Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ
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 management of the signs and symptoms of Parkinson’s disease.
Treatment should be initiated under specialist supervision. The benefit of continued treatment should be regularly reassessed taking into account the risk of fibrotic reactions and valvulopathy (see sections 4.3, 4.4 and 4.8).
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.
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. In view of the long half-life of the compound, increments of the daily dose of 0.5-1 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.
The safety and efficacy of cabergoline has not been investigated in children as Parkinson’s disease does not affect this population.
The tablets are for oral administration.
Symptoms of overdose would likely be those of over-stimulation of dopamine receptors, e.g. nausea, vomiting, gastric complaints, postural hypotension, confusion/psychosis or hallucinations.
Supportive measures should be taken to remove unabsorbed drug and maintain blood pressure, if necessary. In addition, the administration of dopamine antagonist drugs may be advisable.
2 years.
Do not store above 25°C.
Class I amber glass bottles, stoppered with an aluminium tamper-evident screw cap equipped with a low density polyethylene/thermoplastic elastomer (LDPE/TPE) plastic undercap acting as a container holding silica gel, closed by a plastic cap with a porous paper at the lower extremity.
Or
White high-density polyethylene (HDPE) bottles with a child-resistant polypropylene (PP) cap equipped with inner low-density polyethylene (LDPE) desiccant canister containing silica gel.
Each bottle contains 20 or 30 tablets and is enclosed in an outer cardboard carton.
Not all pack sizes may be marketed.
Bottles of Cabaser are supplied with desiccant in the caps. This desiccant must not be removed.
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