AMOXICILLIN powder, for suspension

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

NuCare Pharmaceuticals,Inc.

INN (Kansainvälinen yleisnimi):

AMOXICILLIN

Koostumus:

AMOXICILLIN ANHYDROUS 125 mg in 5 mL

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and other antibacterial drugs, Amoxicillin for Oral Suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin for Oral Suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: - due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . - due to Escherichia coli, Proteus mirabilis , or

Tuoteyhteenveto:

Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted fruity-flavored suspension contains 125, 200, 250, or 400 mg Amoxicillin as the trihydrate. A moxicillin for Oral Suspension, USP 125 mg/5ml NDC 68071-1761-1 Bottles of 150mL Store 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 using a child-resistant closure.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN FOR ORAL SUSPENSION, USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN FOR ORAL SUSPENSION, USP.
AMOXICILLIN FOR ORAL SUSPENSION, USP, FOR ORAL USE
DYE FREE
RX ONLY
INITIAL U.S. APPROVAL: 1974
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.
INDICATIONS AND USAGE
Amoxicillin for Oral Suspension, USP 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. ( 1.6, 1.7)
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)
Treatment of gonorrhea is 3 grams as a single oral dose. ( 2.1)
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
for Oral Suspension: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5
mL ( 3)
CONTRAINDICATIONS
History of a serious hypersensitivity reacti