RANITIDINE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Amneal Pharmaceuticals LLC

INN (שם בינלאומי):

RANITIDINE HYDROCHLORIDE

הרכב:

RANITIDINE 150 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Ranitidine Tablets are indicated in: 1.   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. 2.   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. 3.   The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4.   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. 5.   Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. 6.   Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets 150 mg twice daily. 7.   Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets 150 mg 4 times daily. 8.   Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. 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 Tablets are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

leaflet_short:

Ranitidine Tablets USP, 150 mg (ranitidine HCl equivalent to 150 mg of ranitidine) are supplied as orange, round, biconvex aqueous film-coated tablets debossed “IP 253” on one side and plain on the reverse.  They are available as follows: Bottles of 60:              NDC 65162-253-06 Bottles of 100:            NDC 65162-253-10 Bottles of 180:            NDC 65162-253-18 Bottles of 500:            NDC 65162-253-50 Bottles of 1000:          NDC 65162-253-11 Ranitidine Tablets USP, 300 mg (ranitidine HCl equivalent to 300 mg of ranitidine) are supplied as yellow, capsule-shaped aqueous film-coated tablets debossed “IP 254” on one side and plain on the reverse.  They are available as follows: Bottles of 30:              NDC 65162-254-03 Bottles of 100:            NDC 65162-254-10 Bottles of 250:            NDC 65162-254-25 Bottles of 1000:          NDC 65162-254-11 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP.  Protect from light. Replace cap securely after each opening. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Or Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2017-02

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

RANITIDINE- RANITIDINE TABLET
AMNEAL PHARMACEUTICALS LLC
----------
RANITIDINE TABLETS, USP
(150 MG AND 300 MG)
RX ONLY
DESCRIPTION
The active ingredient in Ranitidine Tablets USP, 150 mg and Ranitidine
Tablets USP, 300
mg is ranitidine hydrochloride (HCl), USP, 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, granular substance that is
soluble in water. It has
a slightly bitter taste and sulfur like odor.
Each Ranitidine Tablet USP, 150 mg for oral administration contains
167.4 mg of
ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also
contains the inactive
ingredients colloidal silicon dioxide, croscarmellose sodium,
hypromellose, magnesium
stearate, microcrystalline cellulose, polydextrose, titanium dioxide,
triethyl citrate and
FD&C Yellow #6.
EACH RANITIDINE TABLET USP, 300 MG FOR ORAL ADMINISTRATION CONTAINS
334.8 MG
OF RANITIDINE HCL EQUIVALENT TO 300 MG OF RANITIDINE. EACH TABLET ALSO
CONTAINS
THE INACTIVE INGREDIENTS COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE
SODIUM,
HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE,
POLYDEXTROSE,
TITANIUM DIOXIDE, TRIETHYL CITRATE AND D&C YELLOW #10.
CLINICAL PHARMACOLOGY
Ranitidine Tablets are a competitive, reversible inhibitor of the
action of histamine at the
histamine H -receptors, including receptors on the gastric cells.
Ranitidine Tablets do not
lower serum Ca
in hypercalcemic states. Ranitidine Tablets are not an anticholinergic
agent.
PHARMACOKINETICS
_ABSORPTION:_ Ranitidine Tablets are 50% absorbed after oral
administration, compared to
2
13
22
4
3
2
++
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