ALDARA

Aldara (imiquimod 5%) Cream is an immune response modifier for topical administration. Each gram contains 50 mg of imiquimod in an off-white oil-in-water vanishing cream base consisting of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.

Chemically, imiquimod is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C14H16N4 and a molecular weight of 240.3. Its structural formula is:

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

Do not use Aldara on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using Aldara.

Before using Aldara, 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.

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. Aldara can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Aldara 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 Aldara. 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 Aldara, avoid sexual activity while the medicine is on your skin. Aldara 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.

Warning!

• Carefully follow the instructions provided with this medicine.
• Do not re-use a sachet once you have opened it.
• This cream is for external use only.
• Avoid contact with the eyes, lips and nostrils.
• Avoid use on broken or inflamed skin.
• Avoid use on normal healthy skin.
• Do not cover the treated area with dressings.
• Wash your hands and the area of skin you are going to treat with mild soap and water and dry thoroughly before applying the cream. Wash your hands again after applying the cream.
• After you have applied the cream, showering or bathing should be avoided until it is time to wash the cream off. It is ESSENTIAL that you remember to remove the cream with mild soap and water after the treatment time is up. Application of an excessive amount of cream, or prolonged contact with the skin may result in a severe application site reaction.
• If you miss a dose, apply the cream as soon as you remember and then continue with your regular schedule. Do not apply the cream more than once in any day.
• If you get a severe skin reaction that causes you discomfort after using the cream, you should remove the cream by washing the area with mild soap and water. On rare occasions, skin reactions may be accompanied by flu-like symptoms such as fever, nausea or aches and pains. If necessary, you can take a rest period of several days before starting the treatment again.
• If you get an infection at the application site you should consult your doctor so that this can be treated. If necessary, you can take a rest period of several days before starting Aldara treatment again.
• Uncircumcised men treating warts under the foreskin should pull back the foreskin and wash the area daily. This is to avoid constriction of the foreskin (phimosis). If you have any trouble pulling back your foreskin during treatment, or you get skin reactions such as redness, ulceration or hardening of the skin, you should stop using this cream and consult your doctor.
• The cream should be washed off before any sexual contact.
• This cream may damage latex condoms and diaphragms, which could make them less effective at preventing pregnancy and sexually transmitted infections. You should use an alternative method of contraception while you are using this cream.
• This cream may not be fully effective at clearing genital warts in people who are HIV positive.
• People treating basal cell carcinoma or actinic keratoses should protect the area being treated from exposure to sunlight by wearing protective clothing and a wide brimmed hat when outdoors. Do not use sunbeds or sunlamps.
• While you are using this cream and until the skin has healed, the area treated is likely to look noticeably different to your normal healthy skin.

side effects of imiquimod topical (Aldara)?
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.