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:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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:

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 tablets (NDC 70934-140-30) and bottles of 40 (NDC 70934-140-40). 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
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN TABLETS
(CHEWABLE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR AMOXICILLIN
TABLETS (CHEWABLE).
AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, AND AMOXICILLIN
TABLETS
(CHEWABLE) FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
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 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, 500 m