Dekapeptil depot lyoph. d / preparation. susp. for v / m and s / c input. prolong. action 3.75 mg syringe 1 pc. (Tryptorelyn)

Latin name

DECAPEPTYL DEPOT

Release form

Lyophilisate for suspension for i / m and s / c administration of prolonged action.

Packing

1 pc

Pharmacological action

Pharmacodynamics

Active ingredient of the drug Decapeptil Depot - Triptorelin - a synthetic analogue of gonadotropin releasing hormone (GnRH). The replacement of the 6th amino acid residue in the natural GnRH molecule results in a more pronounced affinity for GnRH receptors and a longer half-life than the natural molecule.

The initial effect of the administration of the drug Decapeptil Depot is the stimulation of secretion by the pituitary gland of FSH and LH. After prolonged stimulation (a constant concentration of tryptorelin in the blood), the pituitary gland becomes insensitive to the action of GnRH. As a result, the level of gonadotropins in the blood decreases, which leads to a decrease in the level of sex hormones to a post-castration or menopause level. The described effects are reversible.

Pharmacokinetics

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

Absorption

In the first hours after the i / m administration of the drug Dekaleptil Depot, Cmax of triptorelin in the blood plasma is recorded, which decreases noticeably within 24 hours. On the 4th day after the i / m injection, the concentration of tryptorelin in the blood reaches a second maximum, after which the concentration decreases in a biexpanential manner to indefinite values ​​over a period of 44 days.

After sc administration, an increase in the concentration of the active substance is slower compared to the IM administration. Lowering the concentration of tryptorelin in the blood is slower, the duration of the decrease in concentration to uncertain values ​​is 65 days.

Repeated, with an interval of 28 days, injections of the drug Decapeptil Depot do not lead to an increase in its concentration in the blood. When i / m and s / c injections, the concentration of tryptorelin in the blood on the eve of the next injection decreased to 85 pg / ml and 100 pg / ml, respectively.

In men, the permanent bioavailability of the active component of triptorelin from the depot is 38.3% in the first 13 days. Further, the drug release becomes linear with an average daily value of 0.92% of the administered dose.

In women, after 27 days of the study, an average of 35.7% of the initial dose is determined, with 25.5% of the dose being released in the first 13 days with subsequent linear release, on average, 0.73% of the administered dose daily.

Excretion

The half-life of plasma triptorelin is 18.7 minutes, while for natural gonadotropin releasing hormone this indicator is 7.7 minutes. The clearance of triptorelin (503 ml / min) is 3 times slower than that of natural releasing hormone (1766 ml / min) and consists of two components - fast and slow excretion. Less than 4% of tryptorelin unchanged is excreted in the urine.

Indications

In women:

endometriosis

uterine fibroids

infertility treatment using assisted reproductive technology (IVF).

In men:

is a hormone-dependent prostate carcinoma.

Contraindications

Hormone-independent prostate carcinoma

pregnancy

lactation (breastfeeding)

children

hypersensitivity to triptorelin or other components of the drug.

Precautions: Decapeptil Depot should be prescribed when assisted with reproductive technology (IVF) for patients with polycystic ovary, especially in cases where the number of follicles determined by ultrasound is more than 10, as well as in patients with clinical manifestations of osteoporosis or a high risk of it development.

Use during pregnancy and lactation

Use of the drug Decapeptil Depot during pregnancy is contraindicated.

During treatment, breast-feeding should be discontinued.

Composition

1 syringe contains:

Active substances: tryptorelin acetate 4.12 mg, which corresponds to the content of tryptorelin 3.75 mg.

Excipients: a copolymer of lactic and glycolic acids, propylene glycol caprylocaprate.

Solvent: polysorbate 80, dextran 70, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide, water d / u.

Dosage and administration

The drug Decapeptil Depot is administered subcutaneously (in subcutaneous tissue of the abdomen) or IM once every 4 weeks. The injection site should be changed.

With uterine myoma and endometriosis, the drug is administered 1 time in 4 weeks, treatment begins in the first 5 days of the menstrual cycle, the duration of treatment is from 3 to 6 months.

With assisted reproductive technologies (IVF) - once for 2-3 or 22 days of the menstrual cycle.

With hormone-dependent prostate carcinoma - 1 time in 4 weeks, for a long time.

Rules for administering the drug

Take the package of Decapeptil Depot from the refrigerator.

Remove the cap from the syringe with lyophilisate.

Open the packaging from the adapter without removing it.

Screw the syringe with lyophilisate onto the adapter and remove it from the packaging.

Screw the syringe with the solvent onto the free edge of the adapter and make sure the syringes are firmly connected to the adapter.

Distill the solvent into the syringe with lyophilisate and then distill the mixture in the opposite direction. Distill at least 10 times. The mixture should be carefully distilled between two syringes until a homogeneous, milky suspension is formed. The first 2-3 stages should not be performed until the fluid has completely moved from one syringe to another.

Side effects of the

From the reproductive system: side effects are caused by a decrease in the level of sex hormones (testosterone and estrogen) in the blood, which can lead to the appearance in men and women of symptoms such as mood lability, depression, weakening libido, frequent headaches, and violation sleep, weight gain, hot flashes, excessive sweating, nausea, decreased appetite, myalgia, arthralgia, demineralization of bones (with prolonged use) in women - dryness of the vaginal mucosa, uterine bleeding in men - a decrease in potency, gynecomastia, a decrease in the size of the testicles.

Lab performance: rarely - in men and women, increased activity of hepatic transaminases (LDH, GGTP, ALT, ACT), an increase in plasma cholesterol levels can be noted.

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

Local reactions: pain at the injection site. All described side effects, as a rule, have a moderate severity and disappear after the end of the course of treatment.

Drug Interaction

The drug interaction of Decapeptil Depot with other drugs has not been described.

Overdose

No cases of overdose with Decapeptil have been reported.

Storage conditions

Store in a dry place inaccessible to children at a temperature of 2 ° to 8 ° C.

Expiration

3 years.

For prepared suspension, Expiration is 3 minutes.

Deystvuyuschee substances

Tryptorelyn

p176 pharmacy outlets for p176 pharmacy

Prescription

dosage form

dosage form

suspension for injection



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