Simvastatin

Simvastatin

[1 tablet 4 cents]

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

DOSAGE:

• PO:
  Usually 40mg daily at night; slowly increase to a maximum of 80mg if required.

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:

• Dose as in normal renal function

DOSAGE IN PAEDIATRICS:

• PO: 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 this medication.

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: CK should be measured if there is concern about development of myopathy due to statins.
• Drug/Laboratory Test Interactions: None known

IMPORTANT DRUG INTERACTIONS FOR THE ICU

• The risk of myopathy during treatment with other drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, and azole antifungals
• When multiple doses of simvastatin and digoxin were coadministered, 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, derangement of LFTs, flatulence, dyspepsia, and abdominal pain
• Nervous System: Insomnia, dizziness, paresthesia, somnolence
• Skin: Pruritus
• Musculoskeletal: Myalgia, myopathy