Product Monograph - Sodium Acetate Injection USP
PRECAUTIONS
Use only clear solutions and intact vials.
Discard unused portion.
Sodium replacement therapy should be guided primarily by the serum sodium level. Caution should be exercised in administering sodium-containing solutions to patients with severe renal function impairment, cirrhosis, cardiac failure, or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Solutions containing acetate ions should be used with caution as excess administration may result in metabolic alkalosis.
Pregnancy
Teratogenic Effects: Animal reproduction studies have not been conducted with sodium acetate. It is also not known whether sodium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium acetate should be given to a pregnant woman only if clearly needed.
Use in Children
Sodium Acetate is not intended for pediatric use.
ADVERSE REACTIONS
Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions (see WARNINGS and PRECAUTIONS).
DRUG ABUSE AND DEPENDENCE
None known.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
In the event of overdosage, discontinue infusion containing sodium acetate immediately and institute corrective therapy as indicated to reduce elevated serum sodium levels, and restore acid-base balance if necessary (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).
DOSAGE AND ADMINISTRATION
Sodium Acetate Injection USP is administered intravenously only after dilution in a larger volume of intravenous fluids. The dose and rate of administration are dependent upon the individual needs of the patient.
Serum sodium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of sodium with an equal number of acetate.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
AVAILABILITY OF DOSAGE FORMS
Each mL contains:
Sodium Acetate Anhydrous ..................... 328 mg (4 mmol or 4 mEq acetate and sodium)
Water for Injection USP................ q.s.
Acetic acid and sodium hydroxide for pH adjustment (6.0 - 7.0). Osmolarity is 8 mOs / mL The formulation contains no bacteriostat, antimicrobial agent or added buffer. Single use vials of 50 mL in boxes of 10. Must be diluted before use. Discard unused portion.
For management of a suspected drug overdose, contact your regional poison control centre.
Protect from light. Store between 15 °C and 30 °C. Do not freeze. Discard unused portion.
Reporting Side Effects You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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If you want more information about Sodium Acetate Injection USP:
- Talk to your healthcare professional
- Find the full prescribing information that is prepared for healthcare professionals by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website [https://www.omegapharma.ca/], or by calling 1-800-363-0584.
REFERENCES
- 1. SODIUM ACETATE INJECTION, USP (Solution, 328 mg / mL), submission control 181908, Prescribing Information, Fresenius Kabi Canada Ltd. (FEB 2015)
Revision date: October 6, 2023
Omega Laboratories Limited.
Montreal, Canada, H3M 3E4