SUPRAX- cefixime tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

LUPIN PHARMA

INN (International Name):

CEFIXIME

Composition:

CEFIXIME ANHYDROUS 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug resistant bacteria and maintain the effectiveness of Suprax (cefixime) chewable tablets and other antibacterial drugs, Suprax (cefixime) chewable tablets should be used only to treat or prevent 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) chewable tablets are indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis . Otitis Media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis , (most of which are beta-lactamase positive) and S. pyogene

Product summary:

Suprax (cefixime) chewable tablets, 100 mg, 150 mg and 200 mg 100 mg tablet -            Pink round tablet debossed "SUPRAX 100" on one side and "LUPIN" on other side. NDC 27437-203-13 - Outer carton containing 6 monocartons (NDC 27437-203-11) each containing 10’s blister. NDC 27437-203-10  - Bottle of 10’s NDC 27437-203-08  - Bottle of 50’s 150 mg tablet -            Pink round tablet debossed "SUPRAX 150" on one side and "LUPIN" on other side. NDC 27437-204-13 - Outer carton containing 6 monocartons (NDC 27437-204-11) each containing 10’s blister. NDC 27437-204-10  - Bottle of 10’s NDC 27437-204-08  - Bottle of 50’s 200 mg tablet -            Pink round tablet debossed "SUPRAX 200" on one side and "LUPIN" on other side. NDC 27437-205-13 - Outer carton containing 6 monocartons (NDC 27437-205-11) each containing 10’s blister. NDC 27437-205-10 - Bottle of 10’s NDC 27437-205-08 - Bottle of 50’s Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUPRAX- CEFIXIME TABLET, CHEWABLE
LUPIN PHARMA
----------
SUPRAX CEFIXIME CHEWABLE TABLETS
100 MG, 150 MG AND 200 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Suprax
(cefixime) chewable tablets and other antibacterial drugs, Suprax
(cefixime) chewable tablets should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Suprax (cefixime) chewable tablet is a semisynthetic, cephalosporin
antibiotic for oral administration.
Chemically, it is
(_6R,7R_)-7-[2-(2-Amino-4-thia-zolyl)glyoxylamido]-8-oxo-3-vinyl-5-thia-1-
azabicyclo[4.2.0] oct-2-ene-2-carboxylic acid, 7
-(_Z_)-[_O_-(carboxymethyl) oxime] trihydrate.
Molecular weight = 507.50 as the trihydrate. Chemical Formula is C
H N O S .3H O
The structural formula for cefixime is:
Each chewable tablet contains either 100 mg or 150 mg or 200 mg of
cefixime as the trihydrate. In
addition the tablet contains the following inactive ingredients:
aspartame, colloidal silicon dioxide,
crospovidone, low substituted hydroxypropyl cellulose, magnesium
stearate, mannitol, fantasy flavour
permaseal, tutti frutti flavour and F D & C Red # 40 Aluminium Lake.
CLINICAL PHARMACOLOGY
Suprax (cefixime) chewable tablets are bioequivalent to oral
suspension.
Suprax (cefixime) tablets, given orally, is about 40%-50% absorbed
whether administered with or
without food; however, time to maximal absorption is increased
approximately 0.8 hours when
administered with food. Suprax (cefixime) chewable tablets or oral
suspension produces average peak
concentrations approximately 25%-50% higher than the cefixime
immediate-release tablets, when tested
in normal _adult _volunteers. Two hundred and 400 mg doses of Suprax
(cefixime) chewable tablets or
oral suspension produce average peak concentrations of 3 mcg/mL (range
1 to 4.5 mcg/mL) and 4.6
mcg/mL (range 1.9 to 7.7 mcg/mL), respectively, when tested in normal
_adult _volunteers. The area under
the time versus concentration curve is