Mirvaso works by narrowing blood vessels.

Mirvaso gel is used to treat facial rosacea (enlarged facial blood vessels) in adults.

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

Do not apply Mirvaso gel to irritated skin or open wounds. Avoid contact with the eyes and lips.

Some patients using Mirvaso gel may experience redness or flushing.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use Mirvaso gel exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Use Mirvaso once per day, unless your doctor tells you otherwise.

Apply a pea-sized amount of gel to each affected area of the face (forehead, nose, chin, and each cheek). Try not to get any of the medicine near your eyes or on your lips.

Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Wash your hands after applying this medicine.

Store at room temperature away from moisture and heat.

Keep this medicine out of the reach of children. Mirvaso can cause serious medical problems in a child who accidentally swallows the medicine. Seek emergency medical attention if this happens.

Usual Adult Dose for Acne Rosacea:

Maintenance dose: Apply a pea-size amount of gel once daily to: central forehead, chin, nose, each cheek.

Use: Topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. This medicine is not for oral, ophthalmic, or intravaginal use.

You should not use Mirvaso if you are allergic to brimonidine.

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

• coronary artery disease or circulation problems;

• heart disease or a blood vessel disorder;

• Raynaud's syndrome (numbness or cold feeling in your hands or feet);

• depression;

• low blood pressure;

• an autoimmune disorder called Sjögren's syndrome;

• a build-up of scar tissue on your skin (scleroderma);

• if you plan to have laser surgery; or

• if you take a heart or blood pressure medication.

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

It is not known whether brimonidine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Apply 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.

An overdose of Mirvaso is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Do not take by mouth. Mirvaso is for use only on the skin of your face. Avoid getting this medicine in your eyes or mouth.

Get emergency medical help if you have any signs of an allergic reaction to Mirvaso: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• dizziness or feeling light-headed;

• slow heartbeats; or

• severe skin redness, burning, or other irritation.

Common Mirvaso side effects may include:

• mild skin redness or burning;

• flushing (warmth, redness, or tingly feeling); or

• pale or lighter skin where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied brimonidine. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.