Androzhel gel for an external comment of 16.2 mg/g fl. 88 g

Androzhel use as replacement hormonal therapy by testosterone at adult men with a hypogonadism if its deficit is confirmed with a clinical course and laboratory tests.

Structure

• active ingredient: testosterone;
16.2 mg contain
• 1 g of gel testosterone;
• other components: isopropyl myristate, ethanol of 96%, carbomer (karbopol 980), sodium hydroxide 0.1 N, water purified.

Contraindication

Diagnosed or suspected prostate cancer or cancer of chest glands.

Hypersensitivity to testosterone or any other component of drug.

Side reactions

Most often at use of the recommended Androzhel's dose can arise such side reactions as mental disorders and skin reactions in the site of application of gel.

Route of administration

For external use (on skin).

Adult men and men of advanced age

Recommended dose makes 2 pressing of the portioning device (40.5 mg of testosterone) of 1 times a day, it is desirable at the same time, in the morning. The daily dose can individually be regulated for each patient depending on clinical effect and results of laboratory control, but should not exceed 4 pressing of the portioning device (81 mg of testosterone) a day. Dose adjustment should be made by addition of one pressing the portioning device.

Dose should be raised gradually, considering testosterone level in blood in the morning before putting gel. Equilibrium concentration of testosterone in blood is reached usually in second day of the Androzhel medicament treatment. To adjust testosterone dosage, concentration of testosterone should be measured in blood in the morning before putting gel after achievement of an equilibrium state. It is necessary to estimate testosterone levels at blood periodically. The dose can be lowered if concentration of testosterone in blood is raised. If concentration low, the dose can be increased gradually, but it should not exceed 81 mg of gels/days (4 pressing the portioning device).

Therapy should be stopped if testosterone levels in blood constantly exceed the range of normal values at use of the lowest daily dose of 20.25 mg (1.25 g of gel that is equivalent to one pressing the portioning device) or at use of the highest dose of 81 mg of testosterone (5 g of gel that is equivalent to four pressing the portioning device) testosterone levels in blood do not reach the range of normal values.

Route of administration

Gel should be applied to patients independently to clean, dry, healthy skin on both shoulders and upper parts of hands.

with easy movements, smearing it on skin a thin layer. Gel should not be rubbed in skin. To allow to dry within at least 3-5 minutes before putting on. After putting gel to wash up hands with soap and to cover the site of application with clothes after gel dries. In any situations when close contact with the site of application of gel with other person is supposed, the place of use of medicine should be washed up carefully water with soap.

gel on genitalias as alcohol in high concentration can cause local irritation.

For receiving the first dose the portioning device. For this purpose, holding a bottle in vertical position, it is necessary to make three slow and full pressing the portioning device. Gel after the first three pressing should be utilized safely. The portioning device needs to be filled only before the first use.

After the procedure of filling is followed by one full pressing the portioning device for release of 1.25 g of Androzhel medicine in a palm and then to apply it on shoulders and an upper part of hands.

Androzhel is intended to

Feature of use

only for treatment of men.

Androzhel cannot be applied during pregnancy or feeding by a breast because of possible virilescence of a fruit. Clinical trials of such treatment of women were not conducted.

to Pregnant women should avoid contact with sites of application of the medicament Androzhel (see the section "Features of Use"). At contact it is necessary to wash up immediately places of contact by water with soap.

Androzhel can oppress reversibly a spermatogenesis.

Children

Safety and efficiency of use of Androzhel medicine are not established to children (up to 18 years) by

. Data are absent.

Ability to influence speed of response at control of motor transport or other mechanisms

Androzhel does not influence or affects slightly ability to run motor transport or to work with other mechanisms.

Only one case of acute overdose of testosterone after an injection was described by

in literature. It concerned disturbance of a brain blood-groove at the patient with high concentration of testosterone in blood plasma – 114 ng/ml (395th nmol/l). It is improbable that so high level of testosterone can be reached at transdermalny use.

Treatment of overdose has to include phase-out of Androzhel medicine and the corresponding symptomatic maintenance therapy.

Interaction with other medicines and other types of interactions

Because of change of anticoagulating activity (the enhanced effect of oral anticoagulant is possible owing to modification of hepatic synthesis of a factor of coagulation and competitive inhibition of linking with proteins of blood plasma) by

careful monitoring of a prothrombin time and definition of the international normalized relation (INR). The patients receiving oral anticoagulants need careful observation, especially at the beginning of use of androgens or after their cancellation.

Co-administration of testosterone with adrenocorticotropic hormone (AKTG) or corticosteroids can increase risk of developing hypostases. Therefore these medicaments in a combination should be used with care, especially to patients with diseases of heart, kidneys or a liver.

Impact on results of laboratory tests: androgens can reduce the level of tiroksinsvyazyvayushchy globulin that results in reduced concentration of T4 in blood serum and to the increased assimilation of T3 and T4. Levels of free hormone of a thyroid gland remain invariable, and there are no clinical signs of insufficiency of a thyroid gland.

to

At use of androgens it was reported about changes of sensitivity to insulin, tolerance of glucose, control of a glycemia, levels of glucose of blood and glikozilirovanny hemoglobin. Decrease in a dosage of anti-diabetic means can be required by patients with diabetes.

Use of cream or lotion from suntan does not reduce efficiency.

Washing off in 2 h after use has no significant effect on testosterone level in blood.

Storage conditions

does not demand special storage conditions.

out of children's reach.