amoxicillin and clavulanate potassium- Amoxicillin and clavulanate potassium powder, for suspension amoxicillin and clavulanate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Amoxicillin (UNII: 804826J2HU) (Amoxicillin - UNII:804826J2HU), Clavulanate potassium (UNII: Q42OMW3AT8) (Clavulanic acid - UNII:23521W1S24)

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

Amoxicillin and clavulanate potassium

Pharmaceutical form:

POWDER, FOR SUSPENSION

Composition:

200 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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

Product summary:

Amoxicillin and Clavulanate Potassium For Oral Suspension, USP 200 mg/5 mL Each 5 mL of reconstituted white to pale yellow colored, strawberry flavored suspension contains 200 mg of amoxicillin and 28.5 mg of clavulanic acid as the potassium salt and is available as follows: NDC 63304-977-03 50 mL bottles NDC 63304-977-01 75 mL bottles NDC 63304-977-04 100 mL bottles 400 mg/5 mL Each 5 mL of reconstituted white to pale yellow colored, strawberry flavored suspension contains 400 mg of amoxicillin and 57 mg of clavulanic acid as the potassium salt and is available as follows: NDC 63304-979-03 50 mL bottles NDC 63304-979-01 75 mL bottles NDC 63304-979-04 100 mL bottles Amoxicillin and Clavulanate Potassium Tablets, USP (Chewable): 200 mg/ 28.5 mg Amoxicillin and clavulanate potassium tablets (chewable) 200 mg/28.5 mg contain 200 mg of amoxicillin as the trihydrate and 28.5 mg of clavulanic acid as clavulanate potassium. Each tablet is a pink colored, circular, biconvex, mottled tablet, debossed with ‘RX753’ on one side and plain on the other side. NDC 63304-753-03 Bottles of 10 NDC 63304-753-20 Bottles of 20 NDC 63304-753-01 Bottles of 100 NDC 63304-753-21 Unit-Dose Blister Packs of 20 400 mg/57 mg Amoxicillin and clavulanate potassium tablets (chewable) 400 mg/57 mg contain 400 mg of amoxicillin as the trihydrate and 57 mg of clavulanic acid as clavulanate potassium. Each tablet is a pink colored, circular, biconvex, mottled tablet, debossed with ‘RX754’ on one side and plain on the other side. NDC 63304-754-03 Bottles of 10 NDC 63304-754-20 Bottles of 20 NDC 63304-754-01 Bottles of 100 NDC 63304-754-21 Unit-Dose Blister Packs of 20 Store dry powder and tablets at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Dispense in tightly closed, moisture-proof containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, CHEWABLE
RANBAXY PHARMACEUTICALS INC.
----------
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
clavulanate potassium for oral suspension, and amoxicillin and
clavulanate potassium tablets (chewable)
and other antibacterial drugs, amoxicillin and clavulanate potassium
for oral suspension, and amoxicillin
and clavulanate potassium tablets (chewable) 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, and
amoxicillin and clavulanate potassium
tablets(chewable) 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 _)-(