DEKAPEPTIL
Active material: Triptorelin
When ATH: L02AE04
CCF: An analogue of gonadotropin-releasing hormone
ICD-10 codes (testimony): C61, D25, N80, N97, Z31.1
When CSF: 15.07.04
Manufacturer: FERRING GmbH (Germany)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
Solution for injection clear, colorless, odorless and solids.
| 1 ml | |
| triptorelin acetate | 105 g, |
| that respectively. content of triptorelin | 95.6 g |
Excipients: sodium chloride, glacial acetic acid, water d / and.
1 ml – syringe vials (7) complete with injection needles – packings Valium planimetric (1) – cardboard boxes.
Pharmacological action
The synthetic analogue of gonadotropin hormone rilizig (GnRG). The result of the replacement of the 6th amino acid residue of natural GnRH molecule were more pronounced affinity to GnRH receptors and a longer half-life.
Immediately after the administration of triptorelin causes an increase in the level of LH and FSH in the blood, which leads to a transient increase in the concentration of sex hormones. Continuous stimulation of the pituitary gland (triptorelin at a constant concentration in the blood) It leads to the blockade of gonadotrophic function, the result is a decrease in the level of sex hormones in the blood to postcastration or menopausal levels.
These effects are reversible.
Animal studies showed no teratogenic or mutagenic effects.
Pharmacokinetics
Absorption and distribution
In the first hours after the / m injection recorded Cmax triptorelin blood. Then the triptorelin concentration declines notably within 24 no.
Metabolism and excretion
T1/2 triptorelin in plasma is 18.7 m (T1/2 GnRH is a natural 7.7 m). The clearance of triptorelin (503 ml / min) in 3 times slower, than the natural GnRH (1766 ml / min) and it consists of two components, – Fast and slow excretion.
Less 4% triptorelin in unchanged form excreted in the urine.
Pharmacokinetic tests were performed in patients with a confirmed diagnosis of endometriosis or uterine fibroids, patients with carcinoma of the prostate and healthy male volunteers.
Testimony
For women
- Endometriosis;
- Uterine fibroids;
- Treatment of infertility using assisted reproductive technologies (incl. IVF / embryo transfer /).
For men
- Symptomatic treatment of advanced hormone-dependent prostate carcinoma.
Dosage regimen
The drug is administered s / c.
Treatment of female infertility by IVF
Typically, a dose administered 0.1 mg 1 day of the menstrual cycle or early follicular phase before the introduction of human chorionic gonadotropin (hCG) (brief report) or 1 menstrualnoo day cycle or early follicular phase for 3 days (ultrashort protocol).
Hysteromyoma, endometriosis, Prostate cancer
In the early course of treatment for 7 days 1 ml of the drug Dekapeptil 0.5 mg (1 injection) introduced n / a 1 time / day. Starting with the 8th day of treatment, to maintain therapeutic effect should be administered daily Dekapeptil 0.1 mg. The injection site should be changed.
For the duration of treatment is recommended to use the drug depot Dekapeptil (3.75 mg triptorelin sustained release microcapsules) – 1 injection every 28 days.
Side effect
Side effects caused by a decrease in the level of sex hormones in the blood, which can lead to the appearance of men and women such as the symptoms: mood lability, depression, the weakening of the libido, frequent headaches, sleep disorders, weight gain, tides, increased sweating.
With the genitourinary system: urinary tract obstruction, pain during intercourse. Women – vaginal dryness, uterine bleeding. Men – reduced potency, gynecomastia, reducing the size of the testicles.
From the central and peripheral nervous system: paresthesia, visual impairment.
From the digestive system: nausea, decreased appetite, increase in liver transaminases, hypercholesterolemia.
On the part of the musculoskeletal system: backache, ostealgias, caused by metastases, spinal cord compression, muscular weakness, mialgii, artralgii, bone demineralization (Propafenone).
Allergic reactions: itch, erythema, fever, anaphylaxis.
Local reactions: rarely – pain at the site of administration.
Other: tromboflebit, swollen lymph nodes, swelling of the feet, males – reduction in the growth of the beard and hair loss on chest, hands and feet.
All these side effects disappear after treatment.
Contraindications
For women
- Pregnancy;
- Lactation;
- Clinical manifestations and risk of osteoporosis;
It is a caution use in patients with the implementation of the program of assisted reproductive technologies (IVF) in patients with polycystic ovaries, when the number of follicles, determined using ultrasound, more 10.
For men
- Hormone-independent prostate carcinoma;
- Prior surgical castration.
Total
- Hypersensitivity to triptorelin or other ingredients.
Pregnancy and lactation
Do not use this drug during pregnancy and breastfeeding.
Cautions
Dekapeptilom course of treatment should be supervised by the level of sex hormones in the blood plasma.
For women
It should carry out a study in order to exclude the possibility of pregnancy at the time of initiation of treatment. During therapy, the use of hormonal contraceptives is unacceptable. In endometriosis, or uterine fibroids treatment should continue until the full restoration of the menstrual cycle.
During the therapy should not be used Dekapeptilom drugs, containing estrogen.
During the course of treatment is mandatory ultrasonic inspection of fibroids and endometriosis sites. The rapid reduction in the size of the uterus can lead to bleeding.
Women should be advised that, that during the course of treatment will be absent menstruation Dekapeptilom. If you have a regular menstrual periods during therapy Dekapeptilom patient should seek medical advice.
For men
A transient increase in plasma testosterone levels in some patients may result in temporary deterioration: observed urinary tract obstruction, ostealgias, caused by metastases, symptoms of spinal cord compression, muscular weakness, hyperadenosis, swelling of the feet. If one of these symptoms the patient should see a doctor.
In the initial stage of treatment should consider antiandrogen drug to suppress the symptoms, caused by an increase in testosterone levels.
Effects on ability to drive vehicles and management mechanisms
The drug does not affect the ability to drive vehicles and other activities, require high concentration and speed of psychomotor reactions.
Overdose
No cases of overdose were observed. In the event of an overdose should be symptomatic treatment.
Drug Interactions
Dekapeptil interaction with other drugs is not installed.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children, protected from light (in closed packaging) at a temperature of from 2 ° to 8 ° C.. Shelf life – 3 year.
