Medication info
Atorowm Tablets 10/10 mg

Atorowm Tablets 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)옵투스제약
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202101439 · Approved 2021.02.18 · Insurance code 674101940

Summary

Main use
Reduction of cholesterol in hypercholesterolemia and dyslipidemia, and improvement of lipid profiles by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meal times. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily. The recommended starting dose is 10/10 mg or 10/20 mg once daily. For patients needing a greater reduction in LDL cholesterol (over 55%), a starting dose of 10/40 mg once daily is recommended. After starting administration or adjusting the dose, lipid levels should be assessed at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)옵투스제약

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia and dyslipidemia, and improvement of lipid profiles by increasing HDL.

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

This medication helps lower total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, particularly those with heterozygous familial and non-familial hypercholesterolemia, and mixed dyslipidemia, while increasing HDL cholesterol levels. It is also used as an adjunct or when other lipid-lowering therapies are ineffective in patients with homozygous familial hypercholesterolemia. This medication is administered when there is insufficient effect after appropriate dietary measures and non-pharmacological interventions, taking into account the patient's risk factors. It is important to identify and treat secondary causes such as diabetes and hypothyroidism before treatment, and regular lipid testing is used to monitor therapeutic effects. This medication is beneficial in managing the risk of atherosclerotic vascular diseases associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meal times. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily. The recommended starting dose is 10/10 mg or 10/20 mg once daily. For patients needing a greater reduction in LDL cholesterol (over 55%), a starting dose of 10/40 mg once daily is recommended. After starting administration or adjusting the dose, lipid levels should be assessed at intervals of more than 2 weeks.

Precautions

This medication can cause rare side effects that may affect muscles, such as rhabdomyolysis, which can increase the risk of sudden kidney function deterioration; if severe muscle pain or weakness occurs, consult a doctor immediately. This medication should not be taken if there are certain liver diseases or high liver enzyme levels, as the risk of side effects may increase if liver function is impaired. In cases with a history of muscle disease, elderly patients, or those consuming alcohol excessively, this medication should be used with caution. Additionally, patients with impaired kidney function may also have an increased risk of muscle damage when taking this medication. Women who are pregnant, may become pregnant, or are nursing should not take this medication, and women of childbearing age should use adequate contraceptive methods. This medication can interact with various other medications; therefore, if you are currently taking other medications, be sure to inform your doctor or pharmacist. Especially when combined with drugs that inhibit or activate enzymes that metabolize drugs in the liver, the risk of side effects may increase. During treatment, it is essential to regularly monitor liver function and muscle condition and report any adverse symptoms to medical personnel immediately. Symptoms such as dizziness or muscle pain may occur, so caution is needed when driving or operating machinery. This medication is not recommended for children and can be administered to the elderly without dosage adjustment, but care should be taken to monitor for the possibility of myopathy. In case of overdose, there is no specific antidote; therefore, appropriate treatment and supportive care based on symptoms are needed, along with monitoring liver function and muscle enzyme levels. This medication should be stored out of reach of children and should not be transferred to other containers.

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, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Muscle pain
  • abdominal pain
  • hyperkalemia
  • headache
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
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  • musculoskeletal pain
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • malaise
  • chest pain
  • chest discomfort
  • edema
  • asthenia
  • constipation
  • indigestion
  • pharyngitis
  • upper respiratory infection
  • low back pain
  • hyperglycemia
  • hypoglycemia
  • loss of appetite
  • belching
  • nightmares
  • insomnia
  • tinnitus
  • blurred vision
  • hives
  • rash
  • itching
  • hair loss
  • dry skin
  • bruising.

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. This helps maintain the medication's efficacy and safety.

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.