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INDICATION

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

CONTRAINDICATION

Vasopressin Injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.

WARNINGS AND PRECAUTIONS

Worsening Cardiac Function

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

Reversible Diabetes Insipidus

Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a diluted 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.

DRUG INTERACTIONS

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.

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.

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.

Drugs Suspected of Causing Syndrome of Inappropriate Antidiuretic Hormone Secretion (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.

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.

ADVERSE REACTIONS

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. The most common adverse reactions associated with the use of vasopressin include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital).

USE IN SPECIFIC PATIENT POPULATIONS

Pregnancy

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. Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasopressin Injection may need to be increased. Vasopressin Injection may produce tonic uterine contractions that could threaten the continuation of pregnancy.

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.

Pediatric Use

Safety and effectiveness of Vasopressin Injection in pediatric patients with vasodilatory shock have not been established.

Geriatric Use

Clinical studies of vasopressin did not include sufficient number 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.

For safety and dosing guidelines for Vasopressin Injection, see complete Warnings and Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Eagle Pharmaceuticals, Inc. at 1-855-318-2170 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.