AMOXICILLIN capsule

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Northwind Pharmaceuticals, LLC

INN (Међународно име):

AMOXICILLIN

Састав:

AMOXICILLIN ANHYDROUS 500 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Adults and Pediatric Patients - Upper Respiratory Tract Infections of the Ear, Nose, and Throat:   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 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 capsules 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 . - Infections of the Lower Respiratory Tract:  Amoxicillin capsules are indicated in the treatment

Резиме производа:

Amoxicillin Capsules, USP contains 500 mg amoxicillin USP as the trihydrate. 500 mg Capsule Blue/Pink size “0EL” hard gelatin capsule filled with white to off white granular powder and imprinted with “A45” on pink body with black ink. Bottles of 20 NDC 51655-156-20 Bottles of 21 NDC 51655-156-21 Bottles of 30 NDC 51655-156-52 Botltes of 40 NDC 51655-156-51 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.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

AMOXICILLIN- AMOXICILLIN CAPSULE
NORTHWIND PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN CAPSULES.
AMOXICILLIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Warnings and Precautions ( 5) 11/2022
INDICATIONS AND USAGE
Amoxicillin capsules are 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
capsules and other antibacterial drugs, 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 (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. ( 2.4)
Reduce the dose in patients with severe renal impairment (GFR greater
than 30 mL/min). (2.5)
DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg and 500 mg (3)
CONTRAINDICATIONS
History of a s