AMOXICILLIN tablet, chewable

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

PD-Rx Pharmaceuticals, Inc.

INN (Nama Internasional):

AMOXICILLIN

Komposisi:

AMOXICILLIN ANHYDROUS 250 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Amoxicillin tablets, USP: Amoxicillin Tablets (Chewable), USP: 250 mg :   Each 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, USP as the trihydrate. They are available in bottles of 4 tablets (NDC 43063-341-01). 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.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

AMOXICILLIN- AMOXICILLIN TABLET, CHEWABLE
PD-RX PHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: 9963C7B5-E2F5-40D8-B976-61FB453D17F3
REFERENCE LABEL SET ID: 20C86622-85B7-4827-A317-57AEE79DFE57
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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 TABLETS (CHEWABLE), 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 every 12 hours. ( 2.3)
Dosing for _H. pylori_ Infection (in Adults): Triple therapy: 1 gram
amoxicillin, 500 mg clarithromycin, and
30 mg lansoprazole, all given
twice daily (ever