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

          Minor

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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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            Formulary

            FormularyPatient Discounts

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            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.
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            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.