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 Pharma, Inc.

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 52565-101-25, 2 mL single-dose vials (Carton of 25) NDC 52565-102-05, 6 mL multidose vials (Carton of 5) Store between 4° and 25°C (39° and 77°F); excursions permitted to 30°C (86°F). Protect from light. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat; however, brief exposure up to 40°C does not adversely affect the product. Protect from freezing. 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 PHARMA, INC.
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ZANTAC (RANITIDINE) INJECTION
RX ONLY
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.
STERILE INJECTION FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
Each 1 mL of aqueous solution contains ranitidine 25 mg (equivalent to
28 mg ranitidine hydrochloride,
USP); phenol 5 mg as preservative; and 0.96 mg of monobasic potassium
phosphate and 2.4 mg of
dibasic sodium phosphate as buffers.
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 binding averages 15%.
_METABOLISM:_ In humans, the N-oxide is the principal metabolite in
the urine; however, this amounts to
<4% of the dose. Other metabolites are the S-oxide (1%) and the
desmethyl ranitidine (1%)