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ALDARA P is a brand name for Imiquimod, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
ALDARA P (imiquimod) cream is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. WARNINGS Patients with sBCC treated with ALDARA P cream are required to have regular follow-up of the treatment site because the efficacy of imiquimod in the treatment of sBCC is generally less than that with surgery and, as well, because the long-term efficacy and safety of imiquimod in the treatment of sBCC have not yet been established.
The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment since ALDARA P (imiquimod) cream has not been evaluated for the treatment of other types of basal cell carcinomas, including nodular, morpheaform (fibrosing or sclerosing) types and is not recommended for treatment of BCC subtypes other than the superficial variant.
ALDARA P (imiquimod) cream has not been evaluated for the treatment of sBCC on the face, head, hands or feet, and anogenital area. The efficacy of ALDARA P in the prevention of squamous cell carcinoma (SCC) associated with AK has not been established.
One subject who participated in a clinical trial of imiquimod and had complete clearance of AK lesions with imiquimod treatment developed a SCC in situ in the treatment area within 12 to 18 months of treatment (see PHARMACOLOGY, Clinical Studies).
ALDARA P cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and is not recommended for these conditions. Hypersensitivity reactions (urticaria) and erythema multiforme have been reported in patients receiving ALDARA P cream.
Causality has not been established and no other reports of similar cases have been reported in post-marketing surveillance. ALDARA P cream should be discontinued immediately if these events occur. Some reports of localized hypopigmentation and hyperpigmentation following use of ALDARA P cream have been received.
Post-marketing reporting suggests that these skin color changes may be permanent in some patients. PrALDARA® P Product Monograph Page 5 of 38 PRECAUTIONS General ALDARA P cream administration is not recommended until skin or genital/perianal tissue is healed from any previous drug or surgical treatment.
ALDARA P cream has the potential to exacerbate inflammatory conditions of the skin. Local skin reactions such as erythema, erosion, excoriation/flaking, and edema are common. Should a severe local skin reaction occur, the cream should be removed by washing the treatment area with mild soap and water.
Treatment with ALDARA P can be resumed after the skin reaction has subsided. The efficacy and safety of ALDARA P cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum. The safety of ALDARA P cream applied to areas of skin greater than 25cm2 for the treatment of actinic keratosis has not been established.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Imiquimod in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The safety and efficacy of ALDARA P cream in immunosuppressed patients have not been established. Flu-like systemic signs and symptoms including malaise, fever, nausea, myalgias and rigors may occur. Dosing interruption may be required.
ALDARA P cream should be used with caution in patients with pre-existing autoimmune conditions. Rare reports have been received of exacerbation of autoimmune conditions in patients treated with ALDARA P. ALDARA P cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
Exposure to sunlight (including sunlamps) should be avoided or minimized during use of ALDARA P cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (hat) when using ALDARA P cream.
Patients with sunburn should be advised not to use ALDARA P cream until fully recovered. , due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using ALDARA P cream. Phototoxicity has not been adequately assessed for ALDARA P cream.
The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Despite the absence of observed phototoxicity in humans (see PHARMACOLOGY, Clinical Studies), ALDARA P cream shortened the time to skin tumor formation in an animal photoco-carcinogenicity study (see Carcinogenesis, Mutagenesis, Impairment of Fertility).
Therefore, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure. 5 mg/kg applied topically 3 times per week) showed no evidence of a carcinogenic effect in male and female rats and female mice. Liver tumors were increased in male mice exposed to the highest dose concentration, compared to the unexposed controls.
However, the number of tumors was within the range seen historically for male CD-1 mice. It is generally accepted that an increase in liver tumors in male mice, in the absence of other neoplastic responses in mice or rats, is not indicative of a carcinogenic risk for humans.
3% and were irradiated with solar ultraviolet light for 5 days each week for 40 weeks and observed an additional 12 weeks. Vehicle cream enhanced UVR-induced skin tumour development. , the addition of the active ingredient, imiquimod, to the vehicle cream did not result in an additional effect beyond the vehicle effect on tumour development).
Pregnancy Imiquimod was not teratogenic in rat or rabbit teratology […]