AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, 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 tablets USP 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-lacta

Produktu pārskats:

Amoxicillin and Clavulanate Potassium Tablets USP are supplied as follows: Amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 06” on one side and plain on the other side. Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows. Bottles of 14 NDC 70934-057-14 Blister Pack of 30 NDC 70934-057-94 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP.
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1984
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS AND OTHER ANTIBACTERIAL
DRUGS, AMOXICILLIN AND
CLAVULANATE POTASSIUM TABLETS 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 tablets USP are 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 mg/125 mg or 875 mg/125 mg
every 12 hours or 250
mg/125 mg or 500 mg/125 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg/125 mg, 500 mg/125 mg and 875 mg/125 mg ( 3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to
amoxicillin and clavulanate potassium or to other beta-lactams (e.g.,
penicillins or cephalosporins) ( 4)
History of cholestatic jaundice/hepatic dysfunction associated with
amoxicillin and clavulanate
potassium. ( 4)
WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS
Serious (including fatal) hypersensitivity reactions: Discont