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Imichimod - an immunomodulatory agent for external use, is a modifier of the immune response, does not possess direct antiviral activity. The effect is due to the induction of interferon alpha, TNF and other cytokines. With external use of the drug, a decrease in the processes of angiogenesis is observed due to the enhancement of the production of interleukin-18 and interferon-gamma.
Less than 0.9% of the radiolabelled imichimod is absorbed through human skin after a single dose has been applied. A small amount of the drug that enters the systemic circulation, without delay, is excreted by the kidneys and through the intestines in a ratio of approximately 3: 1. The concentration of the drug in the serum after a single or multiple external use did not reach a level quantifiable (> 5 ng / ml).
- treatment of external genital warts localized on the external genital organs and / or in the perianal region in adults.
Cream for external use of white or white with a yellowish sheen color.
Excipients: phenoxyethanol - 2 mg, methyl parahydroxybenzoate - 2 mg, propyl parahydroxybenzoate - 1 mg, oleic acid - 350 mg, diethylene glycol monoethyl ether - 35 mg, carbomer (intercarbomer interpolymer) - 1.5 mg, carbomer (copolymer ether), 1.5 mg, carbomer (polymer interpolymer) - 1.5 mg; 20 - 2.5 mg, trolamine - 2 mg, purified water - up to 1000 mg.
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Dosage and Administration
skin for 6-10 hours. The cream is applied only on the affected previously cleaned skin areas with a thin layer and gently rubbed until completely absorbed. The treated skin area should not be bandaged. Do not use excessive amounts of cream. After the specified time, the cream should be washed off with warm water using neutral pH soap.
A single (daily) dose of the drug is 10 mg of cream per 1 cm2 of the skin surface (a strip of cream with a diameter of 2 mm and a length of 0.5 cm). The maximum area of application is 25 cm2, which corresponds to the maximum dose of the drug - 250 mg. The drug is used 1 time / day, 3 times a week (for example, Monday, Wednesday, Friday or Tuesday, Thursday, Saturday), until the complete disappearance of genital or perianal genital warts, but not more than 16 weeks.
If you forget to apply the cream on a schedule, apply the missed dose of the drug as soon as possible, and then restore the regular treatment schedule. Do not use the cream more than 1 time / day.
The frequency of side effects is defined as follows: very often -> 1/10; often - <1/10> 1/100; infrequently - <1/100> 1/1000; rarely - <1/1000> 1/10 000; very rarely - <1/10 000.
Local skin reactions: very often - itching and pain at the site of application of the drug; often - infection, erythema, erosion, excoriation / desquamation, edema; infrequently - pruritus, dermatitis, folliculitis, erythematous rash, eczema, urticaria; rarely, induration, ulceration, scabbing and blistering, local hypopigmentation and hyperpigmentation.
Disturbances of the nervous system: often - headache, dizziness; infrequently - insomnia, depression, irritability, paresthesia, migraine, drowsiness, tinnitus.
Violations of the digestive system: often - nausea; infrequently - pain in the anus, lesions of the rectum, pain in the abdomen, diarrhea, vomiting, anorexia.
Violations of the genitourinary system: infrequently - fungal, bacterial infection, herpes simplex, vaginitis, vulvitis, painful sexual intercourse, pain in the penis, pain in the vagina, atrophic vaginitis.
Disorders of the hematopoietic system: very rarely - decreased hemoglobin, leukopenia, absolute neutropenia, thrombocytopenia.
Respiratory system disorders: infrequently - pharyngitis, rhinitis.
Disorders of the musculoskeletal system: infrequently - back pain, arthralgia.
Other: often - infection, myalgia, fever, flu-like symptoms, fatigue; infrequently - increased sweating, lymphadenopathy.
If local side effects appear, the cream should be removed by washing it off with soap and water. Treatment can be resumed after relief of skin reaction.
If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects that are not indicated in the instruction, inform your doctor.
- Hypersensitivity to imichymod, auxiliary components of the drug;
- breastfeeding period;
- children's age up to 18 years.
The study of the interaction of imichimod with other drugs, including immunosuppressants, was not conducted. Minimal absorption of the drug through the skin limits the interaction with systemic drugs.
If a hypersensitivity reaction is detected, it is recommended to discontinue therapy. If the local reaction to the drug causes serious discomfort for the patient, or if an infection occurs in the area of application of the cream, it is allowed to take a break in treatment for several days. In case of infection, the necessary measures are taken.
Avoid contact with the drug. If the cream gets into your eyes, it is recommended to wash them with water.
Men who have not undergone circumcision, when treating genital warts located under the foreskin, should wash the affected area daily by pulling the foreskin.It is recommended to stop treatment immediately in case of early signs of phimosis.
The drug should be washed off the skin before intercourse.
Do not expose the skin treated with the drug, the effects of artificial or natural (solar) UV irradiation to complete the course of treatment, because there is a risk of sunburn.
Before and after using the product, wash hands thoroughly with soap and water.
Do not use excessive amounts of cream and longer contact (more than 10 hours) of the drug with the skin, because This may cause a pronounced local reaction.
The drug can cause exacerbations of inflammatory skin diseases.
It is not recommended to use an occlusive dressing during drug treatment. It is better to use cotton linen during the treatment period.
Use of the drug in doses exceeding the recommended, can lead to an increased risk of the development of pronounced local reactions.
The drug is applied only to the affected skin. Avoid contact with the drug on healthy skin and mucous membranes, if ingested, you should immediately wash them with warm water and soap.
It is not recommended to use the drug until the skin heals after other types of medication or surgical treatment.
Do not use the drug on skin with open wounds, ulcers or erosions until they heal.
Not studied efficacy and safety of the drug in the treatment of genital warts, localized in the urethra, vagina, cervix, rectum and the mucous membrane of the anus. At these locations to use the drug is not recommended.
Sexual contact, including sexual, anal or oral sex, should be avoided when the drug is on the skin. The drug can weaken the tightness of condoms and vaginal diaphragms. For your health, you should use other methods of contraception during drug treatment and within a month after the last use of the drug.
Since imichimod does not have a direct antiviral and cytotoxic effect; after the treatment, new genital and perianal condyloma may occur.
In some cases, new warts can develop in other areas of the skin even during the period of drug treatment. In this case, the further tactics of therapy is determined by the attending physician.
In patients with immunodeficiency is not recommended to use the drug Vartotsid® again.
Influence on ability to drive vehicles and mechanisms
The drug does not affect the ability to drive vehicles, work with moving machinery and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Overdose is unlikely due to the low absorbability of the drug.
In case of accidental ingestion of the drug in a dose of 200 mg, which corresponds to 4 g of cream, nausea, vomiting, headache, myalgia, fever can be observed. The most serious from a clinical point of view, the side effect of the ingestion of multiple doses of 200 mg is a reduction in blood pressure. It is necessary to urgently consult a doctor and find symptomatic therapy.
- Brand name: Vartotsid
- Active ingredient: Imichimod
- Manufacturer: Green Dubrava