PRASIVAST

History of hepatopathies History of myopathy

History of acquired myopathy due to statin or fibrate Family history of myopathy Significant alcohol consumption KPC > 5 times the normal upper limit Child under 8 years of age Hypothyroidism Hepatic impairment Renal impairment Myasthenia Patient at risk for diabetes Subject over 70 years Extended treatment.

Mechanism of action

Pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG Co-A) reductase, an enzyme acting in the early stages of cholesterol biosynthesis, and produces its hypolipidemitic effect in two ways.

First, because of its reversible and specific competitive inhibition of HMG Co-A reductase, it induces a moderate decrease in intracellular cholesterol synthesis.

This induces an increase in

LDL receptor counts on the surface of cells as well as a catabolism via these receptors and a reinforced clearance of circulating LDL cholesterol.

Second, pravastatin inhibits LDL production by inhibiting hepatic synthesis of VLDL-cholesterol, precursor of LDL-cholesterol.

In healthy subjects as well as in hypercholesterolemic patients, pravastatin sodium lowers the following lipid parameters: total cholesterol, LDL-cholesterol, apolipoprotein B, VLDL-Cholesterol and triglycerides; HDL-Cholesterol and triglycerides.

• (increase)
• Myoglobinuria Transaminases (increase)
• KPC (increase)
• ALT (increase)
• Urticaria (Uncommon)
• Pathology of the scalp (Uncommon)
• Hair disorder (Uncommon)
• Rash (Uncommon)
• Pruritus (Uncommon)
• Photosensitivity (Rare)
• Alopecia Lichenoid eruption Fatigue (Uncommon)
• Sexual disorder (Uncommon)
• Hepatitis (Very rare)
• Ictery (Very rare)
• Liver necrosis (Very rare)
• Hepatic impairment Hypersensitivity (Very rare)
• Dermatomyosite (Very rare)
• Anaphylactic reaction
• Angioedema Diabetes Vision disorder (Uncommon)
• Blurty vision Diplopia Feeling dizzy (Uncommon)
• Insomnia (Uncommon)
• Sleep disorder (Uncommon)
• Depression Nightmare Dyspepsia (Uncommon)
• Pyrosis (Uncommon)
• Constipation (Uncommon)
• Nausea (Uncommon)
• Abdominal pain (Uncommon)
• Vomiting (Uncommon)
• Flatulence (Uncommon)
• Diarrhoea (Uncommon)
• Pancreatitis (Very rare)
• Tendinopathy (Uncommon)
• Polymyositis (Very rare)
• Myopathy (Very rare)
• Rhabdomyolysis (Very rare)
• Myositis (Very rare)
• Muscle disorder (Very rare)
• Lupus-like syndrome Muscle loss
• Muscle pain Strand cut Joint pain Tendinitis Immune-mediated necrotic myopathy Musculoskeletal pain
• Cramp Muscle weakness Headache (Uncommon)
• Paraesthesia (Very rare)
• Polyneuropathy (Very rare)
• Memory Disorder Myasthenia Myasthenia eye Memory loss Interstitial pneumopathy (Exceptional)
• Dysuria (Uncommon)
• Nycturia Abnormal urination frequency Acute renal impairment.