5% Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic solution of Sodium Bicarbonate, USP in Water for Injection, USP. It contains no antimicrobial agent. Composition, osmolarity, pH and ionic concentration are shown below.

Sodium Bicarbonate Injection may be indicated in the treatment of metabolic acidosis which can occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock, anoxia or severe dehydration, extracorporeal circulation of blood and severe primary lactic acidosis. Sodium Bicarbonate Injection is further indicated in the treatment of certain drug intoxications, including barbiturates, in poisoning by salicylates or methyl alcohol, and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium Bicarbonate Injection may also be indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

For mild acidosis, the usual dosage is 1 to 2 mEq per kg of body weight, administered slowly.

For more severe acidosis, 2 to 5 mEq per kg of body weight may be administered over a 4 to 8 hour period. Subsequent therapy is dependent on the clinical response of the patient.

In emergencies, 300 to 500 mL of the 5% Sodium Bicarbonate Injection should or administered as rapidly as is possible without overalkalinizing the patient.

Generally, to avoid overalkalinizing a patient whose own body mechanisms for correcting metabolic acidosis may be maximally stimulated, only 1/3 to 1/2 of the calculated dose is administered as rapidly as indicated by the patient's cardiovascular and fluid balance status. The serum pH and bicarbonate concentration should then be redetermined.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Sodium Bicarbonate Injection is intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solution containing additives.

5% Sodium Bicarbonate Injection, USP is supplied in the following size.

1A1833     500 mL     NDC 0338-0374-03

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.

Directions for Use

1. Remove outer seal and metal disc.
2. Swab surface of stopper using approved technique.
3. Insert vented connector of set. Refer to directions accompanying set.

Registration Number: 054 21 24750 00.

Manufactured By : Baxter Healthcare Corporation Deerfield, IL 60015 USA. Importer: Teva Medical Marketing Ltd. P.O. Box 2, Ashdod 77100 Israel. Date of approval: July 2006. FDA rev date: n/a

Overdose of sodium bicarbonate may result in a severe degree of alkalosis which may be accompanied by hyperirritability or tetany. Should alkalosis result, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. Severe alkalosis may be controlled by parenteral injections of calcium gluconate or an acidifying agent such as ammonium chloride.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

No information provided.

Rapid administration of sodium salts may precipitate volume overload and acute pulmonary edema. Rapid or excessive administration of Sodium Bicarbonate Injection may produce tetany due to a decrease in ionized calcium and hypokalemia as potassium reenters the cells.

Sodium containing solutions 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 solutions containing sodium ions may result in sodium retention.

Excessive or too rapid administration of Sodium Bicarbonate Injection may produce alkalosis. If evidence of alkalosis develops, symptoms may be readily controlled by rebreathing air from a paper bag or rebreathing mask or, if more severe, by parenteral injections of calcium gluconate. Severe alkalosis, inadvertently produced, can be corrected by intravenous infusion of 2.14% Ammonium Chloride Injection, USP, except in patients with hepatic disease in whom ammonia administration is contraindicated.

This hypertonic solution may cause vein damage.

Do not use this injection if it contains a precipitate.

Correction of acidosis without correction of a potassium deficit may lead to severe hypokalemia. Coexistent hypocalcemia may be associated with carpopedal spasm as the plasma pH rises. These dangers can be minimized if such electrolyte imbalances are appropriately treated prior to or concomitantly with bicarbonate infusion.

Patients losing chloride by vomiting and/or gastrointestinal intubation are more susceptible to development of severe alkalosis if given alkalinizing agents.

The addition of calcium to parenteral solutions containing sodium bicarbonate should be avoided except where compatibility has been previously established. Precipitation or haze may result from sodium bicarbonate-calcium admixtures.

Pregnancy: Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Bicarbonate Injection. It is also not known whether Sodium Bicarbonate Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Bicarbonate Injection should be given to a pregnant woman only if clearly needed.

Do not administer unless vacuum is present and solution is clear. Unit must be used with a vented set or a nonvented set with a vented spike adapter.

No information provided.

Sodium Bicarbonate Injection is contraindicated in patients with metabolic and respiratory alkalosis and in patients with hypocalcemia in which alkalosis may produce tetany.

The bicarbonate-carbonic acid system constitutes the principal extracellular buffer. Increasing the bicarbonate concentration buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.