AMOXICILLIN powder, for suspension

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

MedVantx, Inc.

INN (Isem Internazzjonali):

AMOXICILLIN

Kompożizzjoni:

AMOXICILLIN ANHYDROUS 250 mg in 5 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Amoxicillin Capsules USP are supplied as follows: 250 mg: Opaque caramel cap and opaque buff body, hard gelatin capsule. Printed black “TEVA” on cap and “3107” on body portions of the capsule and contain 250 mg amoxicillin as the trihydrate. They are available in bottles of 100 and 500 capsules. 500 mg: Opaque buff cap and opaque buff body, hard gelatin capsules. Printed black “TEVA” on cap and “3109” on body portions of the capsules and contain 500 mg amoxicillin as the trihydrate. They are available in bottles of 50 and 500 capsules. Amoxicillin for Oral Suspension USP is supplied as follows: 125 mg: Each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 125 mg amoxicillin as the trihydrate. It is available in bottles of 80 mL, 100 mL, and 150 mL. 250 mg: Each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 250 mg amoxicillin as the trihydrate. It is available in bottles of 80 mL, 100 mL, and 150 mL. Amoxicillin Tablets USP (Chewable) are supplied as follows: 125 mg: White to off-white, capsule-shaped tablet, engraved 93 on one side and 2267 on the other side and contain 125 mg amoxicillin as the trihydrate. They are available in bottles of 100 tablets. 250 mg: White to off-white, capsule-shaped tablet, engraved 93 (partial bisect between 9 and 3) on one side and 2268 on the other side and contain 250 mg amoxicillin as the trihydrate. They are available in bottles of 100 and 500 tablets. 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
MEDVANTX, INC.
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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, AMOXICILLIN TABLETS
USP (CHEWABLE) FOR ORAL USE INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
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 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.
DRUG INTERACTIONS
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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 d