SUPRAX- cefixime tablet SUPRAX- cefixime capsule SUPRAX- cefixime tablet, chewable SUPRAX- cefixime powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

CEFIXIME

Composition:

CEFIXIME ANHYDROUS 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SUPRAX 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 . SUPRAX 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)]. SUPRAX 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. SUPRAX is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of SUPRAX in the subsequent prevention of rheumatic fever is not available.) SUPRAX 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. SUPRAX 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 SUPRAX and other antibacterial drugs, SUPRAX 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. SUPRAX  (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:

SUPRAX® is available for oral administration in following dosage forms, strengths and packages listed in the table below:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUPRAX- CEFIXIME TABLET
SUPRAX- CEFIXIME CAPSULE
SUPRAX- CEFIXIME TABLET, CHEWABLE
SUPRAX- CEFIXIME POWDER, FOR SUSPENSION
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUPRAX® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUPRAX®.
SUPRAX® (CEFIXIME) TABLETS, FOR ORAL USE
SUPRAX® (CEFIXIME) CAPSULES, FOR ORAL USE
SUPRAX® (CEFIXIME) CHEWABLE TABLETS, FOR ORAL USE
SUPRAX® (CEFIXIME) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1986
RECENT MAJOR CHANGES
Warnings and Precautions, Risk in Patients with Phenylketonuria (5.6)
03/2017
INDICATIONS AND USAGE
SUPRAX (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 SUPRAX and other
antibacterial drugs, SUPRAX 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
Film-coated, scored Tablets: 400 mg (3)
Capsules: 400 mg (3)
Chewable Tablets: 100 mg, 150 mg and 200 mg (3)
Oral Suspension: 100 mg/5 mL, 200 mg/5 mL and 500 mg/5 mL (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)
Risk in Patients with Phenylketonuria (PKU): Before prescribing SUPRAX
chewable tablets in a pat