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Active ingredients
Imichimod
Release form
Cream
Composition
Active ingredient: imichimod (imiquimod) Active ingredient concentration (mg): imichimod 5 mg
Pharmacological effect
Immunomodulator Imichimod - the active ingredient of the drug Aldara - is a modifier of the immune response. Imichimod does not have a direct antiviral effect, its action is due to the induction of interferon alpha and other cytokines.
Pharmacokinetics
Less than 0.9% of the radiolabeled imichimod is absorbed through human skin after a single dose is applied. A small amount of the drug entering the systemic circulation is removed without delay from the body by the kidneys and through the intestine in a ratio of approximately 3: 1. The serum concentration of the drug in the blood serum after a single or multiple external use did not reach a quantifiable level (> 5 ng / ml).
Indications
treatment of external genital warts in the place of localization on the external genital organs or in the perianal region in adults.
Contraindications
children up to 18 years (due to lack of data); Hypersensitivity to imichimod or any other components of the cream.
Precautionary measures
Do not exceed recommended doses.
Dosage and administration
Aldara cream is applied 3 times a week (for example, Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) before going to bed, and left on the skin for approximately 6-10 hours, during this time you should not take a shower or bath. At the site of application of the cream should not apply a bandage. After this period, the cream should be rinsed with water and mild soap. The treatment should be continued until the visible genital or perianal condylomas disappear, but not more than 16 weeks. Aldar cream is packed in disposable sachets containing the necessary amount of cream for applying to the affected area of 20 cm2. You should not apply the cream more than 1 time / day. It is not allowed to use an excess amount of cream.
Side effects
Local skin reactions: very often - itching and pain at the site of application of the cream; often - infection, erythema, erosion, excoriation / desquamation and edema; infrequently - pruritus, dermatitis, folliculitis, erythematous rash, eczema, urticaria; rarely - indurationulceration, scabbing and blistering, local hypopigmentation and hyperpigmentation. From the side of the central nervous system and the peripheral nervous system: often - headache, dizziness; infrequently - insomnia, depression, irritability, paresthesia, migraine, drowsiness, ringing in the ears. On the part of the digestive system: often - nausea; infrequently - abdominal pain, diarrhea, vomiting, anorexia, pain in the anus, rectal lesions. From the reproductive system: infrequently - fungal and bacterial infection, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, vagina , atrophic vaginitis. From the hemopoietic system: very rarely - decrease in hemoglobin, leukopenia, absolute neutropenia and thrombocytopenia. From the musculoskeletal system: infrequently - back pain, arthralgia. From the respiratory system: infrequently - pharyngitis, rhinitis. From the side about -organisms as a whole: often - an infection, myalgia, fever, flu-like symptoms, fatigue; infrequently - excessive sweating, lymphadenopathy. If local side effects appear, the cream should be removed by washing it with soap and water. Treatment can be resumed after relief of skin reaction.
Overdose
In the case of external use, the likelihood of systemic overdose of Aldar cream is low due to the low absorption of the drug through the skin. If accidentally consumed inside the imichimod at a dose of 200 mg, which corresponds to the contents of approximately 16 sachets, nausea, vomiting, headache, myalgia and fever may occur. The most serious from a clinical point of view, the side effect of the ingestion of multiple doses of 200 mg is arterial hypotension, which is stopped by injecting a liquid orally or intravenously.
Interaction with other drugs
The study of the interaction of imichimod with other drugs, including immunosuppressants, was not conducted. Minimal absorption of imichimod through the skin should limit the interaction with drugs of systemic action.
special instructions
Aldara cream is applied only on the affected areas. You should avoid getting the cream on the mucous membranes, contact of the cream with the eyes. If the cream gets into the eyes, it is recommended to wash them with water. Aldar cream is applied at bedtime.Using an excessive amount of cream or a longer contact with skin can cause a pronounced local reaction. It is not allowed to reuse the opened bag. Wash your hands thoroughly before and after applying the cream. Men who have not performed circumcision when treating genital warts located under the foreskin , must daily wash the affected area, pulling the foreskin. It is recommended to immediately stop treatment in case of early signs of phimosis. If a local reaction to a drug causes serious discomfort for the patient, or if an infection develops in the area of application of the cream, it is allowed to take a break in treatment for several days. If an infection develops, the necessary measures are taken. Aldara cream may cause exacerbation of inflammatory skin diseases. It is not recommended to use Aldar cream until the skin heals after other types of drug or surgical treatment. Aldar cream should not be treated in areas with open ulcers or wounds before they heal . Methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol and stearyl alcohol may cause an allergic reaction. If a hypersensitivity reaction is detected, it is recommended to discontinue therapy. It is not recommended to use an occlusive dressing during treatment with Aldara. Using imichimod at doses higher than recommended can lead to an increased risk of severe local reactions. In the period of use of Aldar cream, avoid or minimize exposure to sunlight (including sunlight lamps), as there is a risk of sunburn. Since imichimod does not have direct antiviral and otoxic effect, after the treatment, the appearance of new genital and perianal warts is possible. Based on the currently available knowledge, treatment of urethral, intravaginal, cervical, rectal or intraanal congenital warts with Aldar cream is not recommended. Aldara cream is able to reduce the effectiveness of a condom or vaginal diaphragm, therefore it is not recommended to use these contraceptives when using olzovanii Aldara cream.An alternative method of contraception should be chosen. In patients with immunodeficiency, it is not recommended to use Aldar cream again. Effects on the ability to drive and work with mechanisms No studies of the effect of the drug on the ability to drive and work with mechanisms were performed.