SUPRAX- cefixime capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx 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 isol

Product summary:

SUPRAX ® is available for oral administration in following dosage form, strength and package listed below: capsules with  pink opaque cap and pink  opaque body, imprinted  with “LU” on cap and  “U43” on body in black  Bottles of 1 capsule NDC 43063-537-79 Store at 20 to 25°C  (68 to 77°F)  [See USP Controlled  Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

SUPRAX- CEFIXIME CAPSULE
PD-RX 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) CAPSULES, FOR ORAL USE
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 patient with PKU,
consider the combined daily amount of phenylalanine from all sources,
including SUPRAX chewable tablets. ( 5.6)
ADVERSE REACTIONS
Most common adverse reactions are gastrointestinal such as diarrhea
(16%), nausea (7%),