Dekapeptil

General characteristics. Structure:

Active agent: triptorelina acetate of 105 mkg that соотв. to the maintenance of a triptorelin of 95.6 mkg

Excipients: sodium chloride, glacial acetic acid, water for and.

Pharmacological properties:

Synthetic analog gonadotrophin-rilizig of hormone (GNRG). Replacements of the 6th amino-acid rest in a molecule of natural GNRG were result more expressed affinity to receptors GNRG and more long half-life.
Right after introduction трипторелин causes increase in the FSG and LG level in blood that leads to short-term increase in concentration of sex hormones. Long stimulation of a hypophysis (at constant concentration of a triptorelin in blood) leads to blockade of gonadotropic function, decrease in level of sex hormones in blood to postkastratsionny or menopauzny level is result of it.
The described effects are reversible.
Researches on animals did not reveal teratogenic or mutagen action.

Pharmacokinetics. Absorption and distribution. During the first hours after administration of drug in oil Cmax of a triptorelin in blood is registered. Then concentration of a triptorelin considerably decreases during 24 h.

Metabolism and removal. T1/2 of a triptorelin in plasma makes 18.7 min. (T1/2 of natural GNRG makes 7.7 min.). The clearance of a triptorelin (503 ml/min.) by 3 times more slowly, than at natural GNRG (1766 ml/min.) also consists of two components - bystry and slow removal.
Less than 4% of a triptorelin in not changed look are allocated with urine.

Pharmacokinetic tests were carried out at patients with the confirmed diagnosis of endometriosis or a hysteromyoma, patients with a carcinoma of a prostate and healthy male volunteers.

Indications to use:

For women
— endometriosis;
— hysteromyoma;
— treatment of infertility using auxiliary reproductive technologies (including EKO and PE/transfer of an embryo/).

For men

— a symptomatic treatment of the progressing hormonedependent carcinoma of a prostate.

Route of administration and doses:

The drug is administered п / to.

Treatment of infertility at women by EKO method

Usually enter in a dose 0.1 mg in 1 day of a menstrual cycle or an early follicular phase until introduction of a chorionic gonadotrophin (chHG) (the short protocol) or from 1 day of a menstrual cycle or an early follicular phase within 3 days (the ultrashort protocol).

Hysteromyoma, endometriosis, prostate carcinoma

At the beginning of a course of treatment within 7 days of 1 ml of drug Dekapeptil of 0.5 mg (1 injection) is entered п / to 1 times/days. Since 8th day of treatment, for maintenance of therapeutic effect it is necessary to enter daily Dekapeptil 0.1 mg. The place of an injection should be changed.

For a long course of treatment it is recommended to use drug of Dekapeptil-depot (3.75 mg of a triptorelin in microcapsules of the slowed-down release) - 1 injection each 28 days.

Features of use:

It is necessary to treat with Dekapeptil under control of level of sex hormones in a blood plasma.
For women
It is necessary to conduct a research for the purpose of an exception of possible pregnancy at the time of an initiation of treatment. During therapy use of hormonal contraceptives is inadmissible. At endometriosis or a hysteromyoma treatment should be continued to a complete recovery of a menstrual cycle.
When performing therapy by Dekapeptil it is not necessary to use the drugs containing estrogen.
During a course of treatment ultrasonic control of the sizes of myoma and endometriozny nodes is obligatory. Bystry reduction of the sizes of a uterus can lead to development of bleeding.
The woman has to be warned that during a course of treatment Dekapeptil periods will be absent. In the presence of regular periods during therapy by Dekapeptil the patient has to see a doctor.

For men
Tranzitorny increase in level of testosterone in plasma at some patients can lead to a temporary aggravation of symptoms: the obstruction of uric ways, ostealgias caused by metastasises, symptoms of a compression of a spinal cord, muscular weakness, a hyperadenosis, puffiness of legs are observed. At emergence of one of these symptoms the patient should see a doctor.
In an initial stage of treatment it is necessary to consider expediency of use of anti-androgenic drug for the purpose of suppression of the symptoms caused by increase in level of testosterone.

Influence on ability to driving of motor transport and to control of mechanisms
Drug does not influence ability to driving of motor transport and other activity demanding high concentration of attention and speed of psychomotor reactions.

Side effects:

Side effects are caused by decrease in level of sex hormones in blood that can lead to emergence in men and women of such symptoms as: lability of mood, a depression, easing a libido, frequent headaches, sleep disorders, increase in body weight, inflows, the increased perspiration.

From urinogenital system: obstruction of uric ways, pains during sexual intercourse. Women have a dryness of a vagina, uterine bleedings. Men have a decrease in a potentiality, a gynecomastia, reduction of the sizes of testicles.

From TsNS and peripheral nervous system: paresthesias, vision disorders.

From the alimentary system: nausea, loss of appetite, increase in activity of hepatic transaminases, hypercholesterolemia.

From a musculoskeletal system: the dorsodynia, ostealgias caused by metastasises, compressions of a spinal cord, muscular weakness, mialgiya, arthralgias, demineralization of bones (at long reception).

Allergic reactions: itch, erubescence, fever, anaphylaxis.

Local reactions: seldom - pain in a drug injection site.

Others: thrombophlebitis, increase in lymph nodes, hypostases of legs, men have a reduction of growth of a beard and loss of hair on a breast, hands and legs.

All described side reactions disappear after the termination of a course of treatment.

Interaction with other medicines:

Dekapeptil's interaction with other drugs is not established.

Contraindications:

For women
— pregnancy;
— lactation period;
— clinical manifestations or risk of developing of osteoporosis;
It is necessary to use with care drug at implementation of the program of auxiliary reproductive technologies (EKO) at patients with a polycystosis of ovaries when number of the follicles defined by means of ultrasonography, more than 10.

For men
— hormonal independent carcinoma of a prostate;
— the previous surgical castration.

The general
— hypersensitivity to a triptorelin or other components of drug.

Use of drug DEKAPEPTIL at pregnancy and feeding by a breast
Use of drug at pregnancy and during breastfeeding is contraindicated.

Overdose:

Cases of overdose of drug were not observed. At emergence of overdose it is necessary to carry out a symptomatic treatment.

Storage conditions:

Drug should be stored in the unavailable to children, protected from light place (in the closed packaging) at a temperature from 2 °C to 8 °C.

Issue conditions:

According to the recipe

Packaging:

Solution for п / to introduction of 95.6 mkg/ml: syringe amp. 7 pieces.