País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Teligent, Inc.
RANITIDINE HYDROCHLORIDE
RANITIDINE 25 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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
New Drug Application
ZANTAC - RANITIDINE HYDROCHLORIDE INJECTION, SOLUTION TELIGENT, INC. ---------- 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 Llegiu el document complet