Vasopressin In 0.9% Sodium Chloride

Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

• This product does not require further dilution prior to administration. (
  2.1 Preparation of Solution

  Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit.

  This product does not require further dilution prior to administration.
  )
• Post-cardiotomy shock: 0.03 units/minute to 0.1 units/minute by intravenous infusion (
  2.2 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 by intravenous infusion

  Septic Shock:

  0.01 units/minute by intravenous infusion

  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 postcardiotomy 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 in Sodium Chloride Injection by 0.005 units/minute every hour as tolerated to maintain target blood pressure.
  )
• Septic shock: 0.01 units/minute to 0.07 units/minute by intravenous infusion (
  2.2 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 by intravenous infusion

  Septic Shock:

  0.01 units/minute by intravenous infusion

  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 postcardiotomy 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 in Sodium Chloride Injection by 0.005 units/minute every hour as tolerated to maintain target blood pressure.
  )

Vasopressin in Sodium Chloride Injection is a clear, colorless premixed solution for intravenous administration in a single-dose, ready to use vial available as:

• 20 units/100 mL (0.2 units/mL) in 0.9% Sodium Chloride
• 40 units/100 mL (0.4 units/mL) in 0.9% Sodium Chloride
• 50 units/50 mL (1 unit/mL) in 0.9% Sodium Chloride

• Pregnancy:
  May induce uterine contractions. (
  8.1 Pregnancy

  Risk Summary

  There are no available data on Vasopressin in Sodium Chloride Injection 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.

  Clinical Considerations

  Dose adjustments during pregnancy and the postpartum period:

  Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasopressin in Sodium Chloride Injection may need to be increased [

  see Dosage and Administration and Clinical Pharmacology

  ].

  Maternal adverse reactions:

  Vasopressin in Sodium Chloride Injection may produce tonic uterine contractions that could threaten the continuation of pregnancy.
  )
• Pediatric Use:
  Safety and effectiveness have not been established. (
  8.4 Pediatric Use

  Safety and effectiveness of Vasopressin in Sodium Chloride Injection in pediatric patients with vasodilatory shock have not been established.
  )
• Geriatric Use:
  No safety issues have been identified in older patients. (
  8.5 Geriatric Use

  Clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [

  see Warnings and Precautions , Adverse Reactions ,

  and

  Clinical Pharmacology

  ].
  )

• Can worsen cardiac function. (
  5.1 Worsening Cardiac Function

  A decrease in cardiac index may be observed with the use of vasopressin.
  )
• Reversible diabetes insipidus (
  5.2 Reversible Diabetes Insipidus

  Patients may experience reversible diabetes insipidus, 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.
  )