RANITIDINE INJECTION USP SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

A02BA02

INN (국제 이름):

RANITIDINE

복용량:

50MG

약제 형태:

SOLUTION

구성:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 50MG

관리 경로:

INTRAMUSCULAR

패키지 단위:

2/50/100ML

처방전 유형:

Prescription

치료 영역:

HISTAMINE H2-ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0115150004; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2021-03-01

제품 특성 요약

_Sandoz Ranitidine & Ranitidine Injection USP _
Page 1 of 31
PRODUCT MONOGRAPH
PR
SANDOZ RANITIDINE
RANITIDINE (AS RANITIDINE HYDROCHLORIDE) TABLETS BP
150 AND 300 MG
PR RANITIDINE INJECTION USP
RANITIDINE (AS RANITIDINE HYDROCHLORIDE) INJECTION USP
25 MG/ML
STERILE
HISTAMINE H
2 RECEPTOR ANTAGONIST
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: March 19, 2015
Boucherville, QC, Canada
J4B 7K8
Control No.: 182758
_Sandoz Ranitidine & Ranitidine Injection USP _
Page 2 of 31
PRODUCT MONOGRAPH
PR
SANDOZ RANITIDINE
Ranitidine Tablets BP
150 and 300 mg
PR
RANITIDINE INJECTION USP
25 mg/mL Injection sterile
HISTAMINE H
2 RECEPTOR ANTAGONIST
ACTIONS AND CLINICAL PHARMACOLOGY
Ranitidine is an antagonist of histamine at gastric H
2
receptor sites. Thus ranitidine inhibits both
basal gastric secretion and gastric acid secretion induced by
histamine, pentagastrin and other
secretagogues. On a weight basis, ranitidine is between 4 and 9 times
more potent than cimetidine.
Inhibition of gastric acid secretion has been observed following
intravenous, intraduodenal and oral
administration of ranitidine. This response is dose-related, a maximum
response being achieved at an
oral dose of 300 mg/day.
Pepsin secretion is also inhibited but secretion of gastric mucous is
not affected. Ranitidine does not
alter the secretion of bicarbonate or enzymes from the pancreas in
response to secretin and
pancreozymin.
Ranitidine is rapidly absorbed after oral administration of 150 mg
ranitidine, peak plasma
concentrations (300 to 550 ng/mL) occurred after 1 to 3 hours. Two
distinct peaks or a plateau in the
absorption phase result from reabsorption of drug excreted into the
intestine. These plasma
concentrations are not significantly influenced by the presence of
food in the stomach at the time of
the oral administration nor by regular doses of antacids.
Bioavailability of oral ranitidine is approximately 50% to 60%. Serum
protein binding of ranitidine
in man is in the range of 10 to 19%. The elimination half-life is
approximately 2 to 3