PARLODEL TAB 2.5MG TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

BROMOCRIPTINE (BROMOCRIPTINE MESYLATE)

Disponible depuis:

NOVARTIS PHARMACEUTICALS CANADA INC

Code ATC:

G02CB01

DCI (Dénomination commune internationale):

BROMOCRIPTINE

Dosage:

2.5MG

forme pharmaceutique:

TABLET

Composition:

BROMOCRIPTINE (BROMOCRIPTINE MESYLATE) 2.5MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0111278001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2007-07-18

Résumé des caractéristiques du produit

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