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CABASER is a brand name for Cabergoline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of Parkinson's disease If treatment with a dopamine agonist is being considered, cabergoline is indicated as second line therapy in patients who are intolerant or fail treatment with a non-ergot compound, as monotherapy, or as adjunctive treatment to levodopa plus dopa- decarboxylase inhibitor, in the…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Since the tolerability of dopaminergic agents is improved when administered with food, it is recommended that cabergoline be taken with meals. Cabergoline is intended for chronic, long term treatment. Adults and elderly patients As expected for dopamine agonists, dose response for both efficacy and side effects appears to be linked to individual sensitivity.
Optimization of dose should be obtained through slow initial dose titration, from starting doses of 1 mg daily. The dosage of concurrent levodopa may be gradually decreased, while the dosage of cabergoline is increased, until the optimum balance is determined.
5-1 mg should be done at weekly (initial weeks) or bi-weekly intervals, up to optimal doses. The recommended therapeutic dosage is 2 mg to 3 mg/day for patients with signs and symptoms of Parkinson’s disease. Cabergoline should be given as a single daily dose.
Paediatric population The safety and efficacy of cabergoline has not been investigated in children as Parkinson's disease does not affect this population. Method of administration The tablets are for oral administration.
The following undesirable effects have been observed and reported during treatment with cabergoline with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
General As with other ergot derivatives, cabergoline should be given with caution to patients with severe cardiovascular disease, Raynaud's syndrome, peptic ulcer or gastrointestinal bleeding, or with a history of serious, particularly psychotic, mental disorders.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The effects of alcohol on overall tolerability of cabergoline are currently unknown.
Hepatic Insufficiency Lower doses of cabergoline should be considered in patients with severe hepatic insufficiency. Compared to normal volunteers and those with lesser degrees of hepatic insufficiency, an increase in AUC has been seen in patients with severe hepatic insufficiency (Child-Pugh Class C) who received a single 1 mg dose.
Postural Hypotension Postural hypotension can occur following administration of cabergoline, particularly during the first days of administration of cabergoline. Care should be exercised when administering cabergoline concomitantly with other drugs known to lower blood pressure.
Fibrosis and Cardiac Valvulopathy and Possibly Related Clinical Phenomena Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as cabergoline.
In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of cabergoline. Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis.
Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values. Serum creatinine measurements can also be used to help in the diagnosis of fibrotic disorder. 3). Valvulopathy has been associated with cumulative doses, therefore patients should be treated with the lowest effective dose.
1, or any ergot alkaloid. • History of pulmonary, pericardial and retroperitoneal fibrotic disorders. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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At each visit, the risk benefit profile of cabergoline treatment for the patient should be reassessed to determine the suitability of continued treatment with cabergoline. Before initiating long-term treatment 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.
3). During long-term treatment Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis. Therefore during treatment, attention should be paid to the signs and symptoms of: • Pleuro-pulmonary disease, such as dyspnoea, shortness of breath, persistent cough, or chest pain.
• Renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank, and lower limb oedema, as well as any possible abdominal masses or tenderness that may indicate retroperitoneal fibrosis. • Cardiac failure: cases of valvular and pericardial fibrosis have often manifested as cardiac failure.
Therefore, valvular fibrosis (and constrictive pericarditis) should be excluded if such symptoms occur. Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential. Following treatment initiation, the first echocardiogram must occur within 3-6 months, thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on the above-mentioned signs and symptoms, but must occur at least every 6 to 12 months.
3). g. physical examination including, cardiac auscultation, X-ray, CT scan) should be determined on an individual basis. Additional appropriate investigations such as erythrocyte sedimentation rate, and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder.
Somnolence/Sudden Sleep Onset Cabergoline has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson’s disease. Sudden onset of sleep during activities, in some cases without awareness or warning signs, has been reported.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with cabergoline. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
7). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Cabaser.
Dose reduction/tapered discontinuation should be considered if […]