Aldara

General characteristics. Structure:

100 mg of drug contain: Active agent: Imikhimod-5,0 mg
Excipients: isostearic acid – 25,0 mg, cetyl alcohol – 2,2 mg, stearyl alcohol – 3,1 mg, white soft paraffin – 3,0 mg, polysorbate-60 – 3,4 mg, sorbitan stearate – 0,6 mg, benzyl alcohol – 2,0 mg, methylparahydroxybenzoate – 0,2 mg, пропилпарагидроксибензоат – 0,02 mg, глицерол – 2,0 mg, xanthane gum – 0,5 mg, the water purified – 52,98 mg.

Description:
Homogeneous cream from white till light yellow color.

Pharmacological properties:

Imikhimod – active ingredient of drug of Aldar - is connection modifier of an immune response. Imikhimod does not possess direct antiviral action, its action is caused by induction of interferon alpha (IFNα) and other cytokines.

Pharmacokinetics. Less than 0,9% marked are soaked up by radioactive isotope of an imikhimod through skin of the person after drawing a single dose.
A small amount of the drug which came to a system blood stream without delay is brought out of an organism by kidneys and through intestines in the ratio about 3: 1.
Concentration of drug in blood serum after single or repeated external use did not reach the level which is giving in to quantitative definition (> 5 ng/ml).

Indications to use:

Treatment of outside sharp-pointed condylomas in the place of localization on external genitals or in perianal area at adults.

Route of administration and doses:

Outwardly. Cream is applied with a thin layer on previously cleared surface of a condyloma and accurately rubbed in skin, before full absorption. Cream should be applied only on the struck area, avoiding hit on internal surfaces. Aldar's cream is applied 3 times a week, (for example: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) before going to bed, is also left on skin, approximately, for 6-10 hours, during this time it is not necessary to take a shower or a bath.
It is not necessary to apply a bandage on the site of use of cream.
After this period cream needs to be washed away water with soft soap.
Treatment should be continued before disappearance of visible genital or perianal condylomas, but no more than 16 weeks.
Aldar's cream is packed into the one-time bags sachets containing necessary amount of cream for drawing on an affected area of 20 cm2.
If you forgot to apply cream according to the schedule, put the passed dose as soon as you remember it, further follow the usual schedule.

It is not necessary to apply cream more than once in day.
Use of excess amount of cream is not allowed.

Features of use:

Aldar's cream is applied only on affected areas.
Avoid hit of cream on mucous membranes.
Avoid contact of cream with eyes. At hit of cream in eyes it is recommended to wash out them water.
Aldar's cream is applied before going to bed. Use of excess amount of cream or longer contact of cream with skin can cause the expressed local reaction.
Reuse of the opened bag sachet is not allowed.
It is necessary to wash up carefully hands before putting cream.
Men who did not carry out trimming at treatment of the sharp-pointed condylomas located under a prepuce have to wash out daily area of defeat, having delayed a prepuce. It is recommended to stop immediately treatment in case of detection of precursory symptoms of a phymosis.
If local reaction to drug serves as the reason of serious discomfort for the patient or if in a zone of use of cream there is an infection, it is allowed to make
having rummaged in treatment for several days. In case of an infection necessary measures are taken.
Aldar's cream can cause an exacerbation of inflammatory diseases of skin.
It is not recommended to use Aldar's cream before healing of skin after other types of drug or surgical treatment.
It is not necessary to start treatment by Aldar's cream on sites with open ulcers or wounds before their healing.
Fillers methylparahydroxybenzoate, пропилпарагидроксибензоат, cetyl alcohol and stearyl alcohol can cause allergic reaction.
At identification of reaction of hypersensitivity it is recommended to stop therapy.
It is not recommended to use an occlusive bandage during treatment by Aldar's drug.
Use of an imikhimod in the doses exceeding recommended can lead to increase in risk of development of heavy local reactions.
During use of cream of Aldar, it is necessary to avoid or minimize impact of a sunlight (including sunlight lamps) as there is a threat of receiving sunblisters.
As имихимод does not possess direct antiviral and cytotoxic action, after the carried-out therapy developing of new condylomas of genital and perianal areas is possible.
On the basis of knowledge which is available now treatment of urethral, intravaginalny, cervical, rectal or intraanalny sharp-pointed condylomas Aldar's cream is not recommended.
Before sexual contact Aldar's cream should be washed away from the surface of skin.
Aldar's cream is capable to reduce efficiency of condom or a vaginal diaphragm therefore it is not recommended to apply these contraceptives when using cream of Aldar. It is necessary to choose an alternative method of contraception.
At patients with an immunodeficiency it is not recommended to reuse Aldar's cream.

Influence on ability to manage vehicles and to work with mechanisms
Researches of influence of drug on ability to drive the car and to work with mechanisms were not conducted.

Side effects:

Frequency of development of side effects is determined as follows:
Very often:> 1/10;
Often: <1/10> 1/100;
Infrequently: <1/100> 1/1000;
Seldom: <1/1000> 1/10000;
Very seldom: <1/10000.
Local skin reactions:
Very often: an itch and pain in a cream site of application.
Often: infection, erythema, erosion, excoriation/peeling and hypostasis.
Infrequently: skin itch, dermatitis, folliculitis, erythematic rash, eczema, small tortoiseshell.
Seldom: induration, ulceration, formation of crusts and emergence of bubbles, local hypopigmentation and hyperpegmentation.
Disturbances of the central and peripheral nervous system:
Often: headache, dizziness.
Infrequently: sleeplessness, a depression, irritability, paresthesia, migraine, drowsiness, a ring in ears.
Disturbances of the alimentary system:
Often: nausea.
Infrequently: an abdominal pain, diarrhea, vomiting, anorexia, pain in an anus, damages of a rectum. Disturbances of urinogenital system:
Infrequently: fungal and bacterial infection, herpes simplex, vaginitis, vulvitis, painful sexual intercourse, phallodynia, vagina, atrophic vaginitis.
Disturbances of system of a hemopoiesis:
Very seldom: decrease in hemoglobin, leukopenia, absolute neutropenia and thrombocytopenia.
Musculoskeletal system:
Infrequently: back pain, arthralgia.
Respiratory system:
Infrequently: pharyngitis, rhinitis.
System manifestations:
Often: infection, mialgiya, fever, grippopodobny symptoms, fatigue.
Infrequently: the increased perspiration, a limfoadenopatiya.
At emergence of local side effects cream should be removed, having washed away its water with soap. Treatment can be resumed after stopping of skin reaction.

Interaction with other medicines:

Studying of interaction of an imikhimod with other medicines, including immunodepressants, was not carried out. The minimum absorption of an imikhimod through skin has to limit interaction with drugs of systemic action.

Contraindications:

Hypersensitivity to an imikhimod or any other components of cream;
Children's age up to 18 years (due to the lack of data).

Use at pregnancy and in the period of a lactation
Use at pregnancy is possible according to strict indications if the estimated advantage for mother exceeds potential risk for a fruit.
In need of use of drug in the period of a lactation breastfeeding should be stopped.

Overdose:

In case of external use probability of system overdose of cream Aldara is small in connection with low absorption of drug through skin.
At the accidental use in a dose of an imikhimod of 200 mg that corresponds to contents about 16 bags sachets, nausea, vomiting, a headache, a mialgiya and fever can be observed. The most serious from the clinical point of view side effect of intake of several doses on 200 mg is arterial hypotension which is stopped by administration of liquid inside or intravenously.

Storage conditions:

Period of validity 2 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Cream for external use of 5%.
250 mg of cream in a bag from the multilayer film consisting of a polyethylene film, a polyester film and aluminum foil; it is corked by thermowelding.
12 bags together with the application instruction place in a cardboard pack.