Throw away any unused medicine after the expiration date. Discard packet after applying to affected area. Partial packets should not be saved or reused. This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider. The staff is always very friendly and helpful. I always get my prescriptions. I would highly recommend them t Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur.
Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment. Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended. Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine. If this occurs you should seek medical help immediately. If you are being treated for basal cell carcinoma: Local skin reactions can be a sign that the drug is working as intended.
Very Commonly the treated skin may be slightly itchy. If a skin reaction becomes too uncomfortable during treatment, speak to your doctor.
The cream should be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours.
During this period, showering and bathing should be avoided. Response of the treated tumour to imiquimod cream should be assessed 12 weeks after the end of treatment. If the treated tumour shows an incomplete response, a different therapy should be used see section 4.
A rest period of several days may be taken see section 4. Avoid contact with the eyes, lips and nostrils. Imiquimod has the potential to exacerbate inflammatory conditions of the skin. Imiquimod cream should be used with caution in patients with autoimmune conditions refer to section 4. Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with a possible worsening of their autoimmune condition.
Imiquimod cream should be used with caution in organ transplant patients refer to section 4. Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with the possibility of organ rejection or graft-versus-host disease.
Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment.
Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events refer to section 4. The excipients methyl hydroxybenzoate E and propyl hydroxybenzoate E may cause allergic reactions possibly delayed. Cetyl alcohol and stearyl alcohol may cause local skin reactions e. Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream.
Local inflammatory reactions may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and rigors. An interruption of dosing should be considered. Imiquimod should be used with caution in patients with reduced haematologic reserve refer to section 4.
There is limited experience in the use of imiquimod cream in the treatment of men with foreskin-associated warts. The safety database in uncircumcised men treated with imiquimod cream three times weekly and carrying out a daily foreskin hygiene routine is less than patients. In other studies, in which a daily foreskin hygiene routine was not followed, there were two cases of severe phimosis and one case of stricture leading to circumcision.
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Nucleoli fruits used as a sedative. Carcinogenesis, Mutagenesis, and Impairment of Fertility Note: If higher doses than 2 packets of Aldara Cream are used clinically, then the animal multiple of human exposure would be reduced for that dose. A non-proportional increase in systemic exposure with increased dose of Aldara Cream was noted in the clinical pharmacokinetic study conducted in actinic keratosis subjects see Pharmacokinetics.
The animal multiples of human exposure calculations were based on weekly dose comparisons for the carcinogenicity studies described in this label.
The animal multiples of human exposure calculations were based on daily dose comparisons for the reproductive toxicology studies described in this label. An increased number of skin papillomas was observed in vehicle cream control group animals at the treated site only. The quantitative composition of the vehicle cream used in the dermal mouse carcinogenicity study is the same as the vehicle cream used for Aldara Cream, minus the active moiety imiquimod.
No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, imiquimod, to the vehicle cream. Imiquimod revealed no evidence of mutagenic or clastogenic potential based on the results of five in vitro genotoxicity tests Ames assay, mouse lymphoma LY assay, Chinese hamster ovary cell chromosome aberration assay, human lymphocyte chromosome aberration assay and SHE cell transformation assay and three in vivo genotoxicity tests rat and hamster bone marrow cytogenetics assay and a mouse dominant lethal test.
Pregnancy Pregnancy Category C: Systemic embryofetal development studies were conducted in rats and rabbits. Intravenous doses of 0. A combined fertility and peri- and post-natal development study was conducted in rats. Oral doses of 1, 1. This fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod. There are no adequate and well-controlled studies in pregnant women.
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