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:

General Injectables & Vaccines, 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 biocarbonate 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 befo

Product summary:

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms: Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]. Revised October, 2005 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
_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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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 (NaHCO3), 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 7.5% and 8.4%. See table in
HOW SUPPLIED
section for contents and characteristics.
Solutions in LVP container has 0.9 mg/mL of edetate disodium anhydrous
added as a
stabilizer.
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 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