Soolantra

Soolantra is a prescription medication used to treat inflammatory skin lesions associated with rosacea. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

• Galderma Laboratories, L.P.

Before taking Soolantra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Soolantra or to any of its ingredients
• frequently develop skin rashes
• have had a serious allergic reaction to a skin product in the past
• are currently using any other skin products on your face
• have any cuts, scars, tattoos, and/or piercings on your face
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Use Soolantra exactly as prescribed.

Soolantra comes in topical cream form and is applied to the affected area(s) of the face, typically once daily.

Always follow your physician's instructions on use exactly. You may refer to the following section for additional information on appropriate use of Soolantra.

Administration

1. Open the tube of Soolantra cream by gently pressing down on the child resistant cap and twist in the direction of the arrow (counterclockwise). To avoid spilling, do not squeeze the tube while opening or closing.
2. To apply Soolantra cream to your face, squeeze a pea-sized amount of Soolantra cream from the tube onto your fingertip. 
3. Apply Soolantra to the affected areas of your face. Use a pea-sized amount of Soolantra cream for each area of your face (forehead, chin, nose, each cheek) that is affected. Spread the cream smoothly and evenly in a thin layer. Avoid contact with your eyes and lips. Soolantra cream is not for oral, ophthalmic, or intravaginal use.
4. To close Soolantra cream, gently press down on the child resistant cap and twist to the right (clockwise).

If you miss a dose, apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and apply your next dose at the regular time. Do not apply two doses of Soolantra at the same time.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ivermectin topical lotion in children 6 months of age and older. However, use is not recommended in infants younger than 6 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of ivermectin topical cream 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 ivermectin topical lotion or cream in the elderly.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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.

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

• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before and after use.
• Do not take Soolantra by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Avoid getting this medicine in the eyes or on the lips.
• Do not put in the vagina.
• 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.

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.

• 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.

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.

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