sodium bicarbonate

5 WARNINGS AND PRECAUTIONS • Edema with Sodium Retention: Monitor patients who are sensitive to sodium intake (heart failure, hypertension, kidney disease, anuria, edema) for signs of fluid overload and adjust as appropriate. ( 5.1 ) • Electrolyte Imbalances: Therapy with sodium bicarbonate injection can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia. Monitor electrolytes periodically during administration and treat abnormalities appropriately. Dosing with sodium bicarbonate injection results in a large volume of administration in younger and lighter weight pediatric patients. Consider use of more concentrated sodium bicarbonate formulations in these pediatric populations. ( 5.2 ) • Extravasation: Prompt elevation of the area, warmth, and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing at the site. ( 5.3 ) 5.1 Edema with Sodium Retention Sodium bicarbonate injection can cause sodium retention and volume overload. Monitor patients who are sensitive to sodium intake (heart failure, hypertension, kidney disease, anuria, edema) for signs of fluid overload and adjust sources of sodium as appropriate. 5.2 Electrolyte Imbalances Sodium bicarbonate injection may cause electrolyte imbalances. Overly aggressive therapy with sodium bicarbonate injection can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia. Monitor electrolytes periodically during administration and treat abnormalities appropriately. Dosing with sodium bicarbonate injection results in a large volume of administration in younger and lighter weight pediatric patients. Consider use of more concentrated sodium bicarbonate formulations in these pediatric populations [see Dosing and Administration (2) ]. 5.3 Extravasation Inadvertent extravasation of intravenously administered hypertonic solutions of sodium bicarbonate have been reported to cause chemical cellulitis because of their alkalinity, with tissue necrosis, ulceration or sloughing at the site of infiltration. Prompt elevation of the area, warmth, and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing at the site of intravenous solution extravasation.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Edema with Sodium Retention [see Warnings and Precautions (5.1) ] • Electrolyte Imbalances [see Warnings and Precautions (5.2) ] • Extravasation [see Warnings and Precautions (5.3) ] Adverse reactions include edema with sodium retention, electrolyte imbalances and extravasation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-877-725-2747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.