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Generic Name: ivermectin
Date of Approval: December 19, 2014
Company: Galderma Laboratories USA

Treatment for: Rosacea

FDA Approves Soolantra

The U.S. Food and Drug Administration (FDA) approved Soolantra (ivermectin) Cream, 1% for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. Recent studies have suggested that generally harmless microscopic Demodex mites may be a cause of rosacea. Soolantra has both anti-inflammatory and antiparasitic activity.

What is Soolantra?

Soolantra is used to treat rosacea.

It is a macrocyclic lactone. Exactly how it works to treat rosacea is unknown.

Do NOT use Soolantra if:

  • you are allergic to any ingredient in this medicine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Soolantra

Some medical conditions may interact with this medicine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with this medicine. Because little, if any, of this medicine is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if this medicine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Soolantra

Use this medicine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet and instructions for use is available with this medicine. Talk to your pharmacist if you have questions about this information.
  • Be sure you understand how to use this medicine. Ask your health care provider if you have questions or if you are unsure how to use it.
  • Wash your hands before and after using this medicine.
  • Clean the affected area before use. Make sure to dry well.
  • Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed.
  • Avoid getting this medicine in the eyes or on the lips.
  • If you miss a dose of this medicine, put it on as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not put on 2 doses at once.

Ask your health care provider any questions you may have about how to use this medicine.

Important safety information

  • Do not get this medicine in your eyes, nose, or mouth. Do not get it in your vagina. If you get this medicine in any of these areas, gently flush them with water.
  • Do not use more than the recommended dose or for longer than prescribed without checking with your doctor.
  • This medicine may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • PREGNANCY and BREASTFEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. It is not known if this medicine is found in breast milk after topical use. Do not breastfeed while using this medicine.

Soolantra side effects

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these common side effects persists or becomes bothersome:

  • Mild burning at the application site; skin irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

  • Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent burning at the application site; severe or persistent skin irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. 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)

If overdose is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Store this medicine at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep this medicine out of the reach of children and away from pets.

General information

  • If you have any questions about this medicine, please talk with your doctor, pharmacist, or other health care provider.
  • This medicine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using this medicine.