Pravastatin

Registered South African indications:

• Hypercholesterolaemia
• Mixed hyperlipidaemia
• Prevention of coronary artery disease

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other HMG-CoA reductase inhibitors
• Pregnancy
• Breastfeeding
• Acute or chronic liver disease
• Unexplained persistent elevations of serum transaminases
• Porphyria: Safety has not been established

Cautions

• Renal impairment
• Elderly
• Homozygous familial hypercholesterolaemia
• Hypercholesterolaemia due to elevated high-density lipoprotein cholesterol
• Children before puberty
• History of liver disease
• Alcohol abuse
• Risk factors for myopathy
• Prolonged therapy
• Diabetes mellitus
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab

Primary hypercholesterolaemia
Heterozygous familial hypercholesterolaemia
Mixed hyperlipidaemia

• Oral (tab): Initial: 10mg, dly at night; Titrate at intervals of 4 weeks; Max: 80mg/24hrs 

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Reduce dose if LDL less than 1.94mmol/l or total cholesterol less than 3.6mmol/l

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Prevention of coronary artery disease 

• Oral (tab): Initial: 20mg, dly at night; Titrate at intervals of 4 weeks; Max: 80mg/24hrs

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Patients must follow a cholesterol-lowering diet before initiation and while on treatment

Paed. forms avail. in SA and covered in this monograph: tab

Heterozygous familial hypercholesterolaemia

Younger than 8 years

• Not established for use

Between 8-13 years

• Oral (tab): 10-20mg, dly

Between 14-18 years

• Oral (tab): 10-40mg, dly

Older than 18 years

• See adult dosage

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Patients must follow a cholesterol-lowering diet before initiation and while on treatment

Pregnancy 

• Contraindicated

Breastfeeding 

• Contraindicated

Renal Impairment 

• Mild: Caution; no dose adjustment recommended
• Moderate to severe: Caution; dose adjustment recommended

Hepatic Impairment

• Acute or chronic liver disease: Contraindicated
• Unexplained persistent elevations of serum transaminases: Contraindicated

Elderly

• Caution; No dose adjustment recommended

Porphyria Information

South African recommendations

• Contraindicated

Recommendations in other jurisdictions

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Headache
• Dizzyness
• Fatigue
• Peripheral polyneuropathy
• Paresthesia
• Nightmares
• Memory loss
• Depression
• Malaise
• Insomnia

Cardiovascular Disorders

• Vasculitis

Respiratory Disorders

• Interstitial lung disease
• Dyspnoea

Gastrointestinal Disorders

• Pancreatitis
• Constipation
• Diarrhoea
• Nausea and vomiting
• Flatulance
• Dyspepsia
• Abdominal pain

Hepatobiliary Disorders

• Jaundice
• Hepatitis
• Fulminant hepatic necrosis
• Elevated serum aminotransaminases

Genitourinary Disorders

• Acute renal failure
• Myoglobinuria
• Dysuria
• Frequency 
• Nocturia
• Sexual dysfunction

Endocrine and Metabolic Disorders

• Diabetes mellitus
• Weight gain
• Elevated creatine phosphoskinase 

Musculoskeletal  Disorders

• Myopathy
• Rhabdomyolysis 
• Myositis
• Polymyositis
• Tendon disorders
• Polymyalgia
• Rheumatica
• Arthritis
• Arthralgia
• Muscle cramps

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Photosensitivity
• Rash
• Alopecia
• Pruritis
• Flushing

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylaxis
• Angioedema
• Lupus erythematous-like syndrome
• Thrombocytopaenia
• Increased erythrocyte sedimentation rate
• Eosinophiolia
• Anaemia
• Neutropaenia
• Fever

Sensory Disorders

• Blurred vision
• Diplopia

• Statins
• Cholestyramine
• Ciclosporin

• Hepatic function
• Blood glucose

Specific cases may require

• Creatine phosphokinase

Pravastatin sodium produces its lipid-lowering effect in two ways:

• As a consequence of its reversible inhibition o HMG-CoA reductase activity, it effects modest reduction in the synthesis of intracellular cholesterol. This results in an increase in the number of low-density lipoprotein (LDL) receptors on cell surfaces and enhanced receptor-mediated catabolism and clearance of circulating LDL-cholesterol. 
• Inhibits LDL production by inhibiting the hepatic synthesis of very low-density lipoprotein (VLDL) cholesterol, the LDL-cholesterol precursor.

Tablet 10mg

• Aspen Pravastatin (Pharmacare)
• Austell Pravastatin (Austell)
• Colite (Zydus)
• Pixeta (Accord)
• Pranalip (Sandoz)
• Sandoz Pravastatin (Sandoz)

Tablet 20mg 

• Aspen Pravastatin (Pharmacare)
• Austell Pravastatin (Austell)
• Colite (Zydus)
• Pixeta (Accord)
• Pranalip (Sandoz)
• Sandoz Pravastatin (Sandoz)

Tablet 40mg 

• Aspen Pravastatin (Pharmacare)
• Austell Pravastatin (Austell)
• Colite (Zydus)
• Pixeta (Accord)
• Pranalip (Sandoz)
• Sandoz Pravastatin (Sandoz)