RANITIDINE tablet film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Ranitidine Hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7)

Boleh didapati daripada:

McKesson Contract Packaging

INN (Nama Antarabangsa):

Ranitidine Hydrochloride

Komposisi:

Ranitidine 150 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

RANITIDINE- RANITIDINE TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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RANITIDINE TABLETS USP
DESCRIPTION
Ranitidine hydrochloride USP 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,
hydrochloride.
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. The structural formula is:
C
H N O S•HCl M.W. 350.87
Each tablet, for oral administration, contains 168 mg or 336 mg of
ranitidine HCl equivalent to 150 mg
or 300 mg of ranitidine, respectively. In addition, each tablet
contains the following inactive
ingredients: croscarmellose sodium, hypromellose, lactose monohydrate,
magnesium stearate,
microcrystalline cellulose, red iron oxide, titanium dioxide, triethyl
citrate and yellow iron oxide.
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 an anticholinergic agent.
PHARMACOKINETICS
Absorption
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.
Distribution
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 amounts to <4% of the
2
13
22
4
3
2
++
dose. Other metabolites are the S-oxide (1%) and the desme