Vartocid cream for external use 5%, 5g

Composition

Cream for external use of white or white with a yellowish tinge of color.

Auxiliary substances:

Phenoxyethanol – 2 mg,

methyl parahydroxybenzoate 2 mg

parahydroxybenzoate – 1 mg,

oleic acid 350 mg

of diethylene glycol monotropy live – 35 mg,

karbomer (karbomer interpolimer) – 1.5 mg,

karbomer (karbomer copolymer) – 2.5 mg,

Polysorbate 20 – 2.5 mg,

trolamine 2 mg,

purified water – up to 1000 mg.

Pharmacological action

Imiquimod – an immunomodulatory agent for external use, is a modifier of the immune response, does not have 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 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 entered the systemic circulation, without delay, is 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 a single or multiple external application did not reach a quantifiable level (>5 ng/ml).

Indications

-treatment of external genital warts with localization on the external genitals and / or in the perianal area in adults.

Contraindications

• Hypersensitivity to Imiquimod, auxiliary components of the drug;
• pregnancy;
• breast-feeding period;
• children under 18 years of age.

Side effects

The frequency of side effects is defined as follows: very often – >1/10; often – ><1/10 > 1/100; infrequently – <1/10 ><1/100 > 1/1000; rarely – <1/100 ><1/1000 > 1/10 000; very rare – <1/1000 >Local skin reactions: very often-itching and pain at the site of application of the drug; often-infection, erythema, erosion, excoriation/peeling, edema; infrequently-pruritus, dermatitis, folliculitis, erythematous rash, eczema, urticaria; rarely-induration, ulceration, scab formation and blistering, local hypopigmentation and hyperpigmentation. Nervous system disorders: often-headache, dizziness; infrequently-insomnia, depression, irritability, paresthesia, migraine, drowsiness, tinnitus. Disorders of the digestive system: often – nausea; infrequently – pain in the anus, rectal lesions, abdominal pain, diarrhea, vomiting, anorexia. Disorders of the genitourinary system: infrequently-fungal, bacterial infection, herpes simplex, vaginitis, vulvitis, painful sexual intercourse, penile pain, vaginal pain, atrophic vaginitis. Hematopoietic disorders: very rarely – decreased hemoglobin, leukopenia, absolute neutropenia, thrombocytopenia. Respiratory system disorders: infrequently-pharyngitis, rhinitis. Musculoskeletal disorders: infrequently-low back pain, arthralgia. Other: often-infection, myalgia, fever, flu-like symptoms, fatigue; infrequently-increased sweating, lymphadenopathy. If local side effects occur, the cream should be removed by washing it off with soap and water. Treatment can be resumed after stopping the skin reaction. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

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.

How to take, course of use and dosage

to the skin for 6-10 hours. The cream is applied only to the affected pre-cleansed areas of the skin in a thin layer and gently rubbed until completely absorbed. The treated area of the skin should not be covered with bandages. It is not allowed to use an excessive amount of cream. After the specified time, the cream should be washed off with warm water and a neutral pH soap. A single (daily) dose of the drug is 10 mg of cream per 1 cm 2 of the 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 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 schedule, apply the missed dose of the drug as soon as possible, and then restore the regular treatment schedule. Do not apply the cream more than 1 time / day.

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, fever may occur. From a clinical point of view, the most serious side effect of taking several doses of 200 mg orally is a decrease in blood pressure. It is necessary to urgently consult a doctor and choose symptomatic therapy.

Special instructions

If a hypersensitivity reaction is detected, it is recommended to stop therapy. If a 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 of the drug with the eyes. If the cream gets into the eyes, it is recommended to rinse them with water. Men who have not been circumcised, when treating genital warts located under the foreskin, should wash the affected area daily, pulling the foreskin. It is recommended to stop treatment immediately 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 radiation until the complete end of the course of treatment, since there is a risk of sunburn. Before and after using the drug, wash your hands thoroughly with soap and water. It is not allowed to use an excessive amount of cream and prolonged contact (more than 10 hours) of the drug with the skin, because this can cause a pronounced local reaction. 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 underwear made of cotton fabric. The use of the drug in doses higher than recommended may lead to an increased risk of severe local reactions. The drug is applied only to the affected areas of the skin. Avoid getting the drug on healthy skin and mucous membranes, in case of contact, it is necessary to immediately wash them with warm water and soap. It is not recommended to use the drug before the skin heals after other types of medical or surgical treatment. Do not apply the product on areas of the skin with open wounds, ulcers or erosions until they heal. The efficacy 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. With these localizations, it is not recommended to use the drug. It is necessary to avoid sexual contact, including sexual, anal or oral sex, 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 treatment with the drug and within a month after the last use of the drug. Since Imiquimod does not have a direct antiviral and cytotoxic effect, new genital and perianal warts may occur after the therapy. In some cases, new warts may develop in other areas of the skin even during treatment with the drug. In this case, the future treatment strategy is determined by the attending physician. In patients with immunodeficiency, it is not recommended to use Vartocid® repeatedly. Influence on the ability to drive vehicles and mechanisms The drug does not affect the ability to drive vehicles, work with moving mechanisms and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Imiquimod

Conditions of release from pharmacies

By prescription

Purpose

Adult Doctor’s prescription