AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Preferred Pharmaceuticals, Inc.

INN (Међународно име):

AMOXICILLIN

Састав:

AMOXICILLIN ANHYDROUS 500 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 should be used only to treat 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 is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . caused by beta‑lactamase–pro

Резиме производа:

Tablets: 500 ‑mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. Bottles of 8 - 68788-9960-8 Bottles of 20 - 68788-9960-2 875 ‑mg/125-mg Tablets: Each scored white capsule‑shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. Bottles of 8 - 68788-9961-8 Bottles of 20 - 68788-9961-2 Dispense in original container. Store tablets and dry powder at or below 25°C (77°F). Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.

Статус ауторизације:

New Drug Application

Карактеристике производа

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: 07B15552-879D-4B04-B0E3-634ADD4632C8
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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.
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, POWDER FOR ORAL
SUSPENSION AND CHEWABLE TABLETS
INITIAL U.S. APPROVAL: 1984
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 SHOULD BE USED
ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE
CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium is a combination
penicillin-class antibacterial and beta lactamase inhibitor indicated
for treatment of the following:
Lower respiratory tract infections (1.1)
Acute bacterial otitis media (1.2)
Sinusitis (1.3)
Skin and skin structure infections (1.4)
Urinary tract infections (1.5)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin/clavulanate content are:
Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg
tablets are scored. (3)
Powder for Oral Suspension: 125 mg/31.25 mg per 5 mL, 200 mg/28.5 mg
per 5 mL, 250 mg/62.5 mg per 5 mL, 400
mg/57 mg per 5 mL (3)
Chewable Tablets: 125 mg/31.25 mg, 200 mg/28.5 mg, 250 mg/62.5 mg, 400
mg/57 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most frequently reported adverse effects were diarrhea/loose
stools (9%), nausea (3%), skin rashes and urticaria
(3%),vomiting (1%) and vaginitis (1%) (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY’S
LABORATORIES INC., AT 1-888-375-3784 OR
Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hou