AMOXICILLIN tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

MedVantx, Inc.

INN (Rahvusvaheline Nimetus):

AMOXICILLIN

Koostis:

AMOXICILLIN ANHYDROUS 875 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, 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 tablets, USP are 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.,

Toote kokkuvõte:

Amoxicillin Tablets, USP contains 500 mg or 875 mg amoxicillin as the trihydrate.   500 mg Tablet   Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side.         Bottles of 20                    NDC 65862-014-20                  Bottles of 100                  NDC 65862-014-01          Bottles of 500                  NDC 65862-014-05   875 mg Tablet   Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side.         Bottles of 20                    NDC 65862-015-20       Bottles of 100                  NDC 65862-015-01       Bottles of 500                  NDC 65862-015-05   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
MEDVANTX, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR AMOXICILLIN TABLETS, USP.
AMOXICILLIN TABLETS, USP
INITIAL U.S. APPROVAL: 1974
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF AMOXICILLIN TABLETS,
USP AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN TABLETS, USP SHOULD BE
USED ONLY TO TREAT INFECTIONS THAT ARE
PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Amoxicillin tablets, USP are 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
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to amoxicillin tablets or to
other beta-lactams (e.g., penicillins or cephalosporins). (4)
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 AUROBINDO PHARMA USA, INC. AT 1-866-850-2876 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 - 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 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 mont