Sodium Bicarbonate, 8.4% — 50 mL Prefilled Syringe, Pack of 1

SODIUM BICARBONATE INJECTION USP, 8.4% (1 mEq/mL)

PRODUCT OVERVIEW

Sodium Bicarbonate Injection USP is a sterile, nonpyrogenic, hypertonic solution for intravenous administration as an electrolyte replenisher and systemic alkalizer. It is labeled for treatment of metabolic acidosis and other conditions requiring systemic alkalinization, including selected drug intoxications and urinary alkalinization. Use only under the direction of a trained healthcare professional.

PRESENTATION

This item is supplied as 10 individually cartoned single-dose 50 mL Luer-Jet Luer-Lock prefilled syringes. Each syringe contains Sodium Bicarbonate Injection USP 8.4%, providing 50 mEq in 50 mL (1 mEq/mL; 84 mg/mL). The solution contains no bacteriostat, antimicrobial agent, or added buffer. Discard unused portion.

ADMINISTRATION

For intravenous use. Dosage, rate, dilution, and monitoring depend on the patient's acid-base status and clinical condition. Use repeated fractional doses and appropriate laboratory monitoring to reduce the risk of overdosage and alkalosis. Inspect before use; do not use unless the solution is clear and the container and seal are intact, or if precipitate is present. Refer to the current full prescribing information.

IMPORTANT SAFETY INFORMATION

Contraindicated in patients losing chloride through vomiting or continuous gastrointestinal suction and in patients receiving diuretics that produce hypochloremic alkalosis. Use great care in congestive heart failure, severe renal insufficiency, edema, sodium-retaining states, oliguria, or anuria. Excessive therapy may cause metabolic alkalosis, hypernatremia, fluid or solute overload, and pulmonary edema. Avoid extravasation because hypertonic alkaline solution can cause tissue injury. Rapid administration in neonates and children under two years may cause hypernatremia, decreased cerebrospinal-fluid pressure, and intracranial hemorrhage.

STORAGE AND HANDLING

Store at controlled room temperature, 68°F to 77°F (20°C to 25°C); excursions are permitted from 59°F to 86°F (15°C to 30°C). Protect from freezing. Use aseptic technique and do not assemble the syringe until ready to use.

PRODUCT DETAILS

• Generic name: Sodium Bicarbonate Injection USP

• Manufacturer: International Medication Systems, Limited (IMS), an Amphastar company

• NDC: 76329-3352-01 (76329335201)

• Form: Single-dose Luer-Lock prefilled syringe

• Concentration: 8.4% (1 mEq/mL; 84 mg/mL)

• Total content: 50 mEq/50 mL per syringe

• Package size: 10 syringes

• Route: Intravenous

• GTIN: 00376329335216

This summary does not replace the full prescribing information. Current label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77698221-a01d-4568-a7bc-d3d4e982875d