Pergolide 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pergolide mesilate

Available from:

Genus Pharmaceuticals Ltd

ATC code:

N04BC02

INN (International Name):

Pergolide mesilate

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100

Patient Information leaflet

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0ERGOLIDEISNOTRECOMMENDEDFORUSEINCHILDRENAND
ADOLESCENTS
OTHER MEDICINES AND PERGOLIDE
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING, HAVE
RECENTLY TAKEN OR MIGHT TAKE ANY OTHER MEDICINES.
ESPECIALLY TALK TO YOUR DOCTOR IF YOU ARE TAKING ANY OF
THE FOLLOWING:
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MAYALSOCAUSEALOWERINGOFBLOODPRESSURE
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MEDICINESMAYREDUCETHEEFFECTOFPERGOLIDE)F
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CONSULTYOURDOCTORORPHARMACISTBEFORETAKING
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HALOPERIDOLBENPERIDOLTHIOXANTHENESSUCHAS
FLUPENTIXOLZUCLOPENTHIXOL
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RYEERGOTALKALOIDSEGERGOTAMINE
DIHYDROERGOTAMINEMETHYLERGOTAMINE
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CLARITHROMYCINERYTHROMYCIN
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pergolide 1 milligram Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains, as the active ingredient, pergolide mesilate
equivalent to
1 milligram of pergolide.
3.
PHARMACEUTICAL FORM
Tablet: light pink, rectangular shaped, scored, marked ‘G’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Second-line therapy of Parkinson’s disease, or as adjunctive
treatment to levodopa,
when treatment with dopamine agonist is considered and when non-ergot
alkaloids
are contraindicated or are no longer adequate.
The treatment should be initiated under specialist supervision. The
benefit of
continuing treatment should be regularly reassessed
taking into account
the risk of
fibrotic reactions and valvulopathy (see sections 4.3, 4.4 and 4.8).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration to adults only.
_Monotherapy _
The following titration should be used for initiation of pergolide as
monotherapy:
Day
Morning
Noon
Evening
Total Dosage
1
-
-
50 micrograms
50 micrograms
2 – 4
-
50 micrograms
50 micrograms
100 micrograms
5 – 7
50 micrograms
50 micrograms
100 micrograms
200 micrograms
8 – 10
100 micrograms
100 micrograms
100 micrograms
300 micrograms
11 – 13
100 micrograms
150 micrograms
150 micrograms
400 micrograms
14 – 17
200 micrograms
200 micrograms
200 micrograms
600 micrograms
18 – 21
250 micrograms
250 micrograms
250 micrograms
750 micrograms
22 – 24
500 micrograms
250 micrograms
250 micrograms
1000 micrograms
25 – 27
500 micrograms
500 micrograms
250 micrograms
1250 micrograms
28 – 30
500 micrograms
500 micrograms
500 micrograms
1500 micrograms
After day 30, the daily dose should be increased by at most 250
micrograms twice a
week until an optimal therapeutic response is achieved. Pergolide
mesilate is usually
administered in divided doses 3 times per day.
In clinical studies of pergolide as monotherapy, the mean dose was
2100 micrograms
per day at 3 months and 2510 micrograms per day at 1 ye