Vasopressin

VASOPRESSIN- vasopressin, unspecified injection
AuroMedics Pharma LLC

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

2.1 Preparation of Solution

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

Vasopressin Injection Solution for Dilution, 20 units/mL

Dilute vasopressin injection 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.

Table 1 Preparation of diluted solutions

Fluid restriction?

Final concentration Mix
Vasopressin injection Diluent
No 0.1 units/mL 2.5 mL (50 units) 500 mL
Yes 1 unit/mL 5 mL (100 units) 100 mL

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

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.

3 DOSAGE FORMS AND STRENGTHS

Vasopressin injection, USP is a clear, practically colorless solution available as 20 units/mL in a single dose vial. To be used after dilution.

4 CONTRAINDICATIONS

Vasopressin injection 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.

5 WARNINGS AND PRECAUTIONS

5.1 Worsening Cardiac Function

A decrease in cardiac index may be observed with the use of vasopressin.

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.

6 ADVERSE REACTIONS

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

Metabolic: Hyponatremia

Skin: Ischemic lesions

Postmarketing Experience

Reversible diabetes insipidus [see Warnings and Precautions (5.2)]

7 DRUG INTERACTIONS

7.1 Catecholamines

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.

7.2 Indomethacin

Use with indomethacin may prolong the effect of vasopressin injection on cardiac index and systemic vascular resistance. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [see Clinical Pharmacology (12.3)].

7.3 Ganglionic Blocking Agents

Use with ganglionic blocking agents may increase the effect of vasopressin injection on mean arterial blood pressure. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [see Clinical Pharmacology (12.3)].

7.4 Drugs Suspected of Causing SIADH

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 vasopressin injection. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.

7.5 Drugs Suspected of Causing Diabetes Insipidus

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 vasopressin injection. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available data on vasopressin 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 injection may need to be increased [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

Maternal adverse reactions: Vasopressin injection may produce tonic uterine contractions that could threaten the continuation of pregnancy.

8.2 Lactation

There are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.

8.4 Pediatric Use

Safety and effectiveness of vasopressin injection in pediatric patients with vasodilatory shock have not been established.

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