Aroting Plus Tablet 10/10 mg (Ezetimibe/Atorvastatin Calcium Trihydrate)

Adult dosage

This medication is administered once daily, irrespective of meals. For primary hypercholesterolemia, the recommended dosage range is 10/10 mg to 10/80 mg per day, with an initial dose of 10/10 mg or 10/20 mg recommended. If more reduction in LDL cholesterol is required, an initial dose of 10/40 mg is recommended. Blood lipid levels should be checked at intervals of more than 2 weeks after administration.

This medication poses a risk of muscle abnormalities; hence, patients should inform their doctor immediately if they experience severe muscle pain or weakness. There is a risk of renal impairment due to muscle-related issues, so patients with a history of kidney disease or risk factors for myopathy should exercise caution. This medication should not be administered to patients with allergies to the active ingredients or components, patients with severely impaired liver function, patients with muscle diseases, pregnant women or those who may become pregnant, nursing mothers, patients taking certain antiviral medications, or patients with genetic issues such as lactose intolerance. Care should be taken when administering this medication to alcoholics, patients with a history of liver disease, patients with severe liver dysfunction, patients with reduced kidney function or hypothyroidism, those with a family history of muscle disease, and elderly patients, as they may have risk factors for myopathy; special care is also needed when taken alongside fibrate-type medications. Possible side effects such as muscle pain, abdominal pain, liver function abnormalities may occur during treatment; if these symptoms are severe or persistent, consult healthcare personnel. Liver function tests should be conducted before starting this medication and regularly during treatment; if signs of liver damage are detected, discontinuation or dosage adjustment may be necessary. This medication can harm the fetus during pregnancy, so women who are pregnant or planning to become pregnant should avoid taking it, and women of childbearing age should use proper contraception. It is also recommended that nursing mothers avoid taking this medication or consult healthcare personnel if necessary. Safety and efficacy in children have not been established, so it is not recommended for use. Older patients are at an increased risk for myopathy, so caution is advised when administering, although specific dosage adjustments are generally not required. When taking this medication concurrently with others, there may be an increased risk of side effects due to interactions, so patients should inform healthcare personnel of all medications they are taking for careful management. In cases of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. This medication should be stored out of reach of children, and it is advisable not to transfer it to another container.

Serious side effects

Hives, angioedema, mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), erythema multiforme, severe allergic reactions, jaundice, liver failure, acute kidney failure, rhabdomyolysis, myopathy, severe muscle weakness, ocular myasthenia, intracranial aneurysm, seizures, altered consciousness, visual disturbances, paralysis, severe swelling, urination abnormalities, severe skin reactions, respiratory distress, asthma attacks, shortness of breath

Mild side effects

• Headache
• dizziness
• cough
• abdominal pain
• nausea
• diarrhea
• joint pain
• muscle pain
• musculoskeletal pain
• hyperkalemia

This medication must be stored in a tightly closed container to prevent exposure to light and air, and it should be kept at a temperature between 1 and 30 degrees Celsius at room temperature. Storing it this way helps maintain its efficacy and prevents deterioration.

Appearance

White or off-white elongated film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP x 3)]