SODIUM BICARBONATE injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Hospira, Inc.

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms. NDC No. (Unit of Sale) 0409-4900-14 NDC No. (Each) 0409-4900-24 Dosage Form LifeShield® Abboject® Syringe Conc. % 8.4 mg/mL (NaHCO3 ) 84 mEq/mL (Na+ ) 1 mEq/mL (HCO3 ¯) 1 mEq/Container Size (mL) 10/10 mOsm/mL 1.56 pH 8.0 (7.0–8.5) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Hospira, Inc., Lake Forest, IL 60045 USA                                                                               ABBOJECT® is a trademark of the Abbott group of companies. LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license. LAB-1018-3.0 01/2018

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
HOSPIRA, INC.
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SODIUM BICARBONATE
INJECTION, USP
FOR THE CORRECTION OF METABOLIC ACIDOSIS
AND OTHER CONDITIONS REQUIRING SYSTEMIC
ALKALINIZATION.
LifeShield ABBOJECT Syringe
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% and has an
approximate pH of 8.0
(7.0 to 8.5). 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
concentration of hydrogen ion
(H ) it may be converted to carbonic acid (H CO ) and thence to its
volatile form,
®
®
3
+
3
3
2
+
3
+