 12.3)] . These differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully [see Dosage and Administration ( 2.3)] .

Product summary:

Cefixime capsules, 400 mg is size "0" capsule with pink opaque cap and pink opaque body, imprinted with "LU" on cap and "U43" on body in black ink, containing white to yellowish white granular powder containing 400 mg of cefixime as the trihydrate and is supplied as follows: NDC: 70518-3221-00 NDC: 70518-3221-01 NDC: 70518-3221-02 NDC: 70518-3221-03 NDC: 70518-3221-04 NDC: 70518-3221-05 PACKAGING: 2 in 1 BOX PACKAGING: 1 in 1 POUCH PACKAGING: 2 in 1 BOX PACKAGING: 1 in 1 POUCH PACKAGING: 2 in 1 BOTTLE PLASTIC PACKAGING: 2 in 1 BOTTLE PLASTIC Store at 20 to 25°C (68 to 77°F) [See USP Controlled Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CEFIXIME- CEFIXIME CAPSULE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFIXIME SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFIXIME.
CEFIXIME FOR ORAL SUSPENSION, 100 MG/5 ML
CEFIXIME FOR ORAL SUSPENSION, 200 MG/5 ML
CEFIXIME CAPSULES, 400 MG
FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
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 cefixime and
other antibacterial drugs, cefixime for oral suspension and cefixime
capsules should be used only to treat
infections that are proven or strongly suspected to be caused by
bacteria. ( 1.6)
DOSAGE AND ADMINISTRATION
Adults: 400 mg daily ( 2.1)
Pediatric patients (6 months and older): 8 mg/kg/day ( 2.2)
DOSAGE FORMS AND STRENGTHS
Oral Suspension: 100 mg/5 mL and 200 mg/5 mL ( 3)
Capsules: 400mg ( 3)
CONTRAINDICATIONS
Contraindicated in patients with known allergy to cefixime or other
cephalosporins. ( 4)
WARNINGS AND PRECAUTIONS
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)
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 PHARMACEUTICALS,
INC. AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
Elevated carbamazepine levels have been reported in postmarketing
exp