AMOXICILLIN tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Clinical Solutions Wholesale

INN (Nome Internazionale):

AMOXICILLIN

Composizione:

AMOXICILLIN ANHYDROUS 875 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Capsules: Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500. 250-mg Capsule NDC 43598-225-01: Bottles of 100 NDC 43598-225-05: Bottles of 500 500-mg Capsule NDC 43598-205-01: Bottles of 100 NDC 43598-205-05: Bottles of 500 Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. 500-mg Tablet NDC 43598-224-14: Bottles of 20 NDC 43598-224-01: Bottles of 100 NDC 43598-224-05: Bottles of 500 875-mg Tablet NDC 43598-219-14: Bottles of 20 NDC 43598-219-01: Bottles of 100 Powder for Oral Suspension: Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate. Each 5 mL of reconstituted bubble-gum-flavored suspension contains 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. 125 mg/5 mL NDC 43598-222-80: 80-mL bottle NDC 43598-222-52: 100-mL bottle NDC 43598-222-53: 150-mL bottle 200 mg/5 mL NDC 43598-223-50: 50-mL bottle NDC 43598-223-51: 75-mL bottle NDC 43598-223-52: 100-mL bottle 250 mg/5 mL NDC 43598-209-80: 80-mL bottle NDC 43598-209-52: 100-mL bottle NDC 43598-209-53: 150-mL bottle 400 mg/5 mL NDC 43598-207-50: 50-mL bottle NDC 43598-207-51: 75-mL bottle NDC 43598-207-52: 100-mL bottle Store at or below 25°C (77°F) Store Dry Powder at 20°C – 25°C (68°F – 77°F)

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
CLINICAL SOLUTIONS WHOLESALE
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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 lansoprazole, all
given twice daily (every 12