TM Owner Bausch Health
Zyclara 2.5% or 3.75% Cream
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Indications & Clinical Uses
- Zyclara is a prescription cream containing imiquimod, a topical medicine that activates immune cells in the skin.
- It comes as 2.5% and 3.75% creams (there is no 3% strength).
- Both are used to treat actinic keratosis (rough, scaly sun-damage patches) on the face or balding scalp in immunocompetent adults: apply a thin layer once daily at bedtime for two 2-week cycles separated by a 2-week rest period, and wash it off after about 8 hours.
- Only the 3.75% cream is approved for external genital and perianal warts, in immunocompetent patients aged 12 years and older, applied once daily at bedtime for up to 8 weeks or until clearance.
- The maximum is 0.5 g per application for actinic keratosis and 0.25 g for genital warts.
- This information comes from the US label (Bausch Health US, LLC); other markets may differ.
Side Effects
- Local skin reactions are expected.
- In actinic keratosis studies of the 3.75% cream, redness occurred in 96% of people, scabbing or crusting in 93%, flaking or dryness in 91%, swelling in 75%, erosion or ulceration in 62% and oozing in 51%; many were severe in a minority.
- Headache (6%), application site itching (4%), tiredness (4%) and nausea (4%) also occurred.
- In genital warts, redness (70%), swelling (41%), erosion (36%), application site pain (7%) and irritation (6%) were common.
- Flu-like symptoms (fatigue, fever, nausea, muscle aches) and swollen lymph nodes can occur.
- Severe vulvar swelling may cause urinary retention.
- There is no boxed warning.
- Stop applying and contact your healthcare provider if reactions are severe or you feel unwell.
Precautions & Warnings
- Rest periods matter: use only the cycles your provider prescribes and do not exceed the maximum amount per application.
- Intense inflammatory reactions such as weeping and erosion can occur, and dosing may need to be paused or stopped, especially with severe vulvar swelling or flu-like symptoms.
- Zyclara can make skin more sensitive to sunburn, so avoid sunlight and sunlamps and cover treated areas with clothing or sunscreen.
- Use with care if you have an autoimmune condition, because imiquimod activates immune cells.
- It may weaken condoms and vaginal diaphragms, so do not rely on them during treatment of genital warts.
- Pregnancy: no established drug-associated risk from case reports.
- Breastfeeding: transfer into milk is likely to be low, but avoid applying it where the infant could touch or feed.
- Do not freeze; store pump bottles upright at 25°C.
Avoid Interactions
- The US label lists no clinically significant drug interactions, so there is no known medicine that increases or reduces the effect of Zyclara.
- Two practical points apply: Zyclara may weaken latex condoms and vaginal diaphragms, reducing protection against pregnancy and infection, so use another method during genital wart treatment; and it increases sun sensitivity, so avoid sunlamps and strong sunlight.
- Tell your healthcare provider about all medicines, creams and supplements you use, particularly other products applied to the same skin area.
- Follow the prescribed cycle and do not apply more than the stated maximum amount.
References
Frequently Asked Questions
Zyclara (imiquimod) cream treats actinic keratosis on the face or balding scalp in immunocompetent adults, using either the 2.5% or 3.75% cream. The 3.75% cream also treats external genital and perianal warts in patients aged 12 and over. Zyclara is a prescription medicine applied to the skin.
Apply a thin layer of Zyclara (imiquimod) once daily at bedtime to the whole treatment area and wash it off after about 8 hours. For actinic keratosis use no more than 0.5 g per application; for genital warts use no more than 0.25 g.
Zyclara (imiquimod) commonly causes skin redness, scabbing, flaking, swelling and erosion where applied. Headache, tiredness, nausea and flu-like symptoms can occur. Severe vulvar swelling can block urination. Contact your healthcare provider if skin reactions are severe or you feel unwell.
Avoid sunlight and sunlamps during Zyclara treatment, as your skin burns more easily. Zyclara may weaken condoms and vaginal diaphragms, so do not rely on them during genital wart treatment. Take care if you have an autoimmune condition. Do not use more than the prescribed amount.
Store Zyclara (imiquimod) cream at 25°C, with excursions between 15°C and 30°C permitted. Do not freeze it. Keep pump bottles upright. Use each single-use packet once and throw away any partly used packet. Discard pump bottles after the full treatment course is finished.
For actinic keratosis, Zyclara (imiquimod) is used for two 2-week treatment cycles separated by a 2-week rest period. For external genital warts, the 3.75% cream is applied daily until the warts clear or for up to 8 weeks. Wash the cream off after about 8 hours.
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