Aldara cream 5% 250mg 12 sachets — Made in UK — Free Delivery
(Aldara)
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Description Aldara cream 5% 250mg 12 sachets — Made in UK — Free Delivery
Pharmacological properties
Pharmacodynamics. Imiquimod is an immune response modifier. Saturated binding studies suggest the presence of protein receptors that respond to imiquimod on immunocyte membranes. imiquimod has no direct antiviral activity. In experimental animal models, imiquimod exhibited antiviral activity and exerted an effect as an antitumor agent, mainly inducing the synthesis of α-interferon and other cytokines. the induction of the synthesis of α-interferon and other cytokines after application of Aldar cream to tissues affected by genital warts was also revealed during clinical studies.
An increase in the systemic level of α-interferon and other cytokines after topical application of the preparation Aldara was determined in pharmacokinetic studies.
Pharmacokinetics. When applied topically, 0.9% of 1 dose of labeled imiquimod penetrated the skin. A small amount of the cream, which was absorbed into the general circulation system, was rapidly excreted through the urinary system and intestines in an average ratio of 3: 1.
The systemic effect (skin penetration) was determined based on the reduction of carbon-14 [14C] imiquimod in urine and feces.
Cmax of the active substance in blood plasma at the end of the 16th week was reached in the range of 9 and 12 hours and was 0.1; 0.2 and 1.6 ng / ml when applied to the face (12.5 mg, 1 sachet for single use), scalp (25 mg, 2 sachets) and hands (75 mg, 6 sachets), respectively. The area of application areas was not taken into account. T1 / 2 after subcutaneous injection - 2 hours. When applied to the skin, T1 / 2 is 10 times higher, which suggests that the preparation remains on the skin for a long time. Excretion in the urine in patients - 0.6% of the applied dose, applied for 16 weeks.
Indications
Aldara cream is used for topical treatment:
- external genital and perianal warts (genital warts);
- small superficial basaliomas;
- clinically typical, non-hyperkeratic, non-hypertrophic actinic keratosis on the face or scalp in patients with a normally functioning immune system, when the size or amount of the lesion limits the effectiveness and / or appropriateness of cryotherapy, and other topical treatments are contraindicated or less appropriate.
Application
The frequency and duration of use is determined by the doctor individually for each patient.
External genital warts in adults. Imiquimod cream should be applied 3 times a week (eg Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) before bedtime and left on the skin for 6-10 hours. Treatment with imiquimod cream should be continued until genital and perianal warts disappear or no more 16 weeks for each appearance of genital warts.
The cream is applied in a thin layer and rubbed into the clean surface of the areas affected by genital warts until completely absorbed. It should only be applied to the affected areas. Do not shower or bathe for 6-10 hours after applying the cream to the skin. After that, it must be washed off with warm water and soap. Excessive application of the cream or prolonged contact with the skin may cause a reaction at the site of application. Cream from 1 sachet is enough for application on a skin area of 20 cm2. It is prohibited to reuse the cream from the previously opened sachet. Before and after applying the cream, you should wash your hands with warm water and soap.
Men who have not undergone circumcision, during treatment with genital warts under the foreskin, should push back the foreskin and wash the area under it daily.
Superficial basalioma in adults. Apply imiquimod cream 5 days a week for 6 weeks (e.g. Monday to Friday) before bedtime and leave on the skin for approximately 8 hours.
Before applying imiquimod cream, wash the affected area with soap and let it dry. A sufficient amount of the cream is applied to the entire affected surface, including healthy skin, 1 cm from the edge of the tumor. The cream should be rubbed into the affected area until it is completely absorbed. The cream should be applied at bedtime and should remain on the skin for 8 hours. Showering or bathing should be avoided during this time. After that, the cream must be washed off with warm water and soap.
It is prohibited to reuse the cream from the previously opened sachet. Before and after applying the cream, you should wash your hands with warm water and soap.
The response of the treated tumor to the cream should be assessed 12 weeks after the end of treatment. If there is no response to the applied therapy, another treatment should be prescribed.
If a local skin reaction to the cream causes increased discomfort or if the treated surface becomes infected, it is necessary to interrupt the treatment for several days.
Actinic keratosis in adults. Treatment is prescribed and monitored by a doctor. Imiquimod cream should be applied 3 times a week (eg Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) at bedtime for 4 weeks and left on the skin for 8 hours. Apply sufficient cream to the entire affected area. 4 weeks after stopping treatment, the presence of actinic keratosis should be assessed. If residual manifestations of the disease are present, treatment should be continued for another 4 weeks.
The maximum single dose is 1 sachet. The maximum duration of treatment is 8 weeks.
If there is a local acute reaction of inflammation or infection of the treated surface, treatment should be discontinued. In the latter case, appropriate measures must be taken. Each treatment period should not exceed 4 weeks, including any missed days.
If the skin lesions do not fully respond to the prescribed therapy, then after 4–8 weeks of the second treatment period, a new therapy should be prescribed.
Before applying the cream, wash the affected areas with soap and let them dry. Apply a sufficient amount of cream to the entire affected area. The cream must be rubbed into the affected area until it is completely absorbed. The cream is applied before going to bed, it should remain on the skin for 8 hours. During this time, you should avoid taking a shower or bath. After the specified time, the cream must be washed off with warm water and soap.
It is prohibited to reuse the cream from the previously opened sachet. Before and after applying the cream, you should wash your hands with warm water and soap.
If a dose is missed, the patient should apply the cream as soon as he remembers, and then continue the treatment according to the usual schedule. However, it should be remembered that the cream can be applied no more than 1 time per day.
Contraindications
Hypersensitivity to the active substance or other components of the preparation.
Side effects
The frequency of adverse reactions is defined as very often (? 1/10), often (from? 1/100, 1/10) and infrequently (from? 1/1000, 1/100).
External genital warts. With 3 times the application of the cream per week, the most common adverse effects were reactions at the site of application of the cream: erythema, erosion, desquamation and edema. Some systemic adverse reactions have also been reported, namely headache, flu-like symptoms, muscle pain.
Delayed skin reactions, mainly erythema, were also noted in unaffected areas that may have come into contact with Aldara cream. Most of these reactions disappeared within 2 weeks after the end of treatment. However, in some cases, these reactions were severe and caused dysuria in women.
Infections and infestations: often - a tendency to bacterial infections; infrequently - herpes simplex, genital candidiasis, vaginitis, bacterial infection, mycosis, upper respiratory tract infections, vulvitis.
On the part of the blood and lymphatic system: infrequently - lymphadenopathy.
From the side of metabolism: infrequently - anorexia.
From the side of the psyche: infrequently - insomnia, depression.
From the nervous system: often - headache; infrequently - paresthesia, dizziness, hemicrania, drowsiness.
On the part of the organ of hearing and balance: infrequently - tinnitus.
From the side of the vessels: infrequently - hyperemia.
From the respiratory system: infrequently - pharyngitis, rhinitis.
From the gastrointestinal tract: often - nausea; infrequently - vomiting, abdominal pain, diarrhea, painful urge to defecate, violation of the rectal area.
Skin and subcutaneous tissue disorders: infrequently - itching, dermatitis, folliculitis, erythematous rash, eczema, increased sweating, urticaria.
Musculoskeletal and connective tissue disorders: often - muscle pain; infrequently - pain in joints, back.
From the side of the kidneys and urinary system: infrequently - dysuria.
From the reproductive system: infrequently - pain in the genital area in men, penile disorders, dyspareunia, erectile dysfunction, prolapse of the uterus and vagina, vaginal pain, atrophic vaginitis, vulvar lesions.
General reactions: very often - itching and pain at the site of application; often - burning and irritation at the site of application, fatigue; infrequently - hyperthermia, flu-like symptoms, pain, asthenia, discomfort, chills.
Superficial basaliomas. With 5 times the application of the cream per week, reactions were noted at the site of application of the cream: erythema, erosion, severe scab and peeling, as well as some systemic adverse reactions, including back pain and flu-like symptoms.
Infections and infestations: often - a tendency to bacterial infections, acne.
From the lymphatic system: often - lymphadenopathy.
From the side of the psyche: infrequently - irritability.
From the gastrointestinal tract: infrequently - nausea, dry mouth.
On the part of the skin and subcutaneous tissue: infrequently - dermatitis.
Musculoskeletal and connective tissue disorders: often - back pain.
General reactions: very often - itching at the site of application; often - burning, irritation and pain at the site of application, erythema, bleeding in the area of application, the formation of papules, paresthesia and rashes at the site of application; infrequently - flu-like symptoms, discharge at the site of application, inflammation, swelling and swelling at the site of application, scab formation, destruction of the site of application, blistering, lethargy.
Actinic keratosis. With 3 times the application of the cream per week, 2 courses lasting 4 weeks, reactions were noted at the site of application of the cream, namely itching and burning. Severe erythema and severe scabs and scaling were common. Some systemic adverse reactions have also been reported, namely muscle pain.
Infections and infestations: infrequently - a tendency to bacterial infections, acne, flu, rhinitis.
On the part of the blood and lymphatic system: infrequently - lymphadenopathy.
From the side of metabolism: often - anorexia.
From the side of the psyche: infrequently - depression.
From the side of the central nervous system: often - headache.
From the side of the organ of vision: infrequently - edema of the eyelids, inflammation of the conjunctiva.
From the respiratory system: infrequently - sore throat, nasal congestion.
From the gastrointestinal tract: often - nausea; infrequently - diarrhea.
Skin and subcutaneous tissue disorders: infrequently - erythema, actinic keratosis, facial edema, skin ulcers.
Musculoskeletal and connective tissue disorders: often - pain in muscles, joints; infrequently - pain in the limbs.
General reactions: very often - itching in the area of application; often - fatigue, burning, irritation and pain in the area of application, erythema, reaction at the site of application; infrequently - bleeding in the area of application, the formation of papules, paresthesia, hyperthermia, asthenia, chills, dermatitis, discharge at the site of application, hyperesthesia of the site of application, edema, the formation of scabs and scars, swelling and ulceration at the site of application, the formation of bubbles, an increase in body temperature at the site of application, a feeling of discomfort, inflammation.
Adverse reactions that were noted for all indications were hypo- and hyperpigmentation after applying the cream, alopecia at the site of application or the surrounding area. In isolated cases, a decrease in the level of hemoglobin, the level of blood leukocytes, the absolute number of neutrophils and platelets was noted, but this did not require intervention. In some reports, elevated liver enzymes and exacerbation of autoimmune conditions have been reported. Severe skin reactions reported in clinical trials include erythema polymorphism, Stevens-Johnson syndrome, and cutaneous manifestations of systemic lupus erythematosus.
Special instructions
Application features for all indications
Avoid contact with the mucous membranes of the eyes, lips and nose.
Imiquimod can exacerbate inflammation in the skin.
The cream should be used with caution in patients with autoimmune diseases, as well as in organ transplant recipients.
Cream treatment is not recommended if the skin is still broken after previous medical or surgical treatment. Applying the cream to the affected skin may increase the systemic absorption of imiquimod, leading to an increased risk of adverse reactions.
The use of an occlusive dressing is not recommended.
In rare cases, an acute inflammatory reaction is possible, including oozing or erosion after several applications of imiquimod cream. Local acute inflammatory reactions may accompany or even precede flu-like systemic signs and symptoms, including malaise, fever, nausea, muscle pain, and chills.
Imiquimod should be used with caution in patients with anemia.
External genital warts. Treatment of men with warts in the foreskin is possible only with daily hygiene procedures. In their absence, a stricture may appear or an increase in the difficulty of shifting the foreskin, which can lead to phimosis and stricture.
Treatment of urethral, intravaginal, cervical, rectal, or intraanal warts is not recommended. Treatment of tissues with open ulcers or wounds until they are completely healed is not prescribed.
Skin reactions are common with cream treatment. In this regard, if the skin reaction becomes unbearable, the area where the cream is applied must be washed with warm water and soap. Cream treatment can be resumed after the severity of skin reactions has subsided.
There are no clinical data on the use of the cream immediately after the treatment of genital and perianal warts with other preparations.
Imiquimod cream should be washed off before intercourse. It can reduce the effect of condoms and vaginal diaphragms. Other contraception must be used.
Re-treatment with the cream is not recommended for immunocompromised patients.
In the treatment of genital warts in HIV-positive patients, the use of the cream has not always been effective.
Superficial basaliomas. When treating basal cell carcinoma, the cream should be applied no closer than 1 cm from the border of hair growth, the edge of the eyes, mouth or nose.
The clinical outcome of treatment can be assessed after skin regeneration approximately 12 weeks after the end of treatment.
There are no clinical data on the use of the cream in immunocompromised patients.
Large tumors (7.25 cm2) are less responsive to imiquimod treatment.
The area of the skin surface to be treated must be protected from ultraviolet radiation.
Actinic keratosis. If lesions are clinically atypical for actinic keratosis or if malignancy is suspected, a biopsy should be performed.
When treating actinic keratosis, the cream should not be applied to the eyelids, the inner surface of the nose or ears, or to the red border of the lips.
There are very limited data regarding the use of the cream for treatment in other anatomical sites than the skin of the face or scalp. Data on the treatment of axillary keratosis and on the hands do not support efficacy.
Imiquimod is not recommended for the treatment of actinic lesions with severe hyperkeratosis or hypertrophy, which are characteristic of horny keratoma.
During treatment and until complete recovery, the affected skin differs markedly from healthy skin. Local skin reactions are normal, but the severity of these reactions usually diminishes during treatment or they disappear after stopping treatment with the cream. There is a relationship between the speed of recovery and the severity of local skin reactions (eg erythema). These local reactions may be associated with the stimulation of a local immune response. You can take a break from treatment for several days due to discomfort in the patient or severe local skin reactions. Treatment can be resumed after a decrease in the severity of skin reactions.
Each treatment period should not exceed 4 weeks due to missed doses.
The clinical outcome of the treatment can be assessed after skin restoration approximately 4–8 weeks after the end of treatment.
There are no clinical data on the use of the cream in immunocompromised patients.
The area of the skin to be treated must be protected from ultraviolet radiation.
Use during pregnancy and lactation. The preparation should not be administered to pregnant women and women who are breastfeeding.
Children. Contraindicated in children.
The ability to influence the speed of reactions when driving or working with other mechanisms. During treatment, care should be taken when driving or working with other mechanisms, as well as when performing work that requires increased concentration of attention, due to the possible appearance of weakness, dizziness.
Interactions
Since aldara stimulates the immune system, the cream should be used with caution in patients receiving immunosuppressants.
Overdose
With local application of the preparation, a general overdose of imiquimod cream is unlikely due to the low skin absorption of the preparation. persistent overdose with skin application of the cream can cause severe local skin reactions.
After accidentally swallowing a single dose of 200 mg imiquimod, which corresponds to the contents of approximately 16 sachets, nausea, vomiting, headache, muscle pain and fever may occur. The most serious adverse event that occurred after repeated oral doses of 200 mg was arterial hypotension, which resolved after oral or IV fluid therapy.
Storage conditions
At a temperature not higher than 25 ° C. reuse of opened sachets is not allowed.
Tags: Aldara
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