VASOPRESSIN

VASOPRESSIN- vasopressin, unspecified injection
HF Acquisition Co LLC, DBA HealthFirst

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VASOSTRICT ® safely and effectively. See full prescribing information for VASOSTRICT ®.
Vasostrict ® (vasopressin injection) for intravenous use
Initial U.S. Approval: 2014

INDICATIONS AND USAGE

Vasostrict® is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. ( 1)

DOSAGE AND ADMINISTRATION

Dilute Vasostrict® with normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) to either 0.1 units/mL or 1 unit/mL for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration. ( 2-2.1)
Post-cardiotomy shock: 0.03 to 0.1 units/minute ( 2-2.2)
Septic shock: 0.01 to 0.07 units/minute ( 2-2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 20 units per mL ( 3)

CONTRAINDICATIONS

Vasostrict® is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. ( 4)

WARNINGS AND PRECAUTIONS

Can worsen cardiac function. ( 5-5.1)

ADVERSE REACTIONS

The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital). ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Pressor effects of catecholamines and Vasostrict® are expected to be additive. ( 7-7.1)
Indomethacin may prolong effects of Vasostrict®. ( 7-7.2)
Co-administration of ganglionic blockers or drugs causing SIADH may increase the pressor response. ( 7-7.3, 7-7.5)
Co-administration of drugs causing diabetes insipidus may decrease the pressor response. ( 7-7.6)

USE IN SPECIFIC POPULATIONS

Pregnancy: May induce uterine contractions. ( 8-8.1)
Pediatric Use: Safety and effectiveness have not been established. ( 8-8.4)
Geriatric Use: No safety issues have been identified in older patients. ( 8-8.5)

Revised: 12/2016

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Preparation of Diluted Solutions
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Worsening Cardiac Function
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Catecholamines
7.2 Indomethacin
7.3 Ganglionic Blocking Agents
7.4 Furosemide
7.5 Drugs Suspected of Causing SIADH
7.6 Drugs Suspected of Causing Diabetes Insipidus
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING

* Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS & USAGE

Vasostrict® is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.

2 DOSAGE & ADMINISTRATION

2.1 Preparation of Diluted Solutions

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

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

2.2 Administration

The goal of treatment is optimization of perfusion to critical organs, but aggressive treatment can compromise perfusion of organs, like the gastrointestinal tract, whose function is difficult to monitor. The following advice is empirical. In general, titrate to the lowest dose compatible with a clinically acceptable response.

For post-cardiotomy shock, start with a dose of 0.03 units/minute. For septic shock, start with a dose of 0.01 units/minute. If the target blood pressure response is not achieved, titrate up by 0.005 units/minute at 10- to 15-minute intervals. The maximum dose for post-cardiotomy shock is 0.1 units/minute and for septic shock 0.07 units/minute. After target blood pressure has been maintained for 8 hours without the use of catecholamines, taper Vasostrict® by 0.005 units/minute every hour as tolerated to maintain target blood pressure.

3 DOSAGE FORMS & 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.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

5.1 Worsening Cardiac Function

Use in patients with impaired cardiac response may worsen cardiac output.

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

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.

7.2 Indomethacin

Use with indomethacin may prolong the effect of Vasostrict® on cardiac index and systemic vascular resistance [see Clinical Pharmacology ( 12-12.3)].

7.3 Ganglionic Blocking Agents

Use with ganglionic blocking agents may increase the effect of Vasostrict® on mean arterial blood pressure [see Clinical Pharmacology ( 12-12.3)].

7.4 Furosemide

Use with furosemide increases the effect of Vasostrict® on osmolar clearance and urine flow [see Clinical Pharmacology ( 12-12.3)].

7.5 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®.

7.6 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®.