Dekapeptil (Decapeptyl)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTriptorelinTriptorelin
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    • Dosage form: & nbsphypodermic solution
    Composition:

    1 syringe with the drug contains:

    Active substance

    dosage 0.1 mg / ml: tryptorelina acetate 105 μg equivalent to tryptorelin (base) 95.6 μg

    dosage 0.5 mg / ml: tryptorelin acetate 525 μg equivalent to tryptorelin (base) 478.1 μg

    Excipients

    Sodium Chloride, Water for Injection, Acetic Acidic Acid

    Description:

    The contents of the syringe is a clear, colorless, odorless solution.

    Pharmacotherapeutic group:Antitumor agent - gonadotropin-releasing hormone analog
    ATX: & nbsp

    L.02.A.E.04   Triptorelin

    Pharmacodynamics:

    The active substance of the drug Decapeptil - tryptorelin - a synthetic analogue of gonadotropin-releasing hormone. The replacement of the 6th amino acid residue in the molecule of the natural substance resulted in a more pronounced affinity for the GnRH receptors and a longer half-life than the natural molecule.

    Immediately after the introduction, tryptorelin causes an increase in the level of FSH (follicle-stimulating hormone) and LH (luteinizing hormone) in the blood, which leads to a short-term increase in the concentration of sex hormones. Prolonged pituitary stimulation (in the case of 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:

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

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

    Metabolism and excretion

    The half-life of triptorelin in plasma is 18.7 min, while for natural gonadotropin-releasing hormone this figure is 7.7 min.Triptorelin's clearance (503 ml / min) is three times slower than the natural releasing hormone (1766 ml / min) and consists of two components - fast and slow elimination.

    Less 4% Triptorelin in unchanged form is excreted in the urine.

    Indications:

    Among women:

    endometriosis, uterine myoma, infertility treatment with the use of assisted reproductive technologies (IVF and PE in vitro fertilization and transfer of embryos into the uterine cavity).

    In men:

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

    Contraindications:

    Hypersensitivity to the components of the drug.

    Have men: hormone-independent prostate carcinoma, previous surgical castration.

    Among women: pregnancy, lactation, clinical manifestations or the risk of osteoporosis. Decapeptil should be administered with extreme caution to patients with polycystic ovaries in the implementation of an assisted reproductive technology (IVF) program, especially in cases where the number of follicles detected by ultrasound is greater than 10.

    Carefully:

    Decapeptil should be administered during the implementation of the assisted reproductive technology (IVF) program for patients with polycystic ovaries, especially when the number of ultrasound detected follicles is more than 10, as well as in patients with clinical manifestations of osteoporosis or a high risk of developing it.

    Pregnancy and lactation:

    The drug is contraindicated for use in pregnancy, at the time of treatment should stop breastfeeding.

    Dosing and Administration:

    The drug is administered subcutaneously. If there are no signs of hypersensitivity, injections can be performed by the patients themselves. However, if an allergic reaction occurs, seek medical help immediately.

    Uterine fibroids, endometriosis, prostate carcinoma: usually inject 0.5 mg of the drug subcutaneously daily for 7 days, then from day 8 - 0.1 mg daily once a day as maintenance therapy. The injection site should be changed.

    For a prolonged course of treatment, it is recommended to use Decapeptyl Depot preparation containing 3.75 mg of triptorelin and possessing prolonged action - 1 injection every 28 days.

    Auxiliary reproductive technologies: the drug is administered at 0.1 mg daily, starting from the first day of the cycle or the early follicular phase. The duration of therapy depends on the protocol used and is determined by the physician individually. Injection of the drug Decapeptil is discontinued the day before the intended administration of the human chorionic gonadotropin drug (hCG).

    Ultra short protocol - 0.1 mg for 3 days.
    Short protocol - 0.1 mg for 10-12 days. With 2-3 days of the cycle, induction of ovulation begins, continuing to administer Decapeptil at a dose of 0.1 mg.
    Long Protocol - daily subcutaneous injections of Decapeptil 0.1 mg begin on the 2nd or 21st-25th day of the menstrual cycle preceding the treatment. When achieving persistent suppression of estradiol (E2<50 pg / ml), usually on the 15th day of therapy, begin stimulation with gonadotropins and continue injections of decapeptil at a dose of 0.1 mg, ending the day before the scheduled administration of hCG.
    Side effects:

    Side effects are caused by a decrease in the level of sex hormones (testosterone and estrogens) 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" , increased sweating;

    From the genitourinary system: obstruction of the urinary tract, pain during intercourse; in women: dryness of the vaginal mucosa, uterine bleeding; in men: a decrease in potency, gynecomastia, a decrease in the size of the testicles.

    From the nervous system: paresthesia, visual impairment.

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

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

    Other: thrombophlebitis, enlarged lymph nodes, swelling of the legs. In men, a decrease in the growth of the beard and loss of hair on the chest, legs and hands.

    Local Reactions: pain in the injection site. Also, there may be reactions of increased sensitivity (itching, redness of the skin, fever, anaphylaxis).

    All described side effects, as a rule, have a moderate degree of severity and disappear after the course of treatment.

    Overdose:

    The cases of drug overdose Decapeptil was not observed, when it occurs - treat symptomatically.

    Interaction:

    Not described.

    Special instructions:

    Treatment should be performed under the control of levels of sex steroid hormones in the blood serum.

    Men's

    A transient increase in plasma testosterone levels in some patients can lead to temporary worsening of the condition (in the form of obstruction of the urinary tract, bone pain caused by metastases, compression of the spinal cord, muscle weakness, increased lymph nodes, edema of the legs). In case of appearance of one of the symptoms, the patient should consult a doctor. In the initial stage of treatment, it may be possible to consider the advisability of using an antiandrogenic agent as a means of suppressing symptoms caused by an increase in testosterone levels.

    Women

    Women should first of all exclude pregnancy. During therapy, the use of hormonal contraceptives is unacceptable, in cases of endometriosis or fibroids treatment should be continued until the menstrual cycle is fully restored. During treatment, Decapeptil is not allowed to take estrogen-containing medications. During the course of treatment, ultrasound monitoring of the size of 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, and the patient should necessarily inform the doctor about the case of regular menstruation.

    Effect on the ability to drive transp. cf. and fur:No.
    Form release / dosage:

    A solution for subcutaneous administration is 0.1 mg / ml, 0.5 mg / ml.

    Packaging:

    1 ml per disposable glass syringe with a needle with a protective cap.

    For 7 syringes in a plastic cell box in a cardboard box with instructions for use.

    Storage conditions:Store at 2 - 8 ° C. The drug, in use, stored at a temperature of 15 ° C to 25 ° C in the original packaging and protected from light for no more than 30 days.
    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013581 / 01
    Date of registration:24.03.2009
    Expiration Date:Unlimited
    The owner of the registration certificate: Ferring GmbH Ferring GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFERRING PHARMACEUTICALS LLCFERRING PHARMACEUTICALS LLCRussia
    Information update date: & nbsp20.03.2017
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