Medication info
Arotin Plus Tablet 10/20 mg (Ezetimibe/Atorvastatin Calcium Hydrate)

Arotin Plus Tablet 10/20 mg (Ezetimibe/Atorvastatin Calcium Hydrate)

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

MFDS item code 202101485 · Approved 2021.02.18 · Insurance code 669502690

Summary

Main use
Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication should be taken once daily regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg per day. A starting dose of 10/10 mg or 10/20 mg once a day is recommended. In patients where greater reduction in LDL-cholesterol (greater than 55%) is required, a starting dose of 10/40 mg once daily is recommended. After starting treatment or adjusting the dose, observe blood lipid levels at intervals of more than 2 weeks and adjust the dosage accordingly.

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

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

This medication is primarily used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia. It can lower levels of total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol, while increasing HDL cholesterol levels, thereby improving blood lipid balance. Particularly in patients with homozygous familial hypercholesterolemia, it can be used as a monotherapy or in combination with other lipid-lowering treatments. However, evidence that this medication is superior to others in reducing cardiovascular morbidity and mortality has not yet been established. Treatment of dyslipidemia should be accompanied by appropriate dietary measures, and it is important to check for and treat secondary causes such as diabetes and hypothyroidism before administration. In summary, this drug helps effectively control blood lipid levels used in managing hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication should be taken once daily regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg per day. A starting dose of 10/10 mg or 10/20 mg once a day is recommended. In patients where greater reduction in LDL-cholesterol (greater than 55%) is required, a starting dose of 10/40 mg once daily is recommended. After starting treatment or adjusting the dose, observe blood lipid levels at intervals of more than 2 weeks and adjust the dosage accordingly.

Precautions

This medication carries a risk of muscle issues; therefore, if symptoms of severe muscle pain or weakness occur, consult a physician immediately. Especially patients with kidney dysfunction due to severe infections, surgery, trauma, electrolyte imbalances, or who are at high risk of myopathy should temporarily discontinue or refrain from using this medication. Patients who are allergic to this medication's active ingredients or components, those with severely impaired liver function, muscle diseases, pregnant or breastfeeding women should not take this medication. Furthermore, patients with certain antiviral medications or genetic lactose intolerance should not be administered this drug. Caution is required when using this medication in alcoholics or those with a history of liver disease, patients with reduced kidney function, patients with hypothyroidism, elderly people, as the risk of myopathy may increase, necessitating regular examinations. This medication may affect liver function; thus, liver function tests should be conducted before and during treatment, and administration should be discontinued immediately if symptoms of hepatitis or jaundice appear. This medication can raise blood sugar levels; however, since its cardiovascular health improvement effect is greater, patients requiring blood sugar management should regularly monitor their blood sugar levels. This medication may interact with other drugs, particularly those taking certain antibiotics, antivirals, antifungals, immunosuppressants, antihypertensives, or diabetes medications should consult a physician regarding dosage adjustments or monitoring. Women of childbearing age should employ adequate contraception while taking this medication and discontinue immediately if pregnancy is confirmed. This medication is not recommended for children as safety and effectiveness have not been established. In case of overdose, there is no specific antidote, so treatment should align with symptoms, and liver and muscle enzyme tests are necessary. Dizziness may occur when taking this medication, so caution is advised when driving or operating machinery. Store this medication out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, oral/eye mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, visual disturbances, paralysis, urine retention

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • constipation
  • fatigue
  • headache
Show 26 more
  • arthralgia
  • muscle weakness
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • rash
  • itching
  • hair loss
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • tinnitus
  • vomiting
  • pancreatitis
  • skin and mucous membrane syndrome
  • toxic epidermal necrolysis
  • erectile dysfunction
  • urinary tract infection
  • frequent urination
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • nocturia
  • epididymitis

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps to maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

White or off-white oval film-coated tablet

Package unit

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