RANITIDINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 15 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Ranitidine Oral Solution USP, a clear  peppermint flavored liquid, contains 16.8 mg of ranitidine HCl, USP equivalent to 15 mg of ranitidine per 1 mL (75 mg/5 mL) in bottles of 16 fluid ounces (one pint) (NDC 65162-664-90). Store between 4° and 25°C (39° and 77°F). Dispense in tight, light-resistant containers as defined in the USP/NF. Do not freeze. MULTISTIX is a registered trademark of Bayer Healthcare LLC. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2017-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE- RANITIDINE SOLUTION
AMNEAL PHARMACEUTICALS LLC
----------
RANITIDINE SYRUP
(RANITIDINE ORAL SOLUTION, USP)
15 MG/ML
RX ONLY
DESCRIPTION
The active ingredient in 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, USP 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, USP contains 16.8 mg of
ranitidine HCl, USP
equivalent to 15 mg of ranitidine. Ranitidine Oral Solution, USP also
contains the inactive
ingredients butylparaben, dibasic sodium phosphate, hypromellose,
monobasic sodium
phosphate, natural peppermint extract, propylene glycol,
propylparaben, purified water,
saccharin sodium, sodium chloride, and sorbitol solution.
CLINICAL PHARMACOLOGY
Ranitidine hydrochloride is a competitive, reversible inhibitor of the
action of histamine at
the histamine H -receptors, including receptors on the gastric cells.
Ranitidine
hydrochloride does not lower serum Ca
in hypercalcemic states. Ranitidine
hydrochloride is not an anticholinergic agent.
PHARMACOKINETICS
_ABSORPTION_: Ranitidine hydrochloride 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
2
13
22
4
3
2
++
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 absorp