Description
Latin name
ALDARA
Release form
Cream for external use, uniform from white to light yellow.
Packaging
250 mg – multilayer bags, heat sealable (12) – packs of cardboard.
Pharmacological action
Immunomodulator. Imichimod – the active substance of the drug – is a modifier of the immune response.
Imichimod does not have a direct antiviral effect, its effect is due to the induction of interferon alpha and other cytokines.
Pharmacokinetics.
Less than 0.9% of the radiolabeled imichimoda is absorbed through human skin after a single dose.
A small amount of the drug that enters 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 single or multiple external use did not reach a level that could be quantified (> 5 ng / ml).
Indications
Treatment of external genital warts at the site of localization on the external genital organs or in the perianal region in adults.
Contraindications
children under 18 years of age (due to lack of data)
hypersensitivity to imichimod or any other components of the cream.
Use during pregnancy and lactation
Use during pregnancy is possible according to strict indications, if the intended benefit to the mother outweighs the potential risk to the fetus.
If you need to use the drug during lactation, breastfeeding should be discontinued.
Composition
100 mg
imichimod 5 mg
Excipients: isostearic acid – 25 mg, cetyl alcohol – 2.2 mg, stearyl alcohol – 3.1 mg, soft white paraffin – 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
Dosage and administration
Applied externally. The cream is applied in a thin layer on the previously cleansed surface of the condyloma and gently rubbed into the skin until completely absorbed. The cream should be applied only to the affected area, avoiding contact with internal surfaces.
Aldar cream is applied 3 times a week (for example, Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) before bedtime, and remains on the skin for approximately 6-10 hours, during which time you should not take a shower or bath. A dressing should not be applied to the area of application of the cream. After this period, the cream must be washed off with water and a mild soap.
Treatment should be continued until the disappearance of visible genital or perianal genital warts, but not more than 16 weeks.
Aldar cream is packaged in disposable sachets containing the necessary amount of cream for application to the affected area, an area of 20 cm2.
Cream should not be used more than 1 time / day.
Do not use excess cream.
Side effects
The frequency of side effects is defined as follows: very often (> 1/10), often (1/100), infrequently (1/1000), rarely (1/10 000), very rarely (
Local skin reactions: very often – itching and pain at the site of application of the cream often – infection, erythema, erosion, excoriation / peeling and swelling infrequently – skin itching, dermatitis, folliculitis, erythematous rash, eczema, urticaria rarely – induction, ulceration, scab formation and appearance 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.
From the reproductive system: infrequently – fungal and bacterial infections, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, vagina, atrophic vaginitis.
From the hemopoietic system: very rarely – a decrease in hemoglobin, leukopenia, absolute neutropenia and thrombocytopenia.
From the musculoskeletal system: infrequently – lower back pain, 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 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 Interaction
The interaction of imihimod with other drugs, including immunosuppressants, has not been studied.
The minimum absorption of imihimod through the skin should limit the interaction with systemic drugs.
Overdose
In the case of external use, the likelihood of systemic overdose of Aldar cream is low due to the low absorption of the drug through the skin.
Nausea, ingestion of 200 mg imihimod, which is approximately 16 sachets, may result in nausea, vomiting, headache, myalgia and fever. The most serious clinical side effect of taking 200 mg multiple doses is arterial hypotension, which is stopped by injecting the liquid inside or in / in.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.
Expiration
2 years.
Deystvuyuschee substances
Ymyhymod
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drugstores Prescription
Formulation
Formulation
cream
