Alert

ingenol topical

Pronunciation: IN je nol TOP i kal

Brand: Picato

What is the most important information I should know about ingenol topical?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is ingenol topical?

Ingenol topical (for the skin) is used to treat actinic keratosis (warty overgrowths of skin) on the face, scalp, arms, and legs.

Ingenol topical may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using ingenol topical?

You should not use ingenol topical if you are allergic to it.

Tell your doctor if you have ever been treated for actinic keratosis.

Tell your doctor if you are pregnant or breastfeeding.

If you apply ingenol topical to your chest, avoid areas that may come into contact with the baby's mouth.

Ingenol topical is not approved for use by anyone younger than 18 years old.

How should I use ingenol topical?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions.

Do not apply ingenol topical less than 2 hours before bedtime. Do not apply the medicine right after taking a shower.

Do not use on sunburned skin, or on areas of skin that are still healing after surgery or treatment with other medications. Wait until these conditions have healed before using ingenol topical.

For 0.015% gel: To treat actinic keratosis on the face and scalp, ingenol topical is usually applied once daily for 3 days in a row.

For 0.05% gel: To treat actinic keratosis on the arms and legs or trunk, ingenol topical is usually applied once daily for 2 days in a row.

Wash your hands with soap and water after applying ingenol topical.

Allow the skin to dry for at least 15 minutes after applying ingenol topical.

Avoid touching or washing the treated skin for 6 hours after applying ingenol topical. Avoid activities that may cause heavy sweating. After 6 hours have passed, you may wash the treated skin with a mild soap.

Call your doctor if your symptoms do not improve, or if they get worse.

Each tube of ingenol is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store this medicine in the refrigerator, do not freeze.

What happens if I miss a dose?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include skin reactions.

What should I avoid while using ingenol topical?

This medicine can cause serious eye problems if it gets in your eyes. Avoid touching your eyes after applying the medicine until you have washed your hands.

If contact does occur, rinse your eyes with water and call your doctor.

Avoid getting this medicine in your mouth or vagina.

What are the possible side effects of ingenol topical?

Get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed, dizzy; difficulty breathing, wheezing, chest tightness; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe skin redness, flaking, scaling, crusting, swelling;
  • blisters, pus, ulcers, or skin breakdown; or
  • (if this medicine gets in your eye) eye pain, redness, burning, swelling around the eye, drooping eyelid.

Ingenol topical may cause scars or changes in skin color where the medicine was applied.

Common side effects may include:

  • a skin reaction where you applied the medicine;
  • pain, itching, irritation, or infection where the medicine was applied;
  • swelling around the eyes;
  • headache; or
  • nose and throat irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ingenol topical?

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

Your pharmacist can provide more information about ingenol topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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