AMOXICILLIN powder, for suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

AMOXICILLIN

구성:

AMOXICILLIN ANHYDROUS 400 mg in 5 mL

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin 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 isolates only), Staphy

제품 요약:

Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted fruity-flavored suspension contains 125, 200, 250, or 400 mg Amoxicillin as the trihydrate. A moxicillin for Oral Suspension, USP 125 mg/5ml Amoxicillin for Oral Suspension, USP 200 mg/5mL Amoxicillin for Oral Suspension, USP 250 mg/5mL Amoxicillin for Oral Suspension, USP 400 mg/5mL 49999-983-00 Store at 20° to 25°C (68° to 77°F ) [ See USP Controlled Room Temperature] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN FOR ORAL
SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMOXICILLIN FOR
ORAL SUSPENSION, USP.
AMOXICILLIN FOR ORAL SUSPENSION, USP, FOR ORAL USE
DYE FREE
RX ONLY
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 for Oral Suspension, USP is 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, 750-1750 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 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
for Oral Suspension: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5
mL (3)
CONTRAINDICATIONS
History of a serious hypersensit