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:

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 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 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.

Product summary:

SODIUM BICARBONATE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1573-1 SODIUM BICARBONATE INJECTION, USP, 8.4% 50 mEq (1 mEq PER mL) 50mL VIAL NDC 51662-1573-2 SODIUM BICARBONATE INJECTION, USP, 8.4% 50 mEq (1 mEq PER mL) 50mL VIAL IN A POUCH NDC 51662-1573-3 SODIUM BICARBONATE INJECTION, USP, 8.4% 50 mEq (1 mEq PER mL) 50mL VIAL IN A POUCH, 25 POUCHES IN A CASE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Also supplied in the following manufacture supplied dosage forms, Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
_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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SODIUM BICARBONATE INJECTION, USP, 8.4% 50 MEQ (1 MEQ PER ML)
SPL UNCLASSIFIED
Sodium Bicarbonate
Injection, USP 4.2%
Sodium Bicarbonate
Injection, USP 8.4%
4.2% Sodium Bicarbonate 0.5 mEq/mL Injection , USP 5 mL Single Dose
Vial and
8.4% Sodium Bicarbonate 1 mEq/mL Injection , USP 50 mL Single Dose
Vial
DESCRIPTION
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic,
hypertonic solution of
Sodium Bicarbonate (NaHCO 3), USP, in Water for Injection for
administration by the
intravenous route as an electrolyte replenisher and systemic
alkalizer. pH of the solution
is 7.0 to 8.5.
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 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 3-.
Sodium Bicarbonate, USP is chemically designated NaHCO 3, a white
crystalline powder
soluble in water.
Water for Injection, USP is chemically designated H 2O.
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 3-) 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 3-) is
a normal
constituent of body fluids and the normal plasma level ranges from