AMOXICILLIN powder, for suspension

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Proficient Rx LP

INN (International Adı):

AMOXICILLIN

Kompozisyon:

AMOXICILLIN ANHYDROUS 125 mg in 5 mL

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. 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 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 Enterococcus faecalis . – due to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . – due to Streptococcus s

Ürün özeti:

Amoxicillin for Oral Suspension USP is supplied as follows: 125 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 125 mg amoxicillin as the trihydrate. It is available in bottles of 80 mL, 100 mL, and 150 mL. 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES USP, AMOXICILLIN FOR
ORAL SUSPENSION USP, AND AMOXICILLIN TABLETS USP (CHEWABLE) SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMOXICILLIN CAPSULES USP, AMOXICILLIN FOR ORAL
SUSPENSION USP, AND AMOXICILLIN TABLETS USP
(CHEWABLE).
AMOXICILLIN CAPSULES USP, AMOXICILLIN FOR ORAL SUSPENSION USP, AND
AMOXICILLIN TABLETS USP
(CHEWABLE) FOR ORAL USE INITIAL U.S. APPROVAL: 1974
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF AMOXICILLIN CAPSULES,
AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE) AND
OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN
CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, AND AMOXICILLIN TABLETS
(CHEWABLE) SHOULD BE USED ONLY TO TREAT
INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY
BACTERIA.
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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DOSAGE AND ADMINISTRATION
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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 (chewable) or oral
suspension were diarrhea, rash, vomiting, and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
Infections of the ear, nose, throat, genitourinary tract, skin and
skin structure, and lower respiratory tract. (1.1 to 1.5)
In combination for treatment of _H. pylori_ infection and duodenal
ulcer disease. (1.6, 1.7)
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