SODIUM BICARBONATE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Exela Pharma Sciences, LLC

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms: NDC Code: Conc % mg/mL (NaHCO3 ) mEq/mL (Na+ ) mEq/mL (HCO3 - ) mEq/Container size (mL) mOsmol 51754-5001-4 51754-5001-5 8.4 84 1 1 50/50 2/mL 51754-5011-4 8.4 84 1 1 10/10 2/mL 51754-5002-5 7.5 75 0.9 0.9 44.6/50 1.79/mL 51754-5012-4 4.2 42 0.5 0.5 5/10 1/mL The 50 mL Sodium Bicarbonate Injection vials are supplied as either 20 vials per carton, or 25 vials per carton, with a single package insert and the 10 mL Sodium Bicarbonate Injection vials are supplied as 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.] Revised: August 2022 Manufactured by: Exela Pharma Sciences, LLC Lenoir, NC 28645

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
EXELA PHARMA SCIENCES, LLC
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SODIUM BICARBONATE INJECTION, USP
FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING
SYSTEMIC ALKALINIZATION.
R 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.
Solutions are offered in concentrations of 4.2%, 7.5% and 8.4%. See
table in HOW SUPPLIED
section for contents and characteristics.
The solutions contain no bacteriostat, antimicrobial agent or added
buffer and are intended only for use
as a single-dose injection, the approximate pH of the solutions 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 rat