Loading…
PRAVASTATIN SODIUM is a brand name for Pravastatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypercholesterolaemia 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. Primary prevention Reduction of cardiovascular mortality and morbidity in patients with…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Prior to initiating pravastatin, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet which should be continued during treatment. Hypercholesterolaemia 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.
Cardiovascular prevention In all preventive morbidity and mortality trials, the only studied starting and maintenance dose was 40 mg daily. 5). 5). 1). 4). Special populations Patients with renal or hepatic impairment 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. g. colestyramine, colestipol). 5). 5). Method of administration Pravastatin is administered orally once daily preferably in the evening with or without food.
4) List of adverse reactions The frequencies of adverse events are ranked according to the following: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to <1/100),); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Clinical trials Pravastatin has been studied at 40 mg in seven randomized double-blind placebo- controlled trials involving over 21,000 patients treated with pravastatin (N = 10764) or placebo (N = 10719), representing over 47,000 patients years of exposure to pravastatin.
9 years. 3% in pravastatin group compared to the placebo group. g. musculoskeletal pain including arthralgia, muscle cramps, myalgia, muscle weakness and elevated CK levels have been reported in clinical trials. 4). A Cholesterol Treatment Trialists’ (CTT) Collaboration meta-analysis in 2022 assessed 19 double-blind trials of statin versus placebo (n=123,940) and four double- blind trials of a more intensive versus a less intensive statin regimen (n=30,724).
The meta-analysis demonstrated statin therapy caused a small relative increase (3%) in the number of first reports of mild muscle pain or weakness largely confined to the first year of treatment. The meta-analysis also demonstrated an increase in first episode of muscle pain or weakness symptoms being more likely for intensive statin regimens compared to moderate/less intense statin regimens.
Most (>90%) of all reports of muscle symptoms by participants allocated statin therapy were not due to the statin.
Hepatobiliary disorders:
Elevations of serum transaminases have been reported. 2%) in both treatment groups. 4) Isolated cases of tendon disorders, sometimes complicated by rupture. 6 mmol/L, BMI>30kg/m 2, raised triglycerides, history of hypertension). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Hypercholesterolaemia Pravastatin has not been evaluated in patients with homozygous familial hypercholesterolaemia. Therapy is not suitable when hypercholesterolaemia is due to elevated HDL-Cholesterol. As for other HMG-CoA reductase inhibitors, combination of pravastatin with fibrates is not recommended.
5) In children before puberty, the benefit/risk of treatment should be carefully evaluated by physicians before treatment initiation. Hepatic disorders As with other lipid-lowering agents, moderate increases in liver transaminase levels have been observed.
In the majority of cases, liver transaminase levels have returned to their baseline value without the need for treatment discontinuation. Special attention should be given to patients who develop increased transaminase levels and therapy should be discontinued if increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) exceed three times the upper limit of normal and persist.
Caution should be exercised when pravastatin is administered to patients with a history of liver disease or heavy alcohol ingestion. There have been rare post-marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pravastatin.
If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with pravastatin, promptly interrupt therapy. If an alternate etiology is not found do not restart pravastatin. Muscle disorders As with other HMG-CoA reductase inhibitors (statins), pravastatin has been associated with the onset of myalgia, myopathy and very rarely, rhabdomyolysis.
Myopathy must be considered in any patient under statin therapy presenting with unexplained muscle symptoms such as pain or tenderness, muscle weakness, or muscle cramps. In such cases creatine kinase (CK) levels should be measured (see below).
4). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Statin therapy should be temporarily interrupted when CK levels are > 5 x ULN or when there are severe clinical symptoms. Very rarely (in about 1 case over 100 000 patient-years), rhabdomyolysis occurs, with or without secondary renal insufficiency.
Rhabdomyolysis is an acute, potentially fatal condition of skeletal muscle which may develop at any time during treatment and is characterised by massive muscle destruction associated with major increase in CK (usually > 30 or 40 x ULN) leading to myoglobinuria.
The risk of myopathy with statins appears to be exposure-dependent and therefore may vary with individual drugs (due to lipophilicity and pharmacokinetic differences), including their dosage and potential for drug interactions. Although there is no muscular contraindication to the prescription of a statin, certain predisposing factors may increase the risk of muscular toxicity and therefore justify a careful evaluation of the benefit/risk and special clinical monitoring.
CK measurement is indicated before starting statin therapy in these patients (see below). The risk and severity of muscular disorders during statin therapy is increased by the co-administration of interacting medicines. The use of fibrates alone is occasionally associated with myopathy.
5). The co-administration of statins and nicotinic acid should be used with caution. An increase in the incidence of myopathy has also been described in patients receiving other statins in combination with inhibitors of cytochrome P450 metabolism.
5) When associated with statin therapy, muscle symptoms usually resolve following discontinuation of statin therapy. 5). Pravastatin Sodium must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment.
In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. 5). The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.
Statin therapy may be re-introduced seven days after the last dose of fusidic acid. , for the treatment of severe infections, the need for co-administration of Pravastatin Sodium and fusidic acid should only be considered on a case by case basis and under close medical supervision.
There have been very rare reports of an immune-mediated necrotising myopathy (IMNM) during or after treatment with some statins. IMNM is clinically characterised by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
5). Creatine kinase measurement and interpretation Routine monitoring of creatine kinase (CK) or other muscle enzyme levels is not recommended in asymptomatic patients on statin therapy. However, measurement of CK is recommended before starting statin therapy in patients with special predisposing factors, and in patients developing muscular symptoms during statin therapy, as described below.
If CK levels are significantly elevated at baseline (> 5 x ULN), CK levels should be re-measured about 5 to 7 days later to confirm the results. When measured, CK levels should be interpreted in the context of other potential factors that can cause transient muscle damage, such as strenuous exercise or muscle trauma.
Before treatment initiation: caution should be used in patients with […]