ranitidine- Ranitidine tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

GENPHARM, L.P.

INN (Internationale Bezeichnung):

Ranitidine

Darreichungsform:

TABLET, FILM COATED

Zusammensetzung:

150 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 eight 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

Produktbesonderheiten:

Ranitidine Tablets USP, 150 mg and 300 mg for oral administration are available as: 150 mg tablets - White to off-white, round, biconvex, film-coated tablets with “G” on one side and “00” over “30” on the other side. Bottles of 60- NDC # 55530-030-06 Bottles of 100- NDC # 55530-030-35 Bottles of 500- NDC # 55530-030-05 Bottles of 1000- NDC # 55530-030-10 300 mg tablets - White to off-white, capsule shaped, film-coated tablets with “G” on one side and “0031” on the other side. Bottles of 30- NDC # 55530-031-03 Bottles of 100- NDC # 55530-031-01 Bottles of 250- NDC # 55530-031-25 Store at controlled room temperature between 15°C and 30°C (59°F and 86°F) in a dry place. Protect from light. Replace cap securely after each opening. Dispense in a tight, light-resistant container as defined in the USP. Rx only. Manufactured for: GENPHARM, L.P. NAPA, CA 94558 Manufactured by: GENPHARM INC. Toronto, Ontario Canada M8Z 2S6  

Fachinformation

RANITIDINE- RANITIDINE TABLET, FILM COATED
GENPHARM, L.P.
----------
RANITIDINE TABLETS USP
DESCRIPTION
Ranitidine hydrochloride 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,
hydrochloride. Ranitidine hydrochloride is a white to pale yellow,
crystalline powder that is very
soluble in water. It has a slightly bitter taste and sulfur-like odor.
It has the following structural formula:
Molecular Formula: C
H N O S•HCl
Molecular Weight: 350.87
Each tablet, for oral administration, contains 168 mg or 336 mg of
ranitidine hydrochloride equivalent to
150 mg or 300 mg of ranitidine respectively. In addition, each tablet
contains the following inactive
ingredients: hydroxypropyl methylcellulose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, titanium dioxide and triethyl
citrate. Each 300 mg tablet also
contains croscarmellose sodium.
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:_The volume of distribution is about 1.4 L/kg. Serum
protein binding averages 15%.
_METABOLISM:_In humans, the N-oxide is the principal metabolite in the
urine; however, this