RANITIDINE- ranitidine hydrochloride syrup

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Aurobindo Pharma Limited

INN (Medzinárodný Name):

RANITIDINE HYDROCHLORIDE

Zloženie:

RANITIDINE 15 mg in 1 mL

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

Ranitidine Syrup (Ranitidine Oral Solution, USP), a clear, colorless to pale yellow, peppermint-flavored liquid, contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine per mL (75 mg/5 mL).                  Bottle of 474 mL                      NDC 65862-431-74 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze.    Dispense in tight, light-resistant containers as defined in the USP/NF. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 038, India Revised: 03/2019

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

RANITIDINE - RANITIDINE HYDROCHLORIDE SYRUP
AUROBINDO PHARMA LIMITED
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RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP)
RX ONLY
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 hydrochloride, USP is a white to pale yellow, crystalline,
practically odorless powder. It is
sensitive to light and moisture.
Each mL of ranitidine oral solution contains 16.8 mg of ranitidine
hydrochloride equivalent to 15 mg of
ranitidine. Ranitidine oral solution also contains the inactive
ingredients alcohol (7.5%), butyl paraben,
dibasic sodium phosphate anhydrous, hypromellose, monobasic potassium
phosphate, natural
peppermint flavor, propyl paraben, purified water, saccharin sodium,
sodium chloride, and sorbitol
solution.
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
2
13
22
4
3
2
++
high-potency antacid (150 mmol) in fasting subjects has been reported
to decrease the absorption of
ranitidine.
_DISTRIBUTION_
The vo