Rhofade

Name: Rhofade

What Is Rhofade?

Oxymetazoline is a decongestant that shrinks blood vessels. Dilated blood vessels under the skin can cause redness.

Oxymetazoline topical (for the skin) is used to treat facial redness caused by rosacea.

Oxymetazoline topical may also be used for purposes not listed in this medication guide.

Do not take by mouth. Topical medicine is for use only on the skin.

Rinse with water if this medicine gets in your eyes.

You should not use this medicine if you are allergic to oxymetazoline.

To make sure oxymetazoline topical is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure;
  • blood circulation problems;
  • glaucoma; or
  • peripheral vascular disease such as Raynaud's syndrome, Buerger's disease, scleroderma, or Sj√∂gren's syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether oxymetazoline topical passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Oxymetazoline topical is not approved for use by anyone younger than 18 years old.

What should I discuss with my healthcare provider before using oxymetazoline topical?

You should not use this medicine if you are allergic to oxymetazoline.

To make sure oxymetazoline topical is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure;

  • blood circulation problems;

  • glaucoma; or

  • peripheral vascular disease such as Raynaud's syndrome, Buerger's disease, scleroderma, or Sjögren's syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether oxymetazoline topical passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Oxymetazoline topical is not approved for use by anyone younger than 18 years old.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What should I avoid while using oxymetazoline topical?

Avoid getting this medicine in your eyes or mouth.

Advice to Patients

Patient Counseling Information

Advise the patient and/or caregiver to read the FDA-approved patient labeling. 1

Important Administration Instructions

Oxymetazoline hydrochloride cream is for topical use only. 1

Oxymetazoline hydrochloride cream pumps require priming before initial use and discard product from the first three pumps. 1

Do not to apply oxymetazoline hydrochloride topical cream to irritated skin or open wounds. 1

Avoid contact with the eyes and lips. 1

Wash hands immediately after application. 1

Keep oxymetazoline hydrochloride topical cream out of reach of children. 1

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Rhofade dosing information

Usual Adult Dose for Acne Rosacea:

Apply a thin layer to cover the entire face (e.g., forehead, nose, cheeks, chin) once a day

Comments:
-The eyes and lips should be avoided during application.
-Patients should wash their hands immediately after application.

Use: Topical treatment of persistent facial erythema associated with rosacea

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