Vasostrict

VASOSTRICT- vasopressin, unspecified injection
Medical Purchasin Solutions, LLC

1 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.

2 DOSAGE AND 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 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.

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 (12.3)].

7.3 Ganglionic Blocking Agents

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

7.4 Furosemide

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

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

Risk Summary: There are no adequate or well-controlled studies of Vasostrict ® in pregnant women. It is not known whether vasopressin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with vasopressin [see Clinical Pharmacology (12.3)].

Clinical Considerations: Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasostrict ® may need to be up-titrated to doses exceeding 0.1 units/minute in post-cardiotomy shock and 0.07 units/minute in septic shock.

Vasostrict ® may produce tonic uterine contractions that could threaten the continuation of pregnancy .

8.3 Nursing Mothers

It is not known whether vasopressin is present in human milk. However, oral absorption by a nursing infant is unlikely because vasopressin is rapidly destroyed in the gastrointestinal tract. Consider advising a lactating woman to pump and discard breast milk for 1.5 hours after receiving vasopressin to minimize potential exposure to the breastfed infant.

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