SODIUM BICARBONATE- sodium bicarbonate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20)

Available from:

International Medication Systems, Limited

INN (International Name):

Sodium Bicarbonate

Composition:

Sodium Bicarbonate 84 mg in 1 mL

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 form. In 50 mL single-dose packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. 10 individual cartons shrink wrapped as a group of 10 cartons.  mEq/Contain- er size (mL)  mOsm/ mL Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at 20° to 25°C (68° to 77°F). Excursions allowed between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING. © INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2016 SO. EL MONTE, CA 91733, U.S.A. An Amphastar Pharmaceuticals Company                      Rev. 1-16 6933520E

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM BICARBONATE - SODIUM BICARBONATE INJECTION
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
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SODIUM BICARBONATE INJECTION, USP
Rx Only
FOR THE CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS
REQUIRING
SYSTEMIC ALKALINIZATION
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.
Solution is offered in 8.4% concentration. See table in HOW SUPPLIED
section for
contents and characteristics.
The solution has an approximate pH of 8.0 (7.5 to 8.5). Carbon dioxide
may have been
added to adjust the pH of the solution to approximately 8.0.
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is
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 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
(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 an excess.
Bicarbonate anion is considered “labile” since at a proper
concentration of hydrogen ion
(H ) it may be con