ranitidine hydrochloride- Ranitidine Hydrochloride tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Ranitidine Hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7)

Prieinama:

Watson Laboratories, Inc.

INN (Tarptautinis Pavadinimas):

Ranitidine Hydrochloride

Vaisto forma:

TABLET

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Ranitidine tablets are 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. 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. 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). The treatment of pathological h

Produkto santrauka:

Ranitidine Tablets USP (each tablet contains ranitidine hydrochloride equivalent to either 150 mg or 300 mg ranitidine) are supplied as follows: 150 mg: Beige, round, biconvex tablet debossed WATSON in a semi-circle around the top edge and 760 across the bottom of one side and plain on the other side, in bottles of 60 and 500. 300 mg: Beige, capsule-shaped, biconvex, film-coated tablet debossed WATSON in a semi-circle around the top edge and 761 across the bottom of one side and plain on the other, in bottles of 30 and 100. Store at 20°-25°C (68°-77°F) in a dry place. [See USP controlled room temperature.] Protect from light. Replace cap securely after each opening. Dispense in a tight, light-resistant container as defined in USP/NF. Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA Rev: June 2005

Prekės savybės

RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE TABLET
WATSON LABORATORIES, INC.
----------
70012980
RANITIDINE
TABLETS USP
REVISED: JUNE 2005
RX ONLY
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, granular substance that is
soluble in water. It has a slightly
bitter taste and sulfur-like odor.
Each tablet, for oral administration, contains 168 mg of ranitidine
HCl equivalent to 150 mg of
ranitidine, or 336 mg of ranitidine HCl equivalent to 300 mg of
ranitidine. In addition, each tablet
contains the following inactive ingredients: colloidal silicon
dioxide, hypromellose, magnesium
stearate, maltodextrin, microcrystalline cellulose, polydextrose,
polyethylene glycol, sodium
bicarbonate, synthetic red iron oxide, synthetic yellow iron oxide,
talc, titanium dioxide and triethyl
citrate.
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 50% absorbed after oral administration, compared to an
intravenous (IV) injection with
mean peak levels of 440 to 545 ng/mL occurring at 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
2
13
22
4
3
2
++
Distribution
The volume of distrib