PRAVASTATIN SODIUM

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

PRAVASTATIN SODIUM

थमां उपलब्ध:

Accord Healthcare Limited

ए.टी.सी कोड:

C10AA03

INN (इंटरनेशनल नाम):

PRAVASTATIN SODIUM

डोज़:

20 Milligram

फार्मास्यूटिकल फॉर्म:

Tablets

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

pravastatin

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2008-09-26

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin Sodium 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg pravastatin sodium.
Excipient: Lactose monohydrate 143.31 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pravastatin Tablets 20 mg: Yellow colored, rounded rectangular shaped,
biconvex, uncoated tablets debossed 'PDT'
on
one side and '20'
on the other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypercholesterolaemia._
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as
an adjunct to diet, when response to diet and
other non-pharmacological treatments (eg. exercise, weight reduction)
is inadequate.
_Primary prevention_
Reduction of cardiovascular mortality and morbidity in patients with
moderate or severe hypercholesterolaemia and at
high risk of a first cardiovascular event, as an adjunct to diet (see
section 5.1)
_Secondary prevention_
Reduction of cardiovascular mortality and morbidity in patients with a
history of myocardial
infarction or unstable
angina pectoris and with either normal or increased cholesterol
levels, as an adjunct to correction of other risk factors
(see section 5.1).
_Post transplantation_
Reduction of
post
transplantation hyperlipidaemia in-patient
receiving immunosuppressive therapy following solid
organ transplantation (see sections 4.2, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating Pravastatin Tablets,
secondary causes of
hypercholesterolaemia should be excluded and patients
should be placed on a standard lipid-lowering diet, which should be
continued during treatment.
Pravastatin sodium is administered orally once daily preferably in the
evening with or without food.
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