AMOXICILLIN- amoxicillin tablet, chewable

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Lake Erie Medical DBA Quality Care Products LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) are 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 capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) are 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 capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) are indicated in the treatment of infections due to susceptible (ONLY β-lact

Produkt oversigt:

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. 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. 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. 250 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 250 mg amoxicillin as the trihydrate. Amoxicillin Tablets USP (Chewable) are supplied as follows: 125 mg: White to off-white, capsule-shaped tablet, debossed 93 on one side and 2267 on the other side and contain 125 mg amoxicillin as the trihydrate. 250 mg: White to off-white, capsule-shaped tablet, debossed 93 (partial bisect between 9 and 3) on one side and 2268 on the other side and contain 250 mg amoxicillin as the trihydrate. 55700-332-30 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

AMOXICILLIN- AMOXICILLIN TABLET, CHEWABLE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES, AMOXICILLIN
FOR ORAL SUSPENSION, AND AMOXICILLIN TABLETS (CHEWABLE) SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL
SUSPENSION, AND
AMOXICILLIN TABLETS (CHEWABLE).
AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, AND AMOXICILLIN
TABLETS (CHEWABLE) FOR ORAL
USE
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Indications and Usage, Gonorrhea (1.5) Removed 9/2015
Dosage and Administration, Gonorrhea (2.1) Removed 9/2015
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 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. (1.6)
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
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)
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
m