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:

Teva Pharmaceuticals USA, Inc.

ИНН (Международная Имя):

AMOXICILLIN

состав:

AMOXICILLIN ANHYDROUS 600 mg in 5 mL

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with - Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)] . Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when t

Обзор продуктов:

How Supplied The color of the dry powder for Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is white to off-white powder. Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin trihydrate and 42.9 mg clavulanic acid as the potassium salt. It is available in bottles of 75 mL (NDC 0093-8675-78), 125 mL (NDC 0093-8675-75), and 200 mL (NDC 0093-8675-74). Storage Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original container. Keep tightly closed. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM FOR
ORAL
SUSPENSION.
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions (5) 6/2022
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9
mg per 5 mL is a combination of
amoxicillin, a penicillin-class antibacterial and clavulanate
potassium, a beta-lactamase inhibitor, indicated
for the treatment of pediatric patients with
Recurrent or persistent acute otitis media due to _S. pneumoniae
_(penicillin MICs less than or equal to 2
mcg/mL), _H. influenzae _(including β-lactamase–producing strains),
or _M. catarrhalis _(including β-
lactamase-producing strains) characterized by the following risk
factors (1):
- Antibacterial exposure for acute otitis media within the preceding 3
months, and either of the
following: 1) age 2 years, or younger or 2) daycare attendance
Limitations of Use
Acute otitis media due to _S. pneumoniae _alone can be treated with
amoxicillin. Amoxicillin and clavulanate
potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not
indicated for the treatment of acute otitis
media due to _S. pneumoniae _with penicillin MIC greater than or equal
to 4 mcg/mL. Therapy may be
instituted prior to obtaining the results from bacteriological studies
when there is reason to believe the
infection may involve both _S. pneumoniae _(penicillin MIC less than
or equal to 2 mcg/mL) and the β-
lactamase-producing organisms listed above. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
clavulanate potassium for oral suspension, 600 mg