AA PHARMA BROMOCRIPTINE TABLET 2.5 mg

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

קנה את זה

הורד מאפייני מוצר (SPC)
20-12-2021

מרכיב פעיל:

BROMOCRIPTINE MESYLATE EQV BROMOCRIPTINE

זמין מ:

PHARMAFORTE SINGAPORE PTE LTD

קוד ATC:

G02CB01

כמות:

2.5 mg

טופס פרצבטיות:

TABLET, FILM COATED

הרכב:

BROMOCRIPTINE MESYLATE EQV BROMOCRIPTINE 2.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

Prescription Only

תוצרת:

APOTEX INC

מצב אישור:

ACTIVE

תאריך אישור:

1996-11-28

מאפייני מוצר

                                AA PHARMA BROMOCRIPTINE
Bromocriptine Mesylate Tablets USP
AA Pharma Inc
Prolactin Inhibitor
Growth Hormone Suppressant in Acromegaly
Adjunctive Medication in Parkinson’s Disease
Date of Revision: 16 August 2021
ACTIONS AND CLINICAL PHARMACOLOGY:
AA PHARMA BROMOCRIPTINE (bromocriptine mesylate) is a dopaminomimetic
ergot derivative with
D
2
type domain receptor agonist activity, and has also D
1
dopamine receptor antagonist properties.
The dopaminomimetic activity of bromocriptine in the striatum is
considered responsible for the
clinical benefits seen in selected patients with Parkinson’s
Disease, when low doses of the drug are
gradually added to levodopa therapy in patients on long-term treatment
who develop late side
effects of levodopa or no longer respond to the medication.
Excessive dopaminomimetic drive may, however, provoke psychotic and
other adverse reactions. It
inhibits the release and synthesis of prolactin y acting directly on
the prolactin secreting cells of the
anterior pituitary.
In patients with acromegaly, apart from lowering prolactin and
elevated levels of growth hormone,
bromocriptine has a beneficial effect on clinical symptoms and on
glucose tolerance.
In man, bromocriptine is rapidly absorbed after oral administration
with an absorption half-life of
approximately 0.3 hours. The amount absorbed is about 65-95% of the
oral dose. About 7% of the
dose reaches the systemic circulation unchanged, due to a high hepatic
extraction rate and first pass
metabolism. The plasma protein binding amounts to 96%. Bromocriptine
is extensively metabolized
by the liver. Only traces of the unchanged compound are found in
urine, together with 2 major
metabolites. Unchanged drug represents about 10-15% of peak levels of
radioactivity in plasma
measured after a single dose of labelled drug. The active parent drug
and the metabolites are
primarily excreted via the liver, with only 6% being eliminated via
the kidney. In plasma, the
elimination half-life was between 2 to 8 hours for the parent drug and
50 to 70
                                
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