DOSTINEX 0.5MG Tablet

General As with other ergoline derivatives, cabergoline should be administered with special caution to patients suffering from severe cardiovascular disease, Raynaud's syndrome, peptic ulcer, gastrointestinal bleeding, and individuals with a history of severe (particularly psychotic) mental disorder. Patients with the rare hereditary conditions of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. Hepatic impairment Lower doses should be considered in patients with severe hepatic impairment who are treated long-term with cabergoline. An increase in AUC was observed in patients with severe hepatic impairment (Child-Pugh class C) following administration of a single 1 mg dose compared to healthy volunteers and patients with a lesser degree of hepatic impairment. Postural hypotension Postural hypotension may occur after administration of cabergoline. Therefore, caution is required whenever cabergoline is to be used concomitantly with other blood pressure-lowering medicinal products. Fibrosis, cardiac valvulopathy, and clinical phenomena that may be associated with these conditions Following long-term use of ergoline derivatives with agonist activity at the serotonin 5HT2B receptor, such as cabergoline, fibrotic and serous inflammatory disorders have occurred, including pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral, and tricuspid), or retroperitoneal fibrosis. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of cabergoline. Abnormally elevated erythrocyte sedimentation rate (ESR) has been observed in association with pleural effusions/fibrosis. In cases of unexplained elevation of ESR to abnormal values, chest X-ray examination is recommended. Since cardiac valvulopathy has been associated with cumulative doses, patients should be treated with the lowest effective dose. At each visit, the benefit/risk profile of continued cabergoline treatment should be reassessed to confirm the appropriateness of ongoing therapy. Before initiating long-term treatment All patients must undergo cardiovascular evaluation including echocardiography to exclude asymptomatic valvular disease. Before initiating treatment, it is also advisable to perform ESR or other inflammatory marker testing, pulmonary function tests/chest X-ray, and renal function tests. It is not known whether cabergoline treatment can worsen underlying disease in patients with valvular regurgitation. If valvular fibrosis is detected, the patient should not be treated with cabergoline (see section 4.3). During long-term treatment Since fibrotic changes develop gradually, patients should be monitored regularly for the development of such changes. Therefore, attention should be given to signs and symptoms of: respiratory tract disease such as dyspnoea, shortness of breath, persistent cough, or chest pain. renal insufficiency, ureteral obstruction, abdominal vascular obstruction, which may be accompanied by lumbosacral pain or lower extremity oedema; retroperitoneal fibrosis may also manifest as abdominal pain or a palpable mass. cardiac failure; cases of valvular and pericardial fibrosis have often manifested as cardiac failure. Therefore, in the presence of signs of cardiac failure, valvular fibrosis and constrictive pericarditis must be excluded. Clinical monitoring for fibrotic changes is essential. After initiation of treatment, echocardiographic examination must be performed within 3–6 months; thereafter, the frequency of echocardiographic examinations is determined by individual clinical assessment (with particular emphasis on the above-mentioned signs and symptoms), but at least every 6–12 months. Cabergoline must be discontinued if echocardiography reveals valvular regurgitation (or worsening of pre-existing regurgitation) or restriction or thickening of valve leaflets (see section 4.3). The need for additional clinical monitoring (e.g. physical examination including cardiac auscultation, X-ray, CT scan) is determined on an individual basis. Additional investigations such as ESR measurement or serum creatinine determination may contribute to the detection of fibrosis. Somnolence/sudden onset of sleep Cabergoline has been associated with somnolence. Dopamine agonists may be associated with episodes of sudden onset of sleep, particularly in patients with Parkinson's disease. Dose reduction or treatment discontinuation should be considered (see section 4.7). Prevention or suppression of physiological lactation Cabergoline, like other ergot derivatives, should not be used in women with a history of pre-eclampsia or in patients with postpartum hypertension, unless the benefit outweighs the potential risk. Serious adverse reactions, including hypertension, myocardial infarction, seizures, cerebrovascular accident, or psychiatric disorders, have been reported in women treated with cabergoline postpartum for lactation inhibition. In some patients, severe headache and/or transient visual disturbances preceded the development of seizures or cerebrovascular accident. Blood pressure should be carefully monitored during treatment. If hypertension, chest tightness, severe progressive or persistent headache (with or without visual disturbance), or signs of central nervous system toxicity develop, cabergoline treatment must be immediately discontinued and the patient evaluated. Breastfeeding women in whom suppression of established lactation is to be induced should not receive cabergoline in single doses exceeding 0.25 mg (see section 4.2). Treatment of disorders associated with hyperprolactinaemia Since amenorrhoea-galactorrhoea syndrome and infertility may be associated with pituitary tumours, a complete pituitary evaluation is indicated before initiating cabergoline therapy. Cabergoline can restore ovulation and fertility in women with hyperprolactinaemic hypogonadism. Pregnancy must be excluded before administration of cabergoline. Given the limited clinical experience and the long half-life of the product, it is advisable to plan conception with a minimum interval of one month after discontinuation of cabergoline following the onset of regular ovulatory cycles. Since the possibility of conception before the first menstruation cannot be excluded, pregnancy tests should be performed at least every four weeks during the amenorrhoeic period, and once menstruation is restored, tests should be performed whenever menstruation is delayed by more than 3 days. Women who do not wish to conceive should be advised to use mechanical contraceptive methods during and after cabergoline treatment until anovulatory cycles return. As an important precaution, all women who become pregnant should be monitored for possible signs of pituitary enlargement, as pre-existing pituitary tumours may grow during gestation. Psychiatric disorders Patients should be regularly monitored for the possible development of impulse control disorders. Patients and their caregivers should be informed that patients treated with dopamine agonists including DOSTINEX may develop symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, and binge eating. If these symptoms develop, dose reduction or gradual withdrawal should be considered.