RANITIDINE capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Aurobindo Pharma Limited

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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. -

Ringkasan produk:

Ranitidine Capsules 150 mg are caramel colored size ‘3’ hard gelatin capsules, imprinted with “RAN” on cap and “150” on body, filled with off white to pale yellow powder.                     Bottle of 60                             NDC 59651-144-60                     Bottle of 500                           NDC 59651-144-05 Ranitidine Capsules 300 mg are caramel colored size ‘1’   hard gelatin capsules, imprinted with “RAN” on cap and “300” on body, filled with off white to pale yellow powder.                      Bottle of 30                             NDC 59651-145-30 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. The brands listed above are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Issued: March 2018

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

RANITIDINE - RANITIDINE CAPSULE
AUROBINDO PHARMA LIMITED
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RANITIDINE 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, crystalline,
practically odorless powder. It is
sensitive to light and moisture.
Each capsule, for oral administration contains 167.395 mg or 334.790
mg of ranitidine hydrochloride
USP equivalent to 150 mg and 300 mg of ranitidine, respectively.
Inactive ingredients: FD & C Blue l,
FD&C Red 40, FD&C Yellow 6, gelatin, magnesium stearate,
microcrystalline cellulose, potassium
hydroxide, propylene glycol, shellac, sodium lauryl sulphate, sodium
starch glycolate, strong ammonia
solution 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 a anticholinergic agent.
PHARMACOKINETICS
_ABSORPTION_
Ranitidine tablets and 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/kg. Serum protein binding
averages 15%.
2
13
22
4
3
2
++
_METABOLISM_
In humans, the N-oxide is th