RANITIDINE HYDROCHLORIDE- ranitidine hydrochloride capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

ANI Pharmaceuticals, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Ranitidine 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 is contraindicated in patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

Povzetek izdelek:

Ranitidine Capsules, for oral administration, are available as: 150 mg: Opaque caramel hard gelatin capsules, imprinted with “AC” on cap and “535” on body in black ink, filled with pale yellow to brownish powder, and supplied as: NDC 62559-690-30 bottles of 30 capsules NDC 62559-690-60 bottles of 60 capsules NDC 62559-690-05 bottles of 500 capsules 300 mg: Opaque caramel hard gelatin capsules, imprinted with “AC” on cap and “536” on body in black ink, filled with pale yellow to brownish powder, and supplied as: NDC 62559-691-30 bottles of 30 capsules NDC 62559-691-05 bottles of 500 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 in a tight, light-resistant container. Manufactured by: Appco Pharma LLC Piscataway, NJ 08854 Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Rev. 03/2019 200259

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE CAPSULE
ANI PHARMACEUTICALS, INC.
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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, crystalline practically
odorless powder. It is very soluble in
water and sparingly soluble in alcohol.
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: magnesium stearate,
microcrystalline cellulose, and sodium starch glycolate. The capsule
shell contains FD&C blue 1,
FD&C red 40, FD&C yellow 6, gelatin, titanium dioxide and sodium
lauryl sulfate. The capsule shells
are imprinted with edible ink black containing black iron oxide,
potassium hydroxide, propylene glycol,
shellac and strong ammonia solution.
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
Absorption
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 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