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Zoladex
- Thread starter ckfanatsy
- Start date
no clone
New member
Are you asking if anyone here wants it ? or do you want it and don't know where to get it?
Either way if you are soliciting it I suggest you remove this thread even if it's not a controlled substance!
And if your looking for it be prepared to get pm's from a hundred scammers.
Bottom line, delete the thread.
p.s. don't hesitate to correct me if I'm wrong.
Either way if you are soliciting it I suggest you remove this thread even if it's not a controlled substance!
And if your looking for it be prepared to get pm's from a hundred scammers.
Bottom line, delete the thread.
p.s. don't hesitate to correct me if I'm wrong.
Zerxes said:
I was wondering the same thing?
hhajdo
New member
http://home.intekom.com/pharm/zeneca/zoladex.html
ZOLADEX* Depot 3,6 mg
SCHEDULING STATUS:
S4
PROPRIETARY NAME:
(and dosage form)
ZOLADEX* Depot 3,6 mg
COMPOSITION:
Each ZOLADEX * Depot contains 3,6 mg goserelin.
PHARMACOLOGICAL CLASSIFICATION:
A 21.10 Tropic hormones
PHARMACOLOGICAL ACTION:
ZOLADEX (goserelin) is a synthetic analogue of naturally occurring Luteinising hormone-releasing hormone (LHRH), a decapeptide found in the hypothalamus. LHRH controls the release of Luteinising hormone (LH) and follicle stimulating hormone (FSH) from the pituitary gland. On chronic administration ZOLADEX results in inhibition of pituitary LH secretion leading to a fall in serum testosterone concentrations in males and serum oestradiol concentrations in females. Initially, ZOLADEX transiently increases serum testosterone concentrations in men and serum oestradiol concentrations in women.
In men by around 21 days after the first depot injection testosterone concentrations have fallen to within the castrate range and remain suppressed with continuous treatment every 28 days. This inhibition leads to prostate tumour regression and symptomatic improvement in the majority of patients.
In women serum oestradiol concentrations are suppressed by around 21 days after the first depot injection and, with continuous treatment every 28 days, remain suppressed at levels comparable to those observed in postmenopausal women. This suppression is associated with a response in hormone dependent disease. It will result in amenorrhoea in the majority of patients.
PHARMACOKINETICS:
The bioavailability of ZOLADEX is almost complete. Administration of a depot every four weeks ensures that effective concentrations are maintained with no accumulation. ZOLADEX is poorly protein bound and has a serum elimination half-life of two to four hours in subjects with normal renal function. The half-life is increased in patients with renal failure. For the compound given monthly in a depot formulation, this change will have minimal effect. Hence, no change in dosing is necessary in these patients.
INDICATIONS:
Prostate cancer suitable for hormonal manipulation.
Advanced or metastatic breast cancer suitable for hormonal manipulation, in pre- and perimenopausal women.
Relief of clinical symptoms associated with endometriosis.
Reduction of uterine fibroid size before surgery.
CONTRA-INDICATIONS:
Previous hypersensitivity to ZOLADEX.
Children: ZOLADEX is not indicated for use in children.
WARNINGS:
Patients with proven non-hormone dependent cancer e.g. those who have failed to respond to previous surgical castration or oestrogens, are less likely to respond to ZOLADEX than previously untreated patients.
The safety and efficacy of ZOLADEX for gynaecological conditions have not been established for periods exceeding 6 months.
DOSAGE AND DIRECTIONS FOR USE:
Adults, including elderly:
One 3,6 mg depot of ZOLADEX injected subcutaneously into the anterior abdominal wall, every 28 days.
No dosage adjustment is necessary for patients with renal impairment, or for the elderly.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects
Hypersensitivity reactions, which may include anaphylaxis, angioedema, urticaria, eczema, bronchospasm have been reported.
Arthralgia has been reported.
Skin rashes have been generally mild and often regressed without discontinuation of therapy.
Changes in blood pressure, manifest as hypotension or hypertension, have been occasionally observed in patients administered ZOLADEX. The changes are usually transient, resolving either during continued therapy or after cessation of therapy with ZOLADEX. Rarely, such changes have been sufficient to require medical intervention including withdrawal of treatment from ZOLADEX. In hypertensive patients blood pressure should be monitored more frequently and therapy may have to be adjusted.
Occasional local reactions including mild bruising at the subcutaneous injection site, have been reported.
Males:
Initially, some patients may experience a temporary increase in bone pain, which can be managed symptomatically. Isolated cases of ureteric obstruction and spinal cord compression have been recorded.
Reduction of serum testosterone may result in:
hot flushes
decrease in potency
breast swelling
breast tenderness
Females:
Initially, some patients may experience a temporary increase in signs and symptoms, which can be managed symptomatically.
During treatment with ZOLADEX some women may experience vaginal bleeding of variable duration and intensity. Such bleeding actually represents oestrogen withdrawal bleeding and is expected to stop spontaneously, but may also be caused by degenerating fibromyoma.
Rarely patients with bony metastases have developed hypercalcaemia on initiation of therapy.
In women with fibroids, degeneration of fibroids may occur resulting in abdomino-pelvic pain, low grade fever, continual bleeding and occasional enlargement of the fibroid and ascites.
Some women may enter the menopause during treatment with LHRH analogues and not resume menses on cessation of therapy. The median time for return of menses after treatment with ZOLADEX is 70 days from time of last injection.
Reduction of serum oestradiol frequently results in:
hot flushes and sweating
loss of libido
headaches, insomnia, tiredness
mood changes including depression
vaginal dryness
change in breast size, weight gain
These side-effects may decrease in intensity and in incidence with prolonged therapy.
Special Precautions:
Following long-term repeated dosing with ZOLADEX, an increased incidence of benign pituitary tumours has been observed in male rats. Whilst this finding is similar to that previously noted in this species following surgical castration, any relevance to man has not been established.
In mice, long term repeated dosing with multiples of the human dose produced histological changes in some regions of the digestive system manifested by pancreatic islet cell hyperplasia and a benign proliferative condition in the pyloric region of the stomach, also reported as a spontaneous lesion in this species. The clinical relevance of these findings is unknown.
Effect on ability to drive or operate machinery: There is no evidence that ZOLADEX results in impairment of these activities.
Males:
The use of ZOLADEX in patients at particular risk of developing ureteric obstruction or spinal cord compression should be considered carefully and the patients monitored closely during the first month of therapy. If spinal cord compression or renal impairment due to ureteric obstruction are present or develop, specific standard treatment of these complications should be instituted.
Females:
Pregnancy: ZOLADEX should not be used in pregnancy as there is a theoretical risk of abortion or foetal abnormality if LHRH agonists are used during pregnancy. Potentially fertile women should be examined carefully before treatment to exclude pregnancy. Non-hormonal methods of contraception should be employed during therapy.
Lactation: The use of ZOLADEX during breast feeding is not recommended.
The use of LHRH agonists in women may cause a loss of bone mineral density. Currently available data suggest that some recovery of bone loss may occur on cessation of therapy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no human experience of overdosage. Animal tests suggest that no effect other than the intended therapeutic effects on sex hormone concentrations and on the reproductive tract will be evident with higher doses of ZOLADEX.
If overdosage occurs, this should be managed symptomatically.
ZOLADEX* Depot 3,6 mg
SCHEDULING STATUS:
S4
PROPRIETARY NAME:
(and dosage form)
ZOLADEX* Depot 3,6 mg
COMPOSITION:
Each ZOLADEX * Depot contains 3,6 mg goserelin.
PHARMACOLOGICAL CLASSIFICATION:
A 21.10 Tropic hormones
PHARMACOLOGICAL ACTION:
ZOLADEX (goserelin) is a synthetic analogue of naturally occurring Luteinising hormone-releasing hormone (LHRH), a decapeptide found in the hypothalamus. LHRH controls the release of Luteinising hormone (LH) and follicle stimulating hormone (FSH) from the pituitary gland. On chronic administration ZOLADEX results in inhibition of pituitary LH secretion leading to a fall in serum testosterone concentrations in males and serum oestradiol concentrations in females. Initially, ZOLADEX transiently increases serum testosterone concentrations in men and serum oestradiol concentrations in women.
In men by around 21 days after the first depot injection testosterone concentrations have fallen to within the castrate range and remain suppressed with continuous treatment every 28 days. This inhibition leads to prostate tumour regression and symptomatic improvement in the majority of patients.
In women serum oestradiol concentrations are suppressed by around 21 days after the first depot injection and, with continuous treatment every 28 days, remain suppressed at levels comparable to those observed in postmenopausal women. This suppression is associated with a response in hormone dependent disease. It will result in amenorrhoea in the majority of patients.
PHARMACOKINETICS:
The bioavailability of ZOLADEX is almost complete. Administration of a depot every four weeks ensures that effective concentrations are maintained with no accumulation. ZOLADEX is poorly protein bound and has a serum elimination half-life of two to four hours in subjects with normal renal function. The half-life is increased in patients with renal failure. For the compound given monthly in a depot formulation, this change will have minimal effect. Hence, no change in dosing is necessary in these patients.
INDICATIONS:
Prostate cancer suitable for hormonal manipulation.
Advanced or metastatic breast cancer suitable for hormonal manipulation, in pre- and perimenopausal women.
Relief of clinical symptoms associated with endometriosis.
Reduction of uterine fibroid size before surgery.
CONTRA-INDICATIONS:
Previous hypersensitivity to ZOLADEX.
Children: ZOLADEX is not indicated for use in children.
WARNINGS:
Patients with proven non-hormone dependent cancer e.g. those who have failed to respond to previous surgical castration or oestrogens, are less likely to respond to ZOLADEX than previously untreated patients.
The safety and efficacy of ZOLADEX for gynaecological conditions have not been established for periods exceeding 6 months.
DOSAGE AND DIRECTIONS FOR USE:
Adults, including elderly:
One 3,6 mg depot of ZOLADEX injected subcutaneously into the anterior abdominal wall, every 28 days.
No dosage adjustment is necessary for patients with renal impairment, or for the elderly.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects
Hypersensitivity reactions, which may include anaphylaxis, angioedema, urticaria, eczema, bronchospasm have been reported.
Arthralgia has been reported.
Skin rashes have been generally mild and often regressed without discontinuation of therapy.
Changes in blood pressure, manifest as hypotension or hypertension, have been occasionally observed in patients administered ZOLADEX. The changes are usually transient, resolving either during continued therapy or after cessation of therapy with ZOLADEX. Rarely, such changes have been sufficient to require medical intervention including withdrawal of treatment from ZOLADEX. In hypertensive patients blood pressure should be monitored more frequently and therapy may have to be adjusted.
Occasional local reactions including mild bruising at the subcutaneous injection site, have been reported.
Males:
Initially, some patients may experience a temporary increase in bone pain, which can be managed symptomatically. Isolated cases of ureteric obstruction and spinal cord compression have been recorded.
Reduction of serum testosterone may result in:
hot flushes
decrease in potency
breast swelling
breast tenderness
Females:
Initially, some patients may experience a temporary increase in signs and symptoms, which can be managed symptomatically.
During treatment with ZOLADEX some women may experience vaginal bleeding of variable duration and intensity. Such bleeding actually represents oestrogen withdrawal bleeding and is expected to stop spontaneously, but may also be caused by degenerating fibromyoma.
Rarely patients with bony metastases have developed hypercalcaemia on initiation of therapy.
In women with fibroids, degeneration of fibroids may occur resulting in abdomino-pelvic pain, low grade fever, continual bleeding and occasional enlargement of the fibroid and ascites.
Some women may enter the menopause during treatment with LHRH analogues and not resume menses on cessation of therapy. The median time for return of menses after treatment with ZOLADEX is 70 days from time of last injection.
Reduction of serum oestradiol frequently results in:
hot flushes and sweating
loss of libido
headaches, insomnia, tiredness
mood changes including depression
vaginal dryness
change in breast size, weight gain
These side-effects may decrease in intensity and in incidence with prolonged therapy.
Special Precautions:
Following long-term repeated dosing with ZOLADEX, an increased incidence of benign pituitary tumours has been observed in male rats. Whilst this finding is similar to that previously noted in this species following surgical castration, any relevance to man has not been established.
In mice, long term repeated dosing with multiples of the human dose produced histological changes in some regions of the digestive system manifested by pancreatic islet cell hyperplasia and a benign proliferative condition in the pyloric region of the stomach, also reported as a spontaneous lesion in this species. The clinical relevance of these findings is unknown.
Effect on ability to drive or operate machinery: There is no evidence that ZOLADEX results in impairment of these activities.
Males:
The use of ZOLADEX in patients at particular risk of developing ureteric obstruction or spinal cord compression should be considered carefully and the patients monitored closely during the first month of therapy. If spinal cord compression or renal impairment due to ureteric obstruction are present or develop, specific standard treatment of these complications should be instituted.
Females:
Pregnancy: ZOLADEX should not be used in pregnancy as there is a theoretical risk of abortion or foetal abnormality if LHRH agonists are used during pregnancy. Potentially fertile women should be examined carefully before treatment to exclude pregnancy. Non-hormonal methods of contraception should be employed during therapy.
Lactation: The use of ZOLADEX during breast feeding is not recommended.
The use of LHRH agonists in women may cause a loss of bone mineral density. Currently available data suggest that some recovery of bone loss may occur on cessation of therapy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no human experience of overdosage. Animal tests suggest that no effect other than the intended therapeutic effects on sex hormone concentrations and on the reproductive tract will be evident with higher doses of ZOLADEX.
If overdosage occurs, this should be managed symptomatically.
