AMOXICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin capsules 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 capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Amoxicillin capsules 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 capsules 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. pneum

Product summary:

Amoxicillin Capsules, USP contains 250 mg 250 mg Capsule Blue/Pink size 1 hard gelatin capsule filled with white to off white granular powder and imprinted with A44 on pink body with black ink. NDC 68071-4064-3 Bottles of 3 NDC 68071-4064-4 Bottles of 4 NDC 68071-4064-6 Bottles of 6 NDC 68071-4064-9 Bottles of 9 NDC 68071-4064-2 Bottles of 21 Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN CAPSULE
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN CAPSULES.
AMOXICILLIN CAPSULES, 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 capsules 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 – 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
capsules and other antibacterial drugs, amoxicillin capsules 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
Capsules: 250 mg and 500 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndr