Aldara

DRUG DESCRIPTION

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:

Aldaraź (imiquimod)  Structural Formula Illustration

What are the possible 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;
  • ...

Read All Potential Side Effects and See Pictures of Aldara »

What are the precautions when taking imiquimod (Aldara)?

Before using imiquimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent/unhealed surgery on the skin area to be treated, immune system problems (including HIV infection), a certain complication of bone marrow or some organ transplants (chronic graft-versus-host disease), autoimmune diseases (such as rheumatoid arthritis, scleroderma, lupus).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear...

Read All Potential Precautions of Aldara »


Aldara Consumer (continued)

SIDE EFFECTS: Treatment area reactions may include redness, swelling, itching, burning, pain/tenderness, thickening/hardening of the skin, peeling/flaking/scabbing/crusting, or leaking a clear fluid. Also, changes in skin color may occur and may not go away. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If the skin reaction is severe (bleeding, formation of sores/blisters/ulcers), imiquimod may need to be temporarily stopped so that the skin can heal. Follow your doctor's directions.

Flu-like symptoms (such as fever, tiredness, muscle aches), runny/stuffy nose, cough, diarrhea, nausea, and back pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swollen glands (lymph nodes), new unusual skin growths/changes, chest pain, trouble urinating.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using imiquimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent/unhealed surgery on the skin area to be treated, immune system problems (including HIV infection), a certain complication of bone marrow or some organ transplants (chronic graft-versus-host disease), autoimmune diseases (such as rheumatoid arthritis, scleroderma, lupus).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Genital/anal warts are caused by a virus called human papillomavirus (HPV). Since imiquimod does not destroy the virus but only helps to eliminate the wart, new warts may form, even while you are being treated. You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV.

To reduce the risk of spreading HPV to others, always use effective barrier protections (such as latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During treatment of genital/anal warts, avoid all sexual contact while the cream is on the skin. Condoms, dental dams, and diaphragms may be weakened by the cream, and therefore they may not work as well to prevent pregnancy or spreading of HPV or HIV.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Aldara Patient Information Including Side Effects

Brand Names: Aldara

Generic Name: imiquimod topical (Pronunciation: i MI kwi mod)

  • What is imiquimod topical (Aldara)?
  • What are the possible side effects of imiquimod topical (Aldara)?
  • What is the most important information I should know about imiquimod topical (Aldara)?
  • What should I discuss with my healthcare provider before using imiquimod topical (Aldara)?
  • How should I apply imiquimod topical (Aldara)?
  • What happens if I miss a dose (Aldara)?
  • What happens if I overdose (Aldara)?
  • What should I avoid while using imiquimod topical (Aldara)?
  • What other drugs will affect imiquimod topical (Aldara)?
  • Where can I get more information?

What is imiquimod topical (Aldara)?

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 are the possible 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.

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

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.

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