Description
Release form for external use
.
Packing
Bags, 12 pcs.
Pharmacological action
Pharmacodynamics
Imihimod belongs to the class of imidazocumolinamines. Imichimod is an immune system inducer, has no direct antiviral activity, but is effective against viral infections and acts as an antitumor agent, mainly activating the cells of the immune system through toll-like receptor 7 (TLR7).
Under the influence of an imichimod, Langerhans cells are activated, NK cells (natural killer cells), B cells. The main result of activation of cells with an imichimod is an increase in the production of a number of cytokines: interferon-alpha (IFN-β), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-β). Cytokines, in turn, stimulate the immune response and antiviral activity.
In addition, imichimod is able to exhibit a cytostatic (antiproliferative) effect. By stimulating the expression of an opioid growth factor receptor (OGFR), imichimod stops the growth of malignant cells.
Pharmacokinetics
When applied topically, less than 0.9% of the isotope-labeled imichimod is absorbed through the skin. A small amount of the drug, which was absorbed into the circulatory system, without delay was quickly excreted through the urinary system and intestines on average in a ratio of 3: 1. The systemic effect (percutaneous penetration) was calculated by the reduction of carbon-14 [14C] from imichimod in urine and feces.
The peak concentration of the active substance in serum by the end of the 16th week was between 9 and 12 hours and was 0.1, 0.2 and 1.6 ng / ml when applied to the skin of the face (12.5 mg, 1 single-use packet) , head (25 mg, 2 sachets) and hands (75 mg, 6 sachets), respectively. When applied to the skin, the half-life is about 20 hours. Excretion in urine was less than 0.6% of the dose that was applied at 16 weeks.
Contraindications
Hypersensitivity to the components of the drug Keravort.
Children under 18 years old.
Pregnancy and lactation.
Use during pregnancy and lactation
No studies have been conducted.
Special instructions
It is not recommended to use the cream in the eyes, mouth, nose and ears, as well as at the same time as an airtight dressing.
Keravort Cream should be used with caution in patients undergoing organ transplantation and in patients with reduced immunity, since a worsening of the existing condition or the development of a graft rejection reaction is possible.
In case of actinic keratosis, it is recommended to avoid the effects of natural or artificial ultraviolet radiation on the eyes, lips, nostrils.
When treating basal cell carcinoma, the cream should be applied no closer less than 1 cm from the border of hair growth, the edge of the eyes, auricles, mouth or nose. The cream is not intended for the treatment of internal – genital, urethral, ² ¹ ² ¹intravaginal, rectal or intraanal warts.
Keravort Cream may weaken the effect of condoms or vaginal diaphragms.
Keravort Cream should be washed off the skin before intercourse.
Apply the cream with caution in anticipation of the vagina – the development of local skin reactions on the surface of the mucosa can cause difficulty urinating.
Keravort Cream Therapy is not recommended unless the skin has healed after a previously used drug or surgical treatment. Use on damaged skin may result in increased absorption of Keravort Cream, which may cause a greater risk of adverse reactions.
Keraworth Cream may exacerbate inflammatory skin reactions.
In rare cases, a local acute inflammatory reaction may occur, including weeping or erosion, even after several applications of Keravort cream. Local acute inflammatory reactions may be accompanied, or even preceded by systemic signs and symptoms resembling influenza, including malaise, fever, nausea, muscle pain and chills. In this case, it is recommended to take a break in treatment for several days.
During treatment, care should be taken when driving vehicles or working with other mechanisms, as well as when performing work that requires increased attention, due to the possible appearance of weakness and dizziness.
Composition
100 g cream for external use contains:
Active ingredient:
Imihimoda 5.0 g
Excipients:
Isostearic acid
Cetyl alcohol,
Stearyl alcohol
White soft paraffin
Poly orbat 60
sorbitan
Metilparagidroskibenzoat
Propyl
Glycerin
Xanthan gum
benzyl alcohol
Purified Water.
Dosage and Administration
Externally.
keravort cream should be applied before bedtime. Before applying the cream, it is necessary to wash the affected areas of the skin with soap and allow them to dry. The cream is applied to the affected areas and gently rubbed into the skin. The cream should remain on the skin for 6-10 hours. Avoid getting water on the affected area, it is necessary to postpone showering and other water procedures for 8 hours. After the specified time, the cream should be washed off with warm water and soap. A cream from one bag is enough to apply on a skin area of 20 cm2.
Do not reuse cream from a previously opened sachet! Before and after applying the cream, wash your hands with warm water and soap. In the treatment of genital / perianal warts, the cream should be used after intercourse.
Genital and perianal warts (genital warts) in adults.
Keravort cream should be applied three times a week (for example, on Monday, Wednesday and Friday or on Tuesday, Thursday and Saturday) before bedtime and leave on the skin for 6-10 hours. The cream is applied in a thin layer and rubbed into a clean surface of the areas affected by genital warts until completely absorbed.
Limited superficial basal cell carcinoma in adults.
Apply Keraworth Cream in a row 5 days a week for 6 weeks (for example, from Monday to Friday) before bedtime and leave on the skin for about 8 hours.
The response of the treated tumor to the cream must be evaluated 12 weeks after the end of treatment. If the treated tumor does not have a sufficient response, another treatment must be applied.
If a local skin reaction to the cream causes increased discomfort to the patient or if infection of the treated surface occurs, interrupt treatment for several days.
Actinic keratosis in adults. Treatment is prescribed and monitored by a physician. Keravort cream should be applied 3 times a week (for example, on Monday, Wednesday and Friday or on Tuesday, Thursday and Saturday) before bedtime for 4 weeks and leave on the skin for 8 hours. A sufficient amount of cream is applied to the entire affected surface. 4 weeks after discontinuation of treatment, the presence of actinic keratosis must be assessed. If any manifestations remain, treatment should be continued for another four weeks. The maximum recommended dose is one sachet. The maximum recommended treatment is 8 weeks.
If a local acute inflammatory reaction is observed or if infection of the treated surface occurs, treatment should be stopped. In the latter case, appropriate measures must be taken. Each treatment period should not exceed 4 weeks due to missed doses or rest periods.
If the lesions do not have a sufficient response to treatment at a subsequent examination 4-8 weeks after the second treatment period, another treatment must be applied.
If the dose is missed, the patient should apply the cream as soon as he remembers this, then it is necessary to continue treatment according to the usual schedule. However, it should be remembered that the cream can be applied no more than once a day.
Side effects
Very often: itching and pain at the site of applying
cream Frequently: increased risk of infection, headaches, erythema, erythema dizziness, fever, flu-like symptoms, nausea fatigue.
Infrequently: skin itching, dermatitis, folliculitis, erythematous rash, eczema, urticaria, insomnia, depression, irritability, paresthesia, migraine, drowsiness, tinnitus, pharyngitis, rhinitis abdominal pain, diarrhea, vomiting, anorexia, anal pain, rectal lesions fungal and bacterial infections, herpes simplex, vaginitis, vulvitis, painful intercourse, penis pain, vagina, atrophic vaginitis, lower back pain, arthralgia increased sweating, lymphadenopathy.
Rarely: induction, ulceration, scab formation and blistering, local hypopigmentation and hyperpigmentation.
Very rare: polymorphic erythema, Stevens-Johnson syndrome, cutaneous lupus erythematosus, decreased hemoglobin, leukopenia, absolute neutropenia and thrombocytopenia, increased levels of liver enzymes.
If local side effects occur, the cream should be removed by washing it with soap and water. Treatment can be resumed after stopping the skin reaction.
Drug Interactions
Not established.
Since Keravort Cream stimulates immunity, use with caution in patients receiving immunosuppressive drugs.
Overdose
When administered topically, a general overdose of Keravort cream is unlikely because of the low skin absorption of the drug.
Permanent overdosage with the use of a skin cream can cause severe local skin reactions. If local side effects occur, the cream should be removed by washing it with soap and water. Treatment can be resumed after stopping the skin reaction.
Symptoms: nausea, vomiting, headache may occur after accidentally swallowing one dose of 200 mg of Keravort cream, which corresponds to the content of approximately 16 sachets, muscle pain and fever. What is the most serious side effect observed after multiple oral doses 200 mg, was arterial hypotension, which was stopped by injecting the fluid inside and intravenously.
Treatment: drug withdrawal, gastric lavage, symptomatic therapy.
Storage Conditions
Store at 4 ° C to 25 ° C.
Shelf life
2 years.
Deystvuyushtee substance
imiquimode
Conditions of release from drugstores
Prescription
Formulation
cream
Possible product names
KERAVORT 5% 0.25 N12 PACK CREAM
Keravort cream 5% sachets 0.25 g, 12 pcs.
keravort cream 5% sachets 25 g, 12 pcs.
KERAVORT CREAM D / NAR. NOTE 5% PAK. 0.25G No. 12
KERAVORT CREAM 5% 25G No. 12
Glenmark Pharmaceuticals Ltd, India
