Buserelin - instructions for use, dose, side effects, contraindications

Active substanceBuserelinBuserelin

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Dosage form: & nbsp

nasal dosing spray

Composition:

Buserelina acetate 2,100 mg *

(* corresponds to the content of 2,000 mg buserelin)

Benzalkonium chloride 0.100 mg

Water for injection up to 1 ml.

Description:

Transparent colorless liquid without foreign inclusions.

Pharmacotherapeutic group:An antineoplastic agent, a gonadotropin-releasing hormone analog

ATX: & nbsp

L.02.A.E.01 Buserelin

Pharmacodynamics:

The drug is a synthetic analogue of natural gonadotropin-releasing hormone (GnRH). Competitively binds to the receptors of the anterior pituitary cells, causing a short-term increase in the level of sex hormones in the blood plasma. Further use of therapeutic doses of the drug leads (on average 12-14 days) to complete blockade of the gonadotropic function of the pituitary, thus inhibiting the release of luteinizing (LH) and follicle-stimulating hormone (FSH). As a result, the synthesis of sex hormones in the ovaries is suppressed and the concentration of estradiol (E2) in the blood plasma is reduced to post-menopausal values.

Pharmacokinetics:

With intranasal administration, the drug is completely absorbed through the nasal mucosa. In small amounts excreted in breast milk.

The half-life is about 3 hours.

Indications:

The hormone-dependent pathology of the reproductive system, caused by absolute or relative hyperestrogenism:

-endometriosis (pre- and postoperative periods);

- uterine myoma;

-hyperplastic processes of the endometrium;

- Treatment of infertility (when carrying out the program of in vitro fertilization (IVF)).

Contraindications:

-pregnancy;

-period of lactation;

-increased sensitivity to the components of the drug.

Carefully:

Use with caution in arterial hypertension, diabetes, depression.

Pregnancy and lactation:

Contraindicated.

Dosing and Administration:A single dose of the drug with a full pressure pump is 150 mcg.
In the treatment of endometriosis, uterine fibroids, endometrial hyperplastic processes:
The drug is injected into the nasal passages after purification at a dose of 900 μg per day.
The daily dose of the drug is administered in equal portions, one injection at each nasal passage 3 times a day at regular intervals (6-8 hours) in the morning, afternoon and evening. Treatment with drug Buserelin should start on the first or second day of the menstrual cycle, the introduction is continuous throughout the course of treatment.
The course of treatment is 4-6 months.
In the treatment of infertility by in vitro fertilization (IVF): Buserelin spray is injected intranasally one injection (150 mcg) into each nostril 3-4 times a day at regular intervals. The daily dose of 900 - 1200 mcg. Buserelin is prescribed at the beginning of the follicular (on the 2nd day of the menstrual cycle) or in the middle of the luteal phase (21-24 days) of the menstrual cycle preceding stimulation. After 14-17 days with a decrease in estradiol in the serum of patients not less than 50% of the baseline level, absence of cysts in the ovaries, thickness of the endometrium is not more than 5 mm, stimulation of superovulation by gonadotropic hormones under ultrasound monitoring and control of estradiol levels in serum begins. If necessary, dose adjustment may be carried out by Buserelin.

Side effects:From the side of the central nervous system: headache, dizziness, nervousness, fatigue, sleep disturbance, drowsiness, decreased memory and ability to concentrate, emotional lability, the development of depression or worsening of its course.
From the sense organs: noise in the ears, hearing and vision impairment (an unclear vision), a feeling of pressure on the eyeball.
From the endocrine system: "tides" of blood to the skin of the face and upper chest, increased sweating, vaginal dryness, decreased libido, lower abdominal pain, demineralization of bones, rarely menstrual bleeding (usually during the first weeks of treatment).
From the cardiovascular system (SSS): palpitation, increased blood pressure (in patients with arterial hypertension).
Allergic reactions: urticaria, skin itching, skin hyperemia, very rarely bronchospasm, anaphylactic and / or anaphylactoid shock, angioedema.
From the digestive tract: nausea, vomiting, thirst, diarrhea, constipation, anorexia, an increase or decrease in body weight.
From the laboratory indicators: a decrease in glucose tolerance, hyperglycemia; changes in the lipid spectrum; an increase in the activity of serum transaminases, hyperbilirubinemia; thrombocytopenia or leukopenia.
Other: in isolated cases - nasal bleeding; pulmonary embolism; edema in the ankles and feet; weakening or strengthening of hair growth on the head and on the body; pain in the back, joints.
Local Reactions - irritation of the nasal mucosa, dryness and pain in the nose.

Overdose:

Currently, cases of drug overdose Buserelin not reported.

Interaction:

Simultaneous use of the drug Buserelin with preparations containing sex hormones (for example, in the induction of ovulation), may contribute to the emergence of the ovarian hyperstimulation syndrome.

With simultaneous application Buserelin can reduce the effectiveness of hypoglycemic agents.

Special instructions:Patients with any form of depression during drug treatment Buserelin should be under close supervision of the doctor.
Induction of ovulation should be carried out under strict medical supervision.
In the initial stage of treatment with the drug, the development of ovarian cysts is possible.
Repeated treatment should be started only after a thorough assessment of the relationship between the expected benefit and the potential risk of osteoporosis.
Patients who use contact lenses may develop signs of eye irritation.
Given the intranasal route of administration, irritation of the nasal mucosa is possible, and sometimes nosebleeds. The drug can be used in rhinitis, but before using it, the nasal passages should be cleared.
Application of the drug Buserelin in combination with surgical treatment for endometriosis reduces the size of pathological foci and their blood supply, inflammatory manifestations and, consequently, shortens the operation time, and postoperative therapy improves the results, reducing the frequency of postoperative relapses and reducing the formation of adhesions.
Before the beginning of treatment with the drug, it is recommended to exclude pregnancy and stop taking hormonal contraceptives, however, during the first two months of using the drug, it is necessary to use other (non-hormonal) methods of contraception.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Spray nasal dosed 0,15 mg / dose: 17,5 ml each (not less than 187 doses).

Packaging:

At 17.5 ml (not less than 187 doses) of the drug in bottles of orange glass brand HC-1, sealed with plastic caps screwed on with the control ring of the first opening.For 1 bottle complete with a dosing plastic stopper and instructions for use are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of 8 to 25 ° C. Keep out of reach of children.

Shelf life:

3 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002373 / 01

Date of registration:10.04.2008 / 12.01.2017

Expiration Date:Unlimited

The owner of the registration certificate:FARM-SYNTHESIS, CJSC FARM-SYNTHESIS, CJSC Russia

Manufacturer: & nbsp

Company DEKO, LLC Russia

Information update date: & nbsp12.03.2017

Illustrated instructions

Instructions

Buserelin (Buserelin)