oxymetazoline topical (Rx)

Brand and Other Names:Rhofade
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

topical cream

  • 1% (available in a tube or pump bottle)
  • Each gram of cream contains 10 mg (1%) oxymetazoline hydrochloride, which is equivalent to 8.8 mg (0.88%) of oxymetazoline free base

Rosacea

Indicated for the topical treatment of persistent facial erythema associated with rosacea in adults

Apply topically qDay; use a pea-sized amount of cream in a thin layer to cover the entire face (forehead, nose, each cheek, and chin), avoiding the eyes and lips

Wash hands immediately after application

<18 years: Safety and efficacy not established

Dosage Forms & Strengths

topical cream 1% (available in a tube or pump bottle)

Rosacea

Indicated for the topical treatment of persistent facial erythema associated with rosacea in adults

Apply topically qDay; use a pea-sized amount of cream in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips

Wash hands immediately after application

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Interactions

Interaction Checker

and oxymetazoline topical

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (31)

                • alfuzosin

                  oxymetazoline topical increases and alfuzosin decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • atenolol

                  oxymetazoline topical increases and atenolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • betaxolol

                  oxymetazoline topical increases and betaxolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • bisoprolol

                  oxymetazoline topical increases and bisoprolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • carvedilol

                  oxymetazoline topical increases and carvedilol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • digoxin

                  oxymetazoline topical decreases effects of digoxin by pharmacodynamic synergism. Use Caution/Monitor. Digoxin reduces catecholamine reuptake at nerve terminals, rendering blood vessels more sensitive to endogenous or exogenous catecholamines.

                • doxazosin

                  oxymetazoline topical increases and doxazosin decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • droxidopa

                  oxymetazoline topical and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • ephedrine

                  oxymetazoline topical and ephedrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • epinephrine

                  oxymetazoline topical and epinephrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • esmolol

                  oxymetazoline topical increases and esmolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • isocarboxazid

                  oxymetazoline topical and isocarboxazid both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • labetalol

                  oxymetazoline topical increases and labetalol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • metoprolol

                  oxymetazoline topical increases and metoprolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • midodrine

                  oxymetazoline topical and midodrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • nadolol

                  oxymetazoline topical increases and nadolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • nebivolol

                  oxymetazoline topical increases and nebivolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • norepinephrine

                  oxymetazoline topical and norepinephrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • penbutolol

                  oxymetazoline topical increases and penbutolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • phenelzine

                  oxymetazoline topical and phenelzine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • phenoxybenzamine

                  oxymetazoline topical increases and phenoxybenzamine decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • phentolamine

                  oxymetazoline topical increases and phentolamine decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • phenylephrine

                  oxymetazoline topical and phenylephrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • prazosin

                  oxymetazoline topical increases and prazosin decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • propranolol

                  oxymetazoline topical increases and propranolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • silodosin

                  oxymetazoline topical increases and silodosin decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • sotalol

                  oxymetazoline topical increases and sotalol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • tamsulosin

                  oxymetazoline topical increases and tamsulosin decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • terazosin

                  oxymetazoline topical increases and terazosin decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • timolol

                  oxymetazoline topical increases and timolol decreases sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Effect of interaction is not clear, use caution. Use Caution/Monitor.

                • tranylcypromine

                  oxymetazoline topical and tranylcypromine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                Minor (0)

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                  Adverse Effects

                  1-10%

                  Application-site dermatitis (2%)

                  Worsening inflammatory lesions of rosacea (1%)

                  Application-site pruritus (1%)

                  Application-site erythema (1%)

                  Application-site pain (1%)

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                  Warnings

                  Contraindications

                  None

                  Cautions

                  Alpha-adrenergic agonists may increase blood pressure; use caution with severe, unstable, or uncontrolled cardiovascular disease, orthostatic hypotension, or uncontrolled hypertension or hypotension; advise patients to seek immediate medical care if their condition worsens

                  Caution with cerebral or coronary insufficiency, Raynaud phenomenon, thromboangiitis obliterans, scleroderma, or SjÖgren syndrome; advise patients to seek immediate medical care if signs and symptoms of vascular insufficiency develop

                  May increase risk of angle-closure glaucoma in patients with narrow-angle glaucoma; advise patients to seek immediate medical care if signs and symptoms of acute angle-closure glaucoma develop

                  Drug interaction overview

                  • Antihypertensives or cardiac glycosides: Alpha-adrenergic agonists, as a class, may increase blood pressure; caution with coadministration of beta-blockers, antihypertensives, and/or cardiac glycosides
                  • Monoamine oxidase (MAO) inhibitors: Caution is advised if coadministered with MAO inhibitors, which can affect the metabolism and uptake of circulating amines
                  • Other alpha1 adrenergic receptor agonists: Use caution in patients receiving alpha1 adrenergic receptor antagonists (eg, treatment of cardiovascular disease, benign prostatic hypertrophy, or Raynaud disease)
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                  Pregnancy

                  Pregnancy

                  No available data on oxymetazoline topical use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage

                  Data describing intranasal decongestant use in pregnant women identified a potential association between second-trimester exposure to oxymetazoline (with no decongestant exposure in the first trimester) and renal collecting system anomalies

                  Lactation

                  Unknown if distributed in human breast milk

                  Oxymetazoline was detected in the milk of lactating rats

                  Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Alpha1A-adrenoceptor agonist; elicits vasoconstriction of the cutaneous microvasculature

                  Absorption

                  Peak plasma concentration: 60.5 pg/mL (first dose); 66.4 pg/mL (28-days)

                  AUC: 895 pg·hr/mL (first dose); 1050 pg·hr/mL (28-days)

                  Distribution

                  Protein bound: ~57%

                  Metabolism

                  Minimally metabolized (~4%)

                  Elimination

                  Not characterized in humans

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                  Administration

                  Topical Preparation

                  Tubes do not require priming

                  Pumps

                  • Pumps require priming before initial use and discard product from the first 3 pumps with the pump in the upright position; repeatedly depress the actuator until cream is dispensed and then pump 3 times
                  • Discard the cream from priming actuations
                  • It is only necessary to prime the pump before the first dose

                  Topical Administration

                  Use a pea-sized amount of cream once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin)

                  Avoid contact with the eyes and lips

                  Wash hands immediately after application For topical use only; not for oral, ophthalmic, or intravaginal use

                  Do not to apply to irritated skin or open wounds

                  Storage

                  Store at controlled room temperature (20-25°C [68-77°F]); excursions permitted to 15-30°C (59-86°F)

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.