Aldara cream 5% 250 mg sachets 12 pcs

Immunomodulator.

The active ingredient of the drug – imiquimod, which is an immune response modifier.

This material (imiquimod) has no direct antiviral effect and its effect is due to the induction of interferon alfa and other cytokines.

Pharmacokinetics.

Less than 0.9% of radiolabeled imiquimod absorbed through human skin after application of the single dose.

A small amount of drug released to the systemic circulation, without delay excreted through the kidneys and intestines in a ratio of about 3: 1.

Concentration in serum after a single or repeated topical use did not reach the level of quantifiable (> 5 ng / ml).

Active substance:
Imiquimod

Manufacturer

Meda Pharma GmbH & Co. KG, Switzerland

Prescribing

For adults on prescription

Composition

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, of 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.

Indications

Treatment of external genital warts at the location on the external genitals or in the perianal region in adults.

Contraindications

• protivopakazano children up to 18 years (due to lack of data);
• Hypersensitivity to imiquimod or any other components of the cream.

Side effects

The incidence of side effects is defined as follows: very often (> 1/10), often (1/100) infrequently (1/1000), rare (1/10 000) are very rare (

Local skin reactions: very often – itching and pain at the site of application of the cream; often – infection, erythema, erosion, excoriation / flaking, and edema; rarely – itching, dermatitis, folliculitis, erythematous rash, eczema, urticaria; rarely – induration, ulceration, scabbing, and the emergence of bubbles, local hypopigmentation and hyperpigmentation.

On the part of the central nervous system and peripheral nervous system: often – headache, dizziness; rarely – insomnia, depression, irritability, paresthesia, headache, drowsiness, ringing in the ears.

From the digestive system: often – nausea; Infrequent – abdominal pain, diarrhea, vomiting, anorexia, pain in the anus, rectum injury.

With the sexual side of the system: Infrequent – fungal and bacterial infections, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, vagina, atrophic vaginitis.

From hemopoiesis system: very rarely – a decrease of hemoglobin, leukopenia, neutropenia, and thrombocytopenia absolute.

On the part of the musculoskeletal system: rarely – back pain, arthralgia.

The respiratory system: rarely – pharyngitis, rhinitis.

On the part of the body as a whole: often – an infection, myalgia, fever, flu-like symptoms, fatigue; Infrequent – increased sweating, lymphadenopathy.

When the local side effects of the cream should be removed by washing with soap and water. The treatment can be resumed after the relief of skin reactions.

How to accept, acceptance rate and dosage

Apply externally. The cream is applied a thin layer to pre-cleaned surface warts and gently rubbed into the skin until fully absorbed. The cream should only be applied to the affected area, avoiding contact with the inner surface.

Aldara cream applied 3 times per week (e.g., Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) before bedtime, and left on the skin, approximately 6-10 hours, during this time should not take a shower or bath. On application portion cream should not be applied bandage. After this period, the cream must be washed off with water and mild soap.

Treatment should be continued until the disappearance of visible genital or perianal warts, but not more than 16 weeks.

Aldara cream packaged in disposable sachets containing a suitable amount of cream for application to the affected area, an area of ​​20 cm ² .

Do not apply the cream more than 1 times / day.

Avoid using an excessive amount of cream.

Storage conditions

At temperatures above 25 ° C

Active substance

Imiquimod

Interaction

Imiquimod study of the interaction with other drugs, including immunosuppressive agents was conducted.

Imiquimod minimum absorption through the skin should limit the interaction with systemic medications.

Special conditions

Aldara cream is applied only to the affected areas.

Avoid exposure to mucous membranes lotions, creams contact with the eyes. After contact with the eye cream is recommended to wash them with water.

Aldara cream is applied before going to bed. Using an excess amount of cream or cream longer contact with the skin can cause pronounced local reaction.

Do not reuse an opened bag.

Wash your hands thoroughly before and after applying the cream.

Men who do not perform circumcision in the treatment of genital warts, located under the foreskin should wash the affected area every day, pulling the foreskin. It is recommended to discontinue treatment immediately in case of detection of early signs of phimosis.

If the local reaction to the drug causes severe discomfort to the patient, or if the area of ​​application of the cream develops the infectious process is allowed to take a break in treatment for several days. necessary measures are taken in case of infection.

Aldara cream may cause aggravation of inflammatory skin diseases.

It is not recommended to use Aldara cream to the skin healing after other types of medical or surgical treatment.

You should not start treatment Aldara cream on areas with open sores or wounds to heal them.

Fillers methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol and stearyl alcohol may cause allergic reactions. In identifying 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 recommended may lead to an increased risk of severe local reactions.

During application of Aldara cream should avoid or minimize the effect of solar light (including sunlight lamp), because there is a risk of sunburn.

Since Imiquimod has no direct antiviral and cytotoxic effects after therapy may experience new genital warts and perianal areas.

On the basis of currently available knowledge of the treatment of urethral, ​​intravaginal, cervical, rectal or genital warts intraanalnyh Aldara cream is not recommended.

Before intercourse Aldara cream should be washed from the skin surface.

Aldara cream is able to reduce the effectiveness of the condom or vaginal diaphragm, it is not recommended to apply these contraceptives using Aldara cream. It is necessary to choose an alternative method of contraception.

In immunocompromised patients is not recommended to use Aldara cream again.

Effects on ability to drive and use machines

Studies of the effect of the drug on the ability to drive and operate machinery have not been conducted.

Pregnancy and lactation

Application of pregnancy is possible under strict indications, if the expected benefit to the mother outweighs the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Overdose

In the case of external application of Aldara cream probability of systemic overdose small due to the low absorption of the drug through the skin.

If accidentally ingested imiquimod in a dose of 200 mg, corresponding content of about 16 bags may experience nausea, vomiting, headache, fever and myalgia. The most serious clinical perspective side effect of oral administration of multiple doses of 200 mg is hypotension, which is docked by introducing fluid into or /.