AMOXICILLIN capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Cambridge Therapeutics Technologies, LLC

INN (nume internaţional):

AMOXICILLIN

Compoziție:

AMOXICILLIN ANHYDROUS 250 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Amoxicillin is 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 is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Amoxicillin is 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 is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae . Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and

Rezumat produs:

Amoxicillin Capsules, USP, for oral administration, contain 250 mg or 500 mg amoxicillin as the trihydrate and are supplied as: 250 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 250 on one side and GG 848 on the other side. NDC 70882-113-30, Package of 30 tablets (3 x 10 unit-of-dose blisters) 500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side. NDC 70882-114-20, Package of 20 tablets (2 x 10 unit-of-dose blisters) Store capsules at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

AMOXICILLIN- AMOXICILLIN CAPSULE
CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN
CAPSULES.
AMOXICILLIN CAPSULES, USP, FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Indications and Usage, Gonorrhea (1.5)
Removed 9/2015
Dosage and Administration, Gonorrhea (2.1)
Removed 9/2015
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 – 1.5)
•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 and other antibacterial
drugs, amoxicillin 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, 750-1750 mg/day in divided doses every 8-12 hours. In
Pediatric Patients > 3 Months of Age, 20-45
mg/kg/day in divided doses every 8-12 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 mg (3)
CONTRAINDICATIONS
•History of a serious hypersensitivity reaction (e.g., anaphylaxis
or Stevens-Johnson syndr