RANITIDINE- ranitidine hydrochloride syrup

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

WOCKHARDT USA LLC

INN (Միջազգային անվանումը):

RANITIDINE HYDROCHLORIDE

Կազմը:

RANITIDINE 15 mg in 1 mL

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

- 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. - The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). - 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. - Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. - Treatment of GERD. Symptoma

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

RANITIDINE - RANITIDINE HYDROCHLORIDE SYRUP
WOCKHARDT USA LLC
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RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP)
DESCRIPTION
The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution,
USP) 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 molecular formula is C
H N O SHCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, crystalline, practically
odorless powder that is very soluble in
water, sparingly soluble in alcohol.
Each 1 mL of ranitidine oral solution contains 16.8 mg of ranitidine
HCl equivalent to 15 mg of
ranitidine. Ranitidine oral solution also contains the inactive
ingredients dehydrated alcohol (7.5%),
butylparaben, dibasic sodium phosphate anhydrous, hypromellose,
monobasic potassium phosphate,
noncrystallizing sorbitol solution (70%), peppermint flavour,
propylparaben, purified water, saccharin
sodium, sodium chloride.
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 2 to 3
hours after a 150-mg dose. The
oral solution formulation is bioequivalent to the tablets. 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 dis