Avoid getting aldara in your eyes, mouth, and nose, or on your lips. Daily oral administration of imiquimod to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 25x mrhd based on auc comparisons ..
The following adverse reactions have been identified during post-approval use of imiquimod ..
Maximum recommended human dose (mrhd) was set at 2 packets (500 mg cream) per treatment of actinic keratosis with imiquimod cream (imiquimod 3 ..
It is not known if imiquimod cream can harm your unborn baby. Egw was observed with once daily dosing for 3 weeks in all subjects ..
Treatment should continue for the full treatment course even if all actinic keratoses appear to be gone ..
The investigator determined the dose applied, either 1, 2 or 3 packets per dose, based on the size of the treatment area and the subjects weight ..
This is not a complete list of side effects and others may occur. Subjects applied up to two packets of imiquimod cream or vehicle daily 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. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.
Imiquimod cream treatment should continue until there is total clearance of the genitalperianal warts or for up to 8 weeks. Should severe local skin reaction occur, the cream should be removed by washing the treatment area with mild soap and water. It is not likely that other drugs you take orally or inject will have an effect on topically applied aldara.
Do not use imiquimod cream for a condition for which it was not prescribed. On a scheduled dosing day, up to two packets of the study cream were applied to the entire treatment area prior to normal sleeping hours and left on for approximately 8 hours. It is recommended that the treatment area be washed with mild soap and water approximately 8 hours following imiquimod cream application.
When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using aldara and call your doctor right away. Imiquimod revealed no evidence of mutagenic or clastogenic potential based on the results of five genotoxicity tests (ames assay, mouse lymphoma l5178y assay, chinese hamster ovary cell chromosome aberration assay, human lymphocyte chromosome aberration assay and she cell transformation assay) and three genotoxicity tests (rat and hamster bone marrow cytogenetics assay and a mouse dominant lethal test). Local skin reactions were recorded as adverse reactions only if they extended beyond the treatment area, if they required any medical intervention, or they resulted in patient discontinuation from the study.
Avoid getting aldara in your eyes, mouth, and nose, or on your lips. Using too much imiquimod cream, or using it too often, or for too long can increase your chances for having a severe skin reaction or other side effects. Intense local skin reactions including skin weeping or erosion can occur after a few applications of imiquimod cream and may require an interruption of dosing imiquimod cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
Treatment should continue for the full treatment course even if all actinic keratoses appear to be gone. This reaction resolved in all subjects by 4 weeks after completion of treatment. Dosing is once daily before bedtime to the skin of the affected area (entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. Throw away the packet after one use, even if there is medicine left in it. Severe local skin reactions reported by imiquimod-treated subjects in the pediatric studies included erythema (28), edema (8), scabbingcrusting (5), flakingscaling (5), erosion (2) and weepingexudate (2).
Most patients using imiquimod cream for the treatment of ak experience erythema, flakingscalingdryness and scabbingcrusting at the application site with normal dosing use of sunscreen is encouraged, and patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or uvab treatment) while using imiquimod cream additional lesions may become apparent in the treatment area during treatment dosing is once daily before bedtime to the skin of the affected wart areas. Aldara is usually applied 2 times per week (such as monday and thursday, or tuesday and friday) for a full 16 weeks. Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions. Imiquimod cream was applied to the face andor scalp in 17 subjects with at least 10 ak lesions. In study 1, the complete clearance rate was 24 (52217) in the imiquimod cream group compared with 26 (28106) in the vehicle group.
Do not have sexual contact including genital, anal, or oral sex when imiquimod cream is on your genital or perianal skin. Use sunscreen and wear protective clothing if you go outside during daylight. Contact with the eyes, lips, nostrils, anus and vagina should be avoided the treatment area should not be bandaged or otherwise occluded. Imiquimod cream is usually left on the skin for approximately 8 hours. Table 3 selected adverse reactions occurring in 2 of imiquimod-treated subjects and at a greater frequency than with vehicle in the combined trials (egw) percentage based on female population of 6216 for imiquimod cream 3.
The investigator determined the dose applied, either 1, 2 or 3 packets per dose, based on the size of the treatment area and the subjects weight. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Use the medicine before going to bed and leave it on for 6 to 10 hours. Do not cover the treated skin areas with any type of plastic bandaging, and avoid nylon underwear. A statistically significant increase in the incidence of liver adenomas and carcinomas was noted in high dose male mice compared to control male mice (21x mrhd based on weekly auc comparisons). The effect of imiquimod cream on the transmission of genitalperianal warts is unknown. For actinic keratosis, imiquimod cream should be applied once daily to the skin of the affected area (either entire face or balding scalp) for two weeks, then stop using for two weeks, then applied once daily again for two weeks. Partial clearance rate was defined as the percentage of subjects in whom the number of baseline aks was reduced by 75 or more. You will not have to repeat this priming process during your treatment. Potential local skin reactions include erythema, edema, erosionsulcerations, weepingexudate, flakingscalingdryness, and scabbingcrusting.J Drugs Dermatol. 2007 Feb;6(2):144-7. Comparison of 5% 5-fluorouracil cream and 5% imiquimod cream in the management of actinic keratoses on the face ...