RANITIDINE HYDROCHLORIDE capsule

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:

Novitium Pharma LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Ranitidine is indicated in: - Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. - The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). - Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. - Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. -

製品概要:

Ranitidine Capsules 150 mg for oral administration, are supplied as follows: Caramel colored capsules, imprinted 001 on cap and novitium 150 mg on body in white ink, filled with white to pale yellow powder. NDC 70954-001 -20                Bottle of 60 capsules NDC 70954-001 -40                Bottle of 500 capsules Ranitidine Capsules 300 mg for oral administration, are supplied as follows: Caramel colored capsules, imprinted 002 on cap and novitium 300 mg on body in white ink, filled with white to pale yellow powder. NDC 70954-002 -10                Bottle of 30 capsules NDC 70954-002 -40                Bottle of 100 capsules Store at 20°-25°C (68°-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: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Revised: September, 2018 LB4034-01

認証ステータス:

Abbreviated New Drug Application

製品の特徴

RANITIDINE HYDROCHLORIDE - RANITIDINE HYDROCHLORIDE CAPSULE
NOVITIUM PHARMA LLC
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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 molecular 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 that is soluble in
water.
Each capsule, for oral administration contains 167.4 mg or 334.8 mg of
ranitidine hydrochloride
equivalent to 150 mg and 300 mg of ranitidine, respectively. In
addition, each capsule contains the
following Inactive ingredients: Colloidal silicon dioxide, FD&C Red No
40, FD&C Yellow No 6,
FD&C Blue No 1, Gelatin, Magnesium stearate, Microcrystalline
Cellulose, Sodium Lauryl Sulfate,
Sodium starch glycolate Type A, Titanium Dioxide. The capsule shells
are imprinted with edible ink
which contains Ammonia, Potassium Hydroxide, Propylene Glycol, Shellac
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 an anticholinergic agent.
PHARMACOKINETICS
_ABSORPTION: _Ranitidine is absorbed 50% 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
2
13
22
4
3
2
++
has been reported to decrease the absorption of ranitidine.
_DISTRIBUTION: _The volume of distribution