PARLODEL TAB 2.5MG TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

BROMOCRIPTINE (BROMOCRIPTINE MESYLATE)

Доступно од:

NOVARTIS PHARMACEUTICALS CANADA INC

АТЦ код:

G02CB01

INN (Међународно име):

BROMOCRIPTINE

Дозирање:

2.5MG

Фармацеутски облик:

TABLET

Састав:

BROMOCRIPTINE (BROMOCRIPTINE MESYLATE) 2.5MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

ERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2007-07-18

Карактеристике производа

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