AMOXICILLIN capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Lake Erie Medical DBA Quality Care Products LLC

INN (Isem Internazzjonali):

AMOXICILLIN

Kompożizzjoni:

AMOXICILLIN ANHYDROUS 500 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Amoxicillin Capsules, USP contains 250 mg or 500 mg amoxicillin as the trihydrate. 250 mg Capsule Blue/Pink size “1” hard gelatin capsule filled with white to off white granular powder and imprinted with “A44” on pink body with black ink. 500 mg Capsule Blue/Pink size “0EL” hard gelatin capsule filled with white to off white granular powder and imprinted with “A45” on pink body with black ink. NDC: 55700-007-21  Bottles of 21 NDC: 55700-007-30  Bottles of 30 NDC: 55700-007-40  Bottles of 40 NDC: 55700-007-42  Bottles of 42 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

AMOXICILLIN- AMOXICILLIN CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN CAPSULES,
USP.
AMOXICILLIN CAPSULES, USP
INITIAL U.S. APPROVAL: 1974
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
AMOXICILLIN CAPSULES, USP AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN
CAPSULES, USP SHOULD
BE USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED
TO BE CAUSED BY
BACTERIA.
INDICATIONS AND USAGE
Amoxicillin capsules, USP are a penicillin-class antibacterial
indicated for treatment of infections due to
susceptible strains of designated microorganisms.
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)
DOSAGE AND ADMINISTRATION
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 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 hours) for 14 days. Dual
Therapy: 1 gram amoxicillin and 30
mg lansoprazole, each given three times daily (every 8 hours) for 14
days. (2.3)
Reduce the dose in patients with severe renal impairment (GFR <30
mL/min). (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg and 500 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to
amoxicillin capsules or to other b