Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
BROMOCRIPTINE (BROMOCRIPTINE MESYLATE)
NOVARTIS PHARMACEUTICALS CANADA INC
G02CB01
BROMOCRIPTINE
2.5MG
TABLET
BROMOCRIPTINE (BROMOCRIPTINE MESYLATE) 2.5MG
ORAL
100
Prescription
ERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Active ingredient group (AIG) number: 0111278001; AHFS:
CANCELLED POST MARKET
2007-07-18
P RODUCT M ONOGRAPH PR PARLODEL* (bromocriptine mesylate) Tablets 2.5 mg _ _ Prolactin Inhibitor Growth Hormone Suppressant in Acromegaly Adjunctive Medication in Parkinson's Disease Novartis Pharmaceuticals Canada Inc. DATE OF PREPARATION: Dorval, Quebec Sept. 14, 1976 H9S 1A9 DATE OF REVISION: Control#: 106906 June 6, 2007 *PARLODEL is a registered trademark. - 2 - PRODUCT MONOGRAPH NAME OF DRUG Pr PARLODEL* (bromocriptine mesylate) Tablets 2.5 mg THERAPEUTIC CLASSIFICATION Prolactin Inhibitor Growth Hormone Suppressant in Acromegaly Adjunctive Medication in Parkinson's Disease CLINICAL PHARMACOLOGY PARLODEL* (bromocriptine mesylate) is a dopaminomimetic ergot derivative with D 2 -type dopamine receptor agonist activity, which also has D 1 dopamine receptor antagonist properties. PARLODEL* inhibits the release and synthesis of prolactin by acting directly on the prolactin secreting cells of the anterior pituitary. In patients with acromegaly, in addition to lowering prolactin and elevated levels of growth hormone, PARLODEL* has a beneficial effect on clinical symptoms and on glucose tolerance. - 3 - The dopaminomimetic activity of PARLODEL* in the nigro-striatal pathway is considered responsible for the clinical benefits seen in patients with Parkinson's disease. The metabolism of dopamine, from exogenous and endogenous origin, is known to involve the formation of peroxides and free radicals. It has been postulated that these agents may in fact contribute to the progression of Parkinson's disease by accelerating the rate at which neuronal cells are lost. Bromocriptine's metabolic pathway does not involve the formation of such peroxides and free radicals. It has been suggested that because bromocriptine attenuates the timing and rate of levodopa dosage increase, early use of the drug may reduce risk of formation of potentially toxic peroxides and free radicals. In man, bromocriptine is rapidly absorbed after oral administration with an absorption half-life of approximately 0.3 hours. An oral dose of 5 mg of brom Přečtěte si celý dokument