"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
Sodium Bicarbonate (sodium bicarbonate 5% injection) 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 (sodium bicarbonate 5% injection) 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 (sodium bicarbonate 5% injection) Injection may also be indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
DOSAGE AND ADMINISTRATION
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 (sodium bicarbonate 5% injection) 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 (sodium bicarbonate 5% injection) 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 (sodium bicarbonate (sodium bicarbonate 5% injection) 5% injection) 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
- Remove outer seal and metal disc.
- Swab surface of stopper using approved technique.
- 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/aThis 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
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.