AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Disponible desde:

Rebel Distributors Corp

Designación común internacional (DCI):

AMOXICILLIN

Composición:

AMOXICILLIN ANHYDROUS 400 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Amoxicillin and Clavulanate Potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower Respiratory Tract Infections − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis . Otitis Media − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis . Sinusitis − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis . Skin and Skin Structure Infections − caused by β-lactamase−producing strains of S. aureus , E. coli , and Klebsiella spp. Urinary Tract Infections − caused by β-lactamase−producing strains of E. coli , Klebsiella spp. and Enterobacter spp. While Amoxicillin and Clavulanate Potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Amoxicillin and Clavulanate Potassium due to its amoxicillin content. Therefore, mixed infections caused by ampicilli

Resumen del producto:

Amoxicillin and Clavulanate Potassium 400 mg/57 mg per 5 mL for Oral Suspension: Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt. NDC 42254-282-00     100 mL bottle Store tablets and dry powder at or below 25°C (77°F). Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.

Estado de Autorización:

New Drug Application

Ficha técnica

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
REBEL DISTRIBUTORS CORP
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AMOXICILLIN AND CLAVULANATE POTASSIUM
POWDER FOR ORAL SUSPENSION AND CHEWABLE TABLETS
Rx Only
Issued: November 2011
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Amoxicillin and
Clavulanate Potassium and other antibacterial drugs, Amoxicillin and
Clavulanate Potassium should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Amoxicillin and Clavulanate Potassium is an oral antibacterial
combination consisting of the
semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor,
clavulanate potassium (the potassium
salt of clavulanic acid). Amoxicillin is an analog of ampicillin,
derived from the basic penicillin
nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula
is C
H N O S•3H O, and the
molecular weight is 419.46. Chemically, amoxicillin is (_2S,5R,6R
_)-6-[(_R_)-(-)-2-Amino-2-(_p_-
hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid
trihydrate and may be represented structurally as:
Clavulanic acid is produced by the fermentation of _Streptomyces
clavuligerus_. It is a β-lactam structurally
related to the penicillins and possesses the ability to inactivate a
wide variety of β-lactamases by
blocking the active sites of these enzymes. Clavulanic acid is
particularly active against the clinically
important plasmid-mediated β-lactamases frequently responsible for
transferred drug resistance to
penicillins and cephalosporins. The clavulanate potassium molecular
formula is C H KNO , and the
molecular weight is 237.25. Chemically, clavulanate potassium is
potassium (_Z_)-(_2R,5R _)-3-(2-
hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate
and may be represented
structurally as:
INACTIVE INGREDIENTS:
Powder for Oral Suspension—Colloidal silicon dioxide, flavorings
(see HOW SUPPLIED),