SODIUM BICARBONATE injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)

제공처:

Henry Schein, Inc.

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Sodium Bicarbonate Injection, USP is supplied as: Product codes listed above are filled in flip-top single dose vials amd packaged in trays of 25s. STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

승인 상태:

unapproved drug other

제품 특성 요약

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
HENRY SCHEIN, 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
451554A /ISSUED: SEPTEMBER 2020 4.2% SODIUM BICARBONATE INJECTION, USP
8.4% SODIUM BICARBONATE INJECTION, USP
FOR THE CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS
REQUIRING SYSTEMIC ALKALINIZATION.
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 and electrolyte replenisher and systemic
alkalizer.
Solutions are offered in concentrations of 4.2% and 8.4%. See table in
HOW
SUPPLIED/STORAGE AND HANDLING section for contents and
characteristics.
The solution has an approximate pH of 8.0 (7.0-8.5). 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 HCO 3-,
42mg is equal to 0.5 milliequivalent each of Na + and HCO 3-. Sodium
Bicarbonate, USP
is chemically designated NaHCO 3, a white crystalline powder soluble
in water.
Water for Injection, USP is chemically designated H 2O.
CLININCAL 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 3-) 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 3-) is
a normal
constituent of body fluids and the normal plasma level ranges from 24
to 31 mEq/lit