SODIUM BICARBONATE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Tilgjengelig fra:

Sun Pharmaceutical Industries Limited

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Sodium Bicarbonate Injection 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 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.

Produkt oppsummering:

Sodium  Bicarbonate  Injection, USP  is  supplied  in  the  following  dosage forms: The 50  mL Sodium Bicarbonate Injection vials are supplied as 25  vials per carton with a single package  insert. Exposure  of pharmaceutical products to  heat should be  minimized. Avoid excessive  heat. Protect from  freezing.  Store  at  20°C  to  25°C  (68°F  to  77°F).  [See  USP  Controlled  Room  Temperature]. Manufactured  by : Steriscience Sp. z o.o. No. 10, Daniszewska Street, Warsaw, Poland – 03-230 Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512   Revised: November 2023

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SODIUM BICARBONATE - SODIUM BICARBONATE INJECTION, SOLUTION
SUN PHARMACEUTICAL INDUSTRIES LIMITED
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SODIUM BICARBONATE INJECTION, USP 8.4% 50 MEQ/50 ML (1 MEQ/ML)
FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS
REQUIRING SYSTEMIC ALKALINIZATION.
DESCRIPTION
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic,
hypertonic solution of
sodium bicarbonate (NaHCO3) in water for injection for administration
by the
intravenous route as an electrolyte replenisher and systemic
alkalizer.
Solutions are offered in concentration of 8.4%. See table in HOW
SUPPLIED
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, the approximate pH
of the
solutions is 8. When smaller doses are required, the unused portion
should be
discarded.
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 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 (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, carbon dioxide (CO ) excreted by the lung. Nor