AMOXICILLIN- amoxicillin capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

REMEDYREPACK INC.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 an

Termék összefoglaló:

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 0781-2020-76............................................ bottles of 30 × 12's NDC 0781-2020-01.................................................... bottles of 100 NDC 0781-2020-05.................................................... bottles of 500 500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side. NDC 0781-2613-76............................................ bottles of 30 × 12's NDC 0781-2613-01.................................................... bottles of 100 NDC 0781-2613-05.................................................... bottles of 500 Amoxicillin Tablets, USP equivalent to 500 mg or 875 mg amoxicillin as the trihydrate and are supplied as: 500 mg: oval-shaped, unscored, white to slightly yellowish film-coated tablets embossed GG-961 on one side and 500 on the other side. NDC 0781-5060-20...................................................... bottles of 20 NDC 0781-5060-01.................................................... bottles of 100 875 mg: oval-shaped, scored on one side, white to slightly yellowish film-coated tablets embossed GG-962 on one side and 875 on the other side. NDC 0781-5061-20...................................................... bottles of 20 NDC 0781-5061-01.................................................... bottles of 100 Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted fruity flavored pink suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. 125 mg/5 mL NDC 0781-6039-58...................................................... 80 mL bottle NDC 0781-6039-46.................................................... 100 mL bottle NDC 0781-6039-55.................................................... 150 mL bottle 200 mg/5 mL NDC 0781-6156-52...................................................... 50 mL bottle NDC 0781-6156-57...................................................... 75 mL bottle NDC 0781-6156-46.................................................... 100 mL bottle 250 mg/5 mL NDC 0781-6041-58...................................................... 80 mL bottle NDC 0781-6041-46.................................................... 100 mL bottle NDC 0781-6041-55.................................................... 150 mL bottle 400 mg/5 mL NDC 0781-6157-52...................................................... 50 mL bottle NDC 0781-6157-57...................................................... 75 mL bottle NDC 0781-6157-46.................................................... 100 mL bottle Store capsules, tablets and unreconstituted powder for oral suspension at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

AMOXICILLIN- AMOXICILLIN CAPSULE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES, TABLETS AND FOR
ORAL SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMOXICILLIN CAPSULES,
TABLETS AND FOR ORAL SUSPENSION, USP.
AMOXICILLIN CAPSULES, TABLETS, AND FOR ORAL SUSPENSION, 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)
Tablets: 500 mg, 875 mg ( 3