For: Acne Rosacea
Rhofade (oxymetazoline hydrochloride) is a topical alpha1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults. These highlights do not include all the information needed to use RHOFADE� topical cream safely and effectively. See full prescribing information for RHOFADE� topical cream.
RHOFADE� (oxymetazoline hydrochloride) cream, 1%, for topical use
Initial U.S. Approval: 1964
INDICATIONS AND USAGE
Rhofade cream is an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. (1)
DOSAGE AND ADMINISTRATION
Not for oral, ophthalmic, or intravaginal use. (2)
Prime pump bottle before initial use and discard product from first three pumps. (2)
Apply a pea-sized amount once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. (2)
Wash hands after application. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 1%. Each gram of cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8 mg (0.88%) of oxymetazoline free base. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Alpha-adrenergic agonists as a class may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens. (5.1)
Use with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sj�gren's syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop. (5.2)
Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ? 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Aclaris Therapeutics, Inc. at 1-833-225-2747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2018
