AMOXICILLIN capsule AMOXICILLIN tablet, film coated AMOXICILLIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-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 beta-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-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 beta-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 inf

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN CAPSULE
AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
SANDOZ INC
REFERENCE LABEL SET ID: F0076447-4D8A-470D-9195-894C553DDCBC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES, TABLETS AND FOR
ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMOXICILLIN CAPSULES, TABLETS
AND FOR ORAL SUSPENSION.
AMOXICILLIN CAPSULES, TABLETS, AND ORAL SUSPENSION, FOR ORAL
ADMINISTRATION
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
Amoxicillin is a penicillin-class antibacterial indicated for
treatment of infections due to susceptible strains of designated
microorganisms.
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•
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)
•
•
•
DOSAGE FORMS AND STRENGTHS
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•
•
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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•
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)
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at
1-800-525-8747 or FDA at 1-800-FDA-1088 or
www.fda.gov/me dwatch
DRUG INTERACTIONS
•
Infections of the ear, nose, throat, genitourinary tract, skin and
skin structure, and lower respiratory tract. (1.1 – 1.4)
In combination for treatment of _H. pylori_ infection and duodenal
ulcer disease. (1.5)
The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day
divided every 12 hours. (2.2)
Dosing for _H. p