AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Pharmasource Meds, LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side, contains 875 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 14 NDC 82982-019-14 Dispense in tightly closed, moisture-proof containers. Advise patients to keep in a closed container. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
PHARMASOURCE MEDS, LLC
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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 ( 5) 8/2022
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 mg/125 mg or 875
mg/125 mg every 12 hours or
250 mg/125 mg or 500 mg/125 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/31.25 mg per 5 mL oral
suspension is recommended. ( 2.3