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:

Steriscience Specialties Private Limited

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Bicarbonate Injection 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 interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO 2  content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis. Sodium Bicarbonate Injection is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis.

Product summary:

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms: The 50 mL Sodium Bicarbonate Injection vials are supplied as 20 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: June 2023 Manufactured by: Steriscience Sp. z o.o. No. 10, Daniszewska Street, Warsaw, Poland – 03-230

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
STERISCIENCE SPECIALTIES PRIVATE LIMITED
----------
SODIUM BICARBONATE INJECTION, USP 8.4% 50 MEQ/ 50 ML (1 MEQ/ ML)
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.
Solutions are offered in concentrations of 8.4%. See table in HOW
SUPPLIEDsection
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 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