AMOXICILLIN AND CLAVULANATE POTASSIUM suspension

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Aidarex Pharmaceuticals LLC

INN (Mezinárodní Name):

AMOXICILLIN

Složení:

AMOXICILLIN ANHYDROUS 600 mg in 5 mL

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 th

Přehled produktů:

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 Milliliter in a package - 53217-220-01 Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM SUSPENSION
AIDAREX PHARMACEUTICALS LLC
----------
AMOXICILLIN AND CLAVULANATE POTASSIUM
FOR ORAL SUSPENSION USP, 600 MG/42.9 MG PER 5 ML
REV. 08/10
RX ONLY
To reduce the development of drug-resistant bacteria and maintain
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 600 mg/42.9
mg per 5 mL is an oral
antibacterial combination consisting of the semisynthetic antibiotic
amoxicillin and the ß-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-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 ß-lactam structurally
related to the penicillins and possesses the ability to inactivate a
wide variety of ß-lactamases by
blocking the active sites of these enzymes. Clavulanic acid is
particularly active against the clinically
important plasmid-mediated ß-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-1-azabicyclo[3.2.0]-heptane-2-carboxylate
and may be represented
structurally as