Золадекс

Золадекс – a synthetic analog of natural gonadotrophin-rileasing-hormone (GNRG).

Form of release and structure

Dosage form – the capsules for hypodermic introduction of the prolonged action representing cylindrical pieces of solid polymeric material, free or almost free from visible inclusions, white or cream color (in the syringe applicators with the protective mechanism (system of safe introduction Safety Glide), on 1 syringe in the aluminum laminated envelopes, in a pack a cardboard 1 envelope).

Active ingredient: гозерелин (in the form of acetate), in 1 capsule – 3,6 or 10,8 mg.

Additional substances of capsules of 3,6 mg: glacial acetic acid, glycolic and milk acids copolymer (50:50).

Additional substances of capsules of 10,8 mg: copolymer of milk and glycolic acids low-molecular (95:5) and high-molecular (95:5).

Indications to use

For mg capsules 3,6 and 10,8:

• Uterus fibroma;
• Endometriosis;
• Prostate cancer.

Only for capsules of 3,6 mg:

• Breast cancer;
• Extracorporal fertilization (for desensitization of a hypophysis);
• The planned operations on an endometria (for its thinning).

Contraindications

Absolute:

• Children's age;
• Pregnancy and lactation;
• Individual hypersensitivity to drug or other analogs of GNRG.

With care of Zoladeks it is necessary to apply at treatment of men who have a risk of development of a prelum of a spinal cord or impassability of ureters, and also when carrying out extracorporal fertilization (EKO) for women with a syndrome of polycystic ovaries.

Route of administration and dosage

Capsules of 3,6 mg
Золадекс enter subcutaneously into a front abdominal wall 1 piece each 28 days.

At malignant new growths drug is used it is long. At benign gynecologic diseases therapy lasts up to 6 months (there are no data on safety and efficiency of more prolonged treatment).

For thinning of an endometria at the planned operations of Zoladeks enter 2 times with a 4 weeks interval. Ablation of a uterus is made at the same time in the first 2 weeks after introduction of the second dose.

At EKO of Zoladeks apply for the purpose of desensitization of a hypophysis which is determined by oestradiol level in blood serum. As a rule, necessary concentration of oestradiol which corresponds to that in an early follicular phase of a cycle (about 150 pmol/L) is reached during the period between 7 and 21 days. After approach of desensitization by means of a gonadotrophin begin stimulation of a superovulation. The caused desensitization of a hypophysis at Zoladeks's use can be more resistant owing to what increase in need for a gonadotrophin is possible. Its introduction is stopped at the corresponding stage of development of a follicle, further for induction of an ovulation enter the chorionic gonadotrophin of the person (CGP).

Capsules of 10,8 mg
Золадекс enter subcutaneously into a front abdominal wall:

• Men: each 3 months;
• Women: each 12 weeks.

Side effects

• Immune system: infrequently – hypersensitivity reactions; in rare instances – anaphylactic reactions;
• Metabolic disturbances: often – decrease in tolerance to glucose (at men); infrequently – a hypercalcemia (at women);
• Endocrine system: very seldom – hemorrhage in a hypophysis;
• Cardiovascular system: very often – inflows; often – heart failure and a myocardial infarction (at men), hypertensia or hypotension;
• Nervous system and mentality: very often – decrease in a libido; often – a depression and a headache (at women), a prelum of a spinal cord (at men), decrease in mood, paresthesia; very seldom – psychotic frustration;
• Musculoskeletal system: often – an ostealgia (at men), an arthralgia (at women); infrequently – an arthralgia (at men);
• Urinogenital system: very often – increase in the size of mammary glands and dryness of a mucous membrane of a vagina (at women), erectile dysfunction (at men); often – a gynecomastia (at men); infrequently – obstruction of ureters and morbidity of chest glands (at men); in rare instances – an oothecoma (at women), a syndrome of hyper stimulation of ovaries (at women to whom Zoladeks is appointed along with gonadotrophins); frequency is unknown – vaginal bleeding (at women);
• Skin and hypodermic cellulose: very often – the increased sweating; often – an alopecia (at women), rash; frequency is unknown – an alopecia (at men);
• New growths: very seldom – a hypophysis tumor; frequency is unknown – a degeneration of fibromatous nodes at women with uterus fibroma;
• Others: very often – reactions in a capsule injection site (at women); often – temporary strengthening of symptoms of a disease in an initiation of treatment of women with a breast cancer, reactions in a drug injection site (at men);
• Laboratory researches: often – increase in body weight, decrease in mineral density of a bone tissue.

Special instructions

Resuming of a menstrual cycle after the termination of a course of treatment at some women can happen to a delay. Before recovery of periods of the woman, receiving medical treatment for Zoladeks, have to apply non-hormonal methods of contraception. Approach of a menopause without recovery of periods after drug withdrawal is in rare instances possible.

At use of a gozerelin in a combination with a gonadotrophin development of a syndrome of hyper stimulation of ovaries (SGSYa) is possible. For this reason it is necessary to watch carefully process of stimulation of a cycle in time to reveal risk of development of SGSYa. If it is required, introduction of HGCh needs to be stopped.

Золадекс can lead to increase in cervical resistance in this connection it is necessary to be careful at dilatation of a neck of uterus.

When carrying out EKO drug has to be used only in specialized medical institution under observation of the doctor having experience in this area.

Analogs of GNRG can cause decrease in mineral density of a bone tissue. Allows to reduce loss of mineral density of bones and manifestation of vasculomotor symptoms at the women receiving Zoladeks for treatment of endometriosis simultaneous performing gormonozamestitelny therapy with daily use of oestrogenic and progestagenny drugs. At men loss of mineral density of a bone tissue is reduced, according to preliminary data, by simultaneous use of a bisfosfonat.

As agonists of GNRG can reduce tolerance to glucose at men, they are regularly recommended to control concentration of glucose in blood.

Messages on a negative impact of Zoladeks on the speed of reactions and ability to concentration of attention did not arrive.

Medicinal interaction

Information on Zoladeks's interaction with other medicines is absent.

Terms and storage conditions

To store at a temperature up to 25 °C in the place, unavailable to children.

Period of validity – 3 years.