Ingenol is used for the topical treatment of Actinic Keratosis, a condition associated with thick, hard and scaly skin patches caused by too much sun exposure. It works by killing skin cells and by causing inflammation where it is applied.

Picato (Ingenol-mebutate) may be available under multiple brand names and/or in several different forms. Any specific brand name of Picato (Ingenol-mebutate) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Picato (Ingenol-mebutate) may not be used for all of the conditions discussed here.

Your doctor may have suggested Picato (Ingenol-mebutate) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using Picato (Ingenol-mebutate), speak to your doctor. Do not stop using Picato (Ingenol-mebutate) without consulting your doctor.

Do not give Picato (Ingenol-mebutate) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use Picato (Ingenol-mebutate) if their doctor has not prescribed it.

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For the treatment of actinic keratosis on the face and scalp, use one unit dosed tube of 0.015% gel once daily for 3 days in a row.

For the treatment of actinic keratosis on the body, arms, hands and legs, use one unit dosed tube of 0.05% gel once daily for 2 days in a row.

Always use a new unit dosed tube each time you apply Picato (Ingenol-mebutate). The contents of each tube can cover about a 5 cm x 5 cm patch of skin.

To apply the gel, squeeze the gel onto your fingertip and gently rub the gel over the affected area of skin. Allow it to dry for 15 minutes. After applying the gel, wash your hands immediately. If you are treating your hands, only wash the fingertip you used to apply the gel. Do not touch the area yourself or allow anyone or any pets to touch the treated area for a period of 6 hours after applying the gel. Do not wash the treated area for 6 hours after applying the gel and do not apply it immediately after taking a shower or less than 2 hours before bedtime. Do not cover the treated area with a bandage or other types of dressings.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Picato (Ingenol-mebutate) exactly as prescribed by your doctor. If you miss a dose, contact your doctor. Do not apply more gel to make up for a missed application. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Picato (Ingenol-mebutate) in the refrigerator, and keep it out of the reach of children and pets.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who used Picato (Ingenol-mebutate). If you are concerned about side effects, discuss the risks and benefits of Picato (Ingenol-mebutate) with your doctor.

The following side effects have been reported by at least 1% of people using Picato (Ingenol-mebutate). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• crusting of the skin
• dry skin (flaking, peeling)
• headache
• itching
• redness at the application site
• skin colour changes (lightening or darkening)
• skin irritation (redness, itching)
• skin pain
• swelling around the eyes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

• blistering or ulceration of skin
• skin infection
• swelling and scabbing of skin

Stop taking the medication and seek immediate medical attention if any of the following occur:

• symptoms of an allergic reaction (shortness of breath or difficulty breathing; Hives; swelling of the eyes, mouth, lips, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Picato (Ingenol-mebutate).

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Ingenol should not be used by anyone who is allergic to ingenol or to any of the ingredients of the medication.

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Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Picato (Ingenol-mebutate).

Proper use: Picato (Ingenol-mebutate) should only be applied to the skin. Do not apply the gel on the inside of the nostrils, on the inside of the ears, on the lips, or on skin outside the treatment area as defined by your doctor. Make sure that the skin has healed from the other treatments or surgery before applying ingenol. If the gel is accidently applied to these areas, rinse thoroughly with mild soap and water.

If Picato (Ingenol-mebutate) is accidentally swallowed, drink plenty of water and get immediate medical attention.

Eyes: Picato (Ingenol-mebutate) can cause swelling around the eyes and eye lids, eye swelling, eye pain, and a droopy eyelid. If these effects occur, they go way over time without long-lasting effects. Since ingenol can irritate and cause burn injuries to the eyes, avoid getting the gel in the eyes. If the gel does get in the eyes, flush them immediately with large amounts of water, and seek immediate medical attention.

Skin: Skin reactions such as redness, flaking or scaling, crusting, swelling, and blistering or ulceration may occur starting from the first day of treatment and may worsen up to one week after you have finished using ingenol. These will usually get better within 2 weeks from when you started treatment on the face and scalp, and within 4 weeks from when you started treatment on the body, arms, hands and legs. If these reactions do not improve, see your doctor.

Pregnancy: Picato (Ingenol-mebutate) has not been studied in pregnant women. It is recommended to avoid using ingenol during pregnancy.

Breast-feeding: If you are a breast-feeding mother, avoid physical contact between the treatment area and your infant for a period of 6 hours after applying ingenol.

Children: The safety and effectiveness of using Picato (Ingenol-mebutate) have not been established for children under the age of 18 years.

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