Qualitative and quantitative composition Galastop® 50 µg ml Oral solution

Qualitative and quantitative composition Galastop® 50 µg ml Oral solution

Cabergoline should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction or valve leaflet thickening (see section 4.3). Cabergoline restores ovulation and fertility in women with hyperprolactinaemic hypogonadism. The effects of alcohol on overall tolerability of cabergoline are currently unknown. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Hypersensitivity to cabergoline, any of the excipients listed in section 6.1 or any ergot alkaloid.

  • Pharmacokinetic studies in dogs were performed with a daily dose of 80 µg/kg bodyweight (16 times the recommended dose).
  • This may happen quickly, even before menstrual periods start again.
  • The weekly dose may be given as a single administration or divided into two or more doses per week according to patient tolerability.

Patients should be regularly monitored for the development of impulse control disorders. Dose reduction/tapered discontinuation should be considered if such symptoms develop. A dose of 0.012 mg/kg/day (approximately 1/7 the maximum recommended human dose) during the period of organogenesis in rats caused an increase in post-implantation embryofoetal losses.

Clinical monitoring

Preclinical safety studies of cabergoline indicate a consistent safety margin for this compound in rodents and in monkeys, as well as a lack of teratogenic, genotoxic or carcinogenic potential. In urine, the main metabolite identified was 6-allyl-8b-carboxy-ergoline, which accounted for 4-6% of the dose. Three additional metabolites were identified in urine, which accounted overall for less than 3% of the dose. The metabolites have been found to be much less potent than cabergoline as D2 dopamine receptor agonists in vitro.

Common side-effects of cabergoline

History of pulmonary, pericardial and retroperitoneal fibrotic disorders. This is not a complete list of side effects and others may occur. You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking cabergoline. Follow all directions on your prescription label and read all medication guides or instruction sheets.

As cabergoline suppresses milk production, you should not take it whilst breast feeding. It is often helpful to see whether your periods start again when you have stopped breast feeding, and reassess your prolactin levels, before deciding whether or not to resume cabergoline treatment. Rarely, women with large macroprolactinomas will be advised to continue cabergoline https://www.suvidhagroup.in/pharmatropin-steroids-what-you-need-to-know-about/ treatment and not to breast feed. Before administration of cabergoline, pregnancy should be excluded. Should pregnancy occur during treatment, cabergoline is to be discontinued. The pharmacokinetic and metabolic profiles of cabergoline have been studied in healthy volunteers of both sexes, in female hyperprolactinemic patients and in parkinsonian patients.