AUGMENTIN- amoxicillin and clavulanate potassium for 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:

Allegis Holdings, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AUGMENTIN is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: - Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . - Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . - Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . - Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. - Urinary Tract Infections - caused by beta‑lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, AUGMENTIN should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN 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. AUGMENTIN 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). AUGMENTIN is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN. Teratogenic Effects : Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to AUGMENTIN. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, 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. Oral ampicillin‑class antibacterials are poorly absorbed during labor. It is not known whether 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 of the necessity for an obstetrical intervention. Amoxicillin has been shown to be excreted in human milk. Amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman. The safety and effectiveness of AUGMENTIN for Oral Suspension and Chewable Tablets have been established in pediatric patients. Use of AUGMENTIN in pediatric patients is supported by evidence from studies of AUGMENTIN Tablets in adults with additional data from a study of AUGMENTIN for Oral Suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see Clinical Studies ( 14.2)] . Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of Amoxicillin and Clavulanate Potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see Dosage and Administration ( 2.3)]. Of the 3,119 patients in an analysis of clinical studies of AUGMENTIN, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Patients with Renal Impairment [see Dosage and Administration ( 2.4)] for specific recommendations in patients with renal impairment.

Product summary:

AUGMENTIN for Oral Suspension, USP : 125 mg/31.25 mg per 5 mL : Banana-flavored powder for oral suspension, each 5 mL of reconstituted suspension contains 125 mg of amoxicillin as the trihydrate and 31.25 mg of clavulanic acid as the potassium salt (equivalent to 37.23 mg of clavulanate potassium). Dispense in original container. Store tablets and dry powder at or below 25°C (77°F). Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

AUGMENTIN- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR SUSPENSION
ALLEGIS HOLDINGS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AUGMENTIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AUGMENTIN.
AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1984
RECENT MAJOR CHANGES
Warnings and Precautions (5) 8/2022
INDICATIONS AND USAGE
AUGMENTIN is a combination of amoxicillin, a penicillin-class
antibacterial and clavulanate potassium, a
beta‑lactamase inhibitor indicated for treatment of the following
infections in adults and pediatric patients:
( 1)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin,
indicating no beta-lactamase production,
AUGMENTIN should not be used. ( 1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AUGMENTIN and
other antibacterial drugs, AUGMENTIN should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria. ( 1)
DOSAGE AND ADMINISTRATION
Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every
12 hours or 250 or 500 mg every
8 hours, based on the amoxicillin component. ( 2.2, 2.3)
Pediatric patients aged 12 weeks (3 months) and older: 25 to 45
mg/kg/day every 12 hours or 20 to 40
mg/kg/day every 8 hours, up to the adult dose. ( 2.3)
Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided
every 12 hours, based on the
amoxicillin component. Use of the 125 mg/5 mL oral suspension is
recommended. ( 2.3)
DOSAGE FORMS AND STRENGTHS
For Oral Suspension: 125 mg/31.25 mg per 5 mL, 250 mg/62.5 mg per 5 mL
( 3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to
AUGMENTIN or to other beta‑lactams (e.g., penicillins or
ce