Dostinex Tablets Summary of Product Characteristics SmPC emc

Dostinex Tablets Summary of Product Characteristics SmPC emc

On the basis of the elimination half-life, steady state conditions should be achieved after 4 weeks, as confirmed by the mean peak plasma levels of cabergoline obtained after a single dose (37 ± 8 pg/ml) and after a 4 week multiple regimen (101 ± 43 pg/ml). No information is available on the excretion in breast milk in humans; however, mothers https://bosla-assiut.com/alles-was-sie-ber-primobolan-injectable-wissen/ should be advised not to breast-feed in case of failed lactation inhibition/suppression by cabergoline. Since it prevents lactation, cabergoline should not be administered to mothers with hyperprolactinemic disorders who wish to breast-feed their infants. Symptomatic hypotension can occur with cabergoline administration for any indication.

  • However, in another study in rabbits, no treatment-related malformations or embryofoetotoxicity were observed at doses up to 8 mg/kg/day (approximately 300 times the maximum recommended human dose).
  • The weekly dose should be increased gradually, preferably by adding 0.5 mg per week at monthly intervals until an optimal therapeutic response is achieved.
  • Cabergoline suppression test can give information about the sensitivity to dopamine agonists in newly diagnosed prolactinomas, allowing a closer follow-up and a better management of patients with tumor hyperprolactinemia.
  • Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential.
  • In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.

The recommended therapeutic dose is 1 mg (two 0.5 mg tablets) given as a single dose. Suppression of milk secretion and relief of breast engorgement and pain are obtained in approximately 85% of nursing women treated with a total dose of 1 mg cabergoline given in four divided doses over two days. All patients must undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of asymptomatic valvular disease. It is also appropriate to perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation of therapy. In patients with valvular regurgitation, it is not known whether cabergoline treatment might worsen the underlying disease. If fibrotic valvular disease is detected, the patient should not be treated with cabergoline (see section 4.3).

Cabergoline Tab 0.5mg

Cabergoline restores ovulation and fertility in women with hyperprolactinaemic hypogonadism. Hypersensitivity to cabergoline, any of the excipients listed in section 6.1 or any ergot alkaloid. As a consequence of the indications for which cabergoline is presently proposed, the experience in elderly is very limited. Cabergoline should only be used during pregnancy if clearly indicated and after an accurate benefit/risk evaluation. The safety and efficacy of cabergoline has not been established in subjects less than 16 years of age. In the event that any heavy or bulky items are ordered, Clear Chemist will contact you and advise you accordingly if you will be subject to any extra delivery charges.

Cabergoline suppression test: assessment tool for management of hyperprolactinemia

Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential. Since in clinical studies cabergoline has been mainly administered with food and since the tolerability of this class of compounds is improved with food, it is recommended that cabergoline be preferably taken with meals for all the therapeutic indications. No information is available about the interaction between cabergoline and other ergot alkaloids; therefore, the concomitant use of these medications during long-term treatment with cabergoline is not recommended. As with other ergot derivatives, cabergoline should not be used in women with pregnancy-induced hypertension, for example, preeclampsia or post-partum hypertension, unless the potential benefit is judged to outweigh the possible risk.

Endocrine Abstracts

In addition, cabergoline exerts a central dopaminergic effect via D2 receptor stimulation at oral doses higher than those effective in lowering serum PRL levels. The long lasting PRL-lowering effect of cabergoline is probably due to its long persistence in the target organ as suggested by the slow elimination of total radioactivity from the pituitary after single oral dose in rats (t½ of approximately 60 hours). Because pregnancy might occur prior to reinitiation of menses, a pregnancy test is recommended at least every four weeks during the amenorrhoeic period and, once menses are reinitiated, every time a menstrual period is delayed by more than three days. Women who wish to avoid pregnancy should be advised to use mechanical contraception during treatment with cabergoline and after discontinuation of cabergoline until recurrence of anovulation. As a precautionary measure, women who become pregnant should be monitored to detect signs of pituitary enlargement since expansion of pre-existing pituitary tumours may occur during gestation.



Leave a Reply