Description
Latin name
ANDROGEL
Release form
Gel for external use.
Packing
30 pcs
Pharmacological action of
Androgel – androgen.
Pharmacodynamics
Endogenous androgens, mainly testosterone, secreted by the testes, and their main metabolite, dihydrotestosterone, is responsible for the development of external and internal genital organs and for the development and preservation of secondary sexual characteristics (stimulating hair growth, coarsening of the voice), libido for the overall effect on protein anabolism for the development of skeletal muscles and the distribution of subcutaneous fat for reducing excretion with urine of nitrogen, sodium, potassium, chlorides, phosphates and water. Testosterone does not cause the development of testicles: it reduces the pituitary secretion of gonadotropins.
The effects of testosterone on certain target organs are manifested after the peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the nuclei of target organ cells (such as the pituitary gland, adipose tissue, brain, bones, etc.).
Pharmacokinetics
The degree of absorption of testosterone through the skin varies from about 9% to 14% of the applied dose.
After absorption through the skin, testosterone enters the systemic circulation in relatively constant concentrations for 24 hours.
The concentration of testosterone in serum increases from the first hour after the use of the drug Androgel, reaching a constant value from the second day of treatment. Daily fluctuations in testosterone concentrations have the same amplitude as the changes in the content of endogenous testosterone observed in circadian rhythms.
With the external route of administration of the drug, there are no supraphysiological peaks in the concentration of testosterone in the blood that occur during the injection method of administration.
In contrast to oral androgen therapy, external use of the drug does not cause an increase in the concentration of steroids in the liver above physiological norms.
The use of 5 g of Androgel causes an average increase in plasma testosterone concentration of approximately 2.5 ng / ml (8.7 nmol / L).
After discontinuation of treatment, testosterone concentration begins to decline approximately 24 hours after the last dose. Concentration returns to baseline approximately 72-96 hours after the last dose.
The main active metabolites of testosterone are dihydrotestosterone and estradiol.
Androgel is excreted mainly with urine and with feces in the form of conjugated testosterone metabolites.
Indications
Replacement therapy for endogenous testosterone deficiency.
Contraindications
– Hypersensitivity to testosterone or other components of the
preparation – the presence of breast carcinoma, prostate cancer or suspected
– there is no experience with Androgel in women and children.
Caution:
malignant neoplasms (due to the risk of hypercalcemia and hypercalciuria) severe heart, liver or kidney failure coronary heart disease arterial hypertension migraine epilepsy.
Use during pregnancy and lactation
Pregnant women should avoid any contact with the drug due to its possible virilizing effect on the fetus.
In case of contact with the drug, wash the contact area with soap as soon as possible.
Composition
Gel for external use. 1 sachet contains:
Active substance: testosterone 0, 050 g
Excipients: isopropyl myristate, ethanol (96%), carbomer, sodium hydroxide, purified water.
Dosage and administration
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once a day at about the same time, preferably in the morning. An individual daily dose can be adjusted by a doctor depending on the clinical and laboratory parameters in patients, but should not exceed 10 g of gel per day. Correction of the dosage regimen should be carried out in steps of 2.5 g of gel per day.
Gel is applied to clean, dry, undamaged skin of the shoulders, shoulders and / or abdomen. After opening the bag, immediately apply all its contents to the skin and distribute with a thin layer. It is not necessary to rub it into the skin. Allow the gel to dry for at least 3-5 minutes before dressing. Wash hands with soap after application.
Do not apply the gel to the genital area, as the high content of ethyl alcohol in the preparation may cause local irritation.
A constant plasma testosterone concentration is reached on the second day of treatment with Androgel. To adjust the dose of testosterone, it is necessary to determine the concentration of testosterone in serum in the morning, before using the drug, from the third day after the start of treatment (within one week). The dosage can be reduced if the testosterone content in the plasma is increased. If the concentrations are low, the dose can be increased, but not more than 10 g of gel per day.
Side effects of
From the blood and lymphatic system: changes in laboratory test results (polycythemia, changes in lipid levels).
From the genitourinary system: changes in the prostate, gynecomastia, mastodynia.
From the nervous system: dizziness, paresthesia, amnesia, hyperesthesia, mood changes.
From the cardiovascular system: increased blood pressure.
From the gastrointestinal tract: diarrhea.
From the skin and its appendages: alopecia, urticaria.
General Disorders: headache.
The product contains alcohol, so if it is applied frequently to the skin, irritation and dryness may appear.
Drug Interaction
Androgel should be used with caution with oral anticoagulants, since it is possible to enhance the action of oral anticoagulants by modifying hepatic coagulation factor synthesis and competitive inhibition of plasma protein binding. It is recommended to monitor prothrombin time. Patients receiving oral anticoagulants require frequent monitoring, especially at the beginning and / or end of androgen treatment.
Co-administration of testosterone and ACTH or corticosteroids may increase the risk of edema. These drugs should be administered together with caution, especially in patients with heart, kidney, or liver disease.
Effects on Laboratory Tests: Androgens can reduce levels of thyroxine-binding globulin, resulting in a decrease in serum T4 concentrations and an increase in sensitivity to T3 and T4. The levels of free thyroid hormones, however, remain unchanged, and there are no clinical manifestations of hypothyroidism.
Overdose
No overdose has been reported with Androgel.
Only one case of overdose after administration of injectable testosterone has been described.
This was a stroke in a patient with a high plasma testosterone concentration of 114 ng / ml (395 nmol / l).
However, it is unlikely that similar concentrations of testosterone in plasma can be achieved by applying the drug to the skin.
Storage conditions
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Expiration
3 years.
Deystvuyuschee substances
Testosterone
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