Sodium Bicarbonate Injection, Solution
FDA Label NDC 0338-0822

Sodium bicarbonate injection is indicated to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis.

Sodium bicarbonate injection is indicated to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion.

Limitation of Use

Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution.

Inspect parenteral drug products for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy or if it contains particulate matter. Discard any unused portion.

Sodium bicarbonate injection is a ready to administer product that requires no further dilution prior to infusion. Administer sodium bicarbonate injection by intravenous infusion, via a dedicated line.

Individualize dosage depending on the severity of the acidosis.

Treatment of metabolic acidosis with sodium bicarbonate should be superimposed on measures designed to address the underlying cause of metabolic acidosis.

Recommended Dosage in Adults and Pediatric Patients 2 Years of Age and Older

Administer 2 mEq/kg to 5 mEq/kg of sodium bicarbonate injection over a four- to eight-hour period, depending upon the severity of metabolic acidosis as assessed by serum bicarbonate concentration, total CO₂, blood pH and the clinical condition of the patient.

Recommended Dosage in Pediatric Patients Less Than 2 Years of Age, including Neonates

Administer 1 mEq/kg to 2 mEq/kg of sodium bicarbonate injection over a four- to eight-hour period. Avoid rapid or bolus administration [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].

Sodium Bicarbonate Injection is a clear, colorless, sterile, nonpyrogenic, isotonic solution intended for intravenous use and available as:

Injection: 12.6 mg/mL (0.150 mEq/mL), 12,600 mg of sodium bicarbonate injection in 1,000 mL single-dose Viaflo container

Sodium bicarbonate injection 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 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.

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)].

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.

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)]

Risk Summary

Available data from published literature over decades of use have not identified a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Physiological replacement of sodium bicarbonate is not expected to lead to increased risk of adverse fetal or maternal outcomes. Animal reproduction studies have not been conducted with sodium bicarbonate.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Risk Summary

There are no data on the presence of sodium bicarbonate in either human or animal milk, the effects on the breast-fed infant or the effects on milk production following administration of sodium bicarbonate injection.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sodium bicarbonate injection and any potential adverse effects on the breast-fed child from sodium bicarbonate or from the underlying maternal condition.

Sodium bicarbonate injection is indicated in pediatric patients:

• To raise plasma pH in pediatric patients with clinically significant metabolic acidosis
• To alkalinize the urine in drug poisoning in cases in which urinary drug elimination is enhanced by urinary alkalinization

Rapid injection of sodium bicarbonate injection 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.

Clinical studies of sodium bicarbonate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

If alkalosis results, discontinue the sodium bicarbonate injection and manage the patient according to the degree of alkalosis present. Administer potassium chloride if hypokalemia is present. Treat severe alkalosis accompanied by hyperirritability or tetany with calcium gluconate. In severe alkalosis, consider use of acidifying agent such as ammonium chloride [see Warnings and Precautions (5.2)].

Sodium bicarbonate is an alkalinizing agent.

Chemically, it is sodium hydrogen carbonate. Sodium bicarbonate is a white, crystalline powder. It is soluble in water and insoluble in alcohol.

Sodium bicarbonate has the empirical formula NaHCO₃, a calculated molecular weight of 84.01 and the following structural formula:

Structural-formula-sodium-bicarbonate-1 (Structural Formula Sodium Bicarbonate 1)

Sodium Bicarbonate Injection is a sterile, non-pyrogenic, isotonic solution for intravenous infusion. Each mL contains 12.6 mg sodium bicarbonate which is equal to 0.150 milliequivalent each of Na⁺ and HCO₃^- injection. The pH is adjusted between 7.00 and 9.25 with carbon dioxide. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection.

Viaflo container is a flexible plastic container fabricated from a multilayer sheeting composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH.

Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH.

Distribution

Sodium bicarbonate in water dissociates to provide sodium (Na⁺) and bicarbonate (HCO₃^-) ions. Sodium (Na⁺) is the principal cation of the extracellular fluid. Bicarbonate (HCO₃^-) is a normal constituent of body fluids.

Elimination

Plasma bicarbonate 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 (H₂CO₃) and then to its volatile form, carbon dioxide (CO₂) excreted by the lung.

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.

Carcinogenesis, mutagenesis and impairment of fertility studies have not been conducted with sodium bicarbonate.

Sodium Bicarbonate Injection, 12.6 mg/mL, is a clear, colorless solution available in 1000 mL Viaflo container closure system. The solution is supplied as following packaging configuration:

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Do not use unless solution is clear and the container or seal is intact. Discard unused portion.

Advise patients to report signs and symptoms suggestive of fluid and/or solute overloading, electrolyte imbalances, overhydration, congested states or pulmonary edema [see Warnings and Precautions (5.1)].

Advise the patient, family or caregiver to report signs of extravasation [see Warnings and Precautions (5.3)].

Manufactured by:
Bieffe Medital SA,
Carretera Nacional 260, S/N,
Sabiñánigo (Senegüé), Spain (ESP)
22666

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Baxter and Viaflo are trademarks of Baxter International Inc. or its subsidiaries.

SA-30-03-157

Bag-label-2 (Bag Label 2)

NDC 0338-0822-10

Rx only

Sodium Bicarbonate Injection

150 mEq/1,000 mL
(0.150 mEq/mL)

1,000 mL

For Intravenous Infusion Only

No further dilution is necessary.

Single-Dose Only - Discard unused portion.

Each mL contains sodium bicarbonate USP, 12.6 mg injection. 0.3 mOsmol/g (calc.). pH 7.00 to 9.25.

Recommended Dosage: see Prescribing Information. Sterile, nonpyrogenic. Contains no bacteriostat.

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

LEAVE BAG IN OVERWRAP UNTIL USE.

After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Viaflo container is not made with natural rubber latex, DEHP, or PVC.

Baxter Logo

Manufactured by:

Bieffe Medital SA,

Carretera Nacional 260, S/N,

Sabiñánigo (Senegüé), Spain (ESP) 22666

Manufactured for:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Baxter and Viaflo are trademarks of Baxter International Inc. or its subsidiaries.

UE1974

UN-35-04-739

Do not use this Port

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