AMOXICILLIN tablet, chewable

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, amoxicillin for oral suspension, amoxicillin tablets (chewable) 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, amoxicillin for oral suspension, amoxicillin tablets (chewable) 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, amoxicillin for oral suspension, amoxicillin tablets (chewable) 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, amoxi

Product summary:

Amoxicillin Tablets USP (Chewable) are supplied as follows: 250 mg: White to off-white, capsule-shaped tablet, debossed 93 (partial bisect between 9 and 3) on one side and 2268 on the other side and contain 250 mg amoxicillin as the trihydrate. They are available in bottles of 30 (NDC 66267-022-30). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN TABLET, CHEWABLE
NUCARE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES, AMOXICILLIN
FOR ORAL SUSPENSION, AND AMOXICILLIN TABLETS (CHEWABLE) SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL
SUSPENSION, AND
AMOXICILLIN TABLETS (CHEWABLE).
AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, AND AMOXICILLIN
TABLETS (CHEWABLE) 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 is 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 capsules, amoxicillin for
oral suspension, amoxicillin tablets (chewable) and other
antibacterial drugs, amoxicillin capsules, amoxicillin for oral
suspension, and amoxicillin tablets (chewable) 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
am