Decapeptil, 0.1 mg/ml 1 ml syringes 7 pcs

Pharmacodynamics

A synthetic analogue of gonadotropin-releasing hormone (GnRH). The replacement of the 6th amino acid residue in the natural GnRH molecule resulted in a more pronounced affinity for GnRH receptors and a longer half-life.

Tryptorelin causes an increase in FSH and LH levels in the blood immediately after administration, resulting in a short-term increase in the concentration of sex hormones. Prolonged stimulation of the pituitary gland (with a constant concentration of tryptorelin in the blood) leads to a blockade of gonadotropic function, resulting in a decrease in the level of sex hormones in the blood to post-castral or menopausal levels.

The effects described are reversible.

Animal studies have shown no teratogenic or mutagenic effects.

Pharmacokinetics

Absorption and distribution

In the first hours after the intravenous administration of the drug, C_max triptorelin in the blood is recorded. Then the concentration of tryptorelin decreases markedly within 24 hours.

Metabolism and excretion

T_1/2 tryptorelin in plasma is 18.7 min (T_1/2 natural GnRH is 7.7 min). The clearance of tryptorelin (503 ml/min) is 3 times slower than that of natural GnRH (1766 ml/min) and consists of two components, fast and slow excretion.

Less than 4% of tryptorelin is excreted unchanged in the urine.

Pharmacokinetic tests were performed in female patients with a confirmed diagnosis of endometriosis or uterine myoma, patients with prostatic carcinoma, and healthy male volunteers.

Indications

For women:

• endometriosis;
• womb uterine myoma;
• infertility treatment using assisted reproductive technologies (including IVF / embryo transfer/.

For men:

• symptomatic treatment for advanced hormone-dependent prostate carcinoma.

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Active ingredient

Triptorelin

Composition

Active substances:

Tryptorelin acetate 105 µg, which corresponds to the content of tryptorelin 95.6 µg.

Associates:

Sodium chloride,

Ical acetic acid,

water d/i.

How to take, the dosage

The drug is administered by injection.

Treatment of infertility in women by IVF

It is usually administered at a dose of 0.1 mg on day 1 of the menstrual cycle or early follicular phase before the injection of chorionic gonadotropin (hCG) (short protocol) or from day 1 of the menstrual cycle or early follicular phase for 3 days (ultra-short protocol).

Myoma of the uterus, endometriosis, prostate carcinoma

At the beginning of treatment for 7 days, 1 ml of Decapeptil 0.5 mg (1 injection) is given by injection once a day. Starting on day 8, Decapeptil 0.1 mg should be injected daily to maintain the therapeutic effect. The injection site should be changed.

For long-term treatment, Decapeptil-depo (3.75 mg of tryptorelin in slow-release microcapsules) is recommended, 1 injection every 28 days.

Interaction

Interaction of Decapeptyl with other drugs has not been established.

Special Instructions

The course of treatment with Decapeptil should be performed under control of plasma levels of sex hormones.

For women

A study should be performed to rule out possible pregnancy at the start of treatment. Hormonal contraceptives should not be used during therapy. In cases of endometriosis or uterine myoma, treatment should be continued until the menstrual cycle is fully restored.

Decapeptil therapy should not use medications containing estrogens.

At the time of treatment, ultrasound monitoring of myoma and endometriosis nodules is mandatory. A rapid decrease in the size of the uterus can lead to bleeding.

The woman should be warned that menstruation will be absent during Decapeptil treatment. If there are regular menstrual periods during Decapeptil therapy, the patient should see her doctor.

For men

The transient increase in plasma testosterone levels in some patients may lead to temporary worsening of condition: urinary tract obstruction, bone pain caused by metastases, spinal cord compression symptoms, muscle weakness, enlarged lymph nodes, and swollen legs are observed. If any of these symptoms occur, the patient should see a doctor.

In the initial phase of treatment, an anti-androgen drug should be considered to suppress symptoms caused by increased testosterone levels.

Impact on ability to drive vehicles and other activities requiring high concentration and speed of psychomotor reactions

The drug does not affect the ability to drive vehicles and other activities requiring high concentration and speed of psychomotor reactions.

Contraindications

In women

• pregnancy
• lactation period
• clinical signs or risk of osteoporosis.

Cautions: Use with caution when performing assisted reproductive technology (IVF) in patients with polycystic ovaries when the number of follicles determined by ultrasound is more than 10.

For men

• hormonally independent prostate carcinoma;
• previous surgical castration.

General

• high sensitivity to tryptorelin or other components of the drug

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Side effects

Side effects are caused by decreased levels of sex hormones in blood, which can lead to the occurrence of such symptoms in men and women as: mood lability, depression, decreased libido, frequent headaches, sleep disorders, weight gain, hot flashes, increased sweating.

Urogenital system disorders: urinary tract obstruction, pain during sexual intercourse. In women – vaginal dryness, uterine bleeding. In men – decreased potency, gynecomastia, reduction of testicular size.

CNS and peripheral nervous system disorders: paresthesias, vision disorders.

Digestive system disorders: nausea, decreased appetite, increased liver transaminase activity, hypercholesterolemia.

Muscular system disorders: back pain, bone pain caused by metastases, spinal cord compression, muscle weakness, myalgia, arthralgia, bone demineralization (in long-term use).

Allergic reactions: itching, skin redness, fever, anaphylaxis.

Local reactions: rarely – pain at the site of administration of the drug.

Others: thrombophlebitis, enlarged lymph nodes, edema of the legs, in men – reduction of beard growth and hair loss on the chest, arms and legs.

All the adverse reactions described disappear after the end of treatment.

Overdose

There have been no cases of overdose of the drug.

In case of overdose symptomatic treatment should be administered.

Pregnancy use

The drug is contraindicated in pregnancy and during breastfeeding.