AMOXICILLIN tablet, film coated AMOXICILLIN powder, for suspension

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Proficient Rx LP

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

Tablets: Each tablet contains 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 875, respectively. The 875-mg tablet is scored on the reverse side. 875-mg Tablet NDC 63187-013-20: Bottles of 20 Powder for Oral Suspension: Each 5 mL of reconstituted bubble-gum-flavored suspension contains 400 mg amoxicillin as the trihydrate. 400 mg/5 mL NDC 63187-027-00: 100-mL bottle Store at or below 25°C (77°F) Store Dry Powder at 20°C – 25°C (68°F – 77°F)

Статус Авторизація:

New Drug Application

Характеристики продукта

AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
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 SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMOXICILLIN.
AMOXICILLIN CAPSULES, TABLETS, AND POWDER FOR ORAL SUSPENSION
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.
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 DR. REDDY’S
LABORATORIES INC., AT 1-888-375-3784 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, 750-1750 mg/day in divided doses every 8-12 hours. In
Pediatric Patients > 3 Months of Age, 20-45
mg/kg/day in divided doses every 8-12 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 months is 30 mg/kg/day
divided every 12 hours. (2.2)
Dosing for _H. pylori _Infection: Triple therapy: 1 gram amoxicillin,
500 mg clarithromycin, and 30 mg lansopraz