Imiquimod

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Imiquimod


Generic Name: Imiquimod (i-mi-KWI-mod)
Brand Name: Aldara

Imiquimod is used for:

Treating certain types of precancerous skin lesions or skin cancer (superficial basal cell carcinoma) in adults with normal immune systems. It may be used to treat external genital and perianal (around the anus) warts in certain patients. It also may be used for other conditions as determined by your doctor.

Imiquimod is an immune response modifier. How it works is unknown.

Do NOT use Imiquimod if:

  • you are allergic to any ingredient in Imiquimod

Contact your doctor or health care provider right away if any of these apply to you.

Before using Imiquimod :

Some medical conditions may interact with Imiquimod . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have warts in areas of your body other than the genital or anal areas, genital rash or inflammation, another type of skin cancer, or human papilloma virus (HPV) infection
  • if you have broken, damaged, or inflamed skin in the area being treated; a weakened immune system; or an autoimmune condition (eg, rheumatoid arthritis, lupus)
  • if you are sunburned, sensitive to sunlight, or spend long periods of time in natural or artificial sunlight

Some MEDICINES MAY INTERACT with Imiquimod . Because little, if any, of Imiquimod is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Imiquimod may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Imiquimod :

Use Imiquimod as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Imiquimod comes with an extra patient leaflet. Read it carefully and reread it each time you get Imiquimod refilled.
  • Apply Imiquimod just before bedtime, unless directed otherwise by your doctor.
  • Wash your hands and the affected area with mild soap and water before using Imiquimod . Allow the area to completely dry (at least 10 minutes) before applying the medicine.
  • Apply a thin layer of medicine to the affected area only. Gently rub the medicine in until it is evenly distributed. Wash your hands immediately after using this medicine.
  • Leave the medicine on the skin for the prescribed amount of time. Do not bathe or get the area wet until it is time to remove the medicine. The amount of time the medicine is left on the skin varies depending on the condition being treated. Ask your doctor or pharmacist if you are unsure how long Imiquimod should be left on the skin. Wash the affected area with a mild soap and water when it is time to remove the medicine.
  • If you are using Imiquimod to treat skin lesions or skin cancer, remove Imiquimod 8 hours after you apply it, unless directed otherwise by your doctor.
  • If you are using Imiquimod to treat genital warts, remove Imiquimod 6 to 10 hours after you apply it, unless directed otherwise by your doctor.
  • Do not apply Imiquimod inside the anus or vagina when applying the medicine to genital or perianal warts.
  • Do not apply excessive amounts of this medicine to the affected area.
  • Do not wrap or otherwise cover the treated area with bandages or wear tight-fitting clothing over the treated area unless specifically directed by your doctor. However, cotton underwear may be worn after applying medicine to the genital or anal area.
  • Men who have not been circumcised and are treating warts under the foreskin should pull back the foreskin and clean the area just before treatment. The area should be cleaned daily while you are using Imiquimod .
  • After applying, throw away any unused medicine that is left in the packet in a trash container, away from children and pets.
  • Continue to use Imiquimod even if you feel well. Do not miss any doses.
  • If you miss a dose of Imiquimod , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Imiquimod .

Important safety information:

  • Imiquimod is for external use only. Avoid getting Imiquimod around your lips, or in your eyes, nose, mouth, or anus. If you get Imiquimod in your eyes or mouth, rinse right away with cool water.
  • Avoid applying Imiquimod in the vagina. Take special care if applying the cream at the opening of the vagina because local skin reactions on the delicate, moist surfaces can result in pain or swelling, or may cause difficulty in passing urine.
  • Imiquimod may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Imiquimod . Using Imiquimod alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • It may take several weeks for Imiquimod to work.
  • Imiquimod is not a cure for genital warts. New warts may appear during treatment with Imiquimod .
  • Do not exceed the recommended dose, leave the medicine on the skin longer, or use the medicine for longer than prescribed without checking with your doctor. Doing so will not improve your condition faster and may increase your risk of side effects.
  • Do not apply Imiquimod to sunburned skin. Wait until your skin has healed before using Imiquimod .
  • Imiquimod may decrease the effectiveness of condoms and diaphragms. Use another form of birth control while you are using Imiquimod .
  • It is unknown if Imiquimod can prevent you from spreading genital or perianal warts to others. For this reason, you should use safe sex practices. Ask your doctor or pharmacist about safe sex practices.
  • If you are being treated for genital or perianal warts, do not have any type of sexual contact while the medicine is on the skin.
  • Imiquimod may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Imiquimod . Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
  • While you are using Imiquimod , the treated area and the skin around it may appear different than normal skin. Discuss any questions or concerns with your doctor.
  • Imiquimod may cause a lightening or darkening of the skin where it is applied. This discoloration may not go away when you stop using the medicine. Discuss any concerns with your doctor.
  • If you have a skin reaction that affects your daily activities, contact your doctor right away.
  • Regular follow-up will be needed to monitor your progress and check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Imiquimod with extreme caution in CHILDREN younger than 12 years of age who have genital or perianal warts. Use Imiquimod with extreme caution in CHILDREN younger than 18 years of age who have skin lesions or skin cancer. Safety and effectiveness in these age groups have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Imiquimod during pregnancy. It is unknown if Imiquimod is excreted in breast milk. If you are or will be breast-feeding while you are using Imiquimod , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Imiquimod :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; blisters or burning; flaking, redness, or crustiness of the skin; diarrhea; dry skin; headache; itching; peeling; scabbing; soreness; stinging or swelling; stuffy nose; thick or hardened skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in skin color at the application site; chest pain; chills; fever; irregular heartbeat; severe irritation, pain, or bleeding at the application site; skin sores; vision changes; vomiting; "weeping" or oozing at the application site.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dizziness or fainting.

Proper storage of Imiquimod :

Store Imiquimod at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Imiquimod out of the reach of children and away from pets.

General information:

  • If you have any questions about Imiquimod , please talk with your doctor, pharmacist, or other health care provider.
  • Imiquimod is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Imiquimod . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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