RANITIDINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine hydrochloride is indicated in: Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis. Ranitidine hydrochloride is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

Product summary:

Ranitidine Hydrochloride Capsules, for oral administration, are available as: 150 mg: Opaque caramel capsules, imprinted GG 614 in white ink, filled with off-white powder and supplied as: NDC 0781-2855-60 bottles of 60 capsules NDC 0781-2855-05 bottles of 500 capsules 300 mg: Opaque caramel capsules, imprinted GG 615 in white ink, filled with off-white powder and supplied as: NDC 0781-2865-31 bottles of 30 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place. Protect from light. Replace cap securely after each opening. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. KEEP OUT OF THE REACH OF CHILDREN. The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE CAPSULE
SANDOZ INC
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RANITIDINE HYDROCHLORIDE CAPSULES
RX ONLY
DESCRIPTION
Ranitidine hydrochloride (HCl), 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,
HCl.
It has the following structure:
The molecular formula is C
H N O S • HCl, representing a molecular weight of 350.87.
Ranitidine hydrochloride, USP is a white to pale yellow, granular
substance that is soluble in water. It
has a slightly bitter taste and sulfur-like odor.
Each capsule, for oral administration contains 167 mg or 335 mg of
ranitidine hydrochloride, USP
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,
simethicone, sodium lauryl sulfate, sodium
starch glycolate, and titanium dioxide.
CLINICAL PHARMACOLOGY
Ranitidine hydrochloride is a competitive, reversible inhibitor of the
action of histamine at the histamine
H -receptors, including receptors on the gastric cells. Ranitidine
hydrochloride does not lower serum
Ca++ in hypercalcemic states. Ranitidine hydrochloride is not an
anticholinergic agent.
PHARMACOKINETICS
Absorption
Ranitidine hydrochloride 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 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 hydrochloride.
Distribution
The volume of distribution is about 1.