AMOXICILLIN- amoxicillin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, Staphylococcus spp., or H. influenzae. Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole: Amoxicillin tablets, in combination with cla

Product summary:

Amoxicillin Tablets, USP contains 500 mg or 875 mg amoxicillin as the trihydrate. 500 mg Tablet Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side. Bottles of 20                    NDC 57237-028-20 Bottles of 100                  NDC 57237-028-01 875 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. Bottles of 20                    NDC 57237-029-20 Bottles of 100                  NDC 57237-029-01 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
REMEDYREPACK 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-Johnson sy