AMOXICILLIN- amoxicillin capsule AMOXICILLIN- amoxicillin powder, for suspension

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

DAVA Pharmaceuticals Inc

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

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 67253-144-10.................................................... bottles of 100 NDC 67253-144-50.................................................... bottles of 500 500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side. NDC 67253-150-10.................................................... bottles of 100 NDC 67253-150-50.................................................... bottles of 500 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 67253-146-45...................................................... 80 mL bottle NDC 67253-146-46.................................................... 100 mL bottle NDC 67253-146-47.................................................... 150 mL bottle 200 mg/5 mL NDC 67253-147-40...................................................... 50 mL bottle NDC 67253-147-43...................................................... 75 mL bottle NDC 67253-147-44.................................................... 100 mL bottle 250 mg/5 mL NDC 67253-148-45...................................................... 80 mL bottle NDC 67253-148-46.................................................... 100 mL bottle NDC 67253-148-47.................................................... 150 mL bottle 400 mg/5 mL NDC 67253-149-40...................................................... 50 mL bottle NDC 67253-149-43...................................................... 75 mL bottle NDC 67253-149-44.................................................... 100 mL bottle Store capsules 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

AMOXICILLIN- AMOXICILLIN CAPSULE
AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
DAVA PHARMACEUTICALS INC
REFERENCE LABEL SET ID: F0076447-4D8A-470D-9195-894C553DDCBC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES AND FOR ORAL
SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMOXICILLIN CAPSULES AND FOR
ORAL SUSPENSION, USP.
AMOXICILLIN CAPSULES 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.
•
•
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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (> 1%) observed in clinical trials
of amoxicillin capsules, tablets or oral suspension
were diarrhea, rash, vomiting, and nausea. (6.1)
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)
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,
50