AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Northstar RxLLC

INN (Διεθνής Όνομα):

AMOXICILLIN

Σύνθεση:

AMOXICILLIN ANHYDROUS 875 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 sh

Περίληψη προϊόντος:

Tablets Amoxicillin and clavulanate potassium tablets, USP 500 mg/125 mg are white to off-white oblong film coated tablets with beveled edges, debossed with 500/125 on one side and AMC on the other side. They are supplied in plastic bottles of 20 (with desiccant) as under: Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg are white to off-white oblong film coated tablets with beveled edges, scored and debossed with 875/125 on one side and AMC on the other side. They are supplied in plastic bottles of 20 and 100 (with desiccant) as under: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. Keep out of the reach of children.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
NORTHSTAR RXLLC
REFERENCE LABEL SET ID: B6583123-8297-4EB9-AD0F-B074F8707683
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM 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
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)
•
•
•
•
•
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin,
indicating no betalactamase production,
amoxicillin and clavulanate potassium 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
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg/125 mg, 875 mg/125 mg. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
Warnings and Precautions (5) 08/2022
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
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 wee