VASOSTRICT- vasopressin, unspecified injection
Par Pharmaceutical, Inc.
Vasostrict® is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit.
Vasostrict® Solution for Dilution, 20 units/mL and 200 units/10 mL (20 units/mL)
Dilute Vasostrict® in normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) prior to use for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration.
|Fluid restriction?||Final concentration||Mix|
2.5 mL (50 units)
5 mL (100 units)
Vasostrict® Premixed Solution, 40 units/100 mL (0.4 units/mL) and 60 units/100 mL (0.6 units/mL)
This product does not require further dilution prior to administration.
In general, titrate to the lowest dose compatible with a clinically acceptable response.
The recommended starting dose is:
Post-cardiotomy shock: 0.03 units/minute
Septic Shock: 0.01 units/minute
Titrate up by 0.005 units/minute at 10- to 15-minute intervals until the target blood pressure is reached. There are limited data for doses above 0.1 units/minute for post-cardiotomy shock and 0.07 units/minute for septic shock. Adverse reactions are expected to increase with higher doses.
After target blood pressure has been maintained for 8 hours without the use of catecholamines, taper vasopressin injection by 0.005 units/minute every hour as tolerated to maintain target blood pressure.
Vasostrict® (vasopressin injection, USP) is a clear, practically colorless solution for intravenous administration available as 20 units/mL in a single dose vial and 200 units/10 mL (20 units/mL) in a multiple dose vial. To be used after dilution.
Vasostrict® is also available premixed as 40 units/100 mL (0.4 units/mL) and 60 units/100 mL (0.6 units/mL) in single dose vials. Ready to use.
Vasostrict® 10 mL multiple dose vial is contraindicated in patients with known allergy or hypersensitivity to 8‑L-arginine vasopressin or chlorobutanol. The 1 mL single dose vial does not contain chlorobutanol and is therefore contraindicated only in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin.
A decrease in cardiac index may be observed with the use of vasopressin.
Patients may experience reversible diabetes inspidus, manifested by the development of polyuria, a dilute urine, and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation. Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts.
The following adverse reactions associated with the use of vasopressin were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Bleeding/lymphatic system disorders: Hemorrhagic shock, decreased platelets, intractable bleeding
Cardiac disorders: Right heart failure, atrial fibrillation, bradycardia, myocardial ischemia
Gastrointestinal disorders: Mesenteric ischemia
Hepatobiliary: Increased bilirubin levels
Renal/urinary disorders: Acute renal insufficiency
Vascular disorders: Distal limb ischemia
Skin: Ischemic lesions
Reversible diabetes insipidus [see Warnings and Precautions (5.2)]
Use with catecholamines is expected to result in an additive effect on mean arterial blood pressure and other hemodynamic parameters. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
Use with indomethacin may prolong the effect of Vasostrict® on cardiac index and systemic vascular resistance. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [see Clinical Pharmacology (12.3)].
Use with ganglionic blocking agents may increase the effect of Vasostrict® on mean arterial blood pressure. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [see Clinical Pharmacology (12.3)].
Use with drugs suspected of causing SIADH (e.g., SSRIs, tricyclic antidepressants, haloperidol, chlorpropamide, enalapril, methyldopa, pentamidine, vincristine, cyclophosphamide, ifosfamide, felbamate) may increase the pressor effect in addition to the antidiuretic effect of Vasostrict®. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
Use with drugs suspected of causing diabetes insipidus (e.g., demeclocycline, lithium, foscarnet, clozapine) may decrease the pressor effect in addition to the antidiuretic effect of Vasostrict®. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
There are no available data on Vasostrict® use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted.
Dose adjustments during pregnancy and the postpartum period: Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasostrict® may need to be increased [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].
Maternal adverse reactions: Vasostrict® may produce tonic uterine contractions that could threaten the continuation of pregnancy.
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