Ingenol

Generic name: Ingenol
Drug class: Topical antineoplastics

Usage of Ingenol

Ingenol topical is used to treat a skin condition called actinic keratosis on the face, scalp, body, arms, or legs.

This medicine is available only with your doctor's prescription.

Ingenol side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Cracking of the skin

flushing, redness of the skin

pain and itching at the application site

redness, blistering, peeling, or loosening of the skin

skin ulcers

swelling of the skin

unusually warm skin

Less common

Burning, dry, or itching eyes

discharge or excessive tearing

eye pain

infection at the application site

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

swelling around the eyes

Incidence not known

Burning, crusting, dryness, flaking of the skin

chills

cough

diarrhea

fast heartbeat

fever

hoarseness

irritations

itching, scaling, severe redness, or soreness of the skin

joint or muscle pain

painful blisters on the trunk of the body

persistent non-healing sore

pink growth

red irritated eyes

red skin lesions, often with a purple center

reddish patch or irritated area

redness, irritation, or itching of the eye, eyelid, or inner lining of the eyelid

shiny bump

sore throat

sores, ulcers, or white spots in the mouth or on the lips

tightness in the chest

trouble breathing or swallowing

unusual tiredness or weakness

white, yellow or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Headache

muscle aches

stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Ingenol

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 on the relationship of age to the effects of ingenol topical for actinic keratosis have not been performed 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 ingenol topical in the elderly.

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.

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How to use Ingenol

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. Do not apply this medicine to your nipple or areola, if you are breastfeeding. If it does get on these areas, rinse it off right away with water.

Be careful not to get any of this medicine in your eyes, because it can cause severe eye disorders (eg, severe eye pain, swelling of the eyes or eyelids, or drooping of the eyelids). If any of the medicine does get in the eyes, wash the eyes with water and check with your doctor or other healthcare professional right away.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present.

To use the gel:

Wash your hands with soap and water before and after using the medicine.

Apply a thin layer to the affected area of the skin. Rub it in gently. Wash your hands again.

Allow the gel to dry for 15 minutes.

Avoid washing and touching the treated area, or participating in activities that may cause heavy sweating for 6 hours after treatment.

After 6 hours, you may wash the area with a mild soap and water.

Do not bandage or otherwise wrap the skin being treated, unless directed to do so by your doctor. Materials that are not airtight, such as cotton gauze or cotton underwear, may be used if needed.

Throw out any unused gel from the single-dose tube.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage form (gel):

For treatment of actinic keratosis on the face and scalp:

Adults—Apply a thin film of 0.015% gel to the affected area once a day for 3 consecutive days.

Children—Use and dose must be determined by your doctor.

For treatment of actinic keratosis on the body, arms, and legs:

Adults—Apply a thin film of 0.05% gel to the affected area once a day for 2 consecutive days.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Warnings

It is very important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.

If your condition does not improve or if it become worse, check with your doctor.

This medicine may cause serious allergic reactions (eg, anaphylaxis), which may require immediate medical attention. Check with your doctor right away if you have cough, difficulty swallowing, dizziness, fast heartbeat, hives or itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, tightness in the chest, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have persistent non-healing sore, pink growth, reddish patch or irritated area, shiny bump, or white, yellow or waxy scar-like area. These may be symptoms of skin cancer (eg, non-melanoma skin cancer).

This medicine may cause serious skin reactions. Check with your doctor right away if you have blisters, peeling, pus, ulcers, cracking, redness, flaking, scaling, crusting, or swelling of the skin.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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