Full Answer
How long do you leave zyclara cream on?
Zyclara is applied once daily for 2 weeks followed by 2 weeks without treatment. Apply the cream to the treatment area in a thin layer, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours.
What happens if I stop taking zyclara?
Your doctor may tell you to stop using Zyclara for several days if you have a skin reaction to this medicine. Even if you have skipped some of your doses, do not add time to the total number of weeks you use this medicine (2 weeks for actinic keratitis, 8 weeks for genital warts). Store at room temperature. Do not freeze.
How long does it take for zyclara to work on genital warts?
Patients Being Treated for External Genital Warts (EGW) Zyclara Cream treatment should continue until there is total clearance of the genital/perianal warts or for up to 8 weeks. It is recommended that the treatment area be washed with mild soap and water approximately 8 hours following Zyclara Cream application.
How many milligrams of zyclara can you take in a day?
Following dosing with 2 packets of ZYCLARA Cream, 3.75% once daily (18.75 mg imiquimod/day) for up to three weeks, systemic absorption of imiquimod was observed in all subjects when ZYCLARA Cream was applied to the face and/or scalp in 17 subjects with at least 10 AK lesions.
What is the half life of imiquimod?
When applied topically, the half-life of imiquimod is approximately 30 hours. Systemic absorption of imiquimod is minimal when the cream is applied to intact skin, with 97% of the drug recovered from the dosing site in one study.
How do I know when to stop imiquimod?
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.
How long do side effects last after stopping Aldara?
Skin redness may take up to 4 weeks to subside (after stopping treatment). If your skin becomes too uncomfortable, take a rest week off treatment until the effects have become better, then restart treatment. If your skin becomes too sore, it may be best to use the cream every other week.
What happens if you use too much imiquimod?
Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting. Avoid swimming or taking a bath or shower while the medicine is on your skin. Avoid using imiquimod on open wounds or on skin that has not yet healed from surgery or other medical treatment.
How long can you use zyclara?
Dosing is once daily before bedtime to the skin of the affected wart areas. ZYCLARA Cream treatment should continue until there is total clearance of the genital/perianal warts or for up to 8 weeks.
Does imiquimod make you tired?
Three cases of patients using imiquimod for anogenital warts reported a range of side effects, including flu-like symptoms and rash exacerbations, with one patient progressing to intense headache, fatigue, lumbar pain, generalized myalgia, and locomotor difficulties during the third week of imiquimod treatment.
Does imiquimod affect your immune system?
When applied topically, imiquimod induces cytokine production by the keratinocytes, activates langerhans cells and induces production of mature B-lymphocytes. This causes activation of the immune system to mount a greater response against the skin lesion, leading to its resolution.
Can imiquimod cream make you sick?
Aside from the well known risks of diabetes and obesity, ice cream really does have the potential to make you very sick. In 2015, five people were hospitalised and three died after eating ice cream that had been contaminated by Listeria in Topeka, Kansas.
Is imiquimod systemic?
Imiquimod induces cytokines in the area of application and causes systemic augmentation of the immune response.
How can you tell if imiquimod is working?
When using imiquimod to treat AKs or skin cancer, your skin should react. You may have redness, swelling, burning, itching, and tenderness. As the skin starts to heal, you will see scabs and flaking. These reactions indicate that the medicine is working.
How long does it take for imiquimod to start working?
It usually takes 8-10 weeks for your warts to disappear, but warts may clear as early as 4 weeks. If your warts reappear, talk to your doctor. If your skin reacts badly to Aldara, your doctor may recommend that you stop treatment for a few days.
Does imiquimod cause hair loss?
A systematic literature research found only 1 case of localized hair loss in the crown region of the scalp after topical IMQ treatment for actinic keratosis, presumably caused by a local rather than a systemic side effect.
Is imiquimod the same as Aldara?
Imiquimod is the generic name for Aldara 5% cream and they contain the same active ingredient. Aldara cream is made by 3M Health Care Limited.
Does Zyclara work for genital warts?
The 3.75% strength of Zyclara topical cream is approved by the FDA to treat external gential and anal area (perianal) warts in people 12 years of a...
Who makes Zyclara and where is it manufactured?
Zyclara Cream is manufactured by Bausch Health Companies Inc. located in Laval, Quebec, Canada. The US headquarters for Bausch Health US is in Brid...
How long does Zyclara cream last?
Zyclara Cream treatment should continue until there is total clearance of the genital/perianal warts or for up to 8 weeks.
How much imiquimod is in 3.75%?
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.
Can you use Zyclara cream with imiquimod?
Concomitant use of Zyclara Cream and any other imiquimod products, in the same treatment area, should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of local skin reactions.
Can zyclara cream cause skin erosion?
Intense local skin reactions including skin weeping or erosion can occur after a few applications of Zyclara Cream and may require an interruption of dosing [see Dosage and Administration (2) and Adverse Reactions (6) ]. Zyclara Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
Is zyclara cream safe for AK?
AK is a condition not generally seen within the pediatric population. The safety and effectiveness of Zyclara Cream for AK in patients less than 18 years of age have not been established.
Can you give Zyclara to other people?
Medicines are sometimes prescribed for purposes other than those listed in the patient information. Do not use Zyclara Cream for a condition for which it was not prescribed. Do not give Zyclara Cream to other people, even if they have the same symptoms you have. It may harm them.
Can imiquimod be excreted in milk?
It is not known whether imiquimod is excreted in human milk following use of Zyclara Cream. Because many drugs are excreted in human milk, caution should be exercised when Zyclara Cream is administered to nursing women.
How long does Zyclara stay on your face?
It can only be obtained with a prescription. One or two sachets of Zyclara are applied in a thin layer to the affected areas of the face or balding scalp once a day before bedtime. The cream should remain on the skin overnight (for about 8 hours) before being washed off. Daily treatment should continue for 2 weeks.
How effective is Zyclara?
Zyclara has been shown to be effective in clearing actinic keratosis from the skin in two main studies involving 479 patients with actinic keratosis on the face and scalp. Two doses of Zyclara (2.5% and 3.75%) were compared with placebo (a dummy treatment) in these studies, and the main measure of effectiveness was the number ...
What is zyclara cream used for?
What is Zyclara and what is it used for? Zyclara is a cream used to treat actinic keratosis on the face and balding parts of the scalp. Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight.
What is the strength of Zyclara?
It contains the active substance imiquimod at 3.75% strength (100 mg cream contains 3.75 mg imiquimod). Zyclara is a ‘ hybrid medicine ’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Zyclara is available in a different strength. The reference medicine for Zyclara is Aldara, ...
Does imiquimod kill keratosis?
This means that it uses the immune system to bring about its effect. When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon. These substances help to kill the abnormal cells in the skin that lead to keratosis.
Is Zyclara better than Aldara?
Treatment with Zyclara has the advantage of being easier to adhere to than Aldara treatment because it has a simpler dosing regimen. In addition, its lower strength allows it to be used across larger areas of the skin and thereby treat more of the affected skin.
Does Zyclara cause headaches?
About 11% of patients in studies with Zyclara required treatment to be interrupted due to this kind of side effect on the skin . Some other side effects, including headache and tiredness, were also reported. For the full list of side effects and restrictions with Zyclara, see the package leaflet.
What are the side effects of Zyclara?
Flu-like symptoms: Tell your healthcare provider if you have tiredness, nausea, vomiting, fever, chills, muscle pain, and joint pain. The most common side effects of ZYCLARA Cream include:
How to report side effects of Zyclara cream?
For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is zyclara cream?
ZYCLARA 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.
Can you use Zyclara cream with imiquimod?
Concomitant use of ZYCLARA Cream and any other imiquimod products, in the same treatment area, should be avoided since they contain the same active ingredient (imiquimod) and may increase the risk for and severity of local skin reactions.
Can you give zyclara cream to other people?
Do not use ZYCLARA Cream for a condition for which it was not prescribed. Do not give ZYCLARA Cream to other people, even if they have the same symptoms you have. It may harm them.
Does Zyclara cream cause flu?
Patients may experience flu-like systemic signs and symptoms during treatment with ZYCLARA Cream. Systemic signs and symptoms may include fatigue, nausea, fever, myalgia , malaise, arthralgia, and chills [see ADVERSE REACTIONS ]. An interruption of dosing and an assessment of the patient should be considered.
Is zyclara cream safe for AK?
AK is a condition not generally seen within the pediatric population. The safety and effectiveness of ZYCLARA Cream for AK in patients less than 18 years of age have not been established.
What is imiquimod, and how does it work (mechanism of action)?
Imiquimod is a topical medication that activates the immune system and is used for treating (not curing) genital warts. Although the exact mechanism of action imiquimod is not known, imiquimod is presumed to work by activating immune cells and chemicals that affect the immune the system.
What is the dosage for imiquimod?
Actinic keratosis: Apply Aldara to specific treatment area two times a week for 16 weeks.
Which drugs or supplements interact with imiquimod?
No drug- drug interactions have been conducted and established with imiquimod.
Is imiquimod safe to take if I'm pregnant or breastfeeding?
There are no adequate studies done on imiquimod to determine safe and effective use in pregnant women.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
We have two recommendations
Keep yourself well protected from the sun. The development of AK lesions are evidence that the skin has taken too much sun damage, and is at risk of developing further malignancies such as AK or skin cancer. It is imperative that you protect your skin at this point as the dangers are here.
Prevention of Actinic Keratosis
Actinic keratosis can be thought of as a symptom of overexposure to the sun over the years. As such, prevention is simple-stay away from sunlight, and use proper protection such as hats and sunscreens-but the precaution must be ongoing. Here are some suggested lifestyle adjustments that are recommended:
How long does it take for a wart to clear?
When treating warts, apply once a day until the warts clear or up to 8 weeks. Do not apply this medication in the eyes, nose, mouth, rectum, or vagina. If you get this medication in those areas, flush with plenty of water. If irritation occurs, talk to your doctor right away.
How to report imiquimod side effects in Canada?
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.
Does imiquimod go away?
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.
Indications and Usage For Zyclara
Dosage Forms and Strengths
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Overdosage
Zyclara Description
Zyclara - Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
- Actinic Keratosis
In two double-blind, randomized, vehicle-controlled clinical studies, 479 subjects with AK were treated with Zyclara Cream, 3.75%, Zyclara Cream, 2.5%, or vehicle cream. Studies enrolled subjects 18 years of age or older with 5 to 20 typical visible or palpable AK lesions of the face o… - External Genital Warts
In two double-blind, randomized, placebo-controlled clinical studies, 601 subjects with EGW were treated with 3.75% imiquimod cream, or a matching placebo cream. Studies enrolled subjects aged from 15 to 81 years. The baseline wart area ranged from 6 to 5579 mm2 (median 60 mm2…