OKA-ATORVASTATIN-10 10MG TABLET

Indications

• Primary hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular disease
• Familial hypercholesterolemia

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for pediatric patients.

Adults: Refer to the BNF for specific dosing recommendations based on individual patient needs and clinical guidelines.

Mechanism of action

Atorvastatin functions as a competitive inhibitor of HMG-CoA reductase, the enzyme responsible for catalyzing the conversion of HMG-CoA to mevalonate, a precursor of cholesterol. This inhibition leads to a reduction in cholesterol synthesis, resulting in increased uptake of low-density lipoprotein (LDL) from the bloodstream and a subsequent decrease in LDL levels.

Pharmacodynamics

The pharmacodynamic effects of atorvastatin include significant reductions in total cholesterol, LDL cholesterol, and triglycerides, while modestly increasing high-density lipoprotein (HDL) cholesterol. These changes contribute to a reduced risk of atherosclerosis and cardiovascular complications. The onset of cholesterol-lowering effects typically occurs within one to two weeks, with maximum effects seen after two to four weeks of consistent use.

Pharmacokinetics

Atorvastatin is well absorbed after oral administration and undergoes extensive first-pass metabolism in the liver, primarily by cytochrome P450 3A4 (CYP3A4). The bioavailability is approximately 14%, and the drug is highly protein-bound (98%). Atorvastatin has a half-life of about 14 hours, with a duration of action that allows for once-daily dosing. The drug and its metabolites are excreted mainly in the bile.

Contra-indications

• Active liver disease
• Pregnancy
• Breastfeeding
• Hypersensitivity to atorvastatin or any components of the formulation

Adverse effects

• Muscle pain or weakness
• Liver enzyme abnormalities
• Gastrointestinal disturbances
• Rash
• Increased risk of diabetes mellitus

Interactions

• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase atorvastatin levels
• Cyclosporine can significantly increase atorvastatin levels
• Gemfibrozil may increase the risk of myopathy
• Warfarin may have altered effects when taken with atorvastatin

Precautions

• Monitor liver function tests before and during treatment
• Use with caution in patients with a history of liver disease
• Assess risk factors for myopathy and rhabdomyolysis
• Consider potential for increased blood glucose levels

Pregnancy

Atorvastatin is contraindicated in pregnancy due to potential harm to the fetus.

Breast-feeding

Atorvastatin is contraindicated during breastfeeding as it may pass into breast milk.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

• Tablets: 10 mg, 20 mg, 40 mg, 80 mg