RANITIDINE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

STAT Rx USA LLC

DCI (Dénomination commune internationale):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 150 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Ranitidine Tablets, USP is 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

Descriptif du produit:

Ranitidine Tablets, USP 150 mg are orange, round, biconvex aqueous film coated tablets debossed “IP 253” on one side and plain on the reverse. They are available in: Bottles of 20     NDC # 16590-200-20 Bottles of 30     NDC # 16590-200-30 Bottles of 40     NDC # 16590-200-40 Bottles of 56     NDC # 16590-200-56 Bottles of 60     NDC # 16590-200-60 Bottles of 90     NDC # 16590-200-90 Bottles of 180   NDC # 16590-200-82 Ranitidine Tablets, USP 300 mg are yellow, capsule-shaped aqueous film coated tablets debossed “IP 254” on one side and plain on the reverse. They are available in: Bottles of 30     NDC # 16590-381-30 Bottles of 60     NDC # 16590-381-60 Bottles of 100   NDC # 16590-381-71 Store at 20° - 25°C (68° - 77°F) (See USP Controlled Room Temperature) in a tight, light resistant container. Protect from light. Replace cap securely after each opening.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

RANITIDINE - RANITIDINE TABLET
STAT RX USA LLC
----------
RANITIDINE TABLETS, USP
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
sulfurlike odor.
Each Ranitidine Tablets, 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 Tablets, 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, USP is a competitive, reversible inhibitor of the
action of histamine at the histamine
H -receptors, including receptors on the gastric cells. Ranitidine
Tablets, USP does not lower serum
Ca
in hypercalcemic states. Ranitidine Tablets, USP is not an
anticholinergic agent.
PHARMACOKINETICS: _ABSORPTION:_ Ranitidine Tablets, USP is 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