Medication info
Atorv 10/20mg Tablets

Atorv 10/20mg Tablets

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
White or off-white rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu*3]
Approval status
Active

MFDS item code 202101493 · Approved 2021.02.18 · Insurance code 621804240

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and reduction of cardiovascular disease risk by increasing HDL.
Who uses it
Adults
Adult dosage
This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg per day. A starting dose of 10/10mg or 10/20mg once daily is recommended. For patients requiring more significant reduction in LDL-cholesterol, a starting dose of 10/40mg once daily is recommended. After initiation of treatment or dose adjustment, lipid levels should be checked with intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and reduction of cardiovascular disease risk by increasing HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B
  • elevated triglycerides
  • elevated non-HDL-cholesterol
  • dyslipidemia
View approved original text

This drug is used as an adjunct to diet to reduce elevated total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial, and mixed dyslipidemia. Additionally, it is administered as an adjunct treatment for patients with homozygous familial hypercholesterolemia, either in conjunction with other lipid-lowering therapies or when other treatments are ineffective. In patients with an increased risk of atherosclerotic vascular disease related to hypercholesterolemia, lipid control medications should be considered along with multiple risk factors, and the appropriate diet and non-pharmacological measures should always be utilized. Secondary causes of dyslipidemia should also be identified, as treatment may be necessary. This drug helps reduce the risk of cardiovascular disease with effective lipid level control.

Dosage and Administration

Adult dosage

This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg per day. A starting dose of 10/10mg or 10/20mg once daily is recommended. For patients requiring more significant reduction in LDL-cholesterol, a starting dose of 10/40mg once daily is recommended. After initiation of treatment or dose adjustment, lipid levels should be checked with intervals of more than 2 weeks.

Precautions

This drug may cause serious muscle problems, so if sudden muscle pain or weakness occurs, you should immediately inform your doctor. Especially in cases of serious infections, major surgery, trauma, electrolyte abnormalities, or other conditions that may affect kidney function, the use of this drug may need to be paused or stopped temporarily. Patients with allergies to any components in this drug, or patients with liver disease, muscle disorders, and women who are pregnant or breastfeeding should not use it. In addition, caution should be exercised in elderly patients, those with specific liver dysfunctions or alcohol addiction, hypothyroidism, reduced kidney function, and those with a history of muscle disease. Regular liver function tests should be conducted during treatment with this drug, and if symptoms of liver dysfunction (abdominal pain, jaundice, nausea, etc.) occur, immediate medical attention should be sought. This drug has many interactions with other medications, especially those metabolized in the liver or affecting muscles, so care must be taken when taken with such medications. Women of childbearing age should use appropriate contraception to avoid pregnancy while taking this medication and should discontinue use immediately if pregnancy occurs. Dizziness and other symptoms may occur, so caution is required when driving or operating machinery. Safety in pediatric patients has not been established, so this drug is not recommended for children. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle status should be monitored. This drug should be kept out of reach of children and should not be transferred to another container.

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 fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision 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
  • headache
  • constipation
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • dyspepsia
  • vomiting
  • belching
  • pancreatitis
  • pharyngolaryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • altered perception
  • sensory loss
  • altered taste
  • memory loss
  • peripheral neuropathy
  • muscle cramps
  • joint swelling

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

Storage

This drug should be stored in a tightly closed container to avoid exposure to air or moisture, and it is important to keep it at room temperature between 1°C and 30°C. Maintaining appropriate temperature and storage conditions will help preserve the drug's efficacy and safety for a long time.

Appearance and packaging

Appearance

White or off-white rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu*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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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.