Mirvaso

PATIENT INFORMATION

MIRVASO
(Mer-VAY-soe)
(brimonidine) Topical Gel

Important: MIRVASO® topical gel is for use on the face only. Do not use MIRVASO topical gel in your eyes, mouth or vagina.

Keep MIRVASO topical gel out of the reach of children.

If anyone, especially a child, accidentally swallows MIRVASO topical 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 MIRVASO topical 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 Sjogren'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 MIRVASO topical gel with certain other medicines may affect each other and can cause serious side effects.

How should I use MIRVASO topical gel?

  • Use MIRVASO topical gel exactly as your doctor tells you. Do not use more MIRVASO topical gel than prescribed. Call your doctor if you are not sure.
  • You should not apply MIRVASO topical gel to irritated skin or open wounds.
  • MIRVASO topical gel is for use on your skin only. Do not use MIRVASO topical gel 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 MIRVASO topical gel correctly.

What are the possible side effects of MIRVASO topical gel?

The most common side effects of using MIRVASO topical gel 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 and 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.

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.

Instructions for Use

MIRVASO
(Mer-VAY-soe)
(brimonidine) Topical Gel

Important: MIRVASO® topical gel is for use on the face only. Do not use MIRVASO topical gel in your eyes, mouth or vagina.

Keep MIRVASO topical gel out of the reach of children.

If anyone, especially a child, accidentally swallows MIRVASO topical 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.

Read and follow the steps below so that you use MIRVASO topical gel correctly:

1. Open the tube of MIRVASO topical gel by gently pressing down on the child resistant cap and twist in the direction of the arrow as shown below, a quarter of a turn (counterclockwise). See Figures A and B. To avoid spilling, do not squeeze the tube while opening or closing.

Figure A

Open the tube of MIRVASO topical gel - Illustration

Figure B

Open the tube of MIRVASO topical gel - Illustration

2. To apply MIRVASO topical gel to your face, squeeze a pea-sized amount of MIRVASO topical gel from the tube onto your fingertip. See Figure C.

Figure C

Squeeze a pea-sized amount of MIRVASO topical gel - Illustration

3. Apply a pea-sized amount of MIRVASO topical gel onto each of the five areas of your face (forehead, chin, nose, each cheek) 1 time each day. You will use a total of 5 pea-sized amounts of MIRVASO topical gel. Spread the gel smoothly and evenly in a thin layer over your face. Avoid contact with your eyes and lips. Do not apply MIRVASO topical gel to irritated skin or open wounds.

4. To close MIRVASO topical gel, line up the grooves on the cap and the tube. Gently press down on the child resistant cap and twist to the right, a quarter of a turn (clockwise). See Figures D and E.

Figure D

MIRVASO (brimonidine) Figure D Illustration

Figure E

Gently press down on the child resistant cap - Illustration

5. Wash your hands right away after applying MIRVASO topical gel.

How should I store MIRVASO topical gel?

  • Store MIRVASO topical gel at room temperature between 68°F to 77°F (20°C to 25°C).

Keep MIRVASO topical gel out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 9/6/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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