Indications

Atova EZ is a combination lipid-lowering medication. It is used as an adjunct to diet when the response to diet and other non-pharmacologic measures has been insufficient.

• Primary Hyperlipidemia: Indicated for reducing elevated total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol, while increasing HDL cholesterol.
• Homozygous Familial Hypercholesterolemia (HoFH): Indicated for reducing total and LDL cholesterol in patients with HoFH, used in addition to other treatments like LDL apheresis.

Pharmacology

Atova EZ contains two active ingredients: atorvastatin and ezetimibe.

• Atorvastatin: This is a statin that inhibits HMG-CoA reductase, a key enzyme in cholesterol synthesis in the liver. It lowers plasma cholesterol by reducing cholesterol production and increasing the number of hepatic LDL receptors, which improves the uptake and breakdown of LDL.
• Ezetimibe: This ingredient works by inhibiting the absorption of cholesterol from the small intestine. Its molecular target is the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1). Ezetimibe reduces the delivery of intestinal cholesterol to the liver, which causes a reduction of hepatic cholesterol stores and an increase in cholesterol clearance from the blood. This mechanism is complementary to that of statins.

Dosage & Administration

• Standard Dosing: The dosage range is 10/10 mg to 80/20 mg daily. The recommended starting dose is 10/10 mg or 20/10 mg daily. For patients who need a larger reduction in LDL-C (greater than 55%), the recommended starting dose is 40/10 mg daily. Doses can be adjusted after 2 or more weeks based on lipid levels.
• HoFH: The dosage is 40/10 mg or 80/10 mg daily, used alongside other lipid-lowering treatments.
• Administration: It can be taken as a single dose at any time of the day, with or without food.
• Renal Impairment: No dosage adjustment is needed, but these patients require closer monitoring for muscle-related side effects.
• Hepatic Impairment: The drug is contraindicated in patients with active liver disease or unexplained elevated liver enzymes.

Interaction

• Myopathy Risk: The risk of myopathy (muscle damage) is increased with the concurrent use of fibric acid derivatives (like gemfibrozil), high doses of niacin, cyclosporine, or strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole). Concomitant use with gemfibrozil and cyclosporine should be avoided.
• Digoxin: Patients taking digoxin should be monitored.
• Oral Contraceptives: Atova EZ can increase the levels of hormones in oral contraceptives, which should be considered when choosing a contraceptive.
• Colchicine: Use with caution when prescribing with colchicine, as there have been reports of myopathy.
• Warfarin: The INR should be monitored if Atova EZ is added to warfarin therapy.

Contraindications

Atova EZ is contraindicated in patients with active liver disease, unexplained persistent elevations of liver enzymes, or a hypersensitivity to any of its components.

Side Effects

Common side effects include rhabdomyolysis (severe muscle breakdown), myopathy, myalgia (muscle pain), abdominal pain, and liver enzyme abnormalities.

Pregnancy & Lactation

This medication is classified as Pregnancy Category X, meaning it is contraindicated in women who are or may become pregnant. Lipid-lowering drugs are not beneficial during pregnancy as cholesterol is essential for normal fetal development. It is not known whether atorvastatin is excreted in human milk, but women taking this medication should not breastfeed.

Precautions & Warnings

• Myopathy and Rhabdomyolysis: Myopathy, including severe rhabdomyolysis, has been reported. Therapy should be temporarily stopped in patients with an acute serious condition that suggests myopathy.
• Liver Enzymes: Liver enzyme tests should be performed before and during therapy. If a serious liver injury occurs, the medication should be stopped and not restarted if another cause is not found.
• Endocrine Function: Caution should be used when administering Atova EZ with drugs that may decrease endogenous steroid hormones.

Use in Special Populations

• Pediatric Use: The safety and effectiveness have not been established in pediatric patients.
• Geriatric Use: No dosage adjustment is necessary for geriatric patients.

Overdose Effects

There is no specific treatment for an overdose. In the event of an overdose, the patient should be treated symptomatically with supportive measures.

Therapeutic Class

Atova EZ is classified as an "other lipid regulating drug."

Storage Conditions

Store below 30°C in a dry place. Protect from light and keep out of the reach of children.