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:

Medical Purchasing Solutions, LLC

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 int

Περίληψη προϊόντος:

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms. NDC No. (Unit of Sale) (NDC No. (Each)) Dosage Form Conc. % mg/mL (NaHCO 3 ) mEq/mL (Na + ) mEq/mL (HCO 3 – ) mEq/ Container size (mL) mOsm / mL pH 0409-4916-14 (0409-4916-24) Lifeshield ® Abboject ® Syringe 7.5 75 0.9 0.9 44.6/50 1.40 8.0 (7.0 – 8.5) 0409-6637-14 (0409-6637-24) Lifeshield ® Abboject ® Syringe 8.4 84 1 1 50/50 1.56 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-1019-3.0 01/2018

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
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SODIUM BICARBONATE INJECTION, USP RX ONLY
FOR THE CORRECTION OF METABOLIC ACIDOSIS AND
OTHER CONDITIONS REQUIRING SYSTEMIC ALKALINIZATION.
LIFESHIELD ABBOJECT SYRINGE
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.
Solutions are offered in concentrations of 7.5% and 8.4%. See table in
_HOW_
_SUPPLIED _section for contents and characteristics.
The solutions have an approximate pH of 8.0 (7.0 to 8.5). They 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
¯.
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 vola