SODIUM BICARBONATE injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)

Fáanlegur frá:

Hospira, Inc.

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Sodium Bicarbonate Injection, USP is supplied in the following dosage form: NDC No. Dosage Form Conc. % mg/mL ( NaHCO3 ) mEq/mL (Na+ ) mEq/mL (HCO3 ¯) mEq/Container size (mL) mOsmol pH 0409-6625-25 Fliptop Vial 8.4 84 1.0 1.0 50/50 2/mL 7.8 (7.0 to 8.5) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: 10/2012                                                                                          EN-3065 Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA N+ and NOVAPLUS are registered trademarks of Novation, LLC.

Leyfisstaða:

unapproved drug other

Vara einkenni

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
HOSPIRA, 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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SODIUM BICARBONATE
INJECTION, USP
FOR CORRECTION OF METABOLIC ACIDOSIS AND
OTHER CONDITIONS REQUIRING SYSTEMIC ALKALINIZATION.
FLIPTOP VIAL
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.
The solution is offered in a concentration of 8.4%. See table in HOW
SUPPLIED section
for contents and characteristics.
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 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 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
concentra