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 solutions containing sodium ions may result in sodium retention. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Extravascular infiltration should be avoided, see ADVERSE REACTIONS. PRECAUTIONS: Note: Do not use the injection if it contains precipitate. Do not use unless solution is clear and the container or seal is intact. Discard unused portion. The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO2 content and blood pH, but the risks of overdosage and alkalosis should be avoided. Hence, repeated fractional doses and periodic monitoring by appropriate laboratory tests are recommended to minimize the possibility of overdosage. The potentially large loads of sodium given with bicarbonate require that caution be exercised in the use of sodium bicarbonate in patients with congestive heart failure or other edematous or sodiumretaining states, as well as in patients with oliguria or anuria. See table in HOW SUPPLIED section for amounts of sodium present in solutions. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Potassium depletion may predispose to metabolic alkalosis and 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. Rapid injection (10 mL/min.) of hypertonic Sodium Bicarbonate Injection, USP, solutions into neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. The rate of administration in such patients should therefore be limited to no more than 8 mEq/kg/day. A solution diluted to 4.2% may be preferred for such slow administration. In emergencies such as cardiac arrest, the risk of rapid infusion must be weighed against the potential for fatality due to acidosis. The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided, except where compatibility has been previously established. Precipitation or haze may result from sodium bicarbonate-calcium admixtures. Pregnancy Category C : Animal reproduction studies have not been conducted with sodium bicarbonate. It is also not known whether sodium bicarbonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium bicarbonate should be given to a pregnant woman only if clearly needed.