Medication info
Zetova Tablets 10/20 Milligrams

Zetova Tablets 10/20 Milligrams

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)비씨월드헬스케어
Appearance
White rectangular film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP package (Alu-Alu)x3)]
Approval status
Active

MFDS item code 202101531 · Approved 2021.02.18 · Insurance code 059400050

Summary

Main use
Improvement of lipids due to reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is taken once daily without regard to meals. For primary hypercholesterolemia, it is administered in a dosage range of 10/10mg to 10/80mg once daily. The recommended initial dose is 10/10mg or 10/20mg once daily. For patients requiring significant reduction in LDL-cholesterol, the initial dose of 10/40mg once daily should be given. Blood lipid levels should be checked at intervals of more than 2 weeks after administration.

Ingredients

Manufacturer
(주)비씨월드헬스케어

Efficacy & effects

Improvement of lipids due to reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia

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

This medicine helps lower total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels, while increasing HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct treatment for patients with homozygous familial hypercholesterolemia or administered when other treatments are ineffective. This medication is used in conjunction with dietary changes that limit saturated fat and cholesterol intake. Other diseases causing dyslipidemia should be identified and treated, and the patient's blood lipid levels should be monitored. Thus, this medication is used to control blood lipid levels to improve vascular health and reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

This medication is taken once daily without regard to meals. For primary hypercholesterolemia, it is administered in a dosage range of 10/10mg to 10/80mg once daily. The recommended initial dose is 10/10mg or 10/20mg once daily. For patients requiring significant reduction in LDL-cholesterol, the initial dose of 10/40mg once daily should be given. Blood lipid levels should be checked at intervals of more than 2 weeks after administration.

Precautions

This medication can cause serious muscle issues, and in rare cases, rhabdomyolysis, characterized by the breakdown of muscle tissue leading to acute kidney injury, has been reported. If severe muscle pain or weakness occurs, consult a physician immediately, and patients with risk factors should consider temporarily stopping or discontinuing this medication. This medication should not be administered to certain patients. For example, those allergic to the drug, patients with severely impaired liver function, those with muscle disorders, pregnant or potentially pregnant women, breastfeeding mothers, patients taking certain antiviral drugs, and those with lactose intolerance should not use this medication. Additionally, caution should be exercised when prescribing to those with a history of alcoholism, liver disease, poor kidney function, hypothyroidism, elderly patients, etc., who have a higher risk of muscle problems. Attention is also required when this medication is taken with other specific drugs. During the use of this medication, side effects such as muscle pain, abdominal pain, and liver function abnormalities may occur. If liver function tests show an increase or muscle-related symptoms develop, notify healthcare personnel immediately. Patients with impaired liver function should undergo liver function tests before administration, and if symptoms of liver damage appear, treatment should be discontinued. Pregnant or breastfeeding women should not take this medication, and women of reproductive age should use appropriate contraceptive methods during treatment. This medication is not recommended for children as safety and efficacy have not been sufficiently established. Elderly patients should be monitored for the risk of muscle problems when administering this medication, but no separate dosage adjustment is needed. Patients with impaired kidney function are at higher risk for muscle problems and require careful observation. In case of overdose, as there is no specific antidote, appropriate treatment and supportive care should be provided depending on symptoms, and liver function and muscle enzyme levels should be monitored. This medication should be stored out of the reach of children, and transferring it to other containers is not advisable for quality maintenance. During treatment, symptoms such as dizziness may occur; therefore, caution is needed when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucous membranes, difficulty breathing or wheezing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and 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
  • diarrhea
  • fatigue
  • lethargy
  • chest pain
  • discomfort in the chest
  • swelling
  • asthenia
  • headache
  • constipation
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • dyspepsia
  • nausea
  • belching
  • pancreatitis
  • pharyngeal-laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • sensory disturbances
  • decreased sensitivity
  • taste alteration

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius. Proper storage will ensure the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

White rectangular film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP package (Alu-Alu)x3)]

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.