AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet, film coated

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:

Micro Labs Limited

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin and clavulanate potassium tablets are 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, amoxicillin and clavulanate potassium tablets should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets 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 tablets are 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 tablets are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium. Teratogenic Effects: Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (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 amoxicillin and clavulanate potassium. 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 amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients. Use of amoxicillin and clavulanate potassium in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium 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 amoxicillin and clavulanate potassium, 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:

Amoxicillin and Clavulanate Potassium Tablets, USP:   250 mg/125 mg Tablets :  White to off-white colored, capsule shaped, biconvex, film-coated tablets, debossed with “I 05” on one side and plain on the other side. Each tablet contains 250 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 30:                                                  NDC 42571-160-30 Bottles of 100:                                                NDC 42571-160-01 Carton of 100 (10x10 unit-dose tablets):        NDC 42571-160-11 500 mg/125 mg Tablets :  White to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 06” on one side and plain on the other side. Each tablet contains 500 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 20:                                                  NDC 42571-161-42 Bottles of 100:                                                NDC 42571-161-01 Carton of 100 (10x10 unit-dose tablets):        NDC 42571-161-11 875 mg/125 mg Tablets:   White to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 07” on one side and score line on the other side. Each tablet contains 875 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 20:                                                  NDC 42571-162-42 Bottles of 100:                                                NDC 42571-162-01 Carton of 40 (4x10 unit-dose tablets):            NDC 42571-162-44 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container. Advise patients to keep in closed container. Keep out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM - AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
MICRO LABS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS.
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1984
RECENT MAJOR CHANGES
Warnings and Precautions, Drug-Induced Enterocolitis Syndrome (DIES)
(5.3) 01/2024
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium tablets are 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,
amoxicillin and clavulanate potassium tablets should not be used. ( 1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
clavulanate potassium tablets and other antibacterial drugs,
amoxicillin and clavulanate potassium tablets
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 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)