ZANTAC ranitidine hydrochloride injection solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)

제공처:

Cardinal Health

INN (International Name):

RANITIDINE HYDROCHLORIDE

구성:

RANITIDINE 25 mg in 1 mL

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

New Drug Application

제품 특성 요약

ZANTAC- RANITIDINE HYDROCHLORIDE INJECTION, SOLUTION
CARDINAL HEALTH
----------
ZANTAC
(RANITIDINE HYDROCHLORIDE)
INJECTION
ZANTAC
(RANITIDINE HYDROCHLORIDE)
INJECTION PREMIXED
DESCRIPTION
The active ingredient in ZANTAC Injection and ZANTAC Injection
Premixed is ranitidine
hydrochloride (HCl), a histamine H -receptor antagonist. Chemically it
is N[2-[[[5-
[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N′-methyl-2-nitro-1,1-ethenediamine,
hydrochloride. It has the following structure:
The empirical formula is C
H N O S●HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, granular substance that is
soluble in water.
ZANTAC Injection is a clear, colorless to yellow, nonpyrogenic liquid.
The yellow color of the liquid
tends to intensify without adversely affecting potency. The pH of the
injection solution is 6.7 to 7.3.
STERILE INJECTION FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
Each 1 mL of aqueous solution contains ranitidine 25 mg (as the
hydrochloride); phenol 5 mg as
preservative; and 0.96 mg of monobasic potassium phosphate and 2.4 mg
of dibasic sodium phosphate
as buffers.
STERILE, PREMIXED SOLUTION FOR INTRAVENOUS ADMINISTRATION IN
SINGLE-DOSE, FLEXIBLE PLASTIC
CONTAINERS
Each 50 mL contains ranitidine HCl equivalent to 50 mg of ranitidine,
sodium chloride 225 mg, and
citric acid 15 mg and dibasic sodium phosphate 90 mg as buffers in
water for injection. It contains no
preservatives. The osmolarity of this solution is 180 mOsm/L
(approx.), and the pH is 6.7 to 7.3.
The flexible plastic container is fabricated from a specially
formulated, nonplasticized, thermoplastic
co-polyester (CR3). Water can permeate from inside the container into
the overwrap but not in amounts
sufficient to affect the solution significantly. Solutions inside the
plastic container also can leach out
certain of the chemical components in very small amounts before the
expiration period is attained.
However, the safety of the plastic has been confirmed by tests in
animals according to U