SODIUM BICARBONATE- 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:

Fresenius Kabi USA, LLC

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 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 CO2 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, USP 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 as: Product codes listed above are filled in flip-top single dose vials and packaged in trays of 25s. STORE AT: 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. Do not freeze. For Product Inquiry: 1-800-551-7176 or www.fresenius-kabi.com/us 451554A Issued: September 2020

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM BICARBONATE - SODIUM BICARBONATE INJECTION, SOLUTION
FRESENIUS KABI USA, 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._
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4.2% SODIUM BICARBONATE
Injection, USP
8.4% SODIUM BICARBONATE
Injection, USP
FOR THE 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 4.2% and 8.4%. See table in
HOW
SUPPLIED/STORAGE AND HANDLING section for contents and
characteristics.
The solution has an approximate pH of 8.0 (7.0 – 8.5). 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, 42 mg is equal to 0.5 milliequivalents 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
3
+
3
-
+
3
-
3
2
+
3
-
+
3
-
constituent of body fluids and the normal plasma level ranges from 24
to 31 mEq/liter.
P