sodium bicarbonate

FDA Drug Profile — SODIUM BICARBONATE, Insect sting relief pad 01, Insect sting relief latex 01, Sodium Bicarbonate

sodium bicarbonate is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including SODIUM BICARBONATE, Insect sting relief pad 01, Insect sting relief latex 01. Available dosage forms: injection, solution, cloth, lotion.

Drug Details

Generic Name
sodium bicarbonate
Brand Names
SODIUM BICARBONATE, Insect sting relief pad 01, Insect sting relief latex 01, Sodium Bicarbonate
Application Number
ANDA202981
Sponsor
Henry Schein, Inc.
NDC Codes
5
Dosage Forms
INJECTION, SOLUTION, CLOTH, LOTION
Routes
INTRAVENOUS, TOPICAL
Active Ingredients
SODIUM BICARBONATE

Indications and Usage

INDICATIONS AND USAGE 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 CO 2 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.

Warnings

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solution containing sodium ions may result in sodium retention. The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Extravascular infiltration should be avoided, see ADVERSE REACTIONS .