AMOXICILLIN AND CLAVULANATE POTASSIUM suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 600 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of pediatric patients with Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg /mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the ß-lactamase-producing organisms listed above. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate, or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin and clavulanate potassium. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral dosages up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. The amoxicillin doses in rodents (based on body surface area and assuming a 20 kg child) were approximately 2 times (rats) or equal to (mice) the recommended clinical amoxicillin and clavulanate potassium for oral suspension dose of 90/6.4 mg/kg/day. For clavulanate, these dose multiples were approximately 15 times and 7.5 times the recommended daily dose of amoxicillin and clavulanate potassium for oral suspension. Oral ampicillin-class antibacterial drugs are generally poorly absorbed during labor. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions. However, it is not known whether the use of amoxicillin and clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary. In a single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment with amoxicillin and clavulanate potassium may be associated with an increased risk of necrotizing enterocolitis in neonates. Ampicillin-class antibacterial drugs are excreted in human milk; therefore, caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman. Safety and efficacy of amoxicillin and clavulanate potassium for oral suspension in infants younger than 3 months have not been established. Safety and efficacy of amoxicillin and clavulanate potassium for oral suspension have been demonstrated for treatment of acute otitis media in infants and children 3 months to 12 years [see Clinical Studies (14)]. The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of pediatric patients (3 months to 12 years) with acute bacterial sinusitis. This use is supported by evidence from adequate and well-controlled studies of amoxicillin and clavulanate potassium extended-release tablets in adults with acute bacterial sinusitis, studies of amoxicillin and clavulanate potassium for oral suspension in pediatric patients with acute otitis media, and by similar pharmacokinetics of amoxicillin and clavulanate in pediatric patients taking amoxicillin and clavulanate potassium for oral suspension [see Clinical Pharmacology (12)] and adults taking amoxicillin and clavulanate potassium extended-release tablets.

Product summary:

How Supplied Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 600 mg/42.9 mg per 5 mL Caramel-orange-raspberry-flavored powder for oral suspension. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt (equivalent to 51.1 mg of clavulanate potassium). NDC 0781-6139-57 75 mL bottle NDC 0781-6139-54 125 mL bottle NDC 0781-6139-48 200 mL bottle Storage Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder for oral suspension at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Dispense in original container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM SUSPENSION
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM FOR
ORAL
SUSPENSION.
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium for oral suspension is a
combination of amoxicillin, a penicillin-class
antibacterial and clavulanate potassium, a beta-lactamase inhibitor,
indicated for the treatment of
pediatric patients with
•
Acute otitis media due to _S. pneumoniae _alone can be treated with
amoxicillin. Amoxicillin and clavulanate
potassium for oral suspension is not indicated for the treatment of
acute otitis media due to _S._
_pneumoniae _with penicillin MIC greater than or equal to 4 mcg/mL.
Therapy may be instituted prior to
obtaining the results from bacteriological studies when there is
reason to believe the infection may involve
both _S. pneumoniae _(penicillin MIC less than or equal to 2 mcg/mL)
and the β-lactamase-producing
organisms listed above. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
clavulanate potassium for oral suspension and other antibacterial
drugs, Amoxicillin and clavulanate
potassium for oral suspension should be used only to treat or prevent
infections that are proven or
strongly suspected to be caused by bacteria. (1)
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
For oral suspension: 600 mg/42.9 mg per 5 mL. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
Warnings and Precautions (5) 6/2022
Recurrent or persistent acute otitis media due to _S. pneumoniae_
(penicillin MICs less than or equal to
2 mcg/mL), _H. influenzae_ (including ß-lactamase–producing
strains), or