SODIUM BICARBONATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)

Available from:

Hospira, Inc.

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:

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms. NDC No. (Unit of Sale) (NDC No. (Each)) Dosage Form Conc. % mg/mL (NaHCO3 ) mEq/mL (Na+ ) mEq/mL (HCO3 – ) mEq/ Container size (mL) mOsm / mL pH 0409-4916-14 (0409-4916-24) Lifeshield® Abboject® Syringe 7.5 75 0.9 0.9 44.6/50 1.40 8.0 (7.0 – 8.5) 0409-6637-14 (0409-6637-24) Lifeshield® Abboject® Syringe 8.4 84 1 1 50/50 1.56 8.0 (7.0 – 8.5) 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                                                                      ABBOJECT® is a trademark of the Abbott group of companies. LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license. LAB-1019-3.0 01/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
HOSPIRA, INC.
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SODIUM BICARBONATE INJECTION, USP RX ONLY
FOR THE CORRECTION OF METABOLIC ACIDOSIS AND
OTHER CONDITIONS REQUIRING SYSTEMIC ALKALINIZATION.
LIFESHIELD ABBOJECT SYRINGE
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 7.5% and 8.4%. See table in
_HOW SUPPLIED _section for
contents and characteristics.
The solutions have an approximate pH of 8.0 (7.0 to 8.5). They 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 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 diox