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  • CLASSES

    Ocular Decongestants, Sympathomimetics
    Topical Nasal Decongestants
    Topical Sympathomimetics

    DEA CLASS

    OTC, Rx

    DESCRIPTION

    Alpha adrenoreceptor agonist that acts as a vasoconstrictor
    Available as a topical cream, intranasal spray, and an ophthalmic solution
    Indicated to treat persistent facial erythema in adults with rosacea (cream), nasal congestion (intranasal spray), redness of the eye due to minor eye irritants (0.025% ophthalmic solution), acquired blepharoptosis io adults (0.1% ophthalmic solution)

    COMMON BRAND NAMES

    12 Hour Nasal, Afrin, Afrin Extra Moisturizing, Afrin Nasal Sinus, Afrin No Drip Severe Congestion, Dristan, Duration, Genasal, Mucinex Children's Stuffy Nose, Mucinex Full Force, Mucinex Moisture Smart, Mucinex Sinus-Max, NASAL Decongestant, Nasal Relief, Neo-Synephrine 12-Hour, Neo-Synephrine Severe Sinus Congestion, Nostrilla Fast Relief, RHOFADE, Sinex 12-Hour, Sudafed OM Sinus Cold Moisturizing, Sudafed OM Sinus Congestion Moisturizing, Vicks Qlearquil Decongestant, Vicks Sinex, Vicks Sinex Severe, Vicks Sinus Daytime, Zicam Extreme Congestion Relief, Zicam Intense Sinus

    HOW SUPPLIED

    12 Hour Nasal/Afrin/Afrin Extra Moisturizing/Afrin Nasal Sinus/Afrin No Drip Severe Congestion/Dristan/Duration/Genasal/Mucinex Children's Stuffy Nose/Mucinex Full Force/Mucinex Moisture Smart/Mucinex Sinus-Max/NASAL Decongestant/Nasal Relief/Neo-Synephrine 12-Hour/Neo-Synephrine Severe Sinus Congestion/Nostrilla Fast Relief/Oxymetazoline/Oxymetazoline Hydrochloride/Sinex 12-Hour/Sudafed OM Sinus Cold Moisturizing/Sudafed OM Sinus Congestion Moisturizing/Vicks Qlearquil Decongestant/Vicks Sinex/Vicks Sinex Severe/Vicks Sinus Daytime/Zicam Extreme Congestion Relief/Zicam Intense Sinus Nasal Sol: 0.05%
    12 Hour Nasal/Afrin/Afrin Extra Moisturizing/Afrin Nasal Sinus/Afrin No Drip Severe Congestion/Dristan/Duration/Genasal/Mucinex Children's Stuffy Nose/Mucinex Full Force/Mucinex Moisture Smart/Mucinex Sinus-Max/NASAL Decongestant/Nasal Relief/Neo-Synephrine 12-Hour/Neo-Synephrine Severe Sinus Congestion/Nostrilla Fast Relief/Oxymetazoline/Oxymetazoline Hydrochloride/Sinex 12-Hour/Sudafed OM Sinus Cold Moisturizing/Sudafed OM Sinus Congestion Moisturizing/Vicks Qlearquil Decongestant/Vicks Sinex/Vicks Sinex Severe/Vicks Sinus Daytime/Zicam Extreme Congestion Relief/Zicam Intense Sinus Nasal Spray: 0.05%
    RHOFADE Topical Cream: 1%

    DOSAGE & INDICATIONS

    For the treatment of persistent facial erythema associated with acne rosacea.
    Topical dosage
    Adults

    Apply a pea-size amount of cream topically once daily as a thin layer to cover the entire face (i.e., forehead, cheeks, nose, and chin). Avoid contact with the eyes and lips. Wash hands immediately after applying cream.

    For the relief of ocular pruritus and redness due to minor ocular irritations.
    Ophthalmic dosage (0.025% solution)
    Adults

    1 or 2 drops in the affected eye(s) every 6 hours as needed. Do not exceed the recommended dose; overuse may result in more eye redness.

    Children and Adolescents 6 to 17 years

    1 or 2 drops in the affected eye(s) every 6 hours as needed. Do not exceed the recommended dose; overuse may result in more eye redness.

    For temporary symptomatic relief of nasal congestion due to the common cold, hay fever, and upper respiratory allergies.
    Nasal dosage
    Adults

    2 or 3 sprays in each nostril every 10 to 12 hours as needed. Max: 2 doses/24 hours. Do not use for more than 3 days; prolonged use may result in recurrent or worsening nasal congestion.[61734]

    Children and Adolescents 6 to 17 years

    2 or 3 sprays in each nostril every 10 to 12 hours as needed. Max: 2 doses/24 hours. Do not use for more than 3 days; prolonged use may result in recurrent or worsening nasal congestion.[61734]

    For the treatment of acquired blepharoptosis.
    Ophthalmic dosage (0.1% solution)
    Adults

    1 drop into the affected eye(s) once daily.

    For the treatment of epistaxis†.
    Nasal dosage
    Adults

    2 to 6 sprays in the affected nostril(s) during the active bleed, then 2 sprays 3 to 4 times daily for 3 to 5 days. Alternatively, soak gauze or a cotton pledget in the decongestant solution and place in the affected nostril(s) for 30 minutes.[48746] [65040] [65041] [65042]

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    8 drops/eye/day of the 0.025% ophthalmic solution; 1 drop/eye/day of the 0.1% ophthalmic solution; 6 sprays/nostril/day of the nasal spray; 1 topical application/day of the cream.

    Geriatric

    8 drops/eye/day of the 0.025% ophthalmic solution; 1 drop/eye/day of the 0.1% ophthalmic solution; 6 sprays/nostril/day of the nasal spray; 1 topical application/day of the cream.

    Adolescents

    8 drops/eye/day of the 0.025% ophthalmic solution; 6 sprays/nostril/day of the nasal spray; safety and efficacy have not been established for the 0.1% ophthalmic solution or the topical cream.

    Children

    6 to 12 years: 8 drops/eye/day of the 0.025% ophthalmic solution; 6 sprays/nostril/day of the nasal spray; safety and efficacy have not been established for the 0.1% ophthalmic solution or the topical cream.
    1 to 5 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Topical Administration
    Cream/Ointment/Lotion Formulations

    The Rhofade pump must be primed prior to its first use. With the pump in the upright position, depress the actuator until cream is dispensed and then pump 3 times. Discard the cream from priming actuations. NOTE: Priming the pump is only required before the initial use; tubes do not require priming.
    Apply pea-size amount of cream as a thin layer to the entire face (i.e., forehead, cheeks, nose, and chin).
    Avoid contact with eyes and lips.
    Wash hands immediately following application.

    Inhalation Administration
    Intranasal Inhalation Administration

    Prior to initial use, remove the protective cap from the tip and prime the pump by depressing firmly several times.
    Shake well before each use.
    Hold upright with thumb at the base and the nozzle placed between the first and second fingers. Insert nozzle into nostril (do not tilt head). Fully depress rim with a firm, even stroke and sniff deeply.
    Wipe nozzle clean after each use. To avoid spreading infection, the container should be used by only 1 person.

    Ophthalmic Administration

    Visually inspect for discoloration. Do not use if solution changes color or becomes cloudy.
    Remove contact lenses before instilling drops. Contact lenses may be reinserted 15 minutes after administering the dose.
    If more than 1 ophthalmic medication is being used, the medications should be administered at least 15 minutes apart.
    To avoid contamination, do not touch the tip of container to any surface.
    To prevent infection, avoid the use of the container by more than 1 person.
    Tilt head back, pull down the lower eyelid with a finger, and instill drop into the conjunctival sac of the affected eye.
    For the 0.1% solution, each single patient-use container will provide enough medicine to treat both eyes (if needed) 1 time each day. There is some extra solution in each single patient-use container in case the drop misses the eye. Discard the single patient-use container and any unused solution immediately after dosing.
    For the 0.025% solution, replace the cap after each use.[61735] [65687]

    STORAGE

    Generic:
    - Store at room temperature (between 59 to 86 degrees F)
    12 Hour Nasal :
    - Store at room temperature (between 59 to 86 degrees F)
    Afrin:
    - Store at room temperature (between 59 to 86 degrees F)
    Afrin Extra Moisturizing:
    - Store at room temperature (between 59 to 86 degrees F)
    Afrin Nasal Sinus:
    - Store at room temperature (between 59 to 86 degrees F)
    Afrin No Drip Severe Congestion:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Dristan:
    - Store at room temperature (between 59 to 86 degrees F)
    Duration:
    - Store at room temperature (between 59 to 86 degrees F)
    Genasal :
    - Store at room temperature (between 59 to 86 degrees F)
    Mucinex Children's Stuffy Nose:
    - Store at room temperature (between 59 to 86 degrees F)
    Mucinex Full Force:
    - Store at room temperature (between 59 to 86 degrees F)
    Mucinex Moisture Smart:
    - Store at room temperature (between 59 to 86 degrees F)
    Mucinex Sinus-Max:
    - Store between 68 to 77 degrees F
    NASAL Decongestant:
    - Store at room temperature (between 59 to 86 degrees F)
    Nasal Relief :
    - Store at room temperature (between 59 to 86 degrees F)
    Neo-Synephrine 12-Hour:
    - Store at room temperature (between 59 to 86 degrees F)
    Neo-Synephrine Severe Sinus Congestion:
    - Store at room temperature (between 59 to 86 degrees F)
    Nostrilla Fast Relief:
    - Store at room temperature (between 59 to 86 degrees F)
    RHOFADE:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Sinex 12-Hour:
    - Store at room temperature (between 59 to 86 degrees F)
    Sudafed OM Sinus Cold Moisturizing:
    - Store at room temperature (between 59 to 86 degrees F)
    Sudafed OM Sinus Congestion Moisturizing:
    - Store at room temperature (between 59 to 86 degrees F)
    Vicks Qlearquil Decongestant:
    - Store at room temperature (between 59 to 86 degrees F)
    Vicks Sinex:
    - Store at room temperature (between 59 to 86 degrees F)
    Vicks Sinex Severe:
    - Store at room temperature (between 59 to 86 degrees F)
    Vicks Sinus Daytime:
    - Store at room temperature (between 59 to 86 degrees F)
    Visine L.R.:
    - Store between 59 to 77 degrees F
    Zicam Extreme Congestion Relief:
    - Store at room temperature (between 59 to 86 degrees F)
    Zicam Intense Sinus:
    - Store at room temperature (between 59 to 86 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Accidental exposure, contact lenses, ocular exposure

    Take care to avoid ocular exposure during the use of oxymetazoline topical cream and nasal spray formulations. To avoid accidental exposure of non-treatment sites, instruct patients to wash hands immediately after applying the topical cream. Prior to the use of the ophthalmic solution, contact lenses must be removed. Contact lenses may be reinserted 15 minutes after administration of the dose.

    MAOI therapy

    Caution is advised when administering oxymetazoline to patients receiving concurrent MAOI therapy. Monoamine oxidase inhibitors can affect the metabolism and uptake of circulating amines; thereby potentiating the vasoconstrictive effects of oxymetazoline.

    Cardiac disease, hypertension, hypotension, orthostatic hypotension

    Oxymetazoline (an alpha-adrenergic agonist) acts as a vasoconstrictor, which may adversely affect blood pressure; thus, caution is advised when administering the drug to patients with severe or unstable cardiovascular diseases, orthostatic hypotension, and uncontrolled hypertension or hypotension. Instruct patients with cardiac disease to seek immediate medical attention if their condition worsens.

    Cerebrovascular disease, coronary artery disease, diabetes mellitus, prostatic hypertrophy, Raynaud's phenomenon, scleroderma, Sjogren's syndrome, thromboangiitis obliterans (Buerger's disease), thyroid disease

    Caution is advised when administering oxymetazoline (a vasoconstrictor) to patients with vascular and autoimmune diseases, such as coronary artery disease, cerebrovascular disease, diabetes mellitus, thyroid disease, prostatic hypertrophy, Sjogren's syndrome, Raynaud's phenomenon, thromboangiitis obliterans (Buerger's disease), and scleroderma. Instruct patients to seek immediate medical care if signs or symptoms of worsening vascular insufficiency develops.

    Closed-angle glaucoma

    Treatment with oxymetazoline may increase the risk of developing angle-closure glaucoma in patients with closed-angle glaucoma. Instruct patients to seek immediate medical care if signs or symptoms of acute angle-closure glaucoma develop.

    Children, infants, neonates

    Safety and efficacy of oxymetazoline topical cream or the 0.1% ophthalmic solution have not been established in pediatric patients younger than 18 years of age (i.e., neonates, infants, children, and adolescents); however, the 0.025% ophthalmic solution and nasal spray may be used in children as young as 6 years of age.

    Pregnancy

    Data are limited regarding the use of oxymetazoline during pregnancy. It is unknown if the use of the drug in pregnant women is associated with an increased risk for major birth defects or miscarriages. In animal reproductive studies, no adverse developmental effects were observed after oral administration of oxymetazoline to pregnant rats and rabbits at systemic exposures up to 7- and 278-times the maximum recommended human ophthalmic dose, respectively. Data from 1 literature article found a potential association between second-trimester exposure to oxymetazoline nasal spray and renal collecting system anomalies. In another case, fetal distress was reported in a 41-week pregnant patient following repeated use of oxymetazoline nasal spray at a dose 5-times the recommended dose. The fetal distress resolved hours later, and prior to delivery of the healthy infant. Exposure to oxymetazoline topical cream has also been reported in 2 pregnant females. One pregnancy resulted in the delivery of a healthy child. The other pregnancy ended in spontaneous abortion, which was not considered related to drug exposure.

    Breast-feeding

    It is not known whether oxymetazoline is distributed into breast milk, or if the drug affects breast milk production. According to the manufacturer, caution should be exercised when administering it to women who are breast-feeding their infants. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Infection, myasthenia gravis, stroke

    Before prescribing oxymetazoline 0.1% ophthalmic solution for the treatment of blepharoptosis, consider that ptosis may be associated with neurologic or orbital diseases, such as stroke, cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection, and orbital masses. It is advised to evaluate the patient for these conditions in the presence of ptosis with decreased levator muscle function or other neurologic signs.

    ADVERSE REACTIONS

    Severe

    keratitis / Delayed / 1.0-5.0
    bradycardia / Rapid / Incidence not known
    coma / Early / Incidence not known
    visual impairment / Early / Incidence not known

    Moderate

    blurred vision / Early / 1.0-5.0
    conjunctival hyperemia / Early / 1.0-5.0
    contact dermatitis / Delayed / 2.0-3.0
    erythema / Early / 1.0-2.0
    sinus tachycardia / Rapid / Incidence not known
    hypertension / Early / Incidence not known
    hypotension / Rapid / Incidence not known
    respiratory depression / Rapid / Incidence not known

    Mild

    ocular irritation / Rapid / 1.0-5.0
    headache / Early / 1.0-5.0
    xerophthalmia / Early / 1.0-5.0
    ocular pain / Early / 1.0-5.0
    pruritus / Rapid / 1.0-2.0
    hypothermia / Delayed / Incidence not known
    vomiting / Early / Incidence not known
    mydriasis / Early / Incidence not known
    lethargy / Early / Incidence not known
    nausea / Early / Incidence not known
    rhinorrhea / Early / Incidence not known
    sneezing / Early / Incidence not known
    nasal irritation / Early / Incidence not known
    nasal congestion / Early / Incidence not known

    DRUG INTERACTIONS

    Acebutolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Alfuzosin: (Major) Caution is advised when administering alfuzosin with oxymetazoline. Alfuzosin, an alpha adrenergic blocker, would likely antagonize the sympathomimetic effects of oxymetazoline, alpha adrenergic agonists; thereby reducing the effectiveness of oxymetazoline.
    Aliskiren; Amlodipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Aliskiren; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Aliskiren; Valsartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Ambrisentan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by ambrisentan. If these drugs are used together, closely monitor for changes in blood pressure.
    Amiloride: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Amiloride; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Amlodipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Amlodipine; Atorvastatin: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Amlodipine; Benazepril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Amlodipine; Celecoxib: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Amlodipine; Olmesartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Amlodipine; Valsartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Angiotensin II receptor antagonists: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Angiotensin-converting enzyme inhibitors: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Atenolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Atenolol; Chlorthalidone: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Azilsartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Azilsartan; Chlorthalidone: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Benazepril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Benazepril; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Bendroflumethiazide; Nadolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Beta-blockers: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Betaxolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Bisoprolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Bisoprolol; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Brimonidine; Timolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Bumetanide: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Butorphanol: (Moderate) The rate of butorphanol absorption through the nasal mucosa is decreased when administered with sympathomimetic nasal decongestants such as oxymetazoline. However, the extent of absorption is not decreased. A slower onset of action should be expected if butorphanol is administered concurrently with or immediately following a sympathomimetic nasal decongestant.
    Caffeine: (Moderate) Caffeine is a CNS stimulant and such actions are expected to be additive when coadministered with other CNS stimulants or psychostimulants. Caffeine should be avoided or used cautiously with oxymetazoline.
    Calcium-channel blockers: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Candesartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Candesartan; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Captopril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Captopril; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Cardiac glycosides: (Major) Caution is advised when taking cardiac glycosides with alpha adrenergic agonists, such as oxymetazoline. Alpha adrenergic agonist can enhance ectopic pacemaker activity; thus, concurrent use with cardiac glycosides may result in arrhythmias.
    Carteolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Carvedilol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Chlorothiazide: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Chlorthalidone: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Chlorthalidone; Clonidine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by clonidine. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Clevidipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Clonidine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by clonidine. If these drugs are used together, closely monitor for changes in blood pressure.
    Diazoxide: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by vasodilators. Also vasodilators can antagonize the effectiveness of oxymetazoline. If these drugs are used together, closely monitor for changes in blood pressure.
    Digitoxin: (Major) Caution is advised when taking cardiac glycosides with alpha adrenergic agonists, such as oxymetazoline. Alpha adrenergic agonist can enhance ectopic pacemaker activity; thus, concurrent use with cardiac glycosides may result in arrhythmias.
    Digoxin: (Major) Caution is advised when taking cardiac glycosides with alpha adrenergic agonists, such as oxymetazoline. Alpha adrenergic agonist can enhance ectopic pacemaker activity; thus, concurrent use with cardiac glycosides may result in arrhythmias.
    Diltiazem: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Dorzolamide; Timolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Doxazosin: (Major) Caution is advised when administering doxazosin with oxymetazoline. Doxazosin, an alpha adrenergic blocker, would likely antagonize the sympathomimetic effects of oxymetazoline, alpha adrenergic agonists; thereby reducing the effectiveness of oxymetazoline.
    Enalapril, Enalaprilat: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Enalapril; Felodipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Enalapril; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Eplerenone: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by eplerenone. If these drugs are used together, closely monitor for changes in blood pressure.
    Epoprostenol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by epoprostenol. If these drugs are used together, closely monitor for changes in blood pressure.
    Eprosartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Eprosartan; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Esmolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Ethacrynic Acid: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Felodipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Fenoldopam: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by vasodilators. Also vasodilators can antagonize the effectiveness of oxymetazoline. If these drugs are used together, closely monitor for changes in blood pressure.
    Fentanyl: (Major) Pain control may be impaired if fentanyl nasal spray is administered in patients receiving vasoconstrictive nasal decongestants (e.g., oxymetazoline); do not titrate fentanyl nasal spray dose in such patients. Oxymetazoline use results in a decrease in the rate and extent of fentanyl absorption through the nasal mucosa. Measured fentanyl pharmacokinetic values decreased as follows in patients treated concurrently with oxymetazoline: mean Cmax decreased approximately 32-40% and mean AUC decreased 10-17%. Further, the mean time to maximum fentanyl plasma concentration was 0.75-1.25 h (range 0.08-3 h) for oxymetazoline-treated patients as compared to 0.25-0.33 h (range 0.17-2 h) in patients who did not receive the drug. This interaction is not expected with other fentanyl administration routes.
    Fosinopril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Fosinopril; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Furosemide: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Guanabenz: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by guanabenz. If these drugs are used together, closely monitor for changes in blood pressure.
    Guanfacine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by guanfacine. If these drugs are used together, closely monitor for changes in blood pressure.
    Hydralazine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by vasodilators. Also vasodilators can antagonize the effectiveness of oxymetazoline. If these drugs are used together, closely monitor for changes in blood pressure.
    Hydralazine; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by vasodilators. Also vasodilators can antagonize the effectiveness of oxymetazoline. If these drugs are used together, closely monitor for changes in blood pressure.
    Hydralazine; Isosorbide Dinitrate, ISDN: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by vasodilators. Also vasodilators can antagonize the effectiveness of oxymetazoline. If these drugs are used together, closely monitor for changes in blood pressure.
    Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Hydrochlorothiazide, HCTZ; Methyldopa: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by methyldopa. If these drugs are used together, closely monitor for changes in blood pressure.
    Hydrochlorothiazide, HCTZ; Moexipril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Indapamide: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Irbesartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Irbesartan; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Isocarboxazid: (Major) Oxymetazoline should generally not be used in patients taking non-selective monoamine oxidase inhibitors (MAOIs). The combination of an MAOI and a sympathomimetic drug, including decongestants given via topical, nasal, or ophthalmic routes, may rarely result in high blood pressure or in more serious cases, hypertensive crisis. Avoid use during and up to 2 weeks following discontinuation of the MAOI. Consider alternative treatments for the patient's condition.
    Isradipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Labetalol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Levamlodipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Levobetaxolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Levobunolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Lisinopril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Lisinopril; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Loop diuretics: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Losartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Losartan; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Methyclothiazide: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Methyldopa: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by methyldopa. If these drugs are used together, closely monitor for changes in blood pressure.
    Metolazone: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Metoprolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Metoprolol; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Minoxidil: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by vasodilators. Also vasodilators can antagonize the effectiveness of oxymetazoline. If these drugs are used together, closely monitor for changes in blood pressure.
    Moexipril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Monoamine oxidase inhibitors: (Major) Oxymetazoline should generally not be used in patients taking non-selective monoamine oxidase inhibitors (MAOIs). The combination of an MAOI and a sympathomimetic drug, including decongestants given via topical, nasal, or ophthalmic routes, may rarely result in high blood pressure or in more serious cases, hypertensive crisis. Avoid use during and up to 2 weeks following discontinuation of the MAOI. Consider alternative treatments for the patient's condition.
    Nadolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Nafarelin: (Moderate) If use of a topical nasal decongestants is necessary during therapy with intranasal nafarelin, the decongestant should not be used for at least 2 hours after nafarelin is administered.
    Nebivolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Nebivolol; Valsartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Nicardipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Nicotine: (Minor) Vasoconstricting nasal decongestants such as oxymetazoline prolong the time to peak effect of nasally administered nicotine (i.e. nicotine nasal spray); however, no dosage adjustments are recommended.
    Nifedipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Nimodipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Nisoldipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Nitroprusside: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by vasodilators. Also vasodilators can antagonize the effectiveness of oxymetazoline. If these drugs are used together, closely monitor for changes in blood pressure.
    Olmesartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Olmesartan; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Penbutolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Perindopril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Perindopril; Amlodipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Phenelzine: (Major) Oxymetazoline should generally not be used in patients taking non-selective monoamine oxidase inhibitors (MAOIs). The combination of an MAOI and a sympathomimetic drug, including decongestants given via topical, nasal, or ophthalmic routes, may rarely result in high blood pressure or in more serious cases, hypertensive crisis. Avoid use during and up to 2 weeks following discontinuation of the MAOI. Consider alternative treatments for the patient's condition.
    Phenoxybenzamine: (Major) Caution is advised when administering phenoxybenzamine with oxymetazoline. Phenoxybenzamine, an alpha adrenergic blocker, would likely antagonize the sympathomimetic effects of oxymetazoline, alpha adrenergic agonists; thereby reducing the effectiveness of oxymetazoline. Clinicians should note that phenoxybenzamine has a long duration of action and its effects may persist for several days after it has been discontinued.
    Phentolamine: (Major) Caution is advised when administering phentolamine with oxymetazoline. Phentolamine, an alpha adrenergic blocker, would likely antagonize the sympathomimetic effects of oxymetazoline, alpha adrenergic agonists; thereby reducing the effectiveness of oxymetazoline.
    Pindolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Potassium-sparing diuretics: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Prazosin: (Major) Caution is advised when administering prazosin with oxymetazoline. Prazosin, an alpha adrenergic blocker, would likely antagonize the sympathomimetic effects of oxymetazoline, alpha adrenergic agonists; thereby reducing the effectiveness of oxymetazoline.
    Propranolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Propranolol; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Quinapril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Quinapril; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Ramipril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Rasagiline: (Moderate) The concomitant use of rasagiline and sympathomimetics was not allowed in clinical studies; therefore, caution is advised during concurrent use of rasagiline and sympathomimetics including non-prescription nasal and ophthalmic decongestants. Although sympathomimetics are contraindicated for use with other non-selective monoamine oxidase inhibitors (MAOIs), hypertensive reactions generally are not expected to occur during concurrent use with rasagiline because of the selective monoamine oxidase-B (MAO-B) inhibition of rasagiline at manufacturer recommended doses. One case of elevated blood pressure has been reported in a patient during concurrent use of the recommended dose of rasagiline and ophthalmic tetrahydrozoline, a drug similar to oxymetazoline. It should be noted that the MAO-B selectivity of rasagiline decreases as the dose increases above the recommended daily dose and interactions with sympathomimetics may be more likely to occur at these higher doses.
    Reserpine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by reserpine. If these drugs are used together, closely monitor for changes in blood pressure.
    Sacubitril; Valsartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Selegiline: (Moderate) Use these drugs together with caution. Monitor blood pressure for hypertension during concomitant use of selegiline and oxymetazoline. Although oxymetazoline is used by nasal or ophthalmic routes, the use of these drugs together may produce substantial elevations in blood pressure. If a hypertensive crisis occurs, selegiline should be discontinued immediately and therapy to lower blood pressure should be instituted immediately.
    Sotalol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Spironolactone: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Spironolactone; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Telmisartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Telmisartan; Amlodipine: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Telmisartan; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Terazosin: (Major) Caution is advised when administering terazosin with oxymetazoline. Terazosin, an alpha adrenergic blocker, would likely antagonize the sympathomimetic effects of oxymetazoline, alpha adrenergic agonists; thereby reducing the effectiveness of oxymetazoline.
    Testosterone: (Moderate) The drug interaction potential between intranasal testosterone (e.g., Natesto) and other intranasally administered drugs other than sympathomimetic decongestants is unknown. Therefore, concomitant use of intranasal testosterone with intranasal drugs other than sympathomimetic decongestants (e.g., oxymetazoline) is not recommended. Eighteen males with seasonal allergic rhinitis were treated with intranasal testosterone and randomized to receive oxymetazoline (30 minutes prior to intranasal testosterone) or no treatment. In general, serum total testosterone concentrations were decreased by 21-24% in males with symptomatic allergic rhinitis, due to the underlying condition. A mean decrease in AUC and Cmax (2.6% and 3.6%, respectively) for total testosterone was observed in males with symptomatic seasonal rhinitis when treated with oxymetazoline compared to untreated patients. Concomitant use of oxymetazoline does not impact the absorption of testosterone.
    Thiazide diuretics: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Timolol: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by beta-blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Torsemide: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Trandolapril: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure.
    Trandolapril; Verapamil: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.
    Tranylcypromine: (Major) Oxymetazoline should generally not be used in patients taking non-selective monoamine oxidase inhibitors (MAOIs). The combination of an MAOI and a sympathomimetic drug, including decongestants given via topical, nasal, or ophthalmic routes, may rarely result in high blood pressure or in more serious cases, hypertensive crisis. Avoid use during and up to 2 weeks following discontinuation of the MAOI. Consider alternative treatments for the patient's condition.
    Treprostinil: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by treprostinil. If these drugs are used together, closely monitor for changes in blood pressure.
    Triamterene: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Triamterene; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Valsartan: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure.
    Valsartan; Hydrochlorothiazide, HCTZ: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin II receptor antagonists. If these drugs are used together, closely monitor for changes in blood pressure. (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by diuretics. If these drugs are used together, closely monitor for changes in blood pressure.
    Vasodilators: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by vasodilators. Also vasodilators can antagonize the effectiveness of oxymetazoline. If these drugs are used together, closely monitor for changes in blood pressure.
    Verapamil: (Major) The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by calcium-channel blockers. If these drugs are used together, closely monitor for changes in blood pressure.

    PREGNANCY AND LACTATION

    Pregnancy

    Data are limited regarding the use of oxymetazoline during pregnancy. It is unknown if the use of the drug in pregnant women is associated with an increased risk for major birth defects or miscarriages. In animal reproductive studies, no adverse developmental effects were observed after oral administration of oxymetazoline to pregnant rats and rabbits at systemic exposures up to 7- and 278-times the maximum recommended human ophthalmic dose, respectively. Data from 1 literature article found a potential association between second-trimester exposure to oxymetazoline nasal spray and renal collecting system anomalies. In another case, fetal distress was reported in a 41-week pregnant patient following repeated use of oxymetazoline nasal spray at a dose 5-times the recommended dose. The fetal distress resolved hours later, and prior to delivery of the healthy infant. Exposure to oxymetazoline topical cream has also been reported in 2 pregnant females. One pregnancy resulted in the delivery of a healthy child. The other pregnancy ended in spontaneous abortion, which was not considered related to drug exposure.

    It is not known whether oxymetazoline is distributed into breast milk, or if the drug affects breast milk production. According to the manufacturer, caution should be exercised when administering it to women who are breast-feeding their infants. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Oxymetazoline stimulates alpha-adrenergic receptors which cause intense vasoconstriction. When administered intranasally, this action promotes drainage and improves ventilation. The 0.025% ophthalmic solution causes vasoconstriction of conjunctival blood vessels thereby providing relief from minor eye irritations. In patients with rosacea, topical use can reduce facial erythema.
     
    For the treatment of blepharoptosis, the 0.1% ophthalmic solution targets a subset of adrenoreceptors in the upper eyelid tarsal smooth muscle (Mueller's muscle). Stimulation of these alpha-adrenoceptors causes contraction of the Mueller's muscle and subsequent opening of the eye.

    PHARMACOKINETICS

    Oxymetazoline is administered via the topical, ophthalmic, and intranasal routes. After systemic absorption, the drug is approximately 57% bound to human plasma proteins. In vitro studies using human liver microsomes showed oxymetazoline was minimally metabolized, with 96% of the parent drug remaining intact after 120-minute incubation. Excretion has not been determined; however, the mean terminal half-life in healthy adults is 8.3 hours (range: 5.6 to 13.9 hours).[61733] [61734] [61735]
     
    Affected cytochrome P450 isoenzymes and drug transporters: none

    Topical Route

    A pharmacokinetic study evaluating use of oxymetazoline topical cream in adults with rosacea identified measurable plasma drug concentrations in most subjects. After the first application, mean peak concentrations (Cmax) and exposure (AUC) were 60.5 +/- 53.9 pg/mL and 895 +/- 798 pg x hour/mL, respectively. After once daily applications for 28 days, the mean Cmax and AUC were 66.4 +/- 67.1 pg/mL and 1,050 +/- 992 pg x hour/mL, respectively; thus indicating little drug accumulation.[61733]

    Other Route(s)

    Ophthalmic Route
    Following administration of a single drop of 0.1% ophthalmic solution in each eye (total oxymetazoline dose of 0.07 mg), the median time to reach peak oxymetazoline concentrations was 2 hours (range: 0.5 to 12 hours). The mean peak concentration (Cmax) and systemic exposure (AUC) were 30.5 +/- 12.7 pg/mL and 468 +/- 214 pg x hour/mL, respectively.