국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37)
Hospira, Inc.
SODIUM LACTATE
SODIUM LACTATE 5.6 g in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
Sodium Lactate Injection, USP 50 mEq (5 mEq/mL), is primarily indicated, after dilution , as a source of bicarbonate for prevention or control of mild to moderate metabolic acidosis in patients with restricted oral intake whose oxidative processes are not seriously impaired. It is not intended nor effective for correcting severe acidotic states which require immediate restoration of plasma bicarbonate levels. Sodium lactate has no advantage over sodium bicarbonate and may be detrimental in the management of lactic acidosis. Sodium Lactate Injection, USP 50 mEq is contraindicated in patients suffering from hypernatremia or fluid retention. It should not be used in conditions in which lactate levels are increased (e.g., shock, congestive heart failure, respiratory alkalosis) or in which utilization of lactate is diminished (e.g., anoxia, beriberi). NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.
Sodium Lactate Injection, USP 50 mEq (5 mEq/mL) is supplied in 10 mL single-dose plastic vials. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, INC., Lake Forest, IL 60045 USA LAB-1170-1.0 Revised: 11/2017
New Drug Application
SODIUM LACTATE- SODIUM LACTATE INJECTION, SOLUTION, CONCENTRATE HOSPIRA, INC. ---------- SODIUM LACTATE Injection, USP R only 50 MEQ (5 MEQ/ML) _FOR ADDITIVE USE ONLY AFTER_ _DILUTION IN I.V. FLUIDS TO CORRECT_ _SERUM-BICARBONATE DEFICIT IN ACIDOSIS._ PLASTIC VIAL DESCRIPTION Sodium Lactate Injection, USP 50 mEq (5 mEq/mL), is a sterile, nonpyrogenic, concentrated solution of sodium lactate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher and systemic alkalizer. IT SHOULD NOT BE ADMINISTERED UNDILUTED. Each 10 mL vial contains sodium lactate, anhydrous 5.6 g (50 mEq each of Na and lactate anion). The solution contains no bacteriostat, antimicrobial agent or added buffer. Contains hydrochloric acid for pH adjustment. The osmolar concentration is 10 mOsmol/mL (calc.). When diluted with water for injection to make a 1/6 molar solution, the pH of sodium lactate injection is 6.5 (6.0 to 7.3). Sodium Lactate, USP is chemically designated CH CH(OH)COONa, a 60% aqueous solution miscible in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration. CLINICAL PHARMACOLOGY Lactate anion [CH CH(OH)COO ] serves the important purpose of providing "raw material" for subsequent regeneration of bicarbonate (HCO ) and thus acts as a source (alternate) of bicarbonate when normal production and utilization of lactic acid is not impaired as a result of disordered lactate metabolism. Lactate anion is usually present in extracellular fluid at a level of less than 1 mEq/liter, but may attain a level of 10 mEq/liter during exercise. It is seldom measured as such and thus is one of the "unmeasured anions" ("anion gap") in determinations of the ionic composition of plasma. Since metabolic convers 전체 문서 읽기