Sodium Bicarbonate Information
Sodium bicarbonate ()
Sodium bicarbonate () Description
Sodium bicarbonate () Injection, USP is a sterile, nonpyrogenic, hypertonic solution of Sodium bicarbonate () (NaHCO) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer.
Solutions are offered in concentrations of 4.2%, 5.0%, 7.5% and 8.4%. See table in section for contents and characteristics.
Solution in LVP container has 0.9 mg/mL of edetate disodium, anhydrous added as a stabilizer.
The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit.
Sodium bicarbonate () , 84 mg is equal to one milliequivalent each of Na+ and HCO¯ . Sodium bicarbonate () , USP is chemically designated NaHCO, a white crystalline powder soluble in water.
Water for Injection, USP is chemically designated HO.
Sodium bicarbonate () Clinical Pharmacology
Intravenous Sodium bicarbonate () therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.
Sodium bicarbonate () in water dissociates to provide sodium (Na+) and bicarbonate (HCO¯) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO¯ ) is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered “labile” since at a proper concentration of hydrogen ion (H+) it may be converted to carbonic acid (HCO) and thence to its volatile form, carbon dioxide (CO) excreted by the lung. Normally a ratio of 1:20 (carbonic acid: bicarbonate) is present in the extracellular fluid. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.
Sodium bicarbonate () Indications And Usage
Sodium bicarbonate () Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate () is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate () also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis — e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.
Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO content is crucial — e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
Sodium bicarbonate () Contraindications
Sodium bicarbonate () Injection, USP is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis
Sodium bicarbonate () 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.
Extravascular infiltration should be avoided, see .
Sodium bicarbonate () Precautions
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 sodium-retaining states, as well as in patients with oliguria or anuria. See table in 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 4.2% solution 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.
Sodium bicarbonate () Adverse Reactions
Overly aggressive therapy with Sodium bicarbonate () Injection, USP can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia.
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 part, warmth and local injection of lidocaine or hyaluronidase are recommended to prevent sloughing of extravasated I.V. infusions.
Sodium bicarbonate () Overdosage
Should alkalosis result, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis. See and .
Sodium bicarbonate () Dosage And Administration
Sodium bicarbonate () Injection, USP is administered by the intravenous route.
In general, it is unwise to attempt full correction of a low total CO content during the first 24 hours of therapy, since this may be accompanied by an unrecognized alkalosis because of a delay in the readjustment of ventilation to normal. Owing to this lag, the achievement of total CO content of about 20 mEq/liter at the end of the first day of therapy will usually be associated with a normal blood pH. Further modification of the acidosis to completely normal values usually occurs in the presence of normal kidney function when and if the cause of the acidosis can be controlled. Values for total CO which are brought to normal or above normal within the first day of therapy are very likely to be associated with grossly alkaline values for blood pH, with ensuing undesired side effects.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See .
Do not use unless solution is clear and the container or seal is intact. Discard unused portion.
Sodium bicarbonate () How Supplied
8.4% Sodium bicarbonate () Injection, USP 50 mEq (1 mEq/mL) is supplied as:
1 syringe packaged in a pouch NDC 63739-460-21
5 pouches (NDC 63739-460-21) packaged in a carton NDC 63739-460-05
Sodium bicarbonate ()
Sodium bicarbonate ()
Sodium bicarbonate () Package/label Principal Display Panel
LABEL TEXT
NDC 63739-460-05
50 mL
8.4% Sodium bicarbonate () Injection, USP 50 mEq (1 mEq/mL)
5 Syringes
Rx Only
Each mL contains Sodium bicarbonate () 84 mg. 2 m0smol/mL (calc.)
Usual Dosage: See insert.
Store at Controlled Room Temperature 20° to 25° C (68° to 77°F). [see USP.]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured By: Hospira, Inc. Lake Forest, IL 60045
Dist. By: McKesson Packaging Concord, NC 28027
