RANITIDINE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Contract Pharmacy Services-PA

INN (Միջազգային անվանումը):

RANITIDINE HYDROCHLORIDE

Կազմը:

RANITIDINE HYDROCHLORIDE 150 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 rantidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acuter 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

Ապրանքի ամփոփագիր:

150 mg tablets: peach to light-brown colored, round unscored tablets debossed“Par 544” on one side and plain on the other, supplied in blisters of 30 and 60 tablets. Store at 15°-30°C (59°-86°F) in a dry place. Protect from light. Rx only Manufactured by Par Pharmaceutical, iNC Spring Valley, NY 10977 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--03/2010--NJW

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

RANITIDINE- RANITIDINE TABLET
CONTRACT PHARMACY SERVICES-PA
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RANITIDINE TABLETS
DESCRIPTION
Ranitidine hydrochloride (HCl), USP, is a histamine H 2-receptor
antagonist. Chemically it is
N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-
N′-methyl-2-nitro-1,1-ethene-diamine,
HCl. It has the following structural formula:
The molecular formula is C 13H22N4O3S•HCl, representing a molecular
weight of 350.87.
Ranitidine HCl is a white to pale yellow, crystalline substance that
is soluble in water. It has a slightly
bitter taste and sulfurlike odor.
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: FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, synthetic
yellow iron oxide, titanium dioxide
and triethyl citrate.
CLINICAL PHARMACOLOGY
Ranitidine is a competitive, reversible inhibitor of the action of
histamine at the histamine H2-receptors,
including receptors on the gastric cells. Ranitidine does not lower
serum Ca++ in hypercalcemic states.
Ranitidine is not an anticholinergic agent.
PHARMACOKINETICS :
ABS ORPTION:
Ranitidine 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 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.
DIS TRIBUTION:
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; howe