Vazculep® is used to treat clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. The product is sold in three forms: 1 mL single use vials, and 5 mL and 10 mL pharmacy bulk package vials. Vazculep® was approved by the FDA in 2014.
Important Safety Information
INDICATIONS AND USAGE
VAZCULEP® (phenylephrine hydrochloride) Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
- Extravasation during intravenous administration may cause necrosis or sloughing of tissue
- Severe bradycardia and decreased cardiac output
- Allergic-type reactions: Sulfite
- Concomitant use with oxytocic drugs: Pressor effect of sympathomimetic pressor amines is potentiated
Most common adverse reactions during treatment: nausea, vomiting, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact Avadel Legacy Pharmaceuticals, LLC at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.1216-A VAZ HCP ISI