RANITIDINE HYDROCHLORIDE tablet film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Cardinal Health

INN（国際名）:

RANITIDINE HYDROCHLORIDE

構図:

RANITIDINE 150 mg

処方タイプ:

PRESCRIPTION DRUG

認証ステータス:

Abbreviated New Drug Application

製品の特徴

RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE TABLET, FILM COATED
CARDINAL HEALTH
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RANITIDINE TABLETS, USP AND RANITIDINE CAPSULES
DESCRIPTION
Ranitidine hydrochloride (HCl), is 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 sulfur like odor.
Each tablet, for oral administration contains 168 mg or 336 mg of
ranitidine hydrochloride equivalent to
150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: D
& C Red #30 Aluminum Lake,
hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium
stearate, microcrystalline
cellulose, triethyl citrate, sodium starch glycolate, titanium dioxide
and flavoring. The 300 MG also
contains: D & C Yellow #10 Aluminum Lake.
Each capsule, for oral administration contains 168 mg or 336 mg of
ranitidine hydrochloride equivalent
to 150 mg and 300 mg of ranitidine, respectively. Inactive
ingredients: Ammonium hydroxide, colloidal
silicon dioxide, corn starch, FD & C Blue #1, FD & C Red #40, FD & C
Yellow #6, gelatin,
magnesium stearate, pharmaceutical glaze, propylene glycol, silicon
dioxide, simethicone, sodium
lauryl sulfate, sodium starch glycolate, and titanium dioxide.
CLINICAL PHARMACOLOGY
Ranitidine is a competitive, reversible inhibitor of the action of
histamine at the histamine H -receptors,
including receptors on the gastric cells. Ranitidine does not lower
serum Ca++ in hypercalcemic states.
Ranitidine is not a anticholinergic agent.
PHARMACOKINETICS
ABS ORPTION
Ranitidine tablets and ranitidine capsules are 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 no