Vartotsid, 1 piece, 5 g, 5%, cream for external use
Avoid contact of the drug with the eyes. If the cream gets into your eyes, it is recommended to rinse them with water.
Uncircumcised men who are treating genital warts located under the foreskin should wash the affected area daily by retracting the foreskin. It is recommended to immediately stop treatment if early signs of phimosis are detected.
The drug should be washed off the skin before sexual intercourse.
Do not expose the skin treated with the drug to artificial or natural (solar) UV irradiation until the course of treatment is completed.
Before and after using the drug, you should wash your hands thoroughly with soap and water.
The use of excess amounts of cream and longer contact (more than 10 hours) of the drug with the skin are not allowed.
The drug may cause exacerbation of inflammatory skin diseases.
It is not recommended to use an occlusive dressing during treatment with the drug.
During the treatment period, it is better to use cotton underwear.
Using the drug in doses higher than recommended may lead to an increased risk of developing severe local reactions.
The drug is applied only to the affected areas of the skin. Avoid contact of the drug with healthy skin and mucous membranes; if contact occurs, wash them immediately with warm water and soap.
It is not recommended to use the drug until the skin has healed after other types of medical or surgical treatment.
Do not use the drug on skin areas with open wounds, ulcers or erosions until they have healed.
Avoid sexual contact, including intercourse, anal or oral sex, when the drug is on the skin. The drug may weaken the seal of condoms and vaginal diaphragms. For contraception, other methods should be used during treatment with the drug and for a month after the last use of the drug.
Since imiquimod does not have a direct antiviral and cytotoxic effect, after therapy, new condylomas of the genital and perianal areas may appear. In some cases, new condylomas may develop on other areas of the skin even during treatment with the drug. In this case, further treatment tactics are determined by the attending physician.
In patients with immunodeficiency, it is not recommended to reuse Vartotsid®.
Influence on the ability to drive vehicles and machinery.
The drug does not affect the ability to drive vehicles, operate moving machinery, or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Compound:
1.0 g of cream contains: Active substance: imiquimod 50 mg. Excipients: phenoxyethanol - 2.0 mg, methyl parahydroxybenzoate - 2.0 mg, propyl parahydroxybenzoate - 1.0 mg, oleic acid - 350 mg, diethylene glycol monoethyl ether - 35.0 mg, carbomer (carbomer interpolymer) - 1.5 mg, carbomer (carbomer copolymer) - 2.5 mg, polysorbate-20 - 2.5 mg, trolamine - 2.0 mg, purified water - up to 1000 mg.
Description:
White or white with a yellowish tint cream.
Pharmacotherapeutic group:
Immunostimulating agent.
ATX code: D06BB10
Pharmachologic effect:
Pharmacodynamics: Imiquimod is an immunomodulatory agent for external use; it is a modifier of the immune response and does not have direct antiviral activity. The action is due to the induction of interferon alpha, tumor necrosis factor and other cytokines. When the drug is used externally, a decrease in angiogenesis processes is observed due to increased production of interleukin-18 and interferon-gamma. Pharmacokinetics: Less than 0.9% of radiolabeled imiquimod is absorbed through human skin after a single dose. A small amount of the drug entering the systemic circulation is immediately excreted from the body by the kidneys and through the intestines in a ratio of approximately 3:1. The concentration of the drug in the blood serum after single or repeated external use did not reach a level that could be quantified (>5 ng/ml).
Indications for use:
Treatment of external genital warts localized on the external genitalia and/or perianal area in adults.
Contraindications:
Hypersensitivity to imiquimod, auxiliary components of the drug. Pregnancy, breastfeeding period, children under 18 years of age.
Use during pregnancy and breastfeeding:
The drug is not prescribed to pregnant women or women during breastfeeding.
Directions for use and dosage:
Externally. The drug is used preferably at night before bedtime and left on the skin for 6-10 hours. The cream is applied only to the affected, previously cleansed areas of the skin in a thin layer and gently rubbed until completely absorbed. For application, you can use an applicator, which can be the spout of a tube. After the specified time, the cream should be washed off with warm water and soap with a neutral pH value. The treated area of skin should not be covered with bandages. A single (daily) dose of the drug is 10 mg of cream per 1 cm2 of skin surface (a strip of cream with a diameter of 2 mm and a length of 0.5 cm). The maximum application area is 25 cm2, which corresponds to the maximum dose of the drug – 250 mg. The drug is used once a day, every other day, until the complete disappearance of genital or perianal genital warts, but not more than 16 weeks. If you forget to apply the cream as scheduled, apply the missed dose of the drug as soon as possible, and then restore the regular treatment schedule. The cream should not be used more than once a day.
Side effects:
The incidence of side effects is determined as follows: Very common: >1/10; Often: 1/100; Uncommon: 1/1000; Rarely: 1/10000; Very rare: Local skin reactions: Very common: itching and pain at the site of application of the drug. Common: infection, erythema, erosion, excoriation/flaking, edema. Uncommon: pruritus, dermatitis, folliculitis, erythematous rash, eczema, urticaria. Rarely: induration, ulceration, scabbing and blistering, local hypopigmentation and hyperpigmentation. From the digestive system: Uncommon: pain in the anus, lesions of the rectum. From the genitourinary system: Uncommon: fungal, bacterial infection, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, pain in the vagina, atrophic vaginitis. If local side effects occur, the cream should be removed by washing it with soap and water. Treatment can be resumed after the skin reaction has subsided. If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Overdose:
Overdose is unlikely due to the low absorption of the drug. If the drug is accidentally ingested at a dose of 200 mg, which corresponds to 4 g of cream, nausea, vomiting, headache, myalgia, and fever may occur. The most clinically serious side effect of multiple 200 mg oral doses is a decrease in blood pressure. It is necessary to urgently consult a doctor and select symptomatic therapy.
Interaction with other drugs:
The interaction of imiquimod with other drugs, including immunosuppressants, has not been studied. Minimal absorption of the drug through the skin limits interaction with systemic drugs.
Special instructions:
Avoid contact of the drug with the eyes. If the cream gets into your eyes, it is recommended to rinse them with water. Uncircumcised men who are treating genital warts located under the foreskin should wash the affected area daily by retracting the foreskin. It is recommended to immediately stop treatment if early signs of phimosis are detected. The drug should be washed off the skin before sexual intercourse. The skin treated with the drug should not be exposed to artificial or natural (solar) ultraviolet irradiation until the course of treatment is completed. Before and after using the drug, you should wash your hands thoroughly with soap and water. The use of excess amounts of cream and longer contact (more than 10 hours) of the drug with the skin are not allowed. The drug may cause exacerbation of inflammatory skin diseases. It is not recommended to use an occlusive dressing during treatment with the drug. During the treatment period, it is better to use cotton underwear. Using the drug in doses higher than recommended may lead to an increased risk of developing severe local reactions. The drug is applied only to the affected areas of the skin. Avoid contact of the drug with healthy skin and mucous membranes; if contact occurs, wash them immediately with warm water and soap. It is not recommended to use the drug until the skin has healed after other types of drug or surgical treatment. Do not use the drug on skin areas with open wounds, ulcers or erosions until they have healed. The effectiveness and safety of the drug in the treatment of genital warts localized in the urethra, vagina, cervix, rectum and anal mucosa have not been studied. In these localizations, the use of the drug is not recommended. Avoid sexual contact, including intercourse, anal or oral sex, when the drug is on the skin. The drug may weaken the seal of condoms and vaginal diaphragms. For your health, you should use other methods of contraception during treatment with the drug and for a month after the last use of the drug. Since imiquimod does not have a direct antiviral and cytotoxic effect, after therapy, new condylomas of the genital and perianal areas may appear. In some cases, new condylomas may develop on other areas of the skin even during treatment with the drug. In this case, further treatment tactics are determined by the attending physician. In patients with immunodeficiency, it is not recommended to reuse Vartotsid®.
Impact on the ability to drive vehicles and machinery:
The drug does not affect the ability to drive vehicles, operate moving machinery, or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Release form:
Cream for external use 5%. 5 g or 10 g in aluminum tubes with a plastic nozzle and a screw cap. One tube along with instructions for use in a cardboard box.
Storage conditions:
At a temperature not higher than 25 ºС. Keep out of the reach of children.
Best before date:
3 years. Do not use after the expiration date stated on the packaging.
Vacation conditions:
Dispensed by prescription.
Manufacturer/owner of the registration certificate/organization receiving complaints about the quality of the drug: Joint-Stock Company Medical-Biological Research and Production Complex Cytomed (JSC MBNPK Cytomed) Russia, 194356, St. Petersburg, Orlovo-Denisovsky Prospekt, building 14 1, tel. 8 (800) 505 – 03 – 01, www.cytomed.ru.
General Director of JSC MBNPK Cytomed A.N. Khromov
Vartocid, 5%, cream for external use, 5 g, 1 pc.
Avoid contact of the drug with the eyes. If the cream gets into your eyes, it is recommended to rinse them with water.
Uncircumcised men who are treating genital warts located under the foreskin should wash the affected area daily by retracting the foreskin. It is recommended to immediately stop treatment if early signs of phimosis are detected.
The drug should be washed off the skin before sexual intercourse.
Do not expose the skin treated with the drug to artificial or natural (solar) UV irradiation until the course of treatment is completed.
Before and after using the drug, you should wash your hands thoroughly with soap and water.
The use of excess amounts of cream and longer contact (more than 10 hours) of the drug with the skin are not allowed.
The drug may cause exacerbation of inflammatory skin diseases.
It is not recommended to use an occlusive dressing during treatment with the drug.
During the treatment period, it is better to use cotton underwear.
Using the drug in doses higher than recommended may lead to an increased risk of developing severe local reactions.
The drug is applied only to the affected areas of the skin. Avoid contact of the drug with healthy skin and mucous membranes; if contact occurs, wash them immediately with warm water and soap.
It is not recommended to use the drug until the skin has healed after other types of medical or surgical treatment.
Do not use the drug on skin areas with open wounds, ulcers or erosions until they have healed.
Avoid sexual contact, including intercourse, anal or oral sex, when the drug is on the skin. The drug may weaken the seal of condoms and vaginal diaphragms. For contraception, other methods should be used during treatment with the drug and for a month after the last use of the drug.
Since imiquimod does not have a direct antiviral and cytotoxic effect, after therapy, new condylomas of the genital and perianal areas may appear. In some cases, new condylomas may develop on other areas of the skin even during treatment with the drug. In this case, further treatment tactics are determined by the attending physician.
In patients with immunodeficiency, it is not recommended to reuse Vartotsid®.
Influence on the ability to drive vehicles and machinery.
The drug does not affect the ability to drive vehicles, operate moving machinery, or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
