Zyclara

What is Zyclara?

Zyclara (imiquimod) cream is an immune response modifier used to treat actinic keratosis and external genital and perianal warts.

Imiquimod

Imiquimod-3D

What are the uses of this medicine?

• Zyclara (imiquimod) Cream, 2.5% and 3.75% are prescription medicines for skin use only (topical) to treat actinic keratosis on the face or balding scalp in adults with a normal immune system.
• Zyclara Cream, 3.75% is a prescription medicine for use on the skin only (topical) to treat external genital and perianal warts in people 12 years and older.

Limitation of use: It is not known if Zyclara Cream is safe and effective in the treatment of:

• human papilloma virus (HPV) disease of the urethra, the inside of the vagina (intravaginal), cervix, rectum, or inside of the anus (intra-anal)
• actinic keratosis, when treated with more than one 2-cycle treatment course in the same affected area
• people who have a weakened immune system
• xeroderma pigmentosum
• superficial basal cell carcinoma

How does this medicine work?

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

Who Should Not Use this medicine ?

Limitation of use: It is not known if Zyclara Cream is safe and effective in the treatment of:

• human papilloma virus (HPV) disease of the urethra, the inside of the vagina (intravaginal), cervix, rectum, or inside of the anus (intra-anal)
• actinic keratosis, when treated with more than one 2-cycle treatment course in the same affected area
• people who have a weakened immune system
• xeroderma pigmentosum
• superficial basal cell carcinoma

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Be sure to mention any other treatments for genital or anal warts, actinic keratoses, or superficial basal cell carcinoma.

Is this medicine FDA approved?

• Imiquimod obtained the first FDA approval for it in 1997.

How should this medicine be used?

Recommended dosage: Actinic Keratosis:

• Once daily to the skin of the affected area (either the entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period.

External Genital Warts:

• Once daily to the external genital/perianal warts until total clearance or up to 8 weeks.

Administration:

• For topical use only; not for oral, ophthalmic, intra-anal, or intravaginal use.
• Imiquimod comes as a cream to apply to the skin.
• Zyclara Cream should be applied once a day just before your bedtime.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cream: 2.5% pump; 3.75% packets or pump.

This medicine is available in fallowing brand namesː

• Zyclar

What side effects can this medication cause?

The most common side effects of this medicine include:

• local skin reactions including skin redness, scabbing, crusting, flaking, scaling, dryness, swelling
• headache
• itching at the treatment area
• tiredness
• nausea
• skin irritation
• pain at the treatment area

Zyclara Cream may cause serious side effects, including:

• Local Skin Reactions
• Flu-like symptoms

What special precautions should I follow?

• Do not cover the treated area with bandages or other closed dressings.
• Cotton gauze dressings can be used. Cotton underwear can be worn after applying Zyclara Cream to the genital or perianal area.
• Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Zyclara Cream. Use sunscreen and wear protective clothing if you go outside during daylight.
• Do not have sexual contact including genital, anal, or oral sex when Zyclara Cream is on your genital or perianal skin. Zyclara Cream may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy.
• Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosing interruption may be required.
• Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling. Severe vulvar swelling can lead to urinary retention; dosing should be interrupted or discontinued.
• Flu-like systemic signs and symptoms including fatigue, nausea, fever, myalgias, arthralgias, and chills can occur. Dosing interruption may be required.
• Avoid concomitant use of Zyclara Cream and any other imiquimod cream because of increased risk for adverse reactions.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe local skin reactions
• Hypotension

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Zyclara Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Pregnancy Category C.

Can this medicine be used in children?

• It is not known if Zyclara Cream is safe and effective for the treatment of actinic keratosis in children less than 18 years of age.
• It is not known if Zyclara Cream is safe and effective in children less than 12 years of age for external genital and perianal warts.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: imiquimod
• Inactive Ingredients: benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum.

Who manufactures and distributes this medicine?

Distributed by:

• Bausch Health US, LLC
• Bridgewater, NJ USA

Manufactured by:

• Bausch Health Companies Inc.
• Laval, Quebec H7L, Canada

What should I know about storage and disposal of this medication?

• Store Zyclara Cream at room temperature 59° to 86°F (15° to 30°C).
• Store Zyclara Cream pumps upright.
• Do not freeze.
• Safely throw away Zyclara Cream that is out of date, unused or partially used.

• Dailymed label info on Zyclara
• FDA Zyclara

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