Product Monograph - Vasopressin Injection USP
PHARMACOLOGY
Vasopressin Injection USP is a synthetic water-soluble pressor principle identical in sequence to arginine vasopressin.
Vasopressin exerts its antidiuretic action by increasing the reabsorption of water by the renal tubules. The drug also can cause contraction of smooth muscle of the gastrointestinal tract and of all parts of the vascular beds, especially the capillaries, small arterioles, and venules, with less effect on the smooth musculature of the large veins.
The direct effect on the contractile elements is neither antagonized by adrenergic blocking agents nor prevented by vascular denervation.
Vasopressin Injection USP is intended for intramuscular (IM) or subcutaneous (SC) injection.
INDICATIONS AND CLINICAL USE
Vasopressin Injection USP is intended for use in the prevention or treatment of post-operation abdominal distention, dispelling of gas shadows in abdominal roentgenography and symptomatic control of diabetes insipidus.
CONTRAINDICATIONS
Vasopressin Injection USP should not be used in patients having cardiorenal disease with hypertension, advanced arteriosclerosis, coronary thrombosis, angina pectoris, epilepsy or toxemia of pregnancy. Anaphylaxis or hypersensitivity to the drug or its components are also contraindications.
Chronic nephritis with nitrogen retention may be a contraindication (see PRECAUTIONS).
WARNINGS
Vasopressin Injection USP should not be used except with extreme caution in patients with vascular disease, especially disease of the coronary arteries. In such patients even small doses of the drug may precipitate anginal pain and with larger doses, the possibility of myocardial infarction should be considered.
Vasopressin may produce water intoxication. The early signs of drowsiness, listlessness, and headaches should be recognized to prevent convulsions and terminal coma.
PRECAUTIONS
Vasopressin Injection USP should be used cautiously in the presence of epilepsy, migraine, asthma, heart failure, or any state in which a rapid addition to extracellular water may produce hazard for an already overburdened system.
Chronic nephritis with nitrogen retention contraindicates the use of vasopressin until reasonable nitrogen blood levels have been attained.
ADVERSE EFFECTS
Local or systemic allergic reactions may occur in hypersensitive individuals. The following side effects have been reported following the administration of vasopressin: tremor, sweating, vertigo, circumoral pallor, "pounding" in the head, abdominal cramps, passage of gas, nausea, vomiting, urticaria, bronchial constriction.
Anaphylaxis (cardiac arrest and/or shock) have been observed shortly after injection of vasopressin.
DOSAGE AND ADMINISTRATION
The dosage of Vasopressin Injection USP should be individualized: 0.25 to 0.5 mL IM or SC at intervals of 3 to 4 hours, as required.
The dosage should be proportionately reduced for children.
Abdominal Distension: Adults – 0.25 to 0.5 mL.
Abdominal Roentgenography: Adults – 0.5 mL given 2 hours and 0.5 hours before exposure of films.
Diabetes Insipidus: The dose by IM or SC injection is 0.25 to 0.5 mL repeated 2 or 3 times daily as required.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
OVERDOSAGE
For management of a suspected drug overdose, contact your regional Poison Control Centre immediately.
DOSAGE FORMS, COMPOSTION AND PACKAGING
Vasopressin Injection USP contains the pressor (8-L-arginine: vasopressin), and is an antidiuretic principle of the posterior lobe of the pituitary gland.
Each mL contains: Vasopressin 20 USP pressor units, chlorobutanol 3.5 mg as a preservative, 8mg sodium chloride for isotonicity, glacial acetic acid and/or sodium hydroxide to adjust pH and water for injection.
Vasopressin Injection USP is available in 5 mL multidose vials (USP type I clear glass vials and grey chlorobutyl rubber stopper), boxes of 1.
STORAGE AND STABILITY
Store between 15 and 25 °C. Discard within 28 days after initial use. Protect from light and heat. Do not freeze.
Keep out of reach and sight of children.
LATEX FREE STOPPER: Stopper contains no dry natural rubber.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
MORE INFORMATION
If you want more information about Vasopressin 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); Sandoz Canada Inc.’s website www.sandoz.ca, or by calling 1-800-361-3062
Last Revised: August 26, 2020