Fluvastatin

Registered South African indications:

• Familial hypercholesterolaemia
• Familial combined hyperlipidaemia
• Mixed dyslipidaemia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Hepatic impairment
  - ­ In patients with active liver disease, or unexplained, persistent elevations in serum transaminases

Cautions

• Severe renal impairment
• History of hepatic disease
• Heavy alcohol ingestion
• Risk factors for rhabdomyolysis
• Risk factors for the development of diabetes
• Children
• Homozygous familial hypercholestrolaemia

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

Familial hypercholesterolaemia
Familial combined hyperlipidaemia
Mixed dyslipidaemia
Secondary prevention in patient with coronary artery disease

Initial

• Oral (cap): 20-40mg, dly

Initial dose: LDL-C reduction goal of < 25%, start with 20 mg, dly;  LDL-C reduction goal of ≥25%, start with 40 mg, dly

If needed, titrate dose at intervals of 4 weeks

Maintenance

• Oral (cap): 40mg, 12hrly; Max: 80mg/24hrs

OR

• Oral (tab): 80mg, dly; Max: 80mg/24hrs

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

Heterozygous familial hypercholesterolaemia

Younger then 9 years

• Not established for use

Older than 9 years

Initial

• Oral (cap): 20mg, dly

If needed, titrate dose at intervals of 6 weeks

Maintenance

• Oral (cap): 40mg, 12hrly; Max: 80mg/24hrs

OR

• Oral (tab): 80mg, dly; Max: 80mg/24hrs

Prior to initiating fluvastatin, patient should be on on standard cholesterol-lowering diet for at least six months; diet should be continued alongside treatment

Pregnancy

• FDA Pregnancy Category X

Breastfeeding

• Contraindicated

Renal Impairment

• Severe: Caution; no information available

Hepatic Impairment

• Contraindicated

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Insomnia
• Headache
• Paresthesia
• Dysesthesia
• Hypoesthesia 

Cardiovascular Disorders

• Vasculitis

Respiratory Disorders

• Interstitial lung disease

Gastrointestinal Disorders

• Nausea
• Abdominal pain
• Dyspepsia
• Pancreatitis

Hepatobiliary Disorders

• Hepatitis
• Increased hepatic transaminases

Genitourinary Disorders

• Erectile dysfunction

Musculoskeletal Disorders

• Myalgia
• Muscular weakness
• Myopathy
• Rhabdomyolysis
• Myositis
• Immune-mediated necrotizing myopathy
• Increased creatine phosphokinase

Skin and Subcutaneous Tissue Disorders

• Angioedema
• Eczema
• Dermatitis
• Bullous exanthema

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Hypersensitivity reactions
• Anaphylactic reaction
• Lupus-like syndrome

• Systemic formulations of fusidic acid
• Ciclosporin
• Fibrates
• Nicotinic acid
• Erythromycin 
• HMG CoA reductase inhibitors
• Colchicine
• Warfarin
• Rifampicin
• Antidiabetic agents
• Cholestyramine
• Fluconazole

• Hepatic function

Specific cases may require

• Creatine kinase

Fluvastatin is a competitive inhibitor of HMG CoA reductase, which is responsible for the conversion of HMG CoA to mevalonate, a precursor of sterols, including cholesterol. This reduces the cholesterol in hepatic cells, which stimulates the synthesis of low density lipoprotein (LDL) receptors and thereby increases the uptake of LDL particles. The ultimate result of these mechanisms is a reduction in total cholesterol, LDL- C, apolipoprotein B and triglycerides, and an increase in high-density lipoprotein C in patients with hypercholesterolaemia and mixed dyslipidaemia.

Capsule 20mg

• Lescol (Novartis)

Capsule 40mg

• Lescol (Novartis)

Tablet 80mg

• Lescol XL (Novartis) originator
• Vaticol XL (Pharmacare)