국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)
OMNIVIUM PHARMACEUTICALS LLC.
INTRAVENOUS
PRESCRIPTION DRUG
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time int
Sodium Bicarbonate Injection, USP is supplied in the following dosage form: The 50 mL Sodium Bicarbonate Injection vials are supplied as 20 vials per carton with a single package insert. 25 vials per carton with a single package insert. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Omnivium Pharmaceuticals LLC Rahway, NJ 07065 PLF145 US/LF/028 V01 Revised: July 2023
Abbreviated New Drug Application
SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION OMNIVIUM PHARMACEUTICALS LLC. ---------- SODIUM BICARBONATE INJECTION, USP FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING SYSTEMIC ALKALINIZATION. RX ONLY _DESCRIPTION_ Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO ) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 8. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na and HCO . Sodium Bicarbonate, USP is chemically designated NaHCO , a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H O. _CLINICAL PHARMACOLOGY_ Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis. Sodium bicarbonate in water dissociates to provide sodium (Na ) and bicarbonate (HCO ) ions. Sodium (Na ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO ) is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered "labile" since at a proper concentration of hydrogen ion (H ) it may be converted to carbonic acid (H CO ) and thence to its volatile form, carbon dioxide (CO ) excreted by the lung. Normally a ratio of 1:20 (carb 전체 문서 읽기