Medication info
Atorowem Tablets 10/20 mg

Atorowem Tablets 10/20 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)옵투스제약
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202101438 · Approved 2021.02.18 · Insurance code 674101950

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia and reduction of cardiovascular disease risk by increasing HDL
Who uses it
Adults
Adult dosage
This medicine is administered once daily, regardless of meals. For primary hypercholesterolemia, the recommended dosage ranges from 10/10 mg to 10/80 mg per day, with an initial dose of either 10/10 mg or 10/20 mg. For patients requiring more significant reduction of LDL cholesterol, an initial dose of 10/40 mg per day is recommended. After starting treatment or adjusting the dosage, check lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)옵투스제약

Efficacy & effects

Reduction of cholesterol in primary hypercholesterolemia (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
  • dyslipidemia
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medicine is used in cases of primary hypercholesterolemia, which is characterized by elevated total cholesterol and LDL cholesterol levels in the blood. It also helps reduce elevated triglycerides and Apo B protein in patients with mixed dyslipidemia and increases HDL cholesterol. It may be used as an adjunct in patients with homozygous familial hypercholesterolemia when other lipid-lowering therapies are insufficient. This drug is used in patients at high risk for cardiovascular disease along with appropriate dietary measures, and it is also important to address secondary causes, such as diabetes or hypothyroidism. It contributes to the overall improvement of the patient's lipid profile considering multiple risk factors. For this reason, it is effectively used in the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medicine is administered once daily, regardless of meals. For primary hypercholesterolemia, the recommended dosage ranges from 10/10 mg to 10/80 mg per day, with an initial dose of either 10/10 mg or 10/20 mg. For patients requiring more significant reduction of LDL cholesterol, an initial dose of 10/40 mg per day is recommended. After starting treatment or adjusting the dosage, check lipid levels at intervals of more than 2 weeks.

Precautions

This drug has rare side effects that may cause serious muscle problems, so caution is needed. Especially, there is a risk of kidney dysfunction due to acute muscle damage, so if symptoms of severe muscle pain or weakness occur, consult a doctor immediately. Additionally, individuals allergic to this drug’s ingredients or components, those with severe liver dysfunction, muscle diseases, and pregnant or breastfeeding women should not take this medication. Individuals with a history of alcohol addiction, liver disease, impaired kidney function, or hypothyroidism, who are at higher risk of muscle problems, should use this drug with caution. Regular liver function tests should be conducted during treatment with this drug, and if symptoms of liver dysfunction (e.g., fatigue, jaundice, nausea, etc.) occur, notify medical staff immediately. This drug may interact with other medications, so if you are taking any other drugs, be sure to inform your healthcare provider. Caution is also needed when taking this drug with certain antibiotics, antivirals, immunosuppressants, or fibrate medications. Women of childbearing age should use appropriate contraception while taking this drug, and should discontinue if pregnancy is confirmed. There may be side effects such as dizziness or muscle pain, so caution is advised when driving or operating machinery. Use in children and elderly patients over the age of 65 should be approached with special caution, and dosage adjustments may be needed as appropriate. In cases of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme tests should be performed. Keep this drug out of reach of children, and it is advisable not to transfer it to another container.

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 sloughing, pain in oral/eye mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination problems.

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • headache
  • nausea
  • diarrhea
  • fatigue
  • constipation
  • joint pain
  • muscle weakness
Show 28 more
  • musculoskeletal pain
  • bronchitis
  • sinusitis
  • flushing
  • hyperkalemia
  • pharyngitis
  • urticaria
  • rash
  • itching
  • hair loss
  • angioedema
  • skin rash
  • chest pain
  • malaise
  • chest discomfort
  • asthenia
  • vascular neurogenic edema
  • facial swelling
  • fever
  • neck stiffness
  • generalized edema
  • tremors
  • depression
  • vomiting
  • gastritis
  • belching
  • dry mouth
  • etc.

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air and moisture. It is advisable to store it at room temperature between 1 and 30 degrees.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle

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.