AMOXICILLIN capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Asclemed USA, Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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 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

Tóm tắt sản phẩm:

Amoxicillin Capsules, USP 500 mg : Opaque buff cap and opaque buff body, hard gelatin capsules. Printed black “TEVA” on cap and “3109” on body portions of the capsules and contain 500 mg amoxicillin, USP as the trihydrate. They are available in bottles of 50 (NDC 76420-545-50 relabeled from NDC 0093-3109-53) capsules. 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.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

AMOXICILLIN- AMOXICILLIN CAPSULE
ASCLEMED USA, INC.
----------
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 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
capsules and other antibacterial drugs, 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 (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: 500 mg ( 3)
CONTRAINDICATIONS
History of a serious hypersensitivity r