imiquimod topical

Pronunciation

Generic Name: imiquimod topical (i MI kwi mod TOP ik al)
Brand Name: Aldara, Zyclara, Zyclara Pump

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 (for the skin) 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 be used in adults and children who are at least 12 years.

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

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

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

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 this medication, tell your doctor if you have a weak immune system, an autoimmune disorder, graft-versus-host disease, or if you have recently received a bone marrow transplant or cord blood transplant.

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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.

Avoid exposure to sunlight or tanning beds. Imiquimod topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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.

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?

To make sure you can safely take imiquimod topical, tell your doctor if you have any of these other conditions:

  • sunburn or other skin problems;

  • a weak immune system or autoimmune disorder;

  • graft-versus-host disease;

  • if you have recently been treated for actinic keratosis or genital warts with surgery or other medications; or

  • if you have recently received a bone marrow transplant or cord blood transplant.

FDA pregnancy category C. It is not known whether imiquimod topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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, 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 exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions 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. Follow your doctor's instructions.

Actinic keratosis:

Aldara is usually applied 2 times per week (such as Monday and Thursday, or Tuesday and Friday) for a full 16 weeks. Zyclara is applied once daily for 2 weeks followed by 2 weeks without treatment. Apply the cream to the treatment area in a thin layer, 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.

Superficial basal cell carcinoma:

Usually applied 5 times per week (such as Monday through Friday) for a full 6 weeks. 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:

Usually applied 3 times per week (such as Monday, Wednesday, and Friday) for no longer than 16 weeks. 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:

Your doctor will need to check your skin on a regular basis, especially if you have a more severe skin reaction to the medication. Do not miss any scheduled appointments.

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 at room temperature away from moisture and heat. Do not freeze. 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 or call the Poison Help line at 1-800-222-1222.

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 urethra. If it does get into any of these areas, rinse with water. Do not use imiquimod topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with imiquimod topical unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Imiquimod topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid having unprotected sex. 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. Talk with your doctor about safe ways to prevent transmission during sex.

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.

Stop using imiquimod topical and call your doctor at once if you have a serious side effect such as flu symptoms such as fever, chills, body aches, tired feeling, swollen glands.

When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using imiquimod topical and call your doctor right away.

Less serious side effects may include:

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

  • changes in the color of treated skin;

  • headache, dizziness, chest pain, back pain;

  • cold sores, fever blisters;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • nausea, diarrhea, loss of appetite; or

  • vaginal itching or discharge.

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.

See also: Side effects (in more detail)

Imiquimod topical dosing information

Usual Adult Dose for Keratosis:

Actinic Keratosis:
2.5% and 3.75% cream: Apply topically to the affected area (either entire face or balding scalp) once a day prior to bedtime. Up to 0.5 g (2 packets or 2 full actuations of the pump) may be applied to the treatment area at each application.

Treatment should continue for two 2-week treatment cycles separated by a 2-week no-treatment period. Neither 2-week treatment cycle should be extended due to rest periods or missed doses.

5% cream: Apply topically to defined treatment area 2 times per week prior to bedtime. The treatment area should be one contiguous area of approximately 5 cm by 5 cm on the face or scalp, but not both concurrently. No more than 1 packet should be applied to the contiguous treatment area at each application.

Treatment should continue for a full 16 weeks. The treatment period should not be extended beyond 16 weeks due to rest periods or missed doses.

2.5%, 3.75%, and 5% cream: The cream should be applied as a thin layer to the entire treatment area and rubbed in until it disappears. It should be left on for approximately 8 hours and then removed by washing with mild soap and water.

Usual Adult Dose for Condylomata Acuminata:

3.75% cream: Apply a thin layer topically to external genital/perianal warts once a day prior to bedtime. Up to 0.25 g (1 packet or 1 full actuation of the pump) may be applied to the treatment area at each application. The cream should be left on for approximately 8 hours and then removed by washing with mild soap and water.

Treatment should continue until total clearance of genital/perianal warts or for up to 8 weeks. The treatment period should not be extended beyond 8 weeks due to rest periods or missed doses.

5% cream: Apply topically to external genital/perianal warts 3 times per week prior to bedtime. The cream should be applied as a thin layer to the wart area and rubbed in until it disappears. The cream should be left on for 6 to 10 hours and then removed by washing with mild soap and water.

Treatment should continue until total clearance of genital/perianal warts or for a maximum of 16 weeks.

Usual Adult Dose for Basal Cell Carcinoma:

Biopsy-confirmed superficial basal cell carcinoma:
5% cream: Apply topically to target tumor 5 times per week prior to bedtime for a full 6 weeks. Sufficient cream should be applied to cover the treatment area (including a 1 cm margin of skin around the tumor) and it should be rubbed in until the cream disappears. The cream should be left on for approximately 8 hours and then removed by washing with mild soap and water.

Amount of imiquimod topical 5% cream to use:
Target tumor diameter 0.5 to less than 1 cm: 4 mm (diameter) droplet of cream (approximately 10 mg of 5% cream)

Target tumor diameter greater than or equal to 1 to less than 1.5 cm: 5 mm (diameter) droplet of cream (approximately 25 mg of 5% cream)

Target tumor diameter greater than or equal to 1.5 to 2 cm: 7 mm (diameter) droplet of cream (approximately 40 mg of 5% cream)

The target tumor should have a maximum diameter of 2 cm and be located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). Treatment area should include a 1 cm margin of skin around the tumor.

Usual Adult Dose for Molluscum Contagiosum:

(Not approved by FDA)

Study (n=15)
Apply to lesion once a day, rub in and leave on for 24 hours, for 5 days or until mollusca no longer visible. Wash with soap and water before applying next dose.

Usual Pediatric Dose for Condylomata Acuminata:

12 years or older:
3.75% cream: Apply a thin layer topically to external genital/perianal warts once a day prior to bedtime. Up to 1 packet may be applied to the treatment area at each application. The cream should be left on for approximately 8 hours and then removed by washing with mild soap and water.

Treatment should continue until total clearance of genital/perianal warts or for up to 8 weeks. The treatment period should not be extended beyond 8 weeks due to rest periods or missed doses.

5% cream: Apply topically to external genital/perianal warts 3 times per week prior to bedtime. The cream should be applied as a thin layer to the wart area and rubbed in until it disappears. The cream should be left on for 6 to 10 hours and then removed by washing with mild soap and water.

Treatment should continue until total clearance of genital/perianal warts or for a maximum of 16 weeks.

Usual Pediatric Dose for Molluscum Contagiosum:

2 to 12 years: Studies have failed to demonstrate effectiveness.

(Not approved by FDA)

Case Reports (n=3):
5, 7, and 8 years: Apply to lesions once or twice a day, rub in and leave on. At the end of 8 weeks of therapy, all lesions had resolved in 2 of the cases, and 75% of the lesions in the third case.

Case Report (n=13):
4 to 11 years: Apply to lesions 3 times a week at bedtime. Rub in until cream disappears. Leave on for approximately 8 hours. Then, remove the cream by washing with mild soap and water. Treatment continued for up to 16 weeks, at which point there was a 69% response rate.

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 topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. 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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.03. Revision Date: 2012-07-05, 11:35:03 AM.

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