Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.

According to IQVIA, US sales of Phenylephrine Hydrochloride Injection, USP, 5mL and 10mL vials, were approximately $28 million in the 12 months ending June 2019.

Dan Motto, Executive Vice President, Commercial and Development, Injectables said, “We have added Phenylephrine Hydrochloride Injection, USP 5mL and 10mL vials, to our product portfolio to address hospitals’ and patients’ needs for this essential medicine. We are pleased to expand our Injectable portfolio with additional Phenylephrine Injection presentations. This launch is another example of our commitment to providing hospitals and doctors with a broad portfolio of high-quality injectable medicines they need to best treat their patients.”

Hikma is the third largest US supplier of generic injectable medicines by volume, with a growing portfolio of over 100 products. Today one in every six injectable generic medicines used in US hospitals is a Hikma product.

Important Safety Information for Phenylephrine Hydrochloride Injection, USP, 5mL and 10mL pharmacy bulk package vials:

WARNINGS AND PRECAUTIONS

The following warnings and precautions should be taken when administering Phenylephrine Hydrochloride Injection, USP:

• Can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
• Severe bradycardia and decreased cardiac output can occur.
• Risk in patients with autonomic dysfunction. Pressor response can be increased.
• Extravasation of phenylephrine can cause necrosis or sloughing of tissue.
• Oxytocic drugs potentiate the pressor effect of sympathomimetic pressor amines with the potential for hemorrhagic stroke.
• This product contains sodium metabisulfite, which may cause allergic-type reactions, including life-threatening or less severe asthmatic episodes in certain susceptible people.
• Can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.
• Monitor renal function. Phenylephrine can increase the need for renal replacement therapy in patients with septic shock.
• Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.
• Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
• Consider larger dosing than usual in hepatic impaired subjects.
• Consider using lower doses in patients with end stage renal disease (ESRD).

Phenylephrine hydrochloride is contraindicated in patients with hypersensitivity to it or any of its components.

The following adverse reactions have been reported: bradycardia, AV block, ventricular extrasystoles, myocardial ischemia, nausea, vomiting, chest pain, extravasation, sulfite sensitivity, headache, nervousness, paresthesia, tremor, excitability, pulmonary edema, rales, diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation and hypertensive crisis.

Drug interactions:

• The pressor effect of phenylephrine hydrochloride is increased in patients receiving agonists such as: (i) monoamine oxidase inhibitors (MAOI); (ii) β-adrenergic blockers; (iii) α-2 adrenergic agonists; (iv) steroids; (v) steroids; (vi) norepinephrine transport inhibitors; (vii) ergot alkaloids’ (viii) centrally-acting sympatholytic agents; and (ix) atropine sulfate.
• Antagonists, α-adrenergic blocking agents, including phenothiazines, and amiodarone block phenylephrine and are in turn blocked by phenylephrine.

Patient Counseling Information should be shared with the patient prior to administration.

For additional information, please refer to the Package Insert for full prescribing information, available on www.hikma.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Manufactured by:

Hikma Pharmaceuticals USA Inc.

Eatontown, NJ 07724 USA

[1] Hikma Pharmaceuticals USA Inc. was formerly known as West-Ward Pharmaceuticals Corp.