RANITIDINE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

St Marys Medical Park Pharmacy

INN:

RANITIDINE HYDROCHLORIDE

composition:

RANITIDINE 300 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

Abbreviated New Drug Application

SPC

RANITIDINE- RANITIDINE TABLET
ST MARYS MEDICAL PARK PHARMACY
----------
RANITIDINE TABLETS, USP
RX ONLY
DESCRIPTION
The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine
Tablets, USP 300 mg is
ranitidine hydrochloride (HCl), USP, 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,
HCl. 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. It has a slightly bitter taste and
sulfurlike odor.
Each Ranitidine Tablets, USP 150 mg for oral administration contains
167.4 mg of ranitidine HCl
equivalent to 150 mg of ranitidine. Each tablet also contains the
inactive ingredients colloidal silicon
dioxide, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, titanium dioxide, triethyl citrate and FD and C Yellow
6.
Each Ranitidine Tablets, USP 300 mg for oral administration contains
334.8 mg of ranitidine HCl
equivalent to 300 mg of ranitidine. Each tablet also contains the
inactive ingredients colloidal silicon
dioxide, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, titanium dioxide, triethyl citrate and D andC Yellow 10.
CLINICAL PHARMACOLOGY
Ranitidine Tablets, USP is a competitive, reversible inhibitor of the
action of histamine at the histamine
H
-receptors, including receptors on the gastric cells. Ranitidine
Tablets, USP does not lower serum
Ca
in hypercalcemic states. Ranitidine Tablets, USP is not an
anticholinergic agent.
PHARMACOKINETICS: _ABSORPTION:_ Ranitidine Tablets, USP is 50%
absorbed after oral administration,
compared to an intravenous (IV) injection with mean peak levels of 440
to 545 ng/mL occurring 2 to 3
hours after a 150-mg dose. Absorption is not significantly impaired by
the administration of food or
antacids. Propantheline slightly delays