AUGMENTIN- amoxicillin and clavulanate potassium for suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Allegis Pharmaceuticals, LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

AUGMENTIN 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: - Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . - Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . - Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . - Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. - Urinary Tract Infections - caused by beta‑lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, AUGMENTIN should not b

Povzetek izdelek:

AUGMENTIN for Oral Suspension, USP : 125 mg/31.25 mg per 5 mL : Banana-flavored powder for oral suspension, each 5 mL of reconstituted suspension contains 125 mg of amoxicillin as the trihydrate and 31.25 mg of clavulanic acid as the potassium salt (equivalent to 37.23 mg of clavulanate potassium). 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.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

AUGMENTIN- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR SUSPENSION
ALLEGIS PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AUGMENTIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AUGMENTIN.
AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1984
INDICATIONS AND USAGE
AUGMENTIN is 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)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin,
indicating no beta-lactamase production,
AUGMENTIN should not be used. ( 1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AUGMENTIN and
other antibacterial drugs, AUGMENTIN should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria. ( 1)
DOSAGE AND ADMINISTRATION
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 the amoxicillin component. ( 2.2, 2.3)
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. ( 2.3)
Neonates and infants less than 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. ( 2.3)
DOSAGE FORMS AND STRENGTHS
For Oral Suspension: 125 mg/31.25 mg per 5 mL, 250 mg/62.5 mg per 5 mL
( 3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to
AUGMENTIN or to other beta‑lactams (e.g., penicillins or
cephalosporins). ( 4.1)
History of cholestatic jaund