Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Mirvaso

Descriptions


Brimonidine topical gel is used in adults to treat facial redness that does not go away and caused by rosacea (a skin disease).

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Gel/Jelly

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of brimonidine topical in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brimonidine topical in the elderly.

Pregnancy

Information about this brimonidine-topical-application-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cerebral or coronary insufficiency or
  • Circulation problems or
  • Depression or
  • Heart or blood vessel disease, severe, unstable, or uncontrolled or
  • Orthostatic hypotension (low blood pressure) or
  • Raynaud's phenomenon or
  • Scleroderma (autoimmune disease) or
  • Sjögren's syndrome (autoimmune disease) or
  • Stroke, history of—Use with caution. May make these conditions worse.

Proper Use

It is important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is for use on the face only. Do not use this medicine in your eyes, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To use:

  • Wash your hands with soap and water before and after using this medicine.
  • Apply a pea-size amount to each of the five areas of the face: central forehead, chin, nose, and each cheek. Rub it in gently.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For topical dosage form (gel):
    • For facial redness:
      • Adults—Apply to the five areas of the face once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

If you (especially your child) get this medicine into the mouth or swallow it accidentally, check with your doctor right away if you have the following symptoms: lack of energy, trouble breathing or stops breathing, a slow heartbeat, confusion, sweating, restlessness, muscle spasms, or twitching.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Flushing or redness of the skin
  2. unusually warm skin

Less common

  1. Blemishes on the skin
  2. blistering, burning, crusting, dryness, or flaking of the skin
  3. itching, scaling, severe redness, soreness, or swelling of the skin
  4. pimples

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Blurred vision
  2. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  3. fever
  4. headache
  5. muscle aches
  6. sore throat
  7. stuffy or runny nose
  8. unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.