Mirvaso

What is Mirvaso?

Mirvaso is a prescription medicine that is used to treat rosacea.

Description

MIRVASO (brimonidine) topical gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist.

The molecular formula of brimonidine tartrate is C11H10BrN5 • C4H6O6. It has the following structural formula:

Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder.

Each gram of MIRVASO (brimonidine) topical gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide.

Mechanism of Action

Brimonidine is a relatively selective alpha-2 adrenergic agonist. Topical application of MIRVASO topical gel may reduce erythema through direct vasoconstriction.

Before taking Mirvaso, tell your doctor:

• If you are allergic to Mirvaso; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Mirvaso with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Mirvaso?

• Tell all of your health care providers that you take Mirvaso. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may make blood vessel problems worse in patients who already have blood vessel problems. Talk with your doctor.
• Slow heartbeat, low blood pressure, and dizziness have happened with Mirvaso. Sometimes, these have been very bad and people needed to get treated in a hospital. Talk with your doctor.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• It may take several weeks to see the full effects.
• Talk with your doctor before you use other drugs or products on your skin.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• It is common to have skin irritation with Mirvaso. This may include a burning feeling of the skin, skin redness, flushing, and pale skin. Call your doctor if you have skin irritation that is very bad, bothers you, or does not go away.
• This medicine may cause harm if swallowed. If Mirvaso is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Mirvaso while you are pregnant.

How is Mirvaso best taken?

Use Mirvaso as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Mirvaso by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not put on open wounds, cuts, or irritated skin.
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are the side effects of Mirvaso that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• Slow heartbeat.

What are some other side effects of Mirvaso?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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.

How do I store and/or throw out Mirvaso?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL 30G PUMP CARTON

• Rx Only
  NDC 0299-5980-35
• Mirvaso®
  (brimonidine) topical gel, 0.33%*
  PUMP
• *Each gram of Mirvaso topical gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base
• For Topical Use Only
  Keep Out of Reach of Children
• GALDERMA
  NET WT. 30 g

 

SRC: NLM .