RANITIDINE- ranitidine syrup

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Nostrum Laboratories, Inc.

INN (nemzetközi neve):

RANITIDINE HYDROCHLORIDE

Összetétel:

RANITIDINE 15 mg in 1 mL

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Ranitidine Oral Solution is 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. - 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

Termék összefoglaló:

Ranitidine Syrup (Ranitidine Oral Solution, USP), a clear to opalescent straw to light-yellow, peppermint-flavored liquid, contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine per 1 mL (75 mg/5 mL). NDC 70408-141-34 Bottle of 16 fl. oz. (473 mL) Store between 4 to 25°C (39 to 77°F). Do not freeze. Dispense in a tight, light-resistant container as defined in the USP/NF. Manufactured by: Nostrum Laboratories, Inc.  Bryan, OH 43506 MULTISTIX®  is a registered trademark of Bayer Healthcare LLC. 5978T06                                                    Iss.: 02/16

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

RANITIDINE- RANITIDINE SYRUP
NOSTRUM LABORATORIES, INC.
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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 S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, crystalline powder that is
soluble in water. It has a slightly
bitter taste and sulfurlike odor.
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 these inactive
ingredients: alcohol (7.5%),
butylparaben, hypromellose, peppermint flavor, potassium phosphate
monobasic, propylparaben,
purified water, sodium chloride, sodium phosphate dibasic, sorbitol
and sucralose.
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 distribution is about 1.4 L/kg. Serum protein binding
averages 15