SODIUM BICARBONATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

US MedSource, LLC

INN (International Name):

SODIUM BICARBONATE

Composition:

SODIUM BICARBONATE 84 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 blood pigments. 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 interval may elapse before

Product summary:

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms: List No. Dosage Form Conc. % mg/mL (NaHCO3 ) mEq/mL (Na+ ) mEq/mL (HCO3 ― ) mEq/Container size (mL) mOsmol pH 6637 6625 4900 4916 1594 5534 Abboject® Syringe Fliptop Vial Abboject® Syringe (Pediatric) Abboject® Syringe LVP Glass Container Abboject® Syringe (Infant) 8.4 8.4 8.4 7.5 5.0 4.2 84 84 84 75 50 42 1.0 1.0 1.0 0.9 0.6 0.5 1.0 1.0 1.0 0.9 0.6 0.5 50/50 50/50 10/10 44.6/50 297.5/500 5/10 2/mL 2/mL 2/mL 1.79/mL 1190/liter 1/mL 8.0 (7.0 to 8.5) 7.8 (7.0 to 8.5) 8.0 (7.0 to 8.5) 8.0 (7.0 to 8.5) 7.8 (7.0 to 8.5) 8.0 (7.0 to 8.5) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: October, 2005 ©Hospira 2005                                                    EN-1064                                               Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA ABBOJECT® is a trademark of the Abbott group of companies.

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
US MEDSOURCE, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
SODIUM BICARBONATE
INJECTION, USP
FOR CORRECTION OF METABOLIC ACIDOSIS AND
OTHER CONDITIONS REQUIRING SYSTEMIC ALKALINIZATION.
ABBOJECT SYRINGE
LVP GLASS CONTAINER
FLIPTOP VIAL
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%, 5.0%, 7.5% and 8.4%.
See table in HOW SUPPLIED
section for contents and characteristics.
Solution in LVP container has 0.9 mg/mL of edetate disodium, anhydrous
added as a stabilizer.
The solutions contain no bacteriostat, antimicrobial agent or added
buffer and are intended only for use
as a single-dose injection. When smaller doses are required, the
unused portion should be discarded
with the entire unit.
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