Pravastatin (Dosage)

Several studies have shown a relationship between SLCO1B1 transporter genotype and the risk of pravastatin-induced myopathy. Knowledge of the SLCO1B1 genotype may help in using doses of pravastatin that are safe for patients with a higher genetic vulnerability to this adverse effect.

Pravastatin is a competitive inhibitor of HMG-CoA reductase, an enzyme that catalyzes the initial limiting step of cholesterol biosynthesis.

This drug has a lipid-lowering effect by reducing intracellular cholesterol synthesis and by inhibiting hepatic VLDL (very-low-density lipoprotein) synthesis.

It has demonstrated the capacity to decrease new events of acute myocardial infarction and overall mortality in patients with elevated cholesterol and LDL-C who have suffered an infarction.

CONTRAINDICATIONS

Hypersensitivity to pravastatin.

Active liver disease (including persistent and unexplained elevations of serum transaminases when its limit is 3 times above the upper limit of normal).

Pregnancy and lactation. Myopathy currently active.

PRECAUTIONS:

Moderate or severe renal impairment, hepatic insufficiency.

History of liver disease or consumption of large amounts of alcohol. Monitor liver function during treatment and discontinue if serum transaminases exceed 3 times the upper limit of normal.

Risk of muscle disorders (myalgia, myopathy and rarely rhabdomyolysis), monitor sensitivity, muscle weakness or muscle cramps.

Prior to initiation of treatment, caution should be exercised in patients with predisposing factors to rhabdomyolysis (renal failure, hypothyroidism, previous history of muscle toxicity by a statin or fibrate, personal or family history of hereditary muscle disease or alcohol abuse and patients over 70 years old). It is mandatory to determine CK (creatine kinase) values (do not start if CK values 5 times the normal upper limit).

Risk of developing immune-mediated necrotizing myopathy.

Efficacy in homozygous familial hypercholesterolemia has not been evaluated. Clinical control of patients at risk of developing diabetes.

Exceptional cases of interstitial lung disease have been reported in long-term treatment.

If it is necessary to prescribe pravastatin in prepubertal children, it is necessary to assess the benefit / risk ratio.

SIDE EFFECTS

Skeletal muscle pain (arthralgia, muscle cramps, myalgia, muscle weakness and elevations of CK levels). Elevations of serum transaminases.

PHARMACOLOGICAL INTERACTIONS

Pravastatin increases the risk of myopathy with: gemfibrozil, fenofibrate and nicotinic acid.

Decreased bioavailability by cholestyramine / colestipol.

Systemic exposure increased by cyclosporine.

AUC (area under the curve) is increased by erythromycin and clarithromycin; so caution is advised.

BRAND NAMES

• Bristacol ®
• Lipemol ®
• Liplat ®
• Minuscol ®
• Prareduct ®
• Pravastatina ®
• Pritadol ®