RANITIDINE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Cardinal Health

INN (International ime):

RANITIDINE HYDROCHLORIDE

Sastav:

RANITIDINE 150 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

RANITIDINE- RANITIDINE TABLET
CARDINAL HEALTH
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RANITIDINE TABLETS
DESCRIPTION
Ranitidine hydrochloride (HCl), USP, is a histamine H 2-receptor
antagonist. Chemically it is
N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-
N′-methyl-2-nitro-1,1-ethene-diamine,
HCl. It has the following structural formula:
The molecular formula is C 13H22N4O3S•HCl, representing a molecular
weight of 350.87.
Ranitidine HCl is a white to pale yellow, crystalline substance that
is soluble in water. It has a slightly
bitter taste and sulfurlike odor.
Each tablet, for oral administration, contains 168 mg or 336 mg of
ranitidine hydrochloride equivalent to
150 mg or 300 mg of ranitidine, respectively. In addition, each tablet
contains the following inactive
ingredients: FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, synthetic
yellow iron oxide, titanium dioxide
and triethyl citrate.
CLINICAL PHARMACOLOGY
Ranitidine is a competitive, reversible inhibitor of the action of
histamine at the histamine H2-receptors,
including receptors on the gastric cells. Ranitidine does not lower
serum Ca++ in hypercalcemic states.
Ranitidine is not an anticholinergic agent.
PHARMACOKINETICS :
ABS ORPTION:
Ranitidine 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 and
increases peak blood levels of ranitidine, probably by delaying
gastric emptying and transit time. In one
study, simultaneous administration of high-potency antacid (150 mmol)
in fasting subjects has been
reported to decrease the absorption of ranitidine.
DIS TRIBUTION:
The volume of distribution is about 1.4 L/kg. Serum protein binding
averages 15%.
Metabolism: In humans, the N-oxide is the principal metabolite in the
urine; however, this amou