INFANT 4.2% SODIUM BICARBONATE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

HF Acquisition Co LLC, DBA HealthFirst

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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.

Produkt oppsummering:

4.2% SODIUM BICARBONATE INJ, USP is supplied in the following dosage forms. NDC 51662-1310-1 4.2% SODIUM BICARBONATE INJ, USP 5mEq (0.5 mEq/mL) 10mL SYR IN A CARTON NDC 51662-1310-2 4.2% SODIUM BICARBONATE INJ, USP 5mEq (0.5 mEq/mL) 10mL SYR IN A CARTON, 1 CARTON/POUCH NDC 51662-1310-3 4.2% SODIUM BICARBONATE INJ, USP 5mEq (0.5 mEq/mL) 10mL SYR IN A CARTON, 1 CARTON/POUCH, 10 POUCHES/CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Autorisasjon status:

unapproved drug other

Preparatomtale

INFANT 4.2% SODIUM BICARBONATE- INFANT 4.2% 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._
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4.2% SODIUM BICARBONATE INJ, USP 5MEQ (0.5 MEQ/ML) 10ML SYR
SPL UNCLASSIFIED
FOR CORRECTION OF METABOLIC ACIDOSIS AND
OTHER CONDITIONS REQUIRING SYSTEMIC ALKALINIZATION.
Abboject® Syringe
LVP Glass Container
Fliptop Vial
Rx only
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 concentrations of 4.2%, 5.0%, 7.5% and 8.4%.
See table in
HOW SUPPLIED section for contents and characteristics.
Solution in LVP container has 0.9 mg/mL of edetate disodium, anhydrous
added as a
stabilizer.
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 to 31
mEq/