Medication info

Atovastjet 10/10 mg Tablet

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)티디에스팜
Appearance
White or off-white rectangular film-coated tablets
Packaging
30 tablets/box [(10 tablets/Alu-Alu x 3)]
Approval status
Approval withdrawn

MFDS item code 202101541 · Approved 2021.02.18

This product's status changed to Approval withdrawn on 2025.03.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of lipids by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, the 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. For patients requiring greater than 55% decrease in LDL-cholesterol, an initial dose of 10/40 mg per day is recommended. The recommended dosage for patients with homozygous familial hypercholesterolemia is

Ingredients

Manufacturer
(주)티디에스팜

Efficacy & effects

Improvement of lipids by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia

  • 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 in patients with primary hypercholesterolemia or mixed dyslipidemia to decrease elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides and to increase HDL-cholesterol. It is also administered as an adjunct or alternative therapy in patients with homozygous familial hypercholesterolemia. This drug is used together with an appropriate diet to reduce the risk of cardiovascular disease, and it is crucial to first identify and treat any other pathological causes. During treatment, regular lipid tests should be conducted to monitor the therapeutic effect. Thus, this drug contributes to health improvement by aiding the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, the 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. For patients requiring greater than 55% decrease in LDL-cholesterol, an initial dose of 10/40 mg per day is recommended. The recommended dosage for patients with homozygous familial hypercholesterolemia is

Precautions

This drug can cause rare side effects such as rhabdomyolysis, which can lead to muscle problems, so if symptoms of severe muscle pain or muscle weakness occur, inform a doctor immediately. Patients with severe infections, hypotension, major surgery or trauma, metabolic and electrolyte disorders may need to temporarily discontinue or stop this medication. This drug should not be used in individuals allergic to the active ingredient or its components, those with severe liver dysfunction, those with muscle diseases, women who are pregnant, who may become pregnant, or those who are breastfeeding, and patients taking certain antiviral medications. Patients with metabolic disorders such as lactose intolerance should also not take this drug. Those who are alcoholics or have a history of liver disease, patients with severe liver dysfunction, those with poor kidney function or hypothyroidism, and elderly people at risk of muscle diseases should use this drug cautiously. This drug may elevate liver enzyme levels, so liver function tests should be conducted regularly before and during treatment. If symptoms of hepatitis or jaundice, nausea, vomiting, or fatigue occur, consult a doctor immediately. During the use of this medication, carefully monitor for symptoms such as muscle pain, muscle cramps, or muscle weakness, and if these symptoms are severe or persistent, discontinue use and consult medical staff. This drug may interact with other medications, so if you are currently taking any other medications, inform your doctor or pharmacist. Particularly when taken with drugs metabolized in the liver or those that increase the risk of myopathy, dose adjustments or caution is necessary. Women of childbearing age should use an appropriate method of contraception while taking this drug, and should discontinue use immediately upon confirmation of pregnancy. This drug is not recommended for children as safety and efficacy have not been established. Elderly patients may be at risk of myopathy, so caution is needed, although dose adjustments are generally not required. Patients with impaired kidney function are also at risk for muscle-related side effects, so careful observation is necessary. In case of overdose, no specific antidote is available, so appropriate treatment and supportive therapy are necessary based on symptoms, along with monitoring of liver function tests and muscle enzyme levels. This drug should be stored out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urination

Mild side effects

  • Myalgia
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • arthralgia
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
Show 26 more
  • bronchitis
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • diarrhea
  • vomiting
  • dyspepsia
  • constipation
  • headache
  • fatigue
  • malaise
  • chest pain
  • discomfort in the chest
  • edema
  • asthenia
  • fever
  • loss of appetite
  • weight gain
  • pharyngodynia
  • epistaxis
  • nightmares
  • paresthesia
  • dysgeusia
  • memory loss
  • thrombocytopenia

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

Storage

This drug may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius for optimal efficacy.

Appearance and packaging

Appearance

White or off-white rectangular film-coated tablets

Package unit

30 tablets/box [(10 tablets/Alu-Alu x 3)]

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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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.