AMOXICILLIN tablet, chewable AMOXICILLIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults and Pediatric Patients - Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and 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 . - Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and 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 . - Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative)

Product summary:

Product: 50090-0455 NDC: 50090-0455-0 30 TABLET, CHEWABLE in a BOTTLE Product: 50090-1814 Product: 50090-3005

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN TABLET, CHEWABLE
AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN TABLETS,
AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), AND
AMOXICILLIN
CAPSULES, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN
TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS
(CHEWABLE), AND
AMOXICILLIN CAPSULES.
AMOXICILLIN TABLETS, FOR ORAL USE
AMOXICILLIN FOR ORAL SUSPENSION,
AMOXICILLIN TABLETS (CHEWABLE), FOR ORAL USE
AMOXICILLIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Warnings and Precautions (5) 11/2022
INDICATIONS AND USAGE
Amoxicillin is a penicillin-class antibacterial indicated for
treatment of infections due to susceptible strains
of designated microorganisms. (1)
Adults and Pediatric Patients (1)
Upper Respiratory Tract Infections of the Ear, Nose, and Throat
Infections of the Genitourinary Tract
Infections of the Skin and Skin Structure
Infections of the Lower Respiratory Tract
Adult Patients only (1)
_Helicobacter pylori_ Infection and Duodenal Ulcer Disease
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin tablets,
amoxicillin for oral suspension, amoxicillin tablets (chewable), and
amoxicillin capsules and other
antibacterial drugs, amoxicillin tablets, amoxicillin for oral
suspension, amoxicillin tablets (chewable), and
amoxicillin capsules should be used only to treat or prevent
infections that are proven or strongly
suspected to be caused by bacteria. (1)
DOSAGE AND ADMINISTRATION
In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours.
In Pediatric Patients over 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.
(2.2, 2.3)
The upper dose for neonates and infants aged 3 months or younger is
30 mg/kg/day divided