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Chemical Name: Pergolide
PERMAX (Pergolide mesilate) is indicated as monotherapy, or as adjunctive treatment to levodopa, in the management of the signs and symptoms of Parkinson's disease. PERMAX (Pergolide mesilate) is a dopamine receptor agonist at D1, D2, and D3 receptor sites.
Permax Side Effects:
Monotherapy: The types of adverse events observed for pergolide as monotherapy generally reflect those seen when pergolide is used as adjunctive treatment to levodopa.
In clinical trials of pergolide as monotherapy, the overall reported incidence of nausea was higher than was reported in trials of pergolide as adjunctive therapy. Overall, only 3.2 percent of patients discontinued due to nausea or nausea and vomiting. However, the incidence of dyskinesia, hallucinations, and dizziness was lower in monotherapy trials in comparison to trials of pergolide as adjunctive therapy.
A symptom complex resembling the neuroleptic malignant syndrome (NMS) (characterised by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious aetiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinson therapy, including pergolide.
Patients should be warned to begin therapy with low doses and to increase dosage in carefully adjusted increments over a period of 3 to 4 weeks (see section 4.2) to minimise the risk of symptomatic postural and/or sustained hypotension. With gradual dosage titration, tolerance to the hypotension usually develops (but see section 4.5).
In controlled trials, pergolide mesilate with l-dopa caused hallucinosis in about 14 percent of patients, as opposed to 3 percent taking placebo with l-dopa. This was of sufficient severity to cause discontinuation of treatment in about 3 percent of those enrolled. Tolerance to this untoward effect was not observed.
In the placebo-controlled trial, 2 of 187 patients treated with placebo died, as compared with 1 of 189 patients treated with pergolide mesilate. Of the 2,299 patients treated with pergolide mesilate in pre-marketing studies evaluated in October 1988, 6.2 percent died while on the drug or shortly after discontinuation. The patient population under evaluation was elderly, ill, and at high risk for death. A case-by-case review of the patients who died failed to disclose any unique set of signs, symptoms, or laboratory results that would suggest that treatment with pergolide caused these deaths.
Caution should be exercised when administering to patients prone to cardiac dysrhythmias or with significant underlying cardiac disease.
In a placebo-controlled study, patients taking pergolide mesilate had significantly more episodes of atrial premature contractions (APCs) and sinus tachycardia.
Fibrotic and serosal inflammatory disorders, such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis, have occurred after prolonged usage of ergot derivatives such as pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide. The factors predisposing patients to the risk of such disorders are not known, however, Parkinson's disease patients with a history of such disorders should not be treated with pergolide, or any other ergot derivative, unless the potential benefit clearly outweighs the risk.
Attention should be paid to the signs and symptoms of:
• Pleuropulmonary 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, as cases of pericardial fibrosis have often manifested as cardiac failure; constrictive pericarditis should be excluded if such symptoms appear.
Appropriate investigations such as erythrocyte sedimentation rate, chest X-ray, and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder. 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.
These disorders can have an insidious onset and patients should be regularly and carefully monitored while taking pergolide for manifestations of progressive fibrotic disorders. Pergolide should be withdrawn if fibrotic or serosal inflammatory changes are diagnosed or suspected.
Pergolide has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with pergolide. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.
The generic alternative is not manufactured by the company that makes the brand product.
All prices are in US dollars.
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