AMPICILLIN capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
15-01-2018

유효 성분:

AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)

제공처:

PD-Rx Pharmaceuticals, Inc.

INN (국제 이름):

AMPICILLIN TRIHYDRATE

구성:

AMPICILLIN 500 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

                                AMPICILLIN- AMPICILLIN CAPSULE
PD-RX PHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: 4DD38D9B-C5CF-450A-8C78-0BA312BDBF6F
----------
AMPICILLIN CAPSULES, USP 500 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ampicillin
capsules, Ampicillin for Oral Suspension and other antibacterial
drugs, Ampicillin Capsules and
Ampicillin for Oral Suspension should be used only to treat or prevent
infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Ampicillin trihydrate is a semisynthetic penicillin derived from the
basic penicillin nucleus, 6-
aminopenicillanic acid. Ampicillin is designated chemically as (2S,
5R, 6R)-6-[(R)-2-Amino-2-
phenylacetamido]-3,
3-dimethyl-7-oxo-4-thia-l-azabicyclo[3.2.0]heptane-2-carboxylic acid
trihydrate.
It has the following chemical structure:
The molecular formula is C
H
N
O
S.3H
O, and the molecular weight is 403.45.
Ampicillin Capsules, USP for oral administration provide ampicillin
trihydrate equivalent to 250 mg and
500 mg ampicillin. Ampicillin Capsules also contain magnesium
stearate. The capsule shell contains
black iron oxide, D&C red No. 28, FD&C blue No. 1, gelatin, silicon
dioxide, sodium lauryl sulfate,
and titanium dioxide.
Ampicillin for Oral Suspension, USP provides ampicillin trihydrate
equivalent to 125 mg/5 mL and 250
mg/5 mL ampicillin. Ampicillin for Oral Suspension also contains
carboxymethylcellulose sodium,
colloidal silicon dioxide, flavors, microcrystalline cellulose, sodium
citrate, sodium propionate, and
sucrose.
CLINICAL PHARMACOLOGY
Ampicillin is bactericidal at low concentrations and is clinically
effective not only against the gram-
positive organisms usually susceptible to penicillin G but also
against a variety of gram-negative
organisms. It is stable in the presence of gastric acid and is well
absorbed from the gastrointestinal
tract. It diffuses readily into most body tissues and fluids; however,
penetration into the cerebrospinal
fluid and brain occurs only with meningeal inf
                                
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