Rhofade (oxymetazoline HCl)

For the topical treatment of facial erythema associated with rosacea in adults, a pea-sized amount of oxymetazoline 1% cream should be applied once daily to the 5 areas of the face (forehead, chin, nose, and each cheek). The cream should be applied smoothly and evenly as a thin layer across the entire face, but avoiding the eyes and lips. The hands should be washed immediately after application of the cream.

Oxymetazoline hydrochloride is applied topically to the skin as a 1% cream, which is available in a tube or pump bottle. Oxymetazoline cream is for external use only and should not be used orally, ophthalmically, or vaginally.

The pump bottle should be primed prior to initial use by actuating the pump until cream appears, then the pump should be actuated 3 additional times. The cream resulting from the priming actuations should be discarded. It is only necessary to prime the pump prior to the first dose.

Oxymetazoline does not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5 in vitro. Oxymetazoline also does not induce CYP1A2, 2B6, or 3A4 in vitro.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

The manufacturer states that there are no known contraindications to the use of oxymetazoline hydrochloride topical cream.

• Angle-closure glaucoma

There are no severe contraindications for this drug.

• Coronary artery disease
• Hypertension
• Orthostatic hypotension
• Raynaud's phenomenon
• Sjogren's syndrome

Adverse effects occurring in at least 1% of patients with persistent facial edema of rosacea receiving topical oxymetazoline cream in clinical studies and at a higher incidence than with vehicle placebo include application site dermatitis, pruritus, erythema, and pain and worsening inflammatory lesions of rosacea.

There are no severe adverse reactions for this drug.

Less Frequent

• Erythema
• Pain
• Pruritus of skin
• Skin inflammation

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Safety and efficacy of oxymetazoline topical cream have not been established in pediatric patients younger than 18 years of age.

Accidental ingestion of oxymetazoline nasal solutions has caused serious adverse reactions in children. (See Serious Adverse Reactions Following Ingestion under Cautions: Warnings/Precautions.)

There are no adequate and well-controlled studies of topical oxymetazoline in pregnant women. Data regarding topical use of oxymetazoline cream in pregnant women are inadequate. Two pregnancies were reported across all clinical studies with oxymetazoline cream resulting in the delivery of a healthy child in one case and a spontaneous abortion in the second case. However, the spontaneous abortion was not considered to be drug related.

Animal reproduction studies using oral oxymetazoline have not revealed evidence of developmental abnormalities in pregnant rats or rabbits at oxymetazoline systemic exposures of 3 or 73 times, respectively, the human exposures at the maximum recommended human dose.

Oxymetazoline is distributed into milk in rats. It is not known whether oxymetazoline is distributed into human milk or affects human milk production. The benefits of breast-feeding and the importance of oxymetazoline to the woman should be considered along with the potential adverse effects on the breast-fed child from the drug or underlying maternal condition.

In clinical trials, no overall differences in safety and efficacy were observed in patients 65 years of age or older compared with younger patients. However, the manufacturer states that clinical studies of oxymetazoline cream did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger adults.