Zoladex capsules for subcutaneous injection. 3,6 ml N1
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Goserelin
Release form
Capsules
Composition
Goserelin (in the form of acetate) 3.6 mg.
Pharmacological effect
Synthetic analogue of natural GnRH (gonadotropin releasing hormone). With constant use, Zoladex inhibits the secretion of pituitary luteinizing hormone (LH), which leads to a decrease in the concentration of testosterone in the blood serum in men and the concentration of estradiol in the blood serum in women. This effect is reversible after discontinuation of therapy. At the initial stage, Zoladex, like other GnRH agonists, can cause a temporary increase in the concentration of testosterone in the blood serum in men and the concentration of estradiol in the blood serum in women. In the early stages of Zoladex therapy, some women may experience vaginal bleeding of varying duration and intensity. In men, by about 21 days after the introduction of the first capsule, the concentration of testosterone decreases to castration levels and continues to be reduced with constant treatment every 28 days. Such a decrease in testosterone concentration in most patients leads to regression of prostate cancer and symptomatic improvement. In women, the serum estradiol concentration also decreases by approximately 21 days after the first capsule is administered and, with regular administration of the drug every 28 days, remains reduced to a level comparable to that observed in women in menopause. This reduction leads to a positive effect in hormone-dependent forms of breast cancer, endometriosis, uterine fibroids and suppressed II development of follicles in the ovaries. It also causes thinning of the endometrium and is the cause of amenorrhea in most patients. It has been shown that Zoladex in combination with iron preparations causes amenorrhea and an increase in hemoglobin level and corresponding hematological parameters in women with uterine fibromas and concomitant anemia. the onset of menopause. Rarely, in some women there is no recovery of menstruation after the end of therapy.
Pharmacokinetics
Synthetic analogue of natural GnRH (gonadotropin releasing hormone).With constant use, Zoladex inhibits the secretion of pituitary luteinizing hormone (LH), which leads to a decrease in the concentration of testosterone in the blood serum in men and the concentration of estradiol in the blood serum in women. This effect is reversible after discontinuation of therapy. At the initial stage, Zoladex, like other GnRH agonists, can cause a temporary increase in the concentration of testosterone in the blood serum in men and the concentration of estradiol in the blood serum in women. In the early stages of Zoladex therapy, some women may experience vaginal bleeding of varying duration and intensity. In men, by about 21 days after the introduction of the first capsule, the concentration of testosterone decreases to castration levels and continues to be reduced with constant treatment every 28 days. Such a decrease in testosterone concentration in most patients leads to regression of prostate cancer and symptomatic improvement. In women, the serum estradiol concentration also decreases by approximately 21 days after the first capsule is administered and, with regular administration of the drug every 28 days, remains reduced to a level comparable to that observed in women in menopause. This reduction leads to a positive effect in hormone-dependent forms of breast cancer, endometriosis, uterine fibroids and suppressed II development of follicles in the ovaries. It also causes thinning of the endometrium and is the cause of amenorrhea in most patients. It has been shown that Zoladex in combination with iron preparations causes amenorrhea and an increase in hemoglobin level and corresponding hematological parameters in women with uterine fibromas and concomitant anemia. the onset of menopause. Rarely, in some women there is no recovery of menstruation after the end of therapy.
Indications
prostate cancer; endometriosis; uterine fibroma.
Contraindications
hypersensitivity to goserelin or other GnRH analogues; pregnancy; lactation (breastfeeding); children’s age. With caution: males exposed to a particular risk of obstruction of the ureters or compression of the spinal cord.
Precautionary measures
Do not exceed the recommended dose. The drug should be used with caution in men who are at particular risk of obstruction of the ureters or compression of the spinal cord, as well as in vitro fertilization in patients with polycystic ovary syndrome.
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation.
Dosage and administration
Zoladex Depot 3.6 mg is injected subcutaneously into the anterior abdominal wall every 28 days. In case of malignant neoplasms, the drug is prescribed for a long time. To thin the endometrium 2 Depot Zoladex, 3.6 mg is administered at 4-week intervals, while the operation is recommended during the first two weeks after the second capsule is injected depot. In case of benign gynecologic neoplasms, the drug is prescribed for no more than 6 months, since at the moment there are no clinical data on longer courses of therapy. Repeat courses should not be prescribed due to the danger of a decrease in bone mineral density. During in vitro fertilization, desensitization of the pituitary is determined by the concentration of estradiol in the blood serum. As a rule, the required level of estradiol, which corresponds to that in the early follicular phase of the cycle (approximately 150 pmol / l), is reached between 7 and 21 days. When desensitization of the pituitary gland begins, stimulation of superovulation (controlled stimulation of the ovaries) with gonadotropin begins. The induced desensitization of the pituitary when using Zoladex can be more persistent, which can lead to an increased need for gonadotropin. At the appropriate stage of follicular development, the introduction of gonadotropin is stopped and then human chorionic gonadotropin is administered to induce ovulation. Monitoring of the treatment, the procedure of oocyte extraction and fertilization is carried out in accordance with the established practice of this medical institution.
Side effects
Neoplasms: very rarely - pituitary tumor; unspecified frequency - degeneration of fibromatous nodes in women with uterine fibroma. On the immune system: infrequently - hypersensitivity reactions; rarely - anaphylactic reactions. From the endocrine system: very rarely - hemorrhage in the pituitary gland. Metabolic disorders: often - impaired glucose tolerance. In men who received GnRH agonists, there was a decrease in glucose tolerance.A decrease in glucose tolerance was manifested by the development of diabetes mellitus or a deterioration in the control of blood glucose levels in patients with diabetes mellitus in history; infrequently - hypercalcemia (in women). From the nervous system and mental sphere: very often - a decrease in libido associated with the pharmacological action of the drug and in rare cases, leading to its abolition; often - decrease in mood, depression (in women), paresthesia, compression of the spinal cord (in men), headache (in women); very rarely - a psychotic disorder. From the CCC: very often - hot flashes associated with the pharmacological action of the drug and in rare cases led to its cancellation; often - myocardial infarction (in men); heart failure (in men), the risk of which increases with the simultaneous prescription of antiandrogenic drugs. Changes in blood pressure, manifested as hypotension or hypertension. These changes are usually transient and are resolved either during the process of treatment with Zoladex or after its termination. In rare cases, these changes required medical intervention, including the abolition of the drug Zoladex. On the side of the skin and subcutaneous tissue: very often - excessive sweating associated with the pharmacological action of the drug and in rare cases leading to its abolition; often - alopecia (in women), as a rule, slightly pronounced, incl. in young patients with benign neoplasms; rash, mostly slightly pronounced, which was often resolved during the continuation of therapy; of unspecified frequency - alopecia (in men), which manifested itself as hair loss throughout the body due to a decrease in the level of androgens. From the musculoskeletal system: often - arthralgia (in women), bone pain (in men). At the beginning of treatment, prostate cancer patients can often experience a temporary increase in bone pain, which is treated symptomatically; infrequently - arthralgia (in men). From the urogenital system: very often - erectile dysfunction (in men), dry vaginal mucosa and an increase in the size of the mammary glands (in women); often - gynecomastia (in men); infrequently - tenderness of the mammary glands (in men), obstruction of the ureters (in men); rarely an ovarian cyst (in women); unspecifiedfrequencies - vaginal bleeding (in women). Other: very often - the reaction at the injection site (in women); often - a reaction at the injection site (in men). Laboratory studies: often - a decrease in bone mineral density, an increase in body weight.
Overdose
Experience overdose in humans is limited. In the case of unintentional administration of Zoladex, no clinically significant adverse events were noted before the expiration date or at a higher dose. Treatment: symptomatic therapy.
Interaction with other drugs
Drug interaction of the drug Zoladex is not described.
special instructions
Zoladex should be carefully prescribed to men who are at particular risk of developing obstruction of the ureters or squeezing of the spinal cord. In this category of patients should be carefully monitored during the first month of therapy. If spinal cord compression or renal failure caused by obstruction of the ureters is observed or developed, a standard treatment for these complications should be prescribed. When using Zoladex in women before menstruation is restored, non-hormonal methods of contraception should be used. As with other GnRH analogues, when using the drug Zoladex in combination with gonadotropin, rare cases of ovarian hyperstimulation syndrome (SGSA) were reported. It is assumed that desensitization caused by the use of Zoladex can, in some cases, lead to an increase in the required dose of gonadotropin. It is necessary to carefully monitor the stimulation of the cycle in order to identify patients at risk of developing UGSS, since the severity and frequency of manifestations of the syndrome may depend on the dose regimen of gonadotropin. The introduction of human chorionic gonadotropin should be stopped if required. The use of GnRH analogues in women can cause a decrease in bone mineral density. After the end of treatment, the majority of women recover bone mineral density. In patients treated with Zoladex for the treatment of endometriosis, the addition of hormone replacement therapy (estrogen and progestogen preparations daily) reduced the loss of bone mineral density and vasomotor symptoms. Resumption of menstruation after treatment with Zoladex may be delayed in some patients.In rare cases, some women during treatment with GnRH analogues may have menopause without restoring menstruation after the end of therapy. Using the drug Zoladex may lead to an increase in cervical resistance, care must be taken when dilating the cervix. There is no data on the efficacy and safety of Zoladex drug therapy benign gynecological diseases lasting more than 6 months. The drug Zoladex should be used for in vitro fertilizer It is recommended to use Zoladex with caution during in vitro fertilization in patients with polycystic ovary syndrome, since It is possible to stimulate a large number of follicles. According to preliminary data, the use of bisphosphonate in combination with GnRH agonists in men helps to reduce the loss of bone mineral density. In connection with the possibility of developing a decrease in glucose tolerance while taking GnRH agonists in men, it is recommended to periodically monitor blood glucose levels. Effect on ability to drive vehicles and control mechanisms There is no evidence that Zoladex impairs ability to drive vehicles and work with mechanisms.