Universal reference book for medicines
Name of the drug: DECAPEPTIL (DECAPEPTYL)

Active substance: triptorelin

Type: Gonadotropin-releasing hormone analogue

Manufacturer: FERRING (Germany)
Composition, form of production and packaging
The solution for injections is
transparent, colorless, odorless and mechanical impurities.

1 ml

tryptorelin acetate 105 μg,

that acc.
the content of tryptorelin 95.6 μg
Auxiliary substances: sodium chloride, glacial acetic acid, water d / u.

1 ml - syringe-ampoules (7) complete with injection needles - packings of cellular contour (1) - cardboard boxes.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

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 the GnRH receptors and a longer half-life.
Immediately after administration, tryptorelin 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 blockade of the gonadotropic function, resulting in a decrease in the level of sex hormones in the blood before the post-cystic or menopausal level.
The effects described are reversible.

Studies in animals have not revealed a teratogenic or mutagenic effect.

PHARMACOKINETICS

Suction and distribution

In the first hours after intravenous administration of the drug, Cmax of Triptorelin in the blood is recorded.
Then, the concentration of tryptorelin decreases markedly within 24 hours.
Metabolism and excretion

T 1/2 of triptorelin in plasma is 18.7 min (T 1/2 of natural GnRH is 7.7 min).
Triptorelin clearance (503 ml / min) is 3 times slower than in natural GnRH (1766 ml / min) and consists of two components - fast and slow elimination.
Less than 4% of triptorelin in unchanged form is excreted in the urine.

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

INDICATIONS

For women

- endometriosis;

- myoma of the uterus;

- Infertility treatment with the use of assisted reproductive technologies (including IVF and PE / embryo transfer).

For men

- symptomatic treatment of progressive hormone-dependent carcinoma of the prostate.

DOSING MODE

The drug is administered sc.

Treatment of infertility in women with IVF

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

Uterine fibroids, endometriosis, prostate carcinoma

At the beginning of the course of treatment for 7 days, 1 ml of Decaepeptil 0.5 mg (1 injection) is administered p / to 1 time / day.
Starting with the 8th day of treatment, to maintain a therapeutic effect should be administered every day Decapeptil 0.1 mg. The injection site should be changed.
For a prolonged course of treatment, it is recommended that Decapeptil Depot (3.75 mg of triptorelin in sustained release microcapsules) be used - 1 injection every 28 days.

SIDE EFFECT

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

From the genitourinary system: obstruction of the urinary tract, pain during intercourse.
Women - dryness of the vagina, uterine bleeding. In men - a decrease in potency, gynecomastia, a decrease in the size of the testicles.
From the side of the central nervous system and the peripheral nervous system: paresthesia, visual impairment.

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

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

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

Local reactions: rarely - pain at the injection site.

Other: thrombophlebitis, an increase in lymph nodes, swelling of the legs, in men - a decrease in the growth of the beard and loss of hair on the chest, arms and legs.

All described adverse reactions disappear after the course of treatment.

CONTRAINDICATIONS

For women

- Pregnancy;

- lactation period;

- clinical manifestations or risk of osteoporosis;

It should be used with care when implementing the program of assisted reproductive technologies (IVF) in patients with polycystic ovaries, when the number of follicles detected by ultrasound is more than 10.

For men

- hormone-independent prostate carcinoma;

- previous surgical castration.

General information

- hypersensitivity to triptorelin or other components of the drug.

PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy and during breastfeeding.

SPECIAL INSTRUCTIONS

The course of treatment Decapeptil should be conducted under the control of the level of sex hormones in the blood plasma.

For women

A study should be conducted to exclude a possible pregnancy at the time of treatment.
During the therapy, the use of hormonal contraceptives is unacceptable. With endometriosis or uterine myoma treatment should continue until the full recovery of the menstrual cycle.
When carrying out therapy with Decapeptil, do not use preparations containing estrogens.

During the course of treatment, ultrasound monitoring of the size of the myoma and endometriosis nodes is mandatory.
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 Decapeptal, menstruation will be absent.
In the presence of regular menstruation during therapy with Decapeptil, the patient should consult a doctor.
For men

A transient increase in plasma testosterone levels in some patients can lead to a temporary deterioration in the condition: urinary tract obstruction, bone pain caused by metastases, symptoms of spinal cord compression, muscle weakness, swelling of the lymph nodes, swelling of the legs.
If one of these symptoms occurs, the patient should consult a doctor.
In the initial stage of treatment should consider the advisability of using an antiandrogenic drug in order to suppress symptoms caused by an increase in testosterone levels.

Impact on the ability to drive vehicles and manage mechanisms

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

OVERDOSE

There were no cases of drug overdose.
If an overdose occurs, symptomatic treatment should be given.
DRUG INTERACTION

The interaction of Decapeptil with other drugs is not established.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children, protected from light (in closed containers) at a temperature of 2 ° to 8 ° C.
Shelf life - 3 years.
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