Description
Indications
TRUVA is indicated for:
- Primary hypercholesterolemia and mixed dyslipidemia in adults and children aged 10 years and older, including those with heterozygous familial hypercholesterolemia.
- Homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments or if such treatments are unavailable.
- Prevention of cardiovascular events in individuals at high risk due to conditions such as coronary artery disease, diabetes, or hypertension.
Dosage and Administration
- The typical starting dose for adults is 10 mg once daily, which can be adjusted based on individual response and treatment goals.
- The usual dose range is 10 mg to 80 mg daily, taken at any time of day, with or without food.
- For pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia, the recommended starting dose is 10 mg once daily, with a maximum dose of 20 mg daily.
Pharmacokinetics
- Atorvastatin is rapidly absorbed after oral administration, with peak plasma concentrations occurring approximately 1–2 hours post-dose.
- It undergoes extensive first-pass metabolism in the liver, resulting in a low systemic bioavailability of about 14%.
- The drug is highly protein-bound (≥98%) and has a large volume of distribution.
- Food intake can slightly reduce the rate and extent of absorption, but it does not significantly affect the drug’s efficacy in lowering LDL-C levels.
Side Effects
Common side effects may include:
- Headache
- Muscle pain or weakness
- Nausea
- Abdominal pain
- Constipation
Serious adverse effects, though rare, can include:
- Rhabdomyolysis (muscle breakdown leading to kidney damage)
- Liver enzyme abnormalities
- Jaundice (yellowing of the skin or eyes)
- Dark urine
Regular monitoring of liver function tests and muscle symptoms is recommended during treatment.
Precautions and Contraindications
- Contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.
- Use with caution in individuals who consume substantial quantities of alcohol or have a history of liver disease.
- Not recommended during pregnancy or breastfeeding due to potential harm to the fetus or infant.
- Periodic monitoring of liver function and muscle symptoms is advised, especially in elderly patients or those with pre-existing conditions.
Drug Interactions
Atorvastatin may interact with various medications, potentially increasing the risk of side effects. Notable interactions include
- Cyclosporine, erythromycin, clarithromycin, itraconazole, and other strong inhibitors of CYP3A4.
- Gemfibrozil and other fibrates.
- Niacin (nicotinic acid) in high doses.
- Warfarin and other anticoagulants.
Patients should inform their healthcare provider of all medications they are taking to assess potential interactions.
Storage
Store at room temperature, away from moisture and heat. Keep out of reach of children.
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