Vasostrict

VASOSTRICT- vasopressin, unspecified injection
Par Pharmaceutical, Inc.

1 INDICATIONS AND USAGE

Vasostrict® 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.

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.

Table 1 Preparation of diluted solutions
Fluid restriction? Final concentration Mix
Vasostrict® Diluent

No

0.1 units/mL

2.5 mL (50 units)

500 mL

Yes

1 unit/mL

5 mL (100 units)

100 mL

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.

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

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.

4 CONTRAINDICATIONS

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.

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 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.

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 Vasostrict® 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 Vasostrict® 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 Vasostrict®. 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 Vasostrict®. 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 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.

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 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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