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Oxymetazoline (Topical)

Medically reviewed by Drugs.com. Last updated on Nov 3, 2020.

Pronunciation

(oks i met AZ oh leen)

Index Terms

  • Oxymetazoline Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External, as hydrochloride:

Rhofade: 1% (30 g) [contains cetostearyl alcohol, edetate (edta) disodium dihydrate, methylparaben, propylparaben]

Brand Names: U.S.

  • Rhofade

Pharmacologic Category

  • Adrenergic Agonist Agent
  • Imidazoline Derivative

Pharmacology

Relatively selective alpha1A-receptor agonist that when applied topically may decrease erythema through direct vasoconstriction.

Metabolism

Hepatic (minimal)

Protein Binding

56.7% to 57.5%

Use: Labeled Indications

Rosacea: Treatment of persistent facial erythema associated with rosacea in adults

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Rosacea: Topical: Apply a pea-sized amount to entire face once daily.

Dosing: Geriatric

Refer to adult dosing.

Administration

For topical use only; not for oral, ophthalmic, or intravaginal use. Prior to use, prime pump several times until cream is dispensed; pump 3 more times onto a tissue and discard tissue (tube does not require priming). Apply smoothly and evenly as a thin layer across entire face (forehead, each cheek, nose, and chin); avoid eyes and lips. Do not apply to irritated skin or open wounds. Wash hands immediately after applying.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Exacerbation of acne rosacea (1%)

Local: Application site dermatitis (2%), application site erythema (1%), application site pain (1%)

Warnings/Precautions

Disease-related concerns:

• Cardiovascular disease: May affect blood pressure; use with caution in patients with uncontrolled hypertension or hypotension, orthostatic hypotension or with severe, unstable, or uncontrolled cardiovascular disease. May potentiate vascular insufficiency; use with caution in patients with cerebral or coronary insufficiency, scleroderma, thromboangiitis obliterans, and Raynaud phenomenon.

• Glaucoma: Use may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma; use with caution.

• Sjögren syndrome: Use with caution in patients with Sjögren syndrome.

Other warnings/precautions:

• Appropriate use: For topical use only; not for oral, ophthalmic, or intravaginal use; avoid contact with eyes and lips. Do not apply to open wounds or irritated skin.

Pregnancy Considerations

Information related to topical use of oxymetazoline in pregnacy is limited. During clinical trials, two pregnancies were reported, resulting in one healthy baby and one spontaneous abortion (not considered related to treatment). Most available information is related to maternal use following nasal inhalation (see the oxymetazoline nasal monograph for additional information).

Patient Education

What is this drug used for?

• It is used to treat rosacea.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe application site irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.