Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4 HF, United Kingdom
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
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).
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).
Reduction of post transplantation hyperlipidaemia in-patient receiving immunosuppressive therapy following solid organ transplantation (see sections 4.2, 4.5 and 5.1).
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.
The recommended dose range is 10-40 mg once daily. The therapeutic response is seen within a week and the full effect of a given dose occurs within four weeks, therefore periodic lipid determinations should be performed and the dosage adjusted accordingly. The maximum daily dose is 40 mg.
In all preventive morbidity and mortality trials, the only studied starting and maintenance dose was 40 mg daily.
Following organ transplantation a starting dose of 20 mg per day is recommended in patients receiving immunosuppressive therapy (see section 4.5). Depending on the response of the lipid parameters, the dose may be adjusted up to 40 mg under close medical supervision (see section 4.5).
The recommended dose range is 10–20 mg once daily between 8 and 13 years of age as doses greater than 20 mg have not been studied in this population and 10- 40 mg daily between 14 and 18 years of age (for children and adolescent females of child–bearing potential see section 4.6; for results of the study see section 5.1).
There is no dose adjustment necessary in these patients unless there are predisposing risk factors (see section 4.4).
A starting dose of 10 mg a day is recommended in patients with moderate or severe renal impairment or significant hepatic impairment. The dosage should be adjusted according to the response of lipid parameters and under medical supervision.
The lipid lowering effects of pravastatin sodium on total cholesterol and LDL-cholesterol are enhanced when combined with a bile acid–binding resin (e.g. colestyramine, colestipol). Pravastatin sodium should be given either one hour before or at least four hours after the resin (see section 4.5).
For patients taking ciclosporin with or without other immunosuppressive medicinal products, treatment should begin with 20 mg of pravastatin sodium once daily and titration to 40 mg should be performed with caution (see section 4.5).
To date there has been limited experience with overdosage of Pravastatin. There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required.
3 years.
Keep out of the reach and sight of children.
Store below 25°C. Store in the original package in order to protect from light and moisture.
The immediate container for Pravastatin Sodium Tablets 10 mg is a laminated aluminium/aluminium foil pack containing 10, 14, 20, 50, 28, 30, 56, 60, 90, 98 or 100 tablets. The blister strips are packed in a carton.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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