Indications

Atova is a medication used in addition to diet to lower high levels of total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglycerides when other methods are insufficient. It is used for:

• Familial hypercholesterolemia (heterozygous and homozygous).
• Mixed dyslipidemia (Fredrickson Type Ia and Ib).
• Hypertriglyceridaemia (Fredrickson Type IV).
• Dysbetalipoproteinaemia (Fredrickson Type III).
• Reducing cardiac ischemic events in patients with coronary artery disease and high LDL-cholesterol.
• Reducing cholesterol levels in patients with hypercholesterolemia associated with diabetes or kidney transplantation.

Pharmacology

Atorvastatin, the active ingredient in Atova, works by selectively inhibiting HMG-CoA reductase, a key enzyme in the liver's cholesterol synthesis pathway. By blocking this enzyme, it lowers cholesterol and lipoprotein levels in the blood. It also increases the number of hepatic LDL receptors, which improves the uptake and breakdown of LDL.

Atorvastatin is quickly absorbed after being taken orally, with peak plasma concentrations occurring within 1-2 hours. Its absolute bioavailability is approximately 14%, and it is extensively metabolized by the cytochrome P450 3A4 enzyme in the liver to form active metabolites. The half-life of its inhibitory activity is 20-30 hours, and it is primarily eliminated in bile.

Dosage & Administration

• Standard Dosing: The recommended starting dose is 10 or 20 mg once daily. For patients needing a significant reduction in LDL-C (more than 45%), the starting dose may be 40 mg once daily. The dose can be adjusted at intervals of at least 4 weeks, with a daily range of 10 to 80 mg.
• Children (10-18 years) with hypercholesterolemia: The recommended starting dose is 10 mg/day, with a maximum recommended dose of 20 mg/day.
• Familial hypercholesterolemia in adults: Start with 10 mg daily and increase to 40 mg once daily at intervals of at least 4 weeks. If necessary, the dose can be increased further to a maximum of 80 mg once daily.
• Atova can be taken as a single dose at any time of day, with or without food.

Interaction

• Myopathy Risk: The risk of myopathy (muscle disease) is increased when Atova is taken with cyclosporine, fibric acid derivatives, niacin, erythromycin, or azole antifungals.
• Antacids: Antacid suspensions can reduce atorvastatin plasma concentrations, but this does not affect its LDL-C-lowering efficacy.
• Digoxin: Atova can increase steady-state plasma concentrations of digoxin, so patients should be monitored.
• Erythromycin: Coadministration with erythromycin can increase atorvastatin plasma concentrations.
• Oral Contraceptives: Atova can increase the levels of hormones in oral contraceptives.

Contraindications

Atova should not be used in patients with a hypersensitivity to any of its components, active liver disease, or unexplained persistent elevated liver enzymes. It is also contraindicated in patients with a history of a serious adverse reaction to other HMG-CoA reductase inhibitors.

Side Effects

Atova is generally well-tolerated. The most common side effects are constipation, flatulence, indigestion, and abdominal pain. Other side effects can include infection, headache, back pain, rash, asthenia, and joint or muscle pain.

Pregnancy & Lactation

Atova is contraindicated during pregnancy and breastfeeding. It can cause harm to a fetus by reducing the levels of mevalonate, a precursor to cholesterol. Women who are pregnant, trying to become pregnant, or suspect they are pregnant should not use this medication. As it is not known whether atorvastatin is excreted in human milk, and due to the potential for serious adverse reactions, women taking this medication should not breastfeed.

Precautions & Warnings

• Liver Effects: Liver function tests should be performed before starting treatment and periodically thereafter. Atova should be used with caution in patients with a history of liver disease or significant alcohol consumption.
• Myopathy: If markedly elevated CPK levels occur or if myopathy is suspected, Atova therapy should be discontinued.

Use in Special Populations

• Geriatric: Plasma concentrations of Atova are higher in healthy elderly patients (over 65), but clinical data suggest a greater LDL-lowering effect in this population.
• Renal Insufficiency: No dose adjustment is needed for patients with kidney dysfunction.
• Hepatic Insufficiency: Plasma concentrations of Atova are significantly increased in patients with chronic alcoholic liver disease.

Overdose Effects

There is no specific treatment for an atorvastatin overdose. Patients should receive symptomatic and supportive care. Liver function tests and serum CK levels should be monitored. Hemodialysis is not effective at clearing atorvastatin due to its high protein binding.

Therapeutic Class

Atova is a statin, and it is also categorized as an anti-anginal and anti-ischemic drug.

Storage Conditions

Store in a dry place, away from light and heat. Keep out of the reach of children.