AMOXICILLIN powder, for suspension

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Proficient Rx LP

INN (इंटरनेशनल नाम):

AMOXICILLIN

रचना:

AMOXICILLIN ANHYDROUS 400 mg in 5 mL

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, 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 for oral suspension, USP 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 isolat

उत्पाद समीक्षा:

Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted bubble-gum-flavored pink suspension contains 200 mg or 400 mg amoxicillin as the trihydrate.       400 mg/5 mL:       100 mL Bottle             NDC 63187-335-00 Store dry powder 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

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 FOR ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR AMOXICILLIN FOR ORAL
SUSPENSION, USP.
AMOXICILLIN FOR ORAL SUSPENSION, USP
INITIAL U.S. APPROVAL: 1974
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. (1)
INDICATIONS AND USAGE
Amoxicillin for oral suspension, USP 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
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to
amoxicillin for oral suspension 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 FOR 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 o