Medication info
Zetova Tablet 10/40 mg

Zetova Tablet 10/40 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
(주)비씨월드헬스케어
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP pack (Alu-Alu) x3]
Approval status
Active

MFDS item code 202101530 · Approved 2021.02.18 · Insurance code 059400040

Summary

Main use
Lipid improvement through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage is 10/10 mg to 10/80 mg daily. The initial dosage recommended is 10/10 mg or 10/20 mg daily. For patients needing greater reduction in LDL-cholesterol, an initial dosage of 10/40 mg daily is recommended. After starting treatment or adjusting the dosage, lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)비씨월드헬스케어

Efficacy & effects

Lipid improvement through 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
  • atherosclerotic vascular diseases due to hypercholesterolemia.
View approved original text

This medication is used as an adjunct to dietary therapy to lower elevated total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol in patients with primary hypercholesterolemia, particularly in heterozygous familial and non-familial cases. It is also administered in patients with homozygous familial hypercholesterolemia when other treatments are difficult or ineffective. This medication is used alongside an appropriate diet in patients with heightened risk of cardiovascular disease, and it is crucial to identify and treat secondary causes beforehand. Before treatment or during acute coronary events, lipid levels must be checked to establish an appropriate treatment plan. In summary, this medication helps to regulate cholesterol levels and improve vascular health in dyslipidemia patients.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage is 10/10 mg to 10/80 mg daily. The initial dosage recommended is 10/10 mg or 10/20 mg daily. For patients needing greater reduction in LDL-cholesterol, an initial dosage of 10/40 mg daily is recommended. After starting treatment or adjusting the dosage, lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication is used to lower blood cholesterol levels. It may affect muscles, and if severe muscle pain or weakness occurs, consult a physician immediately. Particularly in cases of severe infections, hypotension, major surgeries, or trauma where there is a risk of renal functionality impairment, temporary suspension of the medication may be necessary. Individuals with allergies to any ingredients in this medication or those with liver disease, muscle diseases, or pregnant or nursing women should not use it. Patients with specific liver diseases or persistently elevated serum liver enzyme levels should also avoid this medication. Cautious use is advised for individuals with alcoholism, impaired liver function, renal impairment, hypothyroidism, and the elderly. This medication may interact with other drugs, particularly when taken with medications that inhibit enzymes that break down drugs in the liver, which may increase the risk of muscle damage. Regular liver function tests should be performed during treatment, and a physician should be consulted if any abnormal signs appear. Pregnant women or those who may become pregnant should not take this medication and must confirm their pregnancy status if they are taking it. It is not recommended for children as safety and efficacy have not been established. In case of overdose, there is no specific antidote, so appropriate treatment and supportive therapy according to symptoms are necessary. Keep this medication out of reach of children, and it is advisable not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), skin rash, vascular edema, skin-mucosal syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), polymorphic erythema, liver abnormalities (jaundice), acute renal failure, rhabdomyolysis, severe myopathy, severe muscle weakness or ocular muscle weakness, severe allergic reactions, severe skin adverse reactions, serious neurological symptoms (intracranial aneurysm, seizures, confusion, visual disturbances.

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • headache
  • dizziness
  • joint pain
  • joint swelling
  • back pain
  • neck pain
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  • muscle fatigue
  • itching
  • rash
  • hair loss
  • sweating
  • hives
  • chest pain
  • malaise
  • fatigue
  • fever
  • rhinitis
  • pharyngitis
  • sinusitis
  • cough
  • hyperkalemia
  • hypoglycemia
  • decreased appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • belching
  • pancreatitis
  • nosebleeds
  • insomnia
  • nightmares
  • sensory disturbances
  • numbness
  • taste disturbances
  • memory loss
  • speech.

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is recommended to maintain room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP pack (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.