RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP)

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Hi-Tech Pharmacal Co., Inc.

INN (שם בינלאומי):

RANITIDINE HYDROCHLORIDE

הרכב:

RANITIDINE 15.0 mg in 1 mL

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Ranitidine is 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 8 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 out for 1 ye

leaflet_short:

Ranitidine Oral Solution, a clear, pale yellow, peppermint-flavored liquid, contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine per 1 mL (75 mg/5 mL) in bottles of 16 fluid ounces (one pint), in bottles of 4 fluid ounces, and in 10 mL unit dose. Store between 4° and 25°C (39° and 77°F). Do not freeze. Dispense in tight, light-resistant containers as defined in the USP/NF. Rx only

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

RANITIDINE- RANITIDINE SOLUTION
HI-TECH PHARMACAL CO., INC.
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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 empirical formula is C
H N O S•HCl, representing a molecular weight of 350.87. Ranitidine
HCl is a white to pale yellow, granular substance 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 the inactive
ingredients alcohol (7.5% w/v),
butylparaben, dibasic sodium phosphate, hypromellose, monobasic
potassium phosphate, natural
peppermint flavor, propylparaben, purified water, saccharin sodium,
sodium chloride, and sorbitol.
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 p