SODIUM BICARBONATE injection, solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

HF Acquisition Co LLC, DBA HealthFirst

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

SODIUM BICARBONATE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1400-1 SODIUM BICARBONATE INJECTION, USP, 4.2% 2.5mEq (0.5mEq per mL) 5mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Sodium Bicarbonate Injection, USP is supplied in the following dosage forms: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. For Product Inquiry: 1-800-551-7176 or www.fresenius-kabi.us 451554 Issued: June 2017

L-istatus ta 'awtorizzazzjoni:

unapproved drug other

Karatteristiċi tal-prodott

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
_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._
----------
SODIUM BICARBONATE INJECTION, USP, 4.2% 2.5MEQ (0.5MEQ PER ML) 5ML
VIAL
SPL UNCLASSIFIED
Sodium Bicarbonate
Injection, USP 4.2%
Sodium Bicarbonate
Injection, USP 8.4%
4.2% Sodium Bicarbonate 0.5 mEq/mL Injection, USP 5 mL Single Dose
Vial and
8.4% Sodium Bicarbonate 1 mEq/mL Injection, USP 50 mL Single Dose Vial
DESCRIPTION
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic,
hypertonic solution of Sodium
Bicarbonate (NaHCO3), USP, in Water for Injection for administration
by the intravenous route as an
electrolyte replenisher and systemic alkalizer. pH of the solution is
7.0 to 8.5.
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 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 HCO3-. Sodium
Bicarbonate, USP is chemically designated NaHCO3, a white crystalline
powder soluble in water.
Water for Injection, USP 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 (HCO3-) 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 (HCO3-) is a normal
constituent of body fluids and the
normal plasma level ranges from 24