AMOXICILLIN AND CLAVULANATE POTASSIUM tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

PD-Rx Pharmaceuticals, Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. catarrhali

Resumo do produto:

Tablets: 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 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 72789-083-03               bottles of 3 NDC 72789-083-04               bottles of 4 NDC 72789-083-06               bottles of 6 NDC 72789-083-14               bottles of 14 NDC 72789-083-20               bottles of 20 NDC 72789-083-28               bottles of 28 Dispense in original container. Store tablets and dry powder at or below 25°C (77°F). Keep out of the reach of children.

Status de autorização:

New Drug Application

Características técnicas

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET
PD-RX PHARMACEUTICALS, 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,
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
· Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hours
or 250 or 500 mg every 8 hours.
(2.1, 2.2)
· 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. (2.2)
· Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every
12 hours, based on the
amoxicillin component. Use of the 125 mg/5 mL oral suspension is
recommended. (2.2)
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
· History of a serious hypersensitiv