Medication info
Atovjet Tablets 10/10 mg

Atovjet Tablets 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
White, rectangular, film-coated tablet
Packaging
PTP packaging - 30 tablets/box [10 tablets/PTP packaging (Alu-Alu) x3], bottle packaging - 30 tablets/bottle, bottle packaging - 100 tablets/bottle
Approval status
Active

MFDS item code 202100186 · Approved 2021.01.08 · Insurance code 648104690

Summary

Main use
Reduction of cholesterol and LDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, improvement of lipids through increase of HDL
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia: administer within the dosage range of 10/10 mg to 10/80 mg per day. The recommended starting dose is 10/10 mg or 10/20 mg per day; in cases where a greater (more than 55%) reduction in LDL cholesterol is required, 10/40 mg per day is recommended. After starting the treatment or adjusting the dosage, check blood lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Reduction of cholesterol and LDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, improvement of lipids through increase of HDL

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This drug is used as an adjunct to diet to lower elevated total cholesterol, LDL cholesterol, apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, particularly in those with heterozygous familial and non-familial hypercholesterolemia or mixed dyslipidemia, while increasing HDL cholesterol levels. It can also be administered alone or in combination with other lipid-lowering treatments (e.g., LDL-Apheresis) in patients with homozygous familial hypercholesterolemia. This medication is used in conjunction with an appropriate diet in patients at high risk of atherosclerotic cardiovascular disease due to dyslipidemia and is recommended when other treatments are not sufficiently effective. It is important to identify and treat secondary causes of dyslipidemia, such as diabetes and hypothyroidism, before starting therapy. Additionally, lipid levels should be regularly monitored during the treatment process, and rapid lipid testing is necessary in the event of acute coronary accidents. This drug is used to effectively improve cholesterol levels to reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia: administer within the dosage range of 10/10 mg to 10/80 mg per day. The recommended starting dose is 10/10 mg or 10/20 mg per day; in cases where a greater (more than 55%) reduction in LDL cholesterol is required, 10/40 mg per day is recommended. After starting the treatment or adjusting the dosage, check blood lipid levels at intervals of more than 2 weeks.

Precautions

This medication may rarely cause a condition called rhabdomyolysis, leading to serious kidney problems due to muscle tissue damage. Patients with risk factors such as severe infections, low blood pressure, major surgery, trauma, severe metabolic disorders, or uncontrollable seizures should temporarily stop or discontinue this medication. It should not be used in patients with a known allergy to this drug, active liver diseases, persistently elevated liver enzyme levels of unknown origin, muscle disorders, pregnant or potentially pregnant women, nursing mothers, patients taking certain antiviral medications, or those with lactose intolerance. Caution is advised in patients prone to muscle problems, such as those with alcohol dependence, liver dysfunction, reduced kidney function or hypothyroidism, a history of genetic muscle diseases, or a history of muscle toxicity from statins or fibrates, and elderly patients over 70. Attention is also needed for patients taking fibrates or those with severe myasthenia gravis, as well as patients allergic to Yellow No. 4 (Tartrazine). While taking this medication, patients should immediately inform their doctor if they experience muscle pain, muscle cramps, muscle weakness, or muscle pain accompanied by fever or fatigue, and blood tests may be required to check for muscle damage. Liver function abnormalities may also arise, so liver function tests should be conducted before and during treatment; if symptoms of liver damage such as nausea, vomiting, or fatigue appear, the medication should be discontinued. This drug should not be administered to pregnant or nursing women, and women of childbearing age must use appropriate contraception. Caution is also warranted in the elderly or patients with impaired kidney function due to a high risk of muscle damage. This drug may interact with various medications, so patients taking other drugs must inform their doctor or pharmacist. In case of overdose, as there is no specific antidote, appropriate treatment and supportive therapy should be administered according to symptoms, and liver function and muscle damage should be monitored. Safety and efficacy in children have not been established, so use in this population is not recommended.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory irregularities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
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  • bronchitis
  • sinusitis
  • flushing
  • ALT increase
  • AST increase
  • fatigue
  • vomiting
  • diarrhea
  • insomnia
  • nightmares
  • blurred vision
  • tinnitus
  • itching
  • rash
  • hair loss
  • thrombocytopenia
  • cholestasis
  • hepatitis
  • skin nodules
  • sweating
  • excessive sweating
  • increased blood creatine kinase
  • anemia
  • hypoglycemia
  • hyperglycemia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is also important to store it at room temperature, between 1 to 30 degrees Celsius, to maintain the efficacy of the drug.

Appearance and packaging

Appearance

White, rectangular, film-coated tablet

Package unit

PTP packaging - 30 tablets/box [10 tablets/PTP packaging (Alu-Alu) x3], bottle packaging - 30 tablets/bottle, bottle packaging - 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.