ZANTAC- ranitidine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teligent, Inc.

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 25 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZANTAC Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication. ZANTAC Injection is contraindicated for patients known to have hypersensitivity to the drug.

Product summary:

ZANTAC® Injection, 25 mg/mL, containing phenol 0.5% as preservative, is available as follows: NDC 52565-096-04, 40 mL pharmacy bulk package (Carton of 4) Store between 4° and 25°C (39° and 77°F); excursions permitted to 30°C (86°F). Protect from light. Store vial in carton until time of use. Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 ZANTAC® is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc., used under license. MULTISTIX® is a registered trademark of Bayer Healthcare LLC. PI-ZAN-00 Rev 04/2019

Authorization status:

New Drug Application

Summary of Product characteristics

ZANTAC - RANITIDINE HYDROCHLORIDE INJECTION, SOLUTION
TELIGENT, INC.
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ZANTAC (RANITIDINE) INJECTION
RX ONLY
PHARMACY BULK PACKAGE—NOT FOR DIRECT INFUSION
DESCRIPTION
The active ingredient in ZANTAC Injection is ranitidine hydrochloride
(HCl), 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, hydrochloride. 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.
ZANTAC Injection is a clear, colorless to yellow, nonpyrogenic liquid.
The yellow color of the
liquid tends to intensify without adversely affecting potency. The pH
of the injection solution is 6.7 to
7.3.
Each 1 mL of aqueous solution contains ranitidine 25 mg (as the
hydrochloride); phenol 5 mg as
preservative; and 0.96 mg of monobasic potassium phosphate and 2.4 mg
of dibasic sodium phosphate
as buffers.
A pharmacy bulk package is a container of a sterile preparation for
parenteral use that contains many
single doses. The contents are intended for use in a pharmacy
admixture program and are restricted to
the preparation of admixtures for intravenous (IV) infusion.
CLINICAL PHARMACOLOGY
ZANTAC is a competitive, reversible inhibitor of the action of
histamine at the histamine H -receptors,
including receptors on the gastric cells. ZANTAC does not lower serum
Ca++ in hypercalcemic states.
ZANTAC is not an anticholinergic agent.
PHARMACOKINETICS
_ABSORPTION:_ ZANTAC is absorbed very rapidly after intramuscular (IM)
injection. Mean peak levels of
576 ng/mL occur within 15 minutes or less following a 50-mg IM dose.
Absorption from IM sites is
virtually complete, with a bioavailability of 90% to 100% compared
with intravenous (IV)
administration. Following oral administration, the bioavailability of
ZANTAC Tablets is 50%.
_DISTRIBUTION:_ The volume of distribution is about 1.4 L/kg. Serum
protein bi