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.
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
- 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
ADVERSE REACTIONS
Most common adverse reactions during treatment: nausea, vomiting, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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