Composition, form of production and packaging
The cream for external use is uniform from white to light yellow color.
imiquimod 5 mg
Excipients: isostearic acid 25 mg, cetyl alcohol 2.2 mg, stearyl alcohol 3.1 mg, paraffin soft white 3 mg, polysorbate 60 3.4 mg, sorbitan stearate 0.6 mg, benzyl alcohol 2 mg, methyl parahydroxybenzoate 0.2 mg , propyl parahydroxybenzoate 0.02 mg, glycerol 2 mg, xanthan gum 0.5 mg, purified water 52.98 mg.
250 mg - sachets multilayered heat-sealing (12) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
Immunomodulator. Imichimod - the active substance of the drug Aldara - is a modifier of the immune response.
Imiximod does not have a direct antiviral effect, its effect is due to the induction of interferon alfa and other cytokines.
Less than 0.9% of the radiolabeled imiquimod is absorbed through the human skin after a single dose.
A small amount of the drug that enters the systemic bloodstream is excreted from the body by the kidneys and through the intestine at a ratio of approximately 3: 1 without delay.
Concentration of the drug in the blood serum after a single or multiple external application did not reach the level that can be quantified (> 5 ng / ml).
- treatment of external genital warts in the place of localization on the external genitalia or in the perianal region in adults.
Apply externally. The cream is applied a thin layer on the previously cleaned surface of the condyloma and gently rubbed into the skin until completely absorbed.Cream should be applied only to the affected area, avoiding contact with internal surfaces.
Aldara cream is applied 3 times a week (for example, Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) before going to bed, and left on the skin for about 6-10 hours, during this time, do not take a shower or bath. On the site of application of the cream should not be applied bandage. After this period, the cream should be washed off with mild soap and water.
Treatment should continue until the disappearance of visible genital or perianal condylomas, but no more than 16 weeks.
The Aldara cream is packaged in disposable sachets containing the required amount of cream to apply to the affected area, with an area of вЂ‹вЂ‹20 cm 2 .
Do not use the cream more than 1 time / day.
Do not use excess cream.
The incidence 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 in the place of application of the cream; often - infection, erythema, erosion, excoriation / scaling and edema;infrequently - itchy skin, dermatitis, folliculitis, erythematous rash, eczema, urticaria; rarely - induration, ulceration, scabbing and the appearance of vesicles, local hypopigmentation and hyperpigmentation.
From the side of the central nervous system and peripheral nervous system: often - headache, dizziness; infrequently - insomnia, depression, irritability, paresthesia, migraine, drowsiness, ringing in the ears.
From the digestive system: often - nausea; infrequently - abdominal pain, diarrhea, vomiting, anorexia, pain in the anus, lesions of the rectum.
On the part of the reproductive system: infrequently - fungal and bacterial infection, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, vagina, atrophic vaginitis.
From the hemopoietic system: very rarely - reduction of hemoglobin, leukopenia, absolute neutropenia and thrombocytopenia.
From the musculoskeletal system: infrequently - pain in the lower back, arthralgia.
From the respiratory system: infrequently - pharyngitis, rhinitis.
On the part of the body as a whole: often - infection, myalgia, fever, flu-like symptoms, fatigue; infrequently - increased sweating, lymphadenopathy.
If there are local side effects, the cream should be removed by washing it off with soap and water. Treatment can be resumed after a skin reaction has been stopped.
- Children under 18 years of age (due to lack of data);
- hypersensitivity to imichimod or any other components of the cream.
PREGNANCY AND LACTATION
Use in pregnancy is possible on strict indications, if the intended benefit to the mother exceeds the potential risk to the fetus.
If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR CHILDREN
Contraindicated in children under the age of 18 (due to lack of data);
Cream Aldara applied only to the affected areas.
Avoid contact with cream on the mucous membranes, contact the cream with the eyes. In case of contact with eyes, rinse with water.
Aldar's cream is applied before bedtime. The use of excessive amounts of cream or a prolonged contact of the cream with the skin can cause a pronounced local reaction.
Do not re-use the opened sachet.
Wash hands thoroughly before and after applying the cream.
Men who did not have circumcision, when treating genital warts, located under the foreskin, should daily rinse the affected area, pulling the foreskin. It is recommended to immediately stop treatment if early signs of phimosis are detected.
If a local reaction to the drug causes serious discomfort for the patient, or if an infectious process develops in the area of вЂ‹вЂ‹application of the cream, it is allowed to take a break for several days. In case of infection, the necessary measures are taken.
Cream Aldara can cause an exacerbation of inflammatory skin diseases.
It is not recommended to use Aldar cream before healing of the skin after other types of medicamentous or surgical treatment.
Do not start treatment with Aldar cream on sites with open sores or wounds before healing.
Fillers methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol and stearyl alcohol can cause an allergic reaction. When detecting a hypersensitivity reaction, it is recommended to stop therapy.
It is not recommended to use an occlusive dressing during treatment with Aldara.
The use of imiquimod in doses exceeding the recommended levels may lead to an increased risk of developing severe local reactions.
During the period of application of Aldar's cream, exposure to sunlight (including sunlight) should be avoided or minimized, as there is a risk of sunburn.
Since imiquimod does not have direct antiviral and cytotoxic effects, after the treatment, new genital warts and perianal areas may appear.
Based on the currently available knowledge, the treatment of urethral, вЂ‹вЂ‹intravaginal, cervical, rectal or intranalic genital warts with Aldar cream is not recommended.
Before sexual intercourse, Aldara Cream should be washed off the surface of the skin.
Aldara's cream can reduce the effectiveness of a condom or vaginal diaphragm, so it is not recommended to use these contraceptives when using Aldar's cream. You should choose an alternative method of contraception.
In patients with immunodeficiency it is not recommended to use Aldar's cream repeatedly.
Influence on ability to drive vehicles and work with mechanisms
Studies of the effect of the drug on the ability to drive a car and work with mechanisms have not been carried out.
In the case of external use, the probability of a systemic overdose of Aldara cream is low due to low absorption of the drug through the skin.
If the imichimod is randomly ingested at a dose of 200 mg, which corresponds to the contents of approximately 16 packets, nausea, vomiting, headache, myalgia, and fever may occur. The most serious from a clinical point of view, the side effect of ingesting several doses of 200 mg is arterial hypotension, which is stopped by the introduction of a liquid inside or in / in.
The interaction of imiquimod with other drugs, including immunosuppressants, has not been studied.
Minimal absorption of the imichimode through the skin should limit interaction with the drugs of systemic action.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.