AMOXICILLIN tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Proficient Rx LP

INN (Διεθνής Όνομα):

AMOXICILLIN

Σύνθεση:

AMOXICILLIN ANHYDROUS 875 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.,

Περίληψη προϊόντος:

Amoxicillin Tablets, USP contains 875 mg amoxicillin as the trihydrate.  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 14                    NDC 63187-325-14        Bottles of 20                    NDC 63187-325-20         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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
PROFICIENT RX LP
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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 CITRON PHARMA LLC. AT
1-855-5-CITRON (1-
855-524-8766) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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 upp