Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Cardinal Health
RANITIDINE HYDROCHLORIDE
RANITIDINE 25 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application
ZANTAC- RANITIDINE HYDROCHLORIDE INJECTION, SOLUTION CARDINAL HEALTH ---------- ZANTAC (RANITIDINE HYDROCHLORIDE) INJECTION ZANTAC (RANITIDINE HYDROCHLORIDE) INJECTION PREMIXED DESCRIPTION The active ingredient in ZANTAC Injection and ZANTAC Injection Premixed 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 (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. STERILE, PREMIXED SOLUTION FOR INTRAVENOUS ADMINISTRATION IN SINGLE-DOSE, FLEXIBLE PLASTIC CONTAINERS Each 50 mL contains ranitidine HCl equivalent to 50 mg of ranitidine, sodium chloride 225 mg, and citric acid 15 mg and dibasic sodium phosphate 90 mg as buffers in water for injection. It contains no preservatives. The osmolarity of this solution is 180 mOsm/L (approx.), and the pH is 6.7 to 7.3. The flexible plastic container is fabricated from a specially formulated, nonplasticized, thermoplastic co-polyester (CR3). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of the chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to U Baca dokumen lengkap