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

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Sandoz Inc

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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 empiric selection of therapy. Amoxicillin and clavulanate potassium is con

Tóm tắt sản phẩm:

Tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side, and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 0781-1874-31 bottle of 30 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 0781-1831-20 bottle of 20 film coated tablets NDC 0781-1831-01 bottle of 100 film coated tablets NDC 0781-1831-13 Unit Dose (10 x 10) 100 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side, and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 0781-1852-20 bottle of 20 film coated tablets NDC 0781-1852-01 bottle of 100 film coated tablets NDC 0781-1852-13 Unit Dose (4 x 25) 100 film coated tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. For Oral Suspension Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 200 mg/28.5 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt. NDC 0781-6102-52 50 mL bottle NDC 0781-6102-57 75 mL bottle NDC 0781-6102-46 100 mL bottle Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 400 mg/57 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. NDC 0781-6104-52 50 mL bottle NDC 0781-6104-57 75 mL bottle NDC 0781-6104-46 100 mL bottle Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container; Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Chewable Tablets Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg tablets, USP (chewable): Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN2 on one side and plain on the reverse side, and contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt. NDC 0781-1619-66 Carton of 20 (4 x 5) tablets Amoxicillin and Clavulanate Potassium 400 mg/57 mg tablets, USP (chewable): Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN4 on one side and plain on the reverse side, and contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. NDC 0781-1643-66 Carton of 20 (4 x 5) tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container. KEEP OUT OF THE REACH OF CHILDREN.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, CHEWABLE
SANDOZ INC
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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, FOR ORAL USE
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION
AMOXICILLIN AND CLAVULANATE POTASSIUM CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1984
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium tablets, oral suspension and
chewable 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)
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•
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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 should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria. (1)
DOSAGE AND ADMINISTRATION
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•
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DOSAGE FORMS AND STRENGTHS
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•
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CONTRAINDICATIONS
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Warnings and Precautions (5) 8/2022
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