Zyclara
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK), of the full face or balding scalp in immunocompetent adults.
ZYCLARA Cream, 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older.
Imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations (8.4)].
Treatment with ZYCLARA Cream has not been studied for prevention or transmission of HPV.
The safety and efficacy of ZYCLARA Cream have not been established in the treatment of:
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- urethral, intra-vaginal, cervical, rectal or intra-anal human papilloma viral disease .
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- actinic keratosis when treated with more than one 2-cycle treatment course in the same area .
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- patients with xeroderma pigmentosum.
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- superficial basal cell carcinoma.
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- immunosuppressed patients.
History
There is currently no drug history available for this drug.
Other Information
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 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-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% 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.
Sources
Zyclara Manufacturers
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Medicis Pharmaceutical Corp
![Zyclara (Imiquimod) Cream [Medicis Pharmaceutical Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zyclara | Medicis Pharmaceutical Corp
For topical use only; ZYCLARA Cream is not for oral, ophthalmic, intra-anal or intravaginal use.
2.1 Actinic KeratosisZYCLARA Cream should be applied once daily before bedtime to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. ZYCLARA Cream should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. Up to 0.5 grams (2 packets or 2 full actuations of the pump) of ZYCLARA Cream may be applied to the treatment area at each application. ZYCLARA Cream should be left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of ZYCLARA Cream therapy.
Patients should wash their hands before and after applying ZYCLARA Cream.
Avoid use in or on the lips and nostrils. Do not use in or near the eyes.
Local skin reactions in the treatment area are common [see Adverse Reactions (6.1)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, neither 2-week treatment cycle should be extended due to missed doses or rest periods. A transient increase in lesion counts may be observed during treatment. Response to treatment cannot be adequately assessed until resolution of local skin reactions. The patient should continue dosing as prescribed. Treatment should continue for the full treatment course even if all actinic keratoses appear to be gone. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.
Prescribe no more than 2 boxes (56 packets) or two 7.5 g pumps for the total 2-cycle treatment course. Partially-used packets should be discarded and not reused.
2.2 External Genital WartsPatients should apply a thin layer of ZYCLARA Cream once a day to the external genital/perianal warts until total clearance or for up to 8 weeks. Patients should use up to 0.25 grams (one packet or one full actuation of the pump) at each application, which is a sufficient amount of cream to cover the wart area. ZYCLARA Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, then removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of ZYCLARA Cream therapy.
Patients should wash their hands before and after applying ZYCLARA Cream.
Local skin reactions at the treatment site are common [see Adverse Reactions (6.2)], and may necessitate a rest period of several days; resume treatment once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.
Prescribe up to 2 boxes (56 packets) or two 7.5 g pumps for the total treatment course. Use of excessive amounts of cream should be avoided. Partially-used packets should be discarded and not reused.
2.3 Pump AdministrationZYCLARA (imiquimod) Cream pumps should be primed before using for the first time by repeatedly depressing the actuator until cream is dispensed. It is not necessary to repeat this priming process during treatment.
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Graceway Pharmaceuticals, Llc
Zyclara | Graceway Pharmaceuticals, Llc
For topical use only; ZYCLARA Cream is not for oral, ophthalmic, intra-anal or intravaginal use.
2.1 Actinic KeratosisZYCLARA Cream should be applied once daily before bedtime to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. ZYCLARA Cream should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. Up to 0.5 grams (2 packets or 2 full actuations of the pump) of ZYCLARA Cream may be applied to the treatment area at each application. ZYCLARA Cream should be left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of ZYCLARA Cream therapy.
Patients should wash their hands before and after applying ZYCLARA Cream.
Avoid use in or on the lips and nostrils. Do not use in or near the eyes.
Local skin reactions in the treatment area are common [see Adverse Reactions (6.1)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, neither 2-week treatment cycle should be extended due to missed doses or rest periods. A transient increase in lesion counts may be observed during treatment. Response to treatment cannot be adequately assessed until resolution of local skin reactions. The patient should continue dosing as prescribed. Treatment should continue for the full treatment course even if all actinic keratoses appear to be gone. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.
Prescribe no more than 2 boxes (56 packets), two 7.5g pumps or one 15g pump for the total 2-cycle treatment course.Partially-used packets should be discarded and not reused.
2.2 External Genital WartsPatients should apply a thin layer of ZYCLARA Cream once a day to the external genital/perianal warts until total clearance or for up to 8 weeks. Patients should use up to 0.25 grams (one packet or one full actuation of the pump) at each application, which is a sufficient amount of cream to cover the wart area. ZYCLARA Cream should be appliedprior to normal sleeping hours and left on the skin for approximately 8 hours, then removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of ZYCLARA Cream therapy.
Patients should wash their hands before and after applying ZYCLARA Cream.
Local skin reactions at the treatment site are common [see Adverse Reactions (6.2)], and may necessitate a rest period of several days; resume treatment once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.
Prescribe up to 2 boxes (56 packets), two 7.5g pumps or one 15g pump for the total treatment course. Use of excessive amounts of cream should be avoided. Partially-used packets should be discarded and not reused.
2.3 Pump AdministrationZYCLARA (imiquimod) Cream 3.75% pumps should be primed before using for the first time by repeatedly depressing the actuator until cream is dispensed. It is not necessary to repeat this priming process during treatment.
![Zyclara (Imiquimod) Cream [Graceway Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4fc97f16-2ff6-c8a3-7419-b31fff4f7c5b&name=375laminate.jpg)
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