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FDA Approved Cardiovascular & Renal

Vasopressin

also known as: Arginine vasopressin, AVP, Antidiuretic hormone, ADH, Vasostrict, Pitressin

Vasostrict — the endogenous antidiuretic hormone as an ICU vasopressor. FDA-approved April 2014 for adults with vasodilatory shock (post-cardiotomy, sepsis) who remain hypotensive despite fluids and catecholamines. Works through V1a receptors on vascular smooth muscle — a receptor axis pharmacologically distinct from catecholamine receptors, preserving its vasopressor effect when adrenergic receptors are desensitised.

A cyclic nonapeptide (Cys-Tyr-Phe-Gln-Asn-Cys-Pro-Arg-Gly-NH2 with a disulfide bridge between Cys1 and Cys6) identical in sequence to the endogenous human antidiuretic hormone. Three receptors: V1a (vascular smooth muscle — vasoconstriction), V1b / V3 (anterior pituitary — ACTH release), and V2 (renal collecting duct — aquaporin-2 insertion, water reabsorption). Par Pharmaceutical's Vasostrict® received FDA NDA approval on 17 April 2014 (NDA 204485) via the 505(b)(2) pathway — the first and, at the time, only vasopressin injection USP with an approved NDA. Indication: vasodilatory shock (e.g., post-cardiotomy, septic) refractory to fluids and catecholamines. Dosing: 0.01–0.07 U/min for septic shock; 0.03–0.1 U/min for post-cardiotomy shock, titrated up in 0.005 U/min increments.

Mechanism of action

Endogenous agonist at three G-protein-coupled receptors. V1a receptors on vascular smooth muscle couple to Gq / phospholipase C / IP3 / calcium release, producing vasoconstriction — the pharmacologic basis of the vasopressor indication. V2 receptors on renal collecting duct principal cells couple to Gs / adenylate cyclase / cAMP / protein kinase A, driving aquaporin-2 insertion and water reabsorption. V1b / V3 receptors in anterior pituitary corticotrophs potentiate CRH-driven ACTH release. In vasodilatory shock, endogenous vasopressin is relatively deficient (the "vasopressin-deficiency" hypothesis) and sensitivity to catecholamines is reduced by receptor desensitisation; exogenous vasopressin engages an independent vasoconstrictor pathway to restore mean arterial pressure. Clinical dosing is titrated well below anti-diuretic thresholds but V2-mediated free-water retention and hyponatremia remain concerns at prolonged infusion.

Primary uses

  • Vasodilatory shock unresponsive to fluids and catecholamines (FDA-approved)
  • Septic shock as adjunct / catecholamine-sparing agent (Surviving Sepsis Campaign guideline)
  • Post-cardiotomy vasodilatory shock
  • Cardiac arrest (previously in ACLS algorithms; removed 2015)

Typical dosing

0.01–0.1 units/minute (continuous IV infusion) continuous infusion (intravenous)

Septic shock: start 0.01 U/min, titrate up to 0.07 U/min max. Post-cardiotomy shock: start 0.03 U/min, titrate up to 0.1 U/min max. After 8 hours of target MAP without catecholamines, taper by 0.005 U/min every hour. Contraindicated with 8-L-arginine hypersensitivity. Watch for skin / digital / mesenteric ischemia and hyponatremia from V2-mediated free-water retention.

Regulatory status

FDA-approved April 17, 2014 (Vasostrict®, Par Pharmaceutical Companies, NDA 204485) under the 505(b)(2) pathway. Indication: increasing blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Additional premixed formulations approved subsequently (40 units/100 mL, etc.). The older Pitressin® vasopressin product predated modern NDA requirements and had been marketed under a DESI-era grandfather status until the 2014 Vasostrict approval.

References

  1. [fda-pi] Vasostrict® (vasopressin injection) Prescribing Information. Par Pharmaceutical Companies, Inc. Initial US approval April 2014.
  2. [clinical-trial] Russell JA, Walley KR, Singer J, et al. "Vasopressin versus norepinephrine infusion in patients with septic shock (VASST)." N Engl J Med, 2008;358(9):877-887.
  3. [guideline] Evans L, Rhodes A, Alhazzani W, et al. "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021." Crit Care Med, 2021;49(11):e1063-e1143.

Related peptides

Terlipressin

Terlivaz — the first and only FDA-approved drug for hepatorenal syndrome (HRS). FDA-approved September 2022 (Mallinckrodt) for adults with HRS with rapid reduction in kidney function, after a multi-decade regulatory history including four prior Complete Response Letters and the successful CONFIRM Phase 3 trial (NEJM 2021).

Desmopressin

DDAVP — the classic V2-selective vasopressin analog. FDA-approved February 1978 for central diabetes insipidus; decades of label expansion added primary nocturnal enuresis, nocturia (Noctiva / Nocdurna), and hemostatic use in mild hemophilia A and type 1 von Willebrand disease. WHO Essential Medicines List.

Angiotensin II

Giapreza — the first new vasopressor class approved in decades. FDA-approved December 2017 (La Jolla Pharmaceutical) for catecholamine-resistant septic / distributive shock based on the ATHOS-3 trial (NEJM 2017, n=321). Engages a third vasoconstrictor pathway (RAAS / AT1) independent of catecholamines and vasopressin — useful when both of those axes are desensitised.

Guides & tools

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.