AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Hikma Pharmaceutical

INN (International namn):

AMOXICILLIN

Sammansättning:

AMOXICILLIN ANHYDROUS 600 mg in 5 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: - antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 years daycare attendance - age ≤ 2 years - daycare attendance [See CLINICAL PHARMACOLOGY, Microbiology.] NOTE : Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infe

Produktsammanfattning:

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 600 mg/42.9 mg per 5 mL: Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin and 42.9 mg clavulanic acid as the potassium salt. 75 mL bottle 125 mL bottle 200 mL bottle

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
HIKMA PHARMACEUTICAL
----------
AMOXICILLIN AND CLAVULANATE POTASSIUM
FOR ORAL SUSPENSION USP, 600 MG/42.9 MG PER 5 ML
RX. ONLY
REV. 09/11
PRESCRIBING INFORMATION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL and
other antibacterial drugs,
amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9
mg per 5 mL 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 for Oral Suspension, USP 600
mg/42.9 mg per 5 mL 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
(2_S_,5_R_,6_R_)6-[(_R_)-(-)-2-Amino-2-(_p-_hydroxyphenyl)
acetamido]-3,3-dimethyl-7-oxo-4-
thia-1azabicyclo[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_)-(2_R_,5_R_)-3-(2-
hydroxyethylidene)-7-oxo-4-oxa-1azabicyclo[3.2.0]-heptane-2-carboxylate