Use with caution and under direction of a clinician in patients with thyroid disease (e.g., hyperthyroidism), heart disease (including angina), hypertension, advanced arteriosclerotic conditions, or diabetes mellitus in patients experiencing difficulty in urination secondary to prostatic enlargement or in patients receiving monoamine oxidase (MAO) inhibitors. With intranasal use, possible headache, hypertension, cardiac irregularities (e.g., palpitation, reflex bradycardia), nervousness, nausea, dizziness, and insomnia. (See Pediatric Use under Cautions and also see Advice to Patients.) Sympathomimetic Effects (See Advice to Patients.)Īccidental ingestion of imidazoline derivatives (i.e., oxymetazoline, naphazoline, tetrahydrozoline) in children has resulted in serious adverse events requiring hospitalization (e.g., coma, bradycardia, decreased respiration, sedation, somnolence). Possible rebound nasal congestion or ocular hyperemia (redness) avoid prolonged use. Possible irritation of nasal mucosa and adverse systemic effects (particularly in children) with excessive dosage and/or prolonged or too frequent intranasal use. ![]() Warnings/Precautions General Precautions Overuse Known sensitivity to the pharmacologic effects of adrenergic drugs. Known hypersensitivity to oxymetazoline or any ingredient in the formulation. Related/similar drugs phenylephrine ophthalmic, brimonidine ophthalmic, fluorometholone ophthalmic, Upneeq, FML, naphazoline ophthalmic Cautions for Oxymetazoline Contraindications Self-medication: Maximum of 2 times (2 doses) in a 24-hour period. (See Advice to Patients.) Adults Nasal Congestion Intranasal Self-medication in children ≥6 years of age: Maximum of 2 times (2 doses) in a 24-hour period. Prescribing Limits Pediatric Patients Nasal Congestion Intranasal Conjunctival Congestion Ophthalmicįor self-medication: 1 or 2 drops of a 0.025% ophthalmic solution in the affected eye(s) every 6 hours as needed. Adults Nasal Congestion Intranasalįor self-medication: 2 or 3 sprays of a 0.05% nasal solution in each nostril every 10–12 hours (usually in the morning and evening), up to 2 times daily. Conjunctival Congestion Ophthalmicįor self-medication in children ≥6 years of age: 1 or 2 drops of a 0.025% ophthalmic solution in the affected eye(s) every 6 hours as needed. Pediatric Patients Nasal Congestion Intranasalįor self-medication in children ≥6 years of age: 2 or 3 sprays of a 0.05% nasal solution in each nostril every 10–12 hours (usually in the morning and evening), up to 2 times daily. DosageĪvailable as oxymetazoline hydrochloride dosage expressed in terms of the salt. ![]() Remove contact lenses before administering ophthalmic solution.ĭo not administer discolored or cloudy solutions. Ophthalmic AdministrationĪdminister ophthalmic solution topically to the conjunctiva. Prior to initial use of metered sprays, prime nasal inhaler by depressing the pump firmly several times.Īdminister nasal spray or pump into each nostril while head is erect. Intranasal AdministrationĪdminister nasal solution intranasally as sprays or nasal pumps. Oxymetazoline Dosage and Administration AdministrationĪdminister topically to nasal mucosa or conjunctiva. Has been used for self-medication for symptomatic prevention of otitic barotrauma † (aerotitis media) however, no more effective than placebo. Self-medication for temporary relief of ocular redness due to minor irritation. Compliance date for preparations with annual sales <$25,000 is Octocompliance date for all other preparations is April 11, 2007. In October 2005, FDA issued final rule to remove this indication from labeling of OTC nasal decongestants. ![]() Labeled and has been used for self-medication for temporary relief of nasal congestion associated with sinusitis however, efficacy data are lacking and/or controversial. Self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies.Īs effective as other topical vasoconstrictors. Vasoconstrictor an imidazoline-derivative sympathomimetic amine. Eye Drops, Zicam Extreme Congestion Relief, Zicam Intense Sinus Relief Brand names: Afrin No Drip Extra Moisturizing, Afrin No Drip Original, Afrin No Drip Severe Congestion, Afrin No Drip Sinus, Afrin Original,Īfrin Severe Congestion, Afrin Sinus, Dristan 12 Hour, Neo-Synephrine 12 Hour Severe Sinus Congestion, Nostrilla 12 Hour Nasal Decongestant, Vicks Sinex 12 Hour Nasal Decongestant, Visine L.R.
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