Zoladex 10.8 mg, syringe applicators
€371.80 €338.00
Zoladex is a synthetic analogue of the naturally occurring luteinizing hormone-releasing hormone (LHRH).
With constant use, Zoladex inhibits the release of LH by the pituitary gland, which leads to a decrease in serum testosterone concentrations in men and serum estradiol concentrations in women. This effect is reversible after discontinuation of therapy. At the initial stage, Zoladex, like other LHRH agonists, can cause a temporary increase in serum testosterone concentrations in men and serum estradiol concentrations in women. In the early stages of therapy with Zoladex, some women may experience vaginal bleeding of varying duration and intensity.
In men, by about 21 days after administration of the first capsule, testosterone levels are reduced to post-castration levels and continue to be reduced with continuous treatment every 28 days. This decrease in testosterone concentration in most patients leads to regression of the prostate tumor and symptomatic improvement.
In women, serum estradiol concentration also decreases by about 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 menopausal women. This reduction leads to a positive effect in hormone-dependent forms of breast cancer, endometriosis, uterine fibroids and suppression of the 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 and relevant hematological parameters in women with uterine fibroids and concomitant anemia.
Against the background of taking LHRH agonists in women, the onset of menopause may occur. Rarely, some women do not return to menstruation after the end of therapy.
Pharmacokinetics
The introduction of the capsule every 4 weeks ensures the maintenance of effective concentrations. Cumulation in the tissues does not occur.
Plasma protein binding is low. In patients with normal renal function T 1/2 from blood serum is 2-4 hours.
Pharmacokinetics in special clinical situations
In patients with impaired renal function T 1/2 increases. With the introduction of Zoladex 10.8 mg every 12 weeks, this change will not have significant consequences, so changing the dose for this category of patients is not required.
In patients with hepatic insufficiency, significant changes in pharmacokinetics are not observed.
Composition
1 depot capsule for s / c administration of prolonged action contains:
Active substance
Goserelin (as acetate) 10.8 mg.
Excipients:
low molecular weight copolymer of lactide and glycolide (95:5) and high molecular weight copolymer of lactide and glycolide (95:5) in a ratio of 3:1,
glacial acetic acid (removed during production).
Indications
- Hormone sensitive prostate cancer.
- Endometriosis.
- Uterine fibroids (as an aid in combination with surgical treatment).
Use during pregnancy and lactation
Contraindicated in pregnancy and breastfeeding.
Use in children
Contraindicated in childhood.
Contraindications
- Hypersensitivity to goserelin or other LHRH analogues.
- Pregnancy.
- Lactation (breastfeeding).
- Childhood.
Side effects
From the side of the cardiovascular system
Arterial hypotension or hypertension is possible (usually transient, disappeared either during therapy with Zoladex, or after its termination; in rare cases, medical intervention was required, including the abolition of Zoladex).
From the side of the central nervous system and peripheral nervous system
Nonspecific paresthesias are possible.
From the musculoskeletal system
Possible arthralgia.
allergic reactions
Rarely – hypersensitivity reactions, including some manifestations of anaphylaxis.
Dermatological reactions
Possible skin rash (usually mild; often disappeared without discontinuation of therapy).
In men
Hot flashes, sweating, decreased potency are possible (cancellation of therapy is rarely required).
Sometimes – swelling and soreness of the mammary glands.
At the beginning of treatment in patients with prostate cancer, a temporary increase in bone pain is possible (treatment is symptomatic).
In some cases – a violation of the patency of the ureters and compression of the spinal cord. The use of GnRH analogs may cause loss of bone mineral density.
Among women
Hot flashes, increased sweating, changes in libido are possible (withdrawal of therapy is rarely required).
Sometimes – headaches, mood changes, including depression, dryness of the vaginal mucosa and changes in the size of the mammary glands.
In women with uterine fibroids, degeneration of fibromatous nodes is possible. As with other GnRH agonists, ovarian cysts have been reported.
How to take, course of administration and dosage
S / c in the anterior abdominal wall, every 12 weeks.
For malignant neoplasms
The drug is used for a long time.
For benign gynecological diseases
The drug is used for no more than 6 months.
Application in special clinical situations
Elderly patients, patients with renal or hepatic insufficiency do not need to adjust the dose.
Overdose
- Symptoms: The experience of drug overdose in humans is limited.
- In the case of unintentional administration of Zoladex ahead of time or at a higher dose, no clinically significant adverse events were noted.
- Data on overdose in humans are not available.
- Treatment: (in case of overdose) – symptomatic therapy.
Special Instructions
Zoladex 10.8 mg should be used with caution in men at particular risk of developing ureteral obstruction or spinal cord compression. In this category of patients, careful monitoring should be carried out during the first month of therapy. In the event that compression of the spinal cord or renal failure due to obstruction of the ureters is observed or develops, standard treatment for these complications should be prescribed.
In women, Zoladex 10.8 mg is indicated only for the treatment of endometriosis and uterine fibroids.
During treatment and until the restoration of menstruation, non-hormonal methods of contraception should be used.
The use of GnRH analogues in women may cause a decrease in bone mineral density. The results of the study of Zoladex 3.6 mg show that after the end of treatment there is some restoration of bone mineral density, there are currently no separate data on this with the use of Zoladex 10.8 mg.
Currently, there is no experience with the use of hormone replacement therapy in the treatment of Zoladex 10.8 mg.
The resumption of menstruation after the end of treatment with Zoladex 10.8 mg in some patients may be delayed.
The use of Zoldex 10.8 mg can lead to an increase in cervical resistance, care must be taken when dilating the cervix.
There are no data on the effectiveness of therapy with Zoladex 10.8 mg for more than 6 months for benign gynecological diseases.
Influence on the ability to drive vehicles and control mechanisms
There is no evidence that Zoladex 10.8 mg impairs the ability to drive vehicles and work with mechanisms.
Weight | 0.043 kg |
---|---|
Manufacturer | AstraZeneca UK Limited, United Kingdom |
Brand | AstraZeneca |
Shelf life | 3 years. |
Active substance | Goserelin |
Other forms…
Related products
Buy Zoladex 10.8 mg, syringe applicators with delivery to USA, UK, Europe and over 120 other countries.