AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Sandoz Inc

ИНН (Международная Имя):

AMOXICILLIN

состав:

AMOXICILLIN ANHYDROUS 500 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Amoxicillin and clavulanate potassium 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: Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, and 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 emp

Обзор продуктов:

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 and 100 (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: Oral Suspension Amoxicillin and clavulanate potassium for oral suspension, USP 200 mg/28.5 mg per 5 mL (each 5 mL of reconstituted caramel-orange-raspberry-flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt) are supplied as under: Amoxicillin and clavulanate potassium for oral suspension, USP 400 mg/57 mg per 5 mL (each 5 mL of reconstituted caramel-orange-raspberry-flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt) are supplied as under: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
SANDOZ INC
REFERENCE LABEL SET ID: B6583123-8297-4EB9-AD0F-B074F8707683
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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, AND AMOXICILLIN AND
CLAVULANATE
POTASSIUM FOR ORAL SUSPENSION.
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, AND AMOXICILLIN AND
CLAVULANATE
POTASSIUM FOR ORAL SUSPENSION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1984
RECENT MAJOR CHANGES
Warnings and Precautions (5) 8/2022
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium is a combination of amoxicllin,
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 beta-lactamase 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 and other antibacterial drugs, amoxicillin and
clavulanate potassium tablets, and
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
Tablets: 500 mg/125 mg, 875 mg/125 mg. (3)
Oral Suspension: 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per 5 mL (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Adults and Ped