Soolantra

Soolantra is a prescription cream used to treat the inflammatory lesions (the bumps and pimples) of rosacea in adults. It is applied to the face once a day.

Soolantra contains ivermectin, a macrocyclic lactone. It is available as a 1% cream, with each gram containing 10 mg of ivermectin.

Soolantra was approved by the U.S. Food and Drug Administration (FDA) in December 2014 and is manufactured by Galderma Laboratories, L.P. A generic version (ivermectin cream, 1%) has been available since 2021.

The exact mechanism by which Soolantra (ivermectin) treats rosacea is not fully understood. Ivermectin is thought to have both anti-inflammatory effects and activity against Demodex mites, which live on the skin and are believed to contribute to the inflammation seen in rosacea. Together, these effects are thought to help reduce the bumps, pimples, and redness of rosacea.

• Do not get Soolantra in your eyes, nose, or mouth, or in your vagina. If you do, gently flush the area with water.
• Do not use more than the recommended dose, or for longer than prescribed, without checking with your doctor.
• Soolantra may cause harm if it is swallowed. If it is accidentally swallowed, contact your poison control center or emergency room right away.
• Keep Soolantra out of the reach of children and away from pets.

You should not use Soolantra if you are allergic to ivermectin or to any of the other ingredients in the cream. (The prescribing information lists no other contraindications.)

Before using Soolantra, tell your doctor or pharmacist about all of your medical conditions, and in particular if you:

• are pregnant, planning to become pregnant, or breastfeeding;
• have any allergies to medicines, foods, or other substances;
• take any prescription or nonprescription medicine, herbal preparation, or dietary supplement.

The safety and effectiveness of Soolantra have not been established in children.

In clinical trials, the most common side effects (each reported in 1% or fewer of people treated) were a skin burning sensation and skin irritation at the application site.

Contact dermatitis and allergic dermatitis have been reported since the product came to market. Check with your doctor if any of these common side effects persist or become bothersome.

Seek medical attention right away if you have:

• signs of a severe allergic reaction (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 side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088, or to Galderma Laboratories, L.P. at 1-866-735-4137.

Use Soolantra exactly as directed by your doctor. Soolantra cream is for use on the face only. Do not use it in your eyes, mouth, or vagina.

• Apply Soolantra to the affected areas of the face once a day.
• Use a pea-sized amount for each area of the face that is affected (forehead, chin, nose, and each cheek).
• Wash your hands before and after use. Clean the affected area and dry it well before applying.
• Spread the cream smoothly and evenly in a thin layer, avoiding the eyes and lips.
• If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not apply two doses at once.

Soolantra cream is not for oral, ophthalmic (eye), or intravaginal use. If it gets in your eyes, nose, mouth, or vagina, gently rinse the area with water.

Because little, if any, ivermectin is absorbed into the bloodstream after Soolantra is applied to the skin, the risk of it interacting with other medicines is low. In laboratory studies, Soolantra at therapeutic concentrations neither inhibited nor induced cytochrome P450 (CYP450) enzymes, which are involved in the breakdown of many medicines.

Still, tell your doctor and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal preparations, and dietary supplements, and check with your provider before you start, stop, or change the dose of any medicine.

Pregnancy

There are no adequate, well-controlled studies of Soolantra in pregnant women, and the available data are not sufficient to identify a drug-related risk of birth defects or miscarriage. Because very little ivermectin is absorbed through the skin, the risk to a pregnancy is expected to be low. If you are pregnant or planning to become pregnant, talk with your doctor about the benefits and risks of using Soolantra.

Breastfeeding

It is not known whether ivermectin passes into breast milk after Soolantra is applied to the skin. Ivermectin has been detected in breast milk after it was taken by mouth. Because very little is absorbed into the bloodstream after topical use, the amount reaching breast milk is expected to be low. Talk with your healthcare provider about the best way to feed your baby while using Soolantra.

Soolantra was studied in two 12-week, randomized, vehicle-controlled clinical trials in a total of 1,371 adults with moderate or severe rosacea. In both studies, Soolantra was more effective than the vehicle (a cream without the active drug) starting from 4 weeks of treatment.

In one U.S. study, people saw about 27% fewer bumps and blemishes after 2 weeks, and up to 75% fewer after 12 weeks.

Store Soolantra at room temperature between 68°F and 77°F (20°C to 25°C); brief excursions are permitted between 59°F and 86°F (15°C and 30°C). Store away from heat, moisture, and light. Do not freeze, and do not store it in the bathroom. Keep Soolantra out of the reach of children and away from pets. Check with your pharmacist about how to dispose of unused medicine.

Active ingredient: ivermectin (10 mg per gram; 1%).

Inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.