Oxymetazoline Hydrochloride (Ophthalmic Solution)

Oxymetazoline Hydrochloride ophthalmic solution is indicated for the treatment of acquired blepharoptosis in adults.

Oxymetazoline is an alpha adrenoceptor agonist targeting a subset of adrenoreceptors in Mueller's muscle of the eyelid.

Instill one drop of oxymetazoline into one or both ptotic eye(s) once daily. Discard the single patient-use container immediately after dosing.

Contact lenses should be removed prior to instillation of oxymetazoline and may be reinserted 15 minutes following its administration.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least 15 minutes between applications.

Pediatric Use: Safety and effectiveness of UPNEEQ have not been established in pediatric patients under 13 years of age.

Anti-hypertensives/Cardiac Glycosides: Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.

Monoamine Oxidase Inhibitors: Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

Most common adverse reactions (incidence 1-5%) are: punctate keratitis, conjunctival hyperemia, dry eye, vision blurred, instillation site pain, eye irritation and headache.

There are no available data on Oxymetazoline use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. No clinical data are available to assess the effects of oxymetazoline on the quantity or rate of breastmilk production, or to establish the level of oxymetazoline present in human breastmilk postdose. Oxymetazoline was detected in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Oxymetazoline and any potential adverse effects on the breastfed child from Oxymetazoline.

Potential Impacts on Cardiovascular Disease: Alpha-adrenergic agonists may impact blood pressure. Oxymetazoline should be used with caution in patients with severe or unstable cardiovascular disease, orthostatic hypotension, and uncontrolled hypertension or hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.

Potentiation of Vascular Insufficiency: Oxymetazoline should be used with caution in patients with cerebral or coronary insufficiency, or Sjogren’s syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.

Risk of Angle Closure Glaucoma: Oxymetazoline may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.

Risk of Contamination: Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

Accidental oral ingestion of topical intended solutions (including ophthalmic solutions and nasal sprays) containing imidazoline derivatives (e.g., oxymetazoline) in children has resulted in serious adverse events requiring hospitalization, including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma. Keep UPNEEQ out of reach of children.

Other ophthalmic preparations

Store at 20°C to 25°C. Protect from excessive heat. Keep out of reach of children.