Simvastatin

ADMINISTRATION ROUTES:

PO

ALTERNATIVE NAMES

Arrow Simva, Lipex, Simvarex

ICU INDICATIONS:

1. Secondary prevention in patients with coronary artery disease
2. Treatment of hypercholesterolaemia

PRESENTATION AND ADMINISTRATION:

Tablets:

Arrow Simva 10 mg, 20 mg, 40 mg, 80 mg

Lipex 10 mg (peach), 20 mg (tan), 40 mg (red), 80 mg (red)

Simvarex 10 mg (light pink), 20 mg (tan), 40 mg and 80 mg (pink)

DOSAGE:

PO:

40 mg nocte

Can increase to max 80 mg

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:

Dose as in normal renal function

DOSAGE IN PAEDIATRICS:

Not applicable

CLINICAL PHARMACOLOGY:

Simvastatin is a selective, competitive inhibitor of HMG-CoA reductase.

CONTRAINDICATIONS:

1. Active liver disease or unexplained persistent elevations of serum transaminases
2. Hypersensitivity to any component of simvastatin

WARNINGS:

Liver Dysfunction

HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function.

Skeletal Muscle

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with simvastatin and with other drugs in this class.

PRECAUTIONS:

General:

Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Laboratory Tests:

Creatine kinase (CK) should be measured if there is concern about development of myopathy due to statins.

Drug/Laboratory Test Interactions:

None known

IMPORTANT DRUG INTERACTIONS IN ICU:

The risk of myopathy during treatment with other drugs of this class is increased with concurrent administration of cyclosporin, fibric acid derivatives, niacin (nicotinic acid), erythromycin, or azole antifungals.

When multiple doses of simvastatin and digoxin were co-administered, steady-state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.

ADVERSE REACTIONS:

Body as a Whole:

Malaise

Digestive System:

Constipation, LFT derangement, flatulence, dyspepsia, abdominal pain

Nervous System:

Insomnia, dizziness, paraesthesia, somnolence

Skin:

Pruritus

Musculoskeletal:

Myalgia, myopathy