Medication info
Atovastatin Plus Tablets 10/20mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Atovastatin Plus Tablets 10/20mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

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

MFDS item code 202101619 · Approved 2021.02.18 · Insurance code 642405190

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, irrespective of meals. The dosage range for this medication is 10/10mg to 10/80mg per day. An initial dose of 10/10mg or 10/20mg per day is recommended. For patients requiring a greater reduction in LDL cholesterol (over 55%), an initial dose of 10/40mg per day is advised. After starting treatment or adjusting the dosage, blood lipid levels should be monitored at intervals of more than 2 weeks.

Ingredients

Manufacturer
영진약품(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated apo B protein
  • elevated triglycerides
  • elevated non-HDL-cholesterol
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used in conjunction with dietary management to lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase levels of HDL, the good cholesterol. It is especially administered as an adjunctive treatment for patients with homozygous familial hypercholesterolemia when other treatments are either ineffective or inadequate. This medication assists in cholesterol management for patients at high risk for cardiovascular disease and should be used in conjunction with regular blood lipid testing. Before use, it is important to confirm and treat any secondary causes such as diabetes or hypothyroidism. When administered alongside appropriate dietary adjustments, positive effects on blood lipid improvement can be expected.

Dosage and Administration

Adult dosage

This medication is administered once daily, irrespective of meals. The dosage range for this medication is 10/10mg to 10/80mg per day. An initial dose of 10/10mg or 10/20mg per day is recommended. For patients requiring a greater reduction in LDL cholesterol (over 55%), an initial dose of 10/40mg per day is advised. After starting treatment or adjusting the dosage, blood lipid levels should be monitored at intervals of more than 2 weeks.

Precautions

This medication poses a risk of muscle-related issues, so if severe muscle pain or weakness occurs, it should be reported to a physician immediately. Patients with severe infections, low blood pressure, significant surgeries or trauma, or severe metabolic disorders may need to temporarily discontinue or stop this medication. This medication should not be used by those allergic to the active ingredients or other components, those with severely impaired liver function, individuals with muscle disorders, pregnant or nursing women, those taking specific antiviral medications, or individuals with lactose intolerance. Caution should be exercised when administered to alcoholics, individuals with a history of liver disease, those with compromised kidney function, patients with hypothyroidism, those with a family history of muscle disorders or previous muscle toxicity reactions, and seniors aged 70 years and older. Regular liver function and muscle-related tests should be performed during treatment, and if any abnormal symptoms arise, consultation with a physician should be sought immediately. When used in conjunction with other medications, the risk of side effects may increase due to interactions, so patients should inform their physician of any current medications. Women who are pregnant or may become pregnant should not take this medication and should discontinue it immediately and consult a physician if they are currently taking it. It is also recommended that nursing mothers avoid using this medication, consulting a physician if necessary. The safety and efficacy of this medication have not been established in children and it is not recommended for use. No special dosage adjustments are needed for the elderly, but attention should be paid to the possibility of muscle issues. In case of overdose, as there is no specific antidote, appropriate treatment and supportive care should be provided based on symptoms, and liver function and muscle status should be monitored regularly. This medication should be stored 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, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever and respiratory abnormalities, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues.

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • nausea
  • headache
  • fatigue
  • diarrhea
  • hyperkalemia
  • bronchitis
  • sinusitis
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  • flushing
  • allergic reactions
  • joint pain
  • musculoskeletal pain
  • pharyngitis
  • upper respiratory infection
  • nasopharyngitis
  • vomiting
  • dyspepsia
  • constipation
  • itching
  • rash
  • hair loss
  • thrombocytopenia
  • anemia
  • blurred vision
  • tinnitus
  • insomnia
  • nightmares
  • hives
  • angioedema
  • erythema multiforme
  • gynecomastia
  • low back pain
  • neck pain
  • muscle fatigue

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 closed container. Additionally, avoid storing it in extremely hot or cold places, and it is best to keep it at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White or whitish oblong film-coated tablets

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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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.