AMOXICILLIN powder, for suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Teva Pharmaceuticals USA, Inc.

INN (International namn):

AMOXICILLIN

Sammansättning:

AMOXICILLIN ANHYDROUS 200 mg in 5 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Amoxicillin for Oral Suspension 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 for Oral Suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Amoxicillin for Oral Suspension 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 for Oral Suspension 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 . Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole: Am

Produktsammanfattning:

Amoxicillin for Oral Suspension USP is supplied as follows: Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 200 mg amoxicillin as the trihydrate. It is available in bottles of 50 mL (NDC 0093-4160-76), 75 mL (NDC 0093-4160-78), and 100 mL (NDC 0093-4160-73). Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 400 mg amoxicillin as the trihydrate. It is available in bottles of 50 mL (NDC 0093-4161-76), 75 mL (NDC 0093-4161-78), and 100 mL (NDC 0093-4161-73). Store dry powder 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN FOR ORAL SUSPENSION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN FOR ORAL SUSPENSION.
AMOXICILLIN FOR ORAL SUSPENSION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
Amoxicillin for Oral Suspension 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 to 1.4)
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 for Oral Suspension
and other antibacterial drugs, Amoxicillin for Oral Suspension 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 to 1750 mg/day in divided doses every 8 to 12 hours. In
Pediatric Patients > 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. (2.1,
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
for Oral Suspension, 500 mg clarithromycin, and 30
mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
Dual therapy: 1 gram Amoxicillin for Oral
Suspension 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
Powder for Oral Suspension: 200 mg/5 mL, 400 mg/5 mL, (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
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