The solution is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action.
The company said that phenylephrine possesses predominantly a-adrenergic effects and in the eye, it acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial muscle of the iris.
Paragon BioTeck president and CEO Patrick Witham said the company is committed to working proactively with the FDA in an effort to prevent disrupting supply of this and future drugs that play a vital role in managing ocular health.
"We are acutely aware of just how important Phenylephrine’s unique mechanism of action is in providing maximum pupil dilation, which is of paramount importance in protecting the public health through early detection, diagnosis and treatment of serious eye diseases," Witham said.
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension or thyrotoxicosis, as well as in pediatric patients under the age of one due to the increased risk of systemic toxicity, while the USP 2.5% should be used in these patients.
The company said that the solution is for topical ophthalmic use only, and not for injection.