Zyclara

Generic name: imiquimod topical
Drug classes: Topical anti-infectives, Topical antineoplastics

What is Zyclara?

Zyclara is a prescription medicine that is used to treat genital warts. It is used to treat perianal warts. Zyclara is also used to treat skin harmed by the sun and some skin cancers.

Description

ZYCLARA (imiquimod) Cream, 2.5% or 3.75% is intended for topical administration. Each gram contains 25 mg or 37.5 mg of imiquimod, respectively, in a white to faintly yellow oil-in-water cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum.

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

ZYCLARA (imiquimod) Cream, 3.75% comes as a premeasured packet containing 9.4 mg of imiquimod in 0.25 g of cream. ZYCLARA (imiquimod) Cream, 2.5% and 3.75% also come in pumps which dispense 5.9 mg or 8.8 mg of imiquimod, respectively, in 0.235 g of cream per full actuation of the pump after priming.

 Mechanism of Action

The mechanism of action of ZYCLARA Cream in treating AK and EGW lesions is unknown.

Before taking Zyclara, tell your doctor:

• If you are allergic to Zyclara; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If your skin has not healed from other care or surgery.
• If you are using another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Zyclara with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Zyclara?

For all uses of Zyclara:

• Tell all of your health care providers that you take Zyclara. This includes your doctors, nurses, pharmacists, and dentists.
• Have your skin checked as you have been told by your doctor.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• People using Zyclara may get skin reactions where Zyclara is used or around the area. These reactions may include burning, crusting, dryness, flaking, itching, oozing, pain, redness, scabbing, scaling, sores or ulcers, or swelling. If these reactions get very bad, a break from using Zyclara may be needed as told by the doctor. Talk with the doctor.
• Call your doctor right away if you have a skin reaction that bothers you or if the reaction makes it hard to keep putting Zyclara on. Call your doctor right away if you have a skin reaction that causes problems with daily living.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

For genital or perianal warts:

• This medicine will not cure your genital or perianal warts. You may get new warts while using Zyclara. Tell your doctor if you see any new warts.
• Condoms or diaphragms may not work to prevent pregnancy. Use some other kind of birth control while taking Zyclara.
• Do not have any kind of sex when Zyclara is on your genital or anal skin.

How is Zyclara best taken?

Use Zyclara as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• Do not use more or for longer than you have been told. This may raise the chance of a very bad skin reaction or other side effect.
• Do not take Zyclara by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not put in the vagina or anus.
• Use at bedtime.
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• If you are an uncircumcised man with warts under the foreskin, pull back the foreskin and clean every day.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on sunburned skin.
• Avoid putting on healthy skin unless you have been told to do so by the doctor.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Do not bathe, shower, or swim after putting on.
• Leave on the skin for as long as the doctor told you to, then wash off.

Packets:

• Throw away any part of the packet not used after use.

Pump:

• Prime pump before first use.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are the side effects of Zyclara that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of Zyclara:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating.
• Bleeding.
• Swollen gland.

For genital or perianal warts:

• Vaginal pain or swelling.
• Trouble passing urine.

What are some other side effects of Zyclara?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Change in color of skin. This may not go back to normal.
• Headache.
• Upset stomach.
• Feeling tired or weak.
• Signs of a common cold.
• Sinus pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Zyclara?

All products:

• Store at room temperature. Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Pump:

• Store upright with the cap on.

Label

PRINCIPAL DISPLAY PANEL – 7.5 g, 3.75% Pump Bottle Carton

• NDC 99207-271-75
• Zyclara®
  (imiquimod) Cream
  3.75%
• Pump
• For Topical Use Only
  Not for Ophthalmic, Oral,
  or Intravaginal Use
• Store upright
• Delivers no fewer than
  28 full actuations
• Rx only
• Net Wt. 7.5 g
• 9740301
• 20002042C

 

PRINCIPAL DISPLAY PANEL – 7.5 g, 2.5% Pump Bottle Carton

• NDC 99207-276-75
• Zyclara®
  (imiquimod) Cream
  2.5%
• Pump
• For Topical Use Only
• Not for Ophthalmic,
  Oral, or Intravaginal Use
  Store Upright
  Delivers no fewer than
  28 full actuations
• Rx only
• Net Wt. 7.5 g
• 9740100
• 20002041B