Generic Name: brimonidine
Date of Approval: August 23, 2013
Company: Galderma Laboratories, L.P.
Treatment for: Facial Erythema (Redness) of Rosacea
FDA Approves Mirvaso Topical Gel
The U.S. Food and Drug Administration (FDA) has approved Mirvaso (brimonidine) topical gel for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once-daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours.
Mirvaso Patient Information
Mirvaso topical gel is for use on the face only. Do not use the gel in your eyes, mouth or vagina.
Keep Mirvaso topical gel out of the reach of children.
If anyone, especially a child, accidentally swallows the gel, they may have serious side effects and need to be treated in a hospital. Get medical help right away if you, a child, or anyone else swallows Mirvaso topical gel and has any of these symptoms:
- lack of energy, trouble breathing or stops breathing, a slow heart beat, confusion, sweating, restlessness, muscle spasms, or twitching.
What is Mirvaso topical gel?
Mirvaso topical gel is a prescription medicine that is used on your skin (topical) to treat facial redness due to rosacea that does not go away (persistent) in adults who are 18 years of age or older.
What should I tell my doctor before using Mirvaso topical gel?
Before using this gel, tell your doctor about all of your medical conditions including if you:
- have depression
- have heart or blood vessel problems
- have dizziness or blood pressure problems
- have problems with blood circulation or have had a stroke
- have dry mouth or Sjögren’s Syndrome
- have skin tightening or Scleroderma
- have Raynaud’s phenomenon
- have irritated skin or open sores
- are pregnant or plan to become pregnant. It is not known if Mirvaso topical gel will harm your unborn baby.
- are breastfeeding. It is not known if Mirvaso topical gel passes into your breast milk. You and your doctor should decide if you will use Mirvaso topical gel or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, skin products, vitamins, and herbal supplements. Using this gel with certain other medicines may affect each other and can cause serious side effects.
How should I use Mirvaso topical gel?
- Use exactly as your doctor tells you. Do not use more than prescribed. Call your doctor if you are not sure.
- You should not apply the gel to irritated skin or open wounds.
- Mirvaso topical gel is for use on your skin only. Do not use in your eyes, mouth, or vagina. Avoid contact with your lips and eyes.
- See the detailed Instructions for Use that come with Mirvaso topical gel for information about how to apply the gel correctly.
Mirvaso side effects
The most common side effects include:
- redness, flushing, burning sensation of the skin, skin irritation. Skin redness and flushing may happen about 3 to 4 hours after you apply Mirvaso topical gel. Tell your doctor if you get skin redness an d flushing that is uncomfortable for you.
- Mirvaso topical gel can lower blood pressure in people with certain heart or blood vessel problems. See What should I tell my doctor before using Mirvaso topical gel? These are not all the possible side effects of Mirvaso topical gel.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
General information about the safe and effective use of Mirvaso topical gel
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. You can ask your pharmacist or doctor for information about Mirvaso topical gel that is written for health professionals. Do not use Mirvaso topical gel for a condition for which it was not prescribed. Do not give Mirvaso topical gel to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in Mirvaso topical gel?
Active Ingredient: brimonidine tartrate
Inactive Ingredients: carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, titanium dioxide.