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 disodium dihydrate, methylparaben, propylparaben]
Pharmacology
Mechanism of Action
Relatively selective alpha1A-receptor agonist that when applied topically may decrease erythema through direct vasoconstriction.
Pharmacokinetics/Pharmacodynamics
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.
Dosage and Administration
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
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
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
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber severe application site irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
