Decapeptyl solution for subcutaneous injection 0.1mg/ml 1ml syringe with needle, 7pcs

Composition

Active ingredients:

triptorelin acetate is 105 mcg, which corresponds to a triptorelin content of 95.6 mcg.

Auxiliary substances:

sodium chloride,

glacial acetic acid,

d/i water.

Pharmacological action

Pharmacodynamics

Synthetic analog 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.

Immediately after use, triptorelin causes an increase in the level of FSH and LH in the blood, which leads to a short-term increase in the concentration of sex hormones. Prolonged stimulation of the pituitary gland (with a constant concentration of triptorelin in the blood) leads to a blockade of gonadotropic function, which results in a decrease in the level of sex hormones in the blood to post-castration or menopausal levels.

The described effects are reversible.

Animal studies have not shown any teratogenic or mutagenic effects.

Pharmacokinetics

Suction and distribution

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

The metabolism and elimination

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

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

Pharmacokinetic tests were performed in patients with a confirmed diagnosis of endometriosis or uterine fibroids, patients with prostate cancer, and healthy male volunteers.

Indications

For women:

• endometriosis;
• uterine fibroids;
• infertility treatment using assisted reproductive technologies (including IVF and PE/embryo transfer/).

For men:

• symptomatic treatment of progressive hormone-dependent prostate cancer.

Use during pregnancy and lactation

It is contraindicated to use the drug during pregnancy and lactation.

Contraindications

For women

• , pregnancy;
• lactation;
• clinical manifestations or risk of osteoporosis.

With caution: use the drug when performing a program of assisted reproductive technologies (IVF) in patients with polycystic ovaries, when the number of follicles determined by ultrasound is more than 10.

For men

• , hormone-independent prostate carcinoma;
• previous surgical castration.

General

• hypersensitivity to triptorelin or other components of the drug.

Side effects

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

From the genitourinary system: obstruction of the urinary tract, pain during sexual intercourse. In women-vaginal dryness, uterine bleeding. In men-decreased potency, gynecomastia, reduced testicular size.

From the central nervous system and peripheral nervous system: paresthesia, visual disturbances.

From the digestive system: nausea, decreased appetite, increased activity of hepatic transaminases, hypercholesterolemia.

From the musculoskeletal system: back pain, bone pain caused by metastases, spinal cord compression, muscle weakness, myalgia, arthralgia, bone demineralization (with prolonged use).

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

Local reactions: rarely-pain at the injection site.

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

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

Interaction

Interaction of Decapeptyl with other drugs has not been established.

How to take, course of use and dosage

The drug is administered subcutaneously.

IVF treatment of infertility in women

Usually administered at a dose of 0.1 mg on day 1 of the menstrual cycle or early follicular phase until the introduction of chorionic gonadotropin (hCG) (short protocol) or from day 1 of the menstrual cycle or early follicular phase for 3 days (ultra-short protocol).

Uterine fibroids, endometriosis, prostate cancer

At the beginning of the course of treatment for 7 days,1 ml of Decapeptyl 0.5 mg (1 injection) is administered subcutaneously 1 time/day. Starting from the 8th day of treatment, Decapeptyl 0.1 mg should be administered daily to maintain the therapeutic effect. The injection site should be changed.

For a long-term course of treatment, it is recommended to use the drug Decapeptyl-depot (3.75 mg of triptorelin in delayed-release microcapsules) – 1 injection every 28 days.

Overdose

No cases of overdose of the drug were observed.

If an overdose occurs, symptomatic treatment should be performed.

Special instructions

The course of treatment with Decapeptyl should be carried out under the control of the level of sex hormones in the blood plasma.

For women

A study should be conducted to rule out possible pregnancy at the time of starting treatment. During therapy, the use of hormonal contraceptives is unacceptable. For endometriosis or uterine fibroids, treatment should be continued until the menstrual cycle is fully restored.

When conducting therapy with Decapeptyl, drugs containing estrogens should not be used.

During the course of treatment, ultrasound monitoring of the size of fibroids and endometriosis nodes is mandatory. A rapid reduction in the size of the uterus can lead to the development of bleeding.

A woman should be warned that during the course of treatment with Decapeptyl, menstruation will be absent. If you have regular menstruation during Decapeptyl therapy, the patient should consult a doctor.

For men

A transient increase in plasma testosterone levels in some patients can lead to temporary deterioration of the condition: urinary tract obstruction, bone pain caused by metastases, symptoms of spinal cord compression, muscle weakness, enlarged lymph nodes, and swelling of the legs are observed. If one of these symptoms occurs, the patient should consult a doctor.

At the initial stage of treatment, the use of an antiandrogenic drug should be considered in order to suppress symptoms caused by increased testosterone levels.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

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

Form of production

Solution for injection

Storage conditions

In a dry place, at a temperature of 2-8 °C

Shelf life

3 years

Active ingredient

Triptorelin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection