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No dosage adjustment is necessary for patients with renal impairment.
No dosage adjustment is necessary for patients with hepatic impairment.
No dosage adjustment is necessary in the elderly.
Children: ZOLADEX/ZOLADEX LA is not indicated for use in children.
Method of administration: For correct administration of ZOLADEX/ZOLADEX LA, see instructions on the instruction card.
The instruction card has to be read prior to administration.
Caution is needed when administering ZOLADEX/ZOLADEX LA into anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches.
Extra care to be given to patients with a low BMI or who are receiving anticoagulation medication [see Precautions].
Care should be taken to ensure injection is given subcutaneously, using the technique described in the instruction card. Do not penetrate into a blood vessel, muscle or peritoneum.
In the event of the need to surgically remove a Zoladex implant/depot, it may be localised by ultrasound.
For special precautions for disposal and other handling see Instructions for use, handling and disposal under Cautions for Usage.
Zoladex: Adults: One 3.6 mg depot of ZOLADEX injected subcutaneously into the anterior abdominal wall, every 28 days.
Assisted reproduction: ZOLADEX 3.6 mg is administered to downregulate the pituitary gland, as defined by serum oestradiol levels similar to those observed in the early follicular phase (approximately 150 pmol/l). This will usually take between 7 and 21 days.
When downregulation is achieved, superovulation (controlled ovarian stimulation) with gonadotrophin is commenced. The downregulation achieved with a depot agonist is more consistent suggesting that, in some cases, there may be an increased requirement for gonadotrophin. At the appropriate stage of follicular development, gonadotrophin is stopped and human chorionic gonadotrophin (hCG) is administered to induce ovulation. Treatment monitoring, oocyte retrieval and fertilisation techniques are performed according to the normal practice of the individual clinic.
Endometriosis should be treated for a period of six months only, since at present there are no clinical data for longer treatment periods. Repeat courses should not be given due to concern about loss of bone mineral density. In patients receiving ZOLADEX 3.6 mg for the treatment of endometriosis, the addition of hormone replacement therapy (a daily oestrogenic agent and a progestogenic agent) has been shown to reduce bone mineral density loss and vasomotor symptoms.
For use in endometrial thinning; two depots to be administered 4 weeks apart, with surgery timed for between zero and two weeks after the second depot.
For women who are anaemic as a result of uterine fibroids, ZOLADEX 3.6 mg depot with supplementary iron may be given for up to three months before surgery.
Zoladex LA: Adult Males (including the elderly): One 10.8 mg depot of ZOLADEX LA injected subcutaneously into the anterior abdominal wall, every 12 weeks.
Females: ZOLADEX LA 10.8 mg is not indicated for use in females.
