Imiquimod (Topical)

Imiquimod (Topical) is used to treat external warts around the genital and rectal areas, known as condyloma acuminatum. It is not meant for warts inside the vagina, penis, or rectum. Imiquimod is also used to treat a skin condition on the face and scalp called actinic keratosis (AK), which happens due to too much sun exposure. Additionally, Imiquimod may be used to treat certain types of skin cancer called superficial basal cell carcinoma (sBCC).

Imiquimod works with the immune system to help the body fight the viruses that cause warts. It does not kill the viruses directly. It is not known how imiquimod works for actinic keratosis or skin cancer.

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

It is very important for your doctor to check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, pain, redness, swelling, bleeding, oozing, scabbing, or peeling on the skin where the medicine was applied.

Stop using this medicine and check with your doctor right away if you have severe swelling near the opening of the vagina. This may cause painful urination, trouble passing urine, or inability to urinate.

Stop using this medicine and check with your doctor right away if you or your child have severe skin irritation or flu-like symptoms, such as diarrhea, fever, chills, headache, nausea, muscle or joint pain, or unusual tiredness or weakness.

Avoid exposing your skin to sunlight, sunlamps, or tanning beds while you are using this medicine. Always use sunscreen or sun-blocking lotions and wear protective clothing and hats.

If you are being treated for external warts, avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the cream off your skin before you engage in any sexual activity. The medicine contains oils that can weaken latex (rubber) condoms and diaphragms, which will prevent them from working properly.

Imiquimod is not a cure for genital warts. New warts may develop while you are using the cream. Imiquimod will also not prevent you from spreading genital warts to other people.

Do not use cosmetics or any other skin care products on the treated areas unless directed to do so by your doctor.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to the benefits it may provide. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know 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

Studies have not shown any specific problems that would limit the use of imiquimod topical for external warts in children older than 12 years. However, safety and effectiveness have not been established for children younger than 12 years.

Studies on how age affects the use of imiquimod topical for actinic keratosis or skin cancer have not been done in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems that would limit the use of imiquimod topical in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a potential interaction. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Autoimmune disorders, history of or
• Infection of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site or
• Rheumatoid arthritis, juvenile or adult (chronic, always present) or
• Sun exposure, including sunlamps or
• Recent surgery at the application site or
• Systemic lupus erythematosus (SLE), history of or
• Vulvar swelling (swelling near the opening of the vagina)—The risk of side effects may be increased.

• Basal cell nevus syndrome or
• Human papillomavirus disease (cervical, intra-anal, intravaginal, rectal, urethral) or
• Weak immune system or
• Xeroderma pigmentosum (a rare, inherited skin disease)—It is not known if this medicine will be effective in patients with these conditions.

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

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

More common

• Blisters on the skin
• body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• itching in the genital or other skin areas
• loss of voice
• open sores or scabs on the skin
• pain or tenderness around the eyes and cheekbones
• redness of the skin (severe)
• scaling
• shortness of breath or troubled breathing
• skin rash
• sneezing
• sore throat
• stuffy or runny nose
• tightness of the chest or wheezing
• unusual tiredness or weakness

Less common

• Abdominal or stomach pain
• ankle, knee, or great toe joint pain
• bladder pain
• bloody or cloudy urine
• blurred vision
• chest pain
• cold flu-like symptoms
• difficult, burning, or painful urination
• dizziness
• fainting
• fast or irregular heartbeat
• frequent urge to urinate
• hoarseness
• joint stiffness or swelling
• lower back or side pain
• lump in the abdomen or stomach
• nervousness
• persistent non-healing sore
• pink growth on the skin
• pounding in the ears
• reddish patch or irritated area
• severe headache
• shiny bump on the skin
• slow or fast heartbeat
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• white, yellow or waxy scar-like area

Incidence not known

• Blue lips and fingernails
• convulsions
• coughing that sometimes produces a pink frothy sputum
• dilated neck veins
• extreme fatigue
• fast, irregular, or pounding heartbeat
• headache
• irregular breathing
• nausea or vomiting
• pain in the shoulders, arms, jaw, or neck
• slurred speech
• sudden and severe inability to speak
• suicide
• sweating
• swelling of the face, fingers, feet, or lower legs
• temporary blindness
• weakness in the arm or leg on one side of the body
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Burning or stinging of the skin (mild)
• flaking of the skin
• mild headache
• pain, soreness, or tenderness of the skin (mild)
• rash
• redness of the skin (mild)
• swelling at the place of application

Less common

• Back pain
• lightening of the treated skin

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.

In the U.S.

• Aldara
• Zyclara

Available Dosage Forms:

• Cream

Therapeutic Class: Immune Modulator

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, vagina, or anus. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

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. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

If you are using the Zyclara® cream pump for the first time, prime it by pressing the top of the pump until the cream appears.

To use the cream:

• Wash your hands with soap and water before and after using the medicine.
• Use one or two packets or actuations of the pump of cream for each dose as directed by your doctor.
• Apply a thin layer to the affected area of the skin just before bedtime. Rub it in gently.
• Allow the medicine to stay on the treated skin for 8 hours (for actinic keratosis or basal cell carcinoma) or 6 to 10 hours (for genital warts). Do not take a bath, swim, or get the treated area wet during this time.
• After the right amount of time has passed, wash the treated area with mild soap and water.
• Men who are not circumcised and are treating genital warts under the foreskin should retract the foreskin and clean the area daily.
• 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 cream from the single-dose packet.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Do not use this medicine together with any other products containing imiquimod in the same treatment area. This may increase risk for more serious side effects.

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 (cream):For actinic keratosis: Adults—If you use Zyclara®, apply a thin film to the affected area of skin once a day at bedtime for 2 weeks. Your doctor will repeat the treatment after you go 2 weeks without medicine. If you use Aldara®, apply a thin film to the affected area of skin once a day at bedtime 2 times per week for 16 weeks. Your doctor will tell you which days are best during the week. Children—Use and dose must be determined by your doctor. For skin cancer: Adults—Apply a thin film to the affected area of skin once a day at bedtime 5 times per week for 6 weeks. Your doctor will tell you which days are best during the week. Children—Use and dose must be determined by your doctor. For external warts: Adults and children 12 years of age and older—If you use Zyclara®, apply a thin film to the wart once a day at bedtime for up to 8 weeks or until the wart is gone. If you use Aldara®, apply a thin film to the wart once a day at bedtime 3 times per week. Your doctor will tell you which days are best during the week. Use the medicine until the wart is gone, but for no longer than 16 weeks. Children younger than 12 years of age—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

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the Zyclara® cream pump upright.

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