Oxymetazoline Hydrochloride Ophthalmic
Generic Name: oxymetazoline hydrochloride ophthalmic
Brand Names:
Upneeq
11 DESCRIPTION UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% contains oxymetazoline hydrochloride, an alpha adrenoceptor agonist. UPNEEQ is an aseptically prepared, sterile, non-preserved ophthalmic solution. The chemical name is 6-tert-Butyl-3-(2-imidazolin-2-ylmethyl)-2,4- dimethylphenol monohydrochloride, and the molecular mass is 296.84. Oxymetazoline HCl is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water.
Overview
11 DESCRIPTION UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% contains oxymetazoline hydrochloride, an alpha adrenoceptor agonist. UPNEEQ is an aseptically prepared, sterile, non-preserved ophthalmic solution. The chemical name is 6-tert-Butyl-3-(2-imidazolin-2-ylmethyl)-2,4- dimethylphenol monohydrochloride, and the molecular mass is 296.84. Oxymetazoline HCl is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water.
Uses
1 INDICATIONS AND USAGE UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Instill one drop of UPNEEQ 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 UPNEEQ 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. Instill one drop into one or both ptotic eye(s) once daily. ( 2 )
Side Effects
6 ADVERSE REACTIONS Most common adverse reactions (incidence 1-5%) are: punctate keratitis, conjunctival hyperemia, dry eye, vision blurred, instillation site pain, eye irritation and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact RVL Pharmaceuticals, Inc. at 1-877-482-3788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS 7.1 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. 7.2 Monoamine Oxidase Inhibitors Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Warnings
5 WARNINGS AND PRECAUTIONS Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses. Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs. ( 5.1 ) Alpha-adrenergic agonists as a class may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on UPNEEQ use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 7 and 278 times the maximum recommended human ophthalmic dose (MRHOD), respectively, based on dose comparison. [see Data] . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% is an aseptically prepared, sterile, non-preserved, clear, colorless to slightly yellow ophthalmic solution; 0.3 mL fill in a clear, low-density polyethylene, single patient-use container in a child-resistant foil pouch.
Frequently Asked Questions
What is Oxymetazoline Hydrochloride Ophthalmic used for?▼
1 INDICATIONS AND USAGE UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. ( 1 )
What are the side effects of Oxymetazoline Hydrochloride Ophthalmic?▼
6 ADVERSE REACTIONS Most common adverse reactions (incidence 1-5%) are: punctate keratitis, conjunctival hyperemia, dry eye, vision blurred, instillation site pain, eye irritation and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact RVL Pharmaceuticals, Inc. at 1-877-482-3788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Oxymetazoline Hydrochloride Ophthalmic during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on UPNEEQ use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 7 and 278 times the maximum recommended human ophthalmic dose (MRHOD), respectively, based on dose comparison. [see Data] . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown.
What are the important warnings for Oxymetazoline Hydrochloride Ophthalmic?▼
5 WARNINGS AND PRECAUTIONS Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses. Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs. ( 5.1 ) Alpha-adrenergic agonists as a class may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.