"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Rapid administration of sodium salts may precipitate volume overload and acute pulmonary edema. Rapid or excessive administration of Sodium Bicarbonate (sodium bicarbonate 5% injection) 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 (sodium bicarbonate 5% injection) 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 (sodium bicarbonate 5% injection) should be avoided except where compatibility has been previously established. Precipitation or haze may result from sodium bicarbonate (sodium bicarbonate 5% injection) -calcium admixtures.
Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Bicarbonate (sodium bicarbonate 5% injection) Injection. It is also not known whether Sodium Bicarbonate (sodium bicarbonate 5% injection) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Bicarbonate (sodium bicarbonate 5% injection) 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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/16/2008
Additional Sodium Bicarbonate Information
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