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, SODIUM CATION - UNII:LYR4M0NH37)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

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 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

Product summary:

4.2% SODIUM BICARBONATE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1497-1 4.2% SODIUM BICARBONATE INJECTION, USP 2.5mEq/5mL (0.5mEq/mL) 5mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Sodium Bicarbonate Injection, USP is supplied in the following dosage forms. NDC 51662-1497-1 2.5mEq/5mL (0.5mEq/mL) 5mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufactures dosage forms Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Hospira, Inc., Lake Forest, IL 60045 USA LAB-0809-2.0 Revised: 01/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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4.2% SODIUM BICARBONATE INJECTION, USP 2.5MEQ/5ML (0.5MEQ/ML) 5ML VIAL
SPL UNCLASSIFIED
Injection, USP
FOR THE CORRECTION OF
METABOLIC ACIDOSIS AND
OTHER CONDITIONS REQUIRING
SYSTEMIC ALKALINIZATION.
Glass Vial
Rx only
DESCRIPTION
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic,
hypertonic solution of sodium
bicarbonate (NaHCO3) in water for injection for administration by the
intravenous route as an
electrolyte replenisher and systemic alkalizer.
The solution is offered in a concentration of 4.2%. See table in HOW
SUPPLIED section for contents
and characteristics.
The solution has an approximate pH of 8.0 (7.0 – 8.5). It contains
no bacteriostat, antimicrobial agent or
added buffer and is intended only for use as a single-use injection.
When smaller doses are required, the
unused portion should be discarded.
Sodium bicarbonate, 42 mg is equal to 0.5 milliequivalent each of Na+
and HCO3-. Sodium
Bicarbonate, USP is chemically designated NaHCO3, a white crystalline
powder soluble in water.
Water for Injection, USP is chemically designated H2O.
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 (HCO3-) 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 (HCO3-) 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 (H2CO3) an