SODIUM BICARBONATE injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Tillgänglig från:

OMNIVIUM PHARMACEUTICALS LLC.

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

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

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
OMNIVIUM PHARMACEUTICALS LLC.
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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