Aldara

Generic Name: imiquimod topical (i MI kwi mod)Brand Names: Aldara

What is imiquimod topical?

Imiquimod is an immune response modifier. Imiquimod topical is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.

Imiquimod topical is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment.

Imiquimod topical also treats genital warts that appear on the outside of the body, but this medicine is not a cure for genital warts.

Imiquimod may also be used for other purposes not listed in this medication guide.

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

Imiquimod topical is used to treat different types of skin disorders, including actinic keratosis, a minor form of skin cancer, and genital warts that appear on the outside of the body.

Imiquimod topical is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with imiquimod topical. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

Wash your hands before and after applying imiquimod topical cream. Also wash the skin area to be treated, and allow it to dry for at least 10 minutes before applying the medicine. Do not use imiquimod topical on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using imiquimod topical. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Imiquimod topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Imiquimod will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

If you are treating the genital or rectal area with imiquimod topical, avoid sexual activity while the medicine is on your skin. Imiquimod topical can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm for birth control, these items could break if the rubber weakens and an unplanned pregnancy could result.What should I discuss with my healthcare provider before using imiquimod topical?Do not use imiquimod topical on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using imiquimod topical.

Before using imiquimod topical, tell your doctor if you have graft-versus-host disease or if you have recently received a bone marrow transplant or cord blood transplant. You may not be able to use imiquimod topical, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. If you are treating the genital or rectal area with imiquimod topical, avoid sexual acvitity while the medicine is on your skin. Imiquimod topical can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm, these items could break if the rubber weakens, and an unplanned pregnancy could result. It is not known whether imiquimod topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 12 years old. Imiquimod topical is for use in treating genital warts in patients who are at least 12 years old. All other uses of this medication are for adults over 18 only.

How should I apply imiquimod topical?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions.

Before applying imiquimod topical, wash your hands and wash the skin area to be treated. Allow the skin to dry for at least 10 minutes before applying the medicine. Always wash your hands after applying the medicine also. Do not use imiquimod topical on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using imiquimod topical.

Imiquimod topical is normally used 2 to 5 times per week for up to 16 weeks. How you use this medication will depend on the condition you are treating.

Actinic keratosis:

Use imiquimod topical 2 times per week (such as Monday and Thursday, or Tuesday and Friday). Apply the cream from one imiquimod topical packet to the treatment area, and rub in the cream until it disappears. A single treatment area should be no larger than a 2-inch square. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Superficial basal cell carcinoma:

Use imiquimod topical 5 times per week (such as Monday through Friday). Apply the cream from one imiquimod topical packet to the treatment area and the border of skin around it, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Genital warts:

Use imiquimod topical 3 times per week (such as Monday, Wednesday, and Friday). Apply the cream from one imiquimod topical packet to the treatment area, and rub in the cream until it disappears. Do not cover the treated skin areas with any type of plastic bandaging, and avoid nylon underwear. You may wear cotton gauze or underwear over the treated area. Use the medicine before going to bed and leave it on for 6 to 10 hours. Then wash off the medicine with water and a mild soap.

When treating genital warts under the foreskin of an uncircumcised penis, pull back the foreskin and wash it with mild soap and water before applying imiquimod topical. Clean this area daily during treatment. When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination.

Imiquimod topical is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with imiquimod topical. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

All conditions:

To be sure this medication is helping your condition, your skin may need to be checked on a regular basis. This is especially important if you have a more severe skin reaction to the medication. Do not miss any scheduled visits to your doctor. Call your doctor if your skin condition does not improve or if it gets worse during treatment.

Do not use imiquimod topical to treat any skin condition that has not been checked by a doctor. Do not share this medication with anyone else, even if they have the same symptoms you have.

Each packet of imiquimod topical is for a single application only. Throw away the packet after one use, even if there is medicine left in it. If you treat more than one skin area at a time, ask your doctor how many packets to use.

Store imiquimod topical at room temperature away from moisture and heat. Keep each packet unopened until you are ready to use it.

What happens if I miss a dose?

Skip the missed dose and wait until the next time you are getting ready for bed to use the medicine. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting.

What should I avoid while using imiquimod topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. Do not place the cream in your rectum, vagina, or uretha. If it does get into any of these areas, wash with water. Do not use imiquimod topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Imiquimod topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Imiquimod is not a cure for genital warts, and it will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

Imiquimod topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied.

Less serious side effects may include:

• mild skin irritation, dryness, flaking, scabbing, redness, or hardening of the skin where the medicine was applied;

• changes in the color of treated skin;

• fever, chills, body aches, swollen glands, flu symptoms;

• runny or stuffy nose, cough, sore throat;

• headache, back ache, muscle pain; or

• diarrhea, upset stomach.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect imiquimod topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied imiquimod. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about imiquimod 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum'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. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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