Product Monograph - Vasopressin Injection, USP
RECENT MAJOR LABEL CHANGES
| 2 CONTRAINDICATIONS | 03/2022 |
| 3 SERIOUS WARNINGS AND PRECAUTIONS BOX | 03/2022 |
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ..................................................................................................2
TABLE OF CONTENTS ..................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION .............................................................................4
1 INDICATIONS ..................................................................................................................4
1.1 Pediatrics............................................................................................................. 4
1.2 Geriatrics ............................................................................................................. 4
2 CONTRAINDICATIONS......................................................................................................4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................................4
4 DOSAGE AND ADMINISTRATION .......................................................................................5
4.1 Dosing Considerations ........................................................................................... 5
4.2 Recommended Dose and Dosage Adjustment ........................................................... 5
5 OVERDOSAGE .................................................................................................................5
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...........................................5
7 WARNINGS AND PRECAUTIONS ........................................................................................6
8 ADVERSE REACTIONS.......................................................................................................6
8.5 Post-Market Adverse Reactions............................................................................... 6
9 DRUG INTERACTIONS ......................................................................................................7
9.4 Drug-Drug Interactions .......................................................................................... 7
9.5 Drug-Food Interactions .......................................................................................... 8
9.6 Drug-Herb Interactions .......................................................................................... 8
9.7 Drug-Laboratory Test Interactions ........................................................................... 8
10 CLINICAL PHARMACOLOGY ..............................................................................................8
10.1 Mechanism of Action ....................................................................................... 8
10.2 Pharmacodynamics.......................................................................................... 8
10.3 Pharmacokinetics ............................................................................................ 9
11 STORAGE, STABILITY AND DISPOSAL .................................................................................9
12 SPECIAL HANDLING INSTRUCTIONS ...................................................................................9
PART I: HEALTH PROFESSIONAL INFORMATION
1 INDICATIONS
Vasopressin Injection, USP (vasopressin) is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows, and in diabetes insipidus.
1.1 Pediatrics
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
1.2 Geriatrics
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
2 CONTRAINDICATIONS
Vasopressin Injection, USP is contraindicated 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.
Vasopressin Injection, USP is contraindicated in patients with chronic nephritis with nitrogen retention. See 7 WARNINGS AND PRECAUTIONS.
Vasopressin Injection, USP is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
Serious Warnings and Precautions
Vasopressin Injection, USP should not be used in patients with vascular disease, especially disease of the coronary arteries, except with extreme caution. In such patients, even small doses may precipitate anginal pain, and with larger doses, the possibility of myocardial infarction should be considered. Vasopressin Injection, USP may produce water intoxication. The early signs of drowsiness, listlessness, and headaches should be recognized to prevent terminal coma and convulsions. |
4 DOSAGE AND ADMINISTRATION
4.1 Dosing Considerations
When determining the dose of Vasopressin Injection, USP for a given case, the following should be kept in mind:
It is particularly desirable to give a dose not much larger than is just sufficient to elicit the desired physiologic response. Excessive doses may cause undesirable side actions – blanching of the skin, abdominal cramps, nausea – which, though not serious, may be alarming to the patient. Spontaneous recovery from such side effects occurs in a few minutes. It has been found that one or two glasses of water given at the time the Vasopressin Injection, USP is administered reduces such symptoms.
Parental drug products should be inspected visually for particulate matter and discolouration prior to administration wherever solution and container permit.
4.2 Recommended Dose and Dosage Adjustment
Vasopressin Injection, USP may be administered intramuscularly (IM) or subcutaneously (SC).
Ten units (0.5 mL) of Vasopressin Injection, USP will usually elicit full physiologic response in adult patients; 5 units (0.25 mL) will be adequate in many cases. Vasopressin Injection, USP should be given IM at three or four hour intervals as needed. (For an additional discussion of dosage, consult the sections below).
Abdominal Distention
For the average postoperative adult patient, give 5 units (0.25 mL) initially, and then increase to 10 units (0.5 mL) at subsequent injections, if necessary. It is recommended that vasopressin be given IM and that injections be repeated at three or four hour intervals as required.
Vasopressin used in this manner will frequently prevent, or relieve, postoperative distention.
Abdominal Roentgenography
For the average case, two Vasopressin Injection, USP of 10 units (0.5 mL) each are suggested. The first should be given two hours and the second, one-half hour before films are exposed.
Diabetes Insipidus
The dose by injection is 5 to 10 units (0.25 to 0.5 mL) repeated two or three times daily as needed.
5 OVERDOSAGE
| For management of a suspected drug overdose, contact your regional poison control centre. |
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
Vasopressin Injection, USP is a sterile, nonpyrogenic solution of synthetic vasopressin of the posterior pituitary gland. It is substantially free from the oxytocic principle and is standardized to contain 20 pressor units/mL. The chemical name is Vasopressin, 8-L-arginine and has the following structural formula:
| C46H65N15O12S2 | 1084.23 g/mol |
Each mL contains: 20 USP Vasopressin units; chlorobutanol (anhydrous) 5 mg as preservative; Water for Injection q.s. Glacial acetic acid and/or sodium hydroxide for pH adjustment (2.5 - 4.5).
Vasopressin Injection, USP, 20 USP units/mL, 1 mL in 2 mL (partially filled) flip-top multiple-use vials (USP Type I glass vial, gray bromobutyl stopper and aluminum seal) is available in packages of 25.
The stopper is not made with natural rubber latex.
7 WARNINGS AND PRECAUTIONS
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
Vasopressin Injection, USP should be used cautiously in the presence of 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 Injection, USP until reasonable nitrogen blood levels have been attained.
Regular monitoring of blood urea nitrogen (BUN) levels is required in patients with chronic nephritis to ensure an adequate level is maintained.
8 ADVERSE REACTIONS
8.5 Post-Market Adverse Reactions
Local or systemic allergic reactions may occur in hypersensitive individuals.
The following side effects have been reported following the administration of vasopressin with the following frequency:
Not known – cannot be estimated from the available data
Immune system disorders: hypersensitivity, anaphylaxis.
Metabolism and nutrition disorders: hyperhydration/water intoxication.
Nervous system disorders: headache, vertigo, tremor.
Cardiac disorders: chest pain due to angina, cardiac arrest.
Vascular disorders: peripheral ischaemia, pallor, hypertension.
Respiratory, thoracic and mediastinal disorders: bronchospasm.
 |
Gastrointestinal disorders: flatulence, nausea, vomiting, diarrhoea, abdominal pain.
Skin and subcutaneous tissue disorders: gangrene, hyperhidrosis, urticaria.
Renal and urinary disorders: fluid retention
General disorders and administration site conditions: non-cardiac chest pain.
9 DRUG INTERACTIONS
9.4 Drug-Drug Interactions
The drugs listed in this table are based on either drug interaction case reports or studies, or potential interactions due to the expected magnitude and seriousness of the interaction (i.e., those identified as contraindicated).
Table 1 - Established or Potential Drug-Drug Interactions
| Proper/Common name | Effect | Clinical comment |
| Alcohol | Alcohol may decrease the antidiuretic effect of vasopressin when given concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Carbamazepine | Carbamazepine may potentiate the antidiuretic effect of vasopressin when used concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Chlorpropamide | Chlorpropamide may potentiate the antidiuretic effect of vasopressin when used concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Clofibrate | Clofibrate may potentiate the antidiuretic effect of vasopressin when used concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Demeclocycline | Demeclocycline may decrease the antidiuretic effect of vasopressin when given concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Fludrocortisone | Fludrocortisone may potentiate the antidiuretic effect of vasopressin when used concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Ganglion blocking agents or drugs causing SIADH | Ganglion blocking agents or drugs causing SIADH may produce a marked increase in sensitivity to the pressor effect of vasopressin. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Heparin | Heparin may decrease the antidiuretic effect of vasopressin when given concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Lithium | Lithium may decrease the antidiuretic effect of vasopressin when given concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Noradrenaline | Noradrenaline may decrease the antidiuretic effect of vasopressin when given concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Tricyclic antidepressants | Tricyclic antidepressants may potentiate the antidiuretic effect of vasopressin when used concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
| Urea | Urea may potentiate the antidiuretic effect of vasopressin when used concurrently. | Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. |
9.5 Drug-Food Interactions
Interactions with food have not been established.
9.6 Drug-Herb Interactions
Interactions with herbal products have not been established.
9.7 Drug-Laboratory Test Interactions
Interactions with laboratory tests have not been established.
10 CLINICAL PHARMACOLOGY
10.1 Mechanism of Action
Vasopressin Injection, USP is a synthetic water-soluble pressor principle identical in sequence to arginine vasopressin.
10.2 Pharmacodynamics
Vasopressin exerts its antidiuretic action by increasing reabsorption of water by the renal tubules. Vasopressin can cause contraction of smooth muscle of the gastrointestinal tract and of all parts of the vascular bed, 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.
10.3 Pharmacokinetics
Absorption
Following subcutaneous or intramuscular administration of vasopressin injection, the duration of antidiuretic activity is variable, but effects are usually maintained for 2-8 hours.
Distribution
Vasopressin does not appear to bind plasma protein. The volume of distribution is 140 mL/kg.
Metabolism
The majority of the dose of vasopressin is metabolized and rapidly destroyed in the liver and kidneys. Vasopressin has a plasma half-life of about 10 to 20 minutes.
Elimination
Approximately 5% of a subcutaneous dose of vasopressin is excreted unchanged in the urine four hours after dosing.
11 STORAGE, STABILITY AND DISPOSAL
Store at 15 °C and 30 °C. Discard within 14 days after initial use. Do not permit to freeze.
Stability: Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
12 SPECIAL HANDLING INSTRUCTIONS
There are no special handling instructions for Vasopressin Injection, USP.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Questions or concerns? 1-877-821-7724
Last Revised: MAR 28, 2022