AMOXICILLIN tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)

Tillgänglig från:

NuCare Pharmaceuticals,Inc.

INN (International namn):

AMOXICILLIN

Sammansättning:

AMOXICILLIN ANHYDROUS 875 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis. Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, S

Produktsammanfattning:

Amoxicillin Tablets, USP contains 500 mg or 875 mg amoxicillin as the trihydrate. 875 mg Tablet Pink colored, capsule shaped, film coated tablets debossed with A on one side and with a score line in between 6 and 7 on the other side. NDC 68071-4086-2 Bottles of 20 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN TABLETS.
AMOXICILLIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Indications and Usage, Gonorrhea ( 1.5) Removed 9/2015
Dosage and Administration, Gonorrhea ( 2.1) Removed 9/2015
INDICATIONS AND USAGE
Amoxicillin tablets are a penicillin-class antibacterial indicated for
treatment of infections due to
susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and
skin structure, and lower respiratory
tract. ( 1.1 to 1.4)
In combination for treatment of _H. pylori _infection and duodenal
ulcer disease. ( 1.5)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin tablets
and other antibacterial drugs, amoxicillin tablets should be used only
to treat infections that are proven or
strongly suspected to be caused by bacteria. ( 1.6)
DOSAGE AND ADMINISTRATION
In adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In
Pediatric Patients > 3 Months of
Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to
full prescribing information for
specific dosing regimens. ( 2.1, 2.2, 2.3)
The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day
divided every 12 hours. ( 2.2)
Dosing for _H. pylori _Infection: Triple therapy: 1 gram amoxicillin,
500 mg clarithromycin, and 30 mg
lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual
therapy: 1 gram amoxicillin and 30
mg lansoprazole, each given three times daily (every 8 hours) for 14
days. ( 2.3)
Reduce the dose in patients with severe renal impairment (GFR <30
mL/min). ( 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg and 875 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-