Medication info
Beatorin Tablets 10/20

Beatorin Tablets 10/20

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
White to off-white, double-convex, rectangular tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201601144 · Approved 2016.02.29 · Insurance code 694001010

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (familial homozygous primary) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This drug is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg once daily, with the typical initial recommended dose being 10/20mg daily. For patients with less need for LDL-cholesterol reduction, treatment can start at 10/10mg once daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg daily.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (familial homozygous primary) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medicine helps to lower elevated total cholesterol, LDL-cholesterol, apoB protein, and triglycerides in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial hypercholesterolemia, and raises HDL-cholesterol levels. It is additionally used in homozygous familial hypercholesterolemia patients when other treatments are ineffective or used in combination with other treatments. This drug is indicated for patients who do not respond adequately to appropriate dietary changes and non-drug therapy, and it is important to confirm and treat secondary causes such as diabetes and hypothyroidism before administration. During treatment, lipid values such as total cholesterol, LDL, HDL, and triglycerides should be monitored regularly, considering risk factors carefully. This drug is used to reduce the risk of cardiovascular disease and improve dyslipidemia.

How to take

Adult dose

This drug is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg once daily, with the typical initial recommended dose being 10/20mg daily. For patients with less need for LDL-cholesterol reduction, treatment can start at 10/10mg once daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg daily.

Precautions

This drug may cause muscle-related side effects such as myopathy and rhabdomyolysis, so consult a doctor immediately if symptoms of muscle pain or weakness occur. Additionally, this drug should not be administered to patients with hypersensitivity to its components, those with active liver disease, or pregnant or breastfeeding women. This drug may affect liver function, so patients with a history of liver disease or abnormal liver function tests should use it with caution. Particularly, elderly patients, those with hypothyroidism, and renal impairment are at higher risk for muscle disorders and require closer observation. This drug may interact with other medications, so inform your doctor or pharmacist about any current medications you are taking. Specifically, concurrent use with certain antifungal agents, antibiotics, immunosuppressants, calcium channel blockers, and fibrate drugs may increase the risk of muscle-related side effects. It is advisable to avoid certain foods like grapefruit juice while taking this drug, and regular blood tests to monitor liver function and muscle enzyme levels are recommended. Women who are planning to become pregnant or who are potentially pregnant should consult a doctor before taking this medicine, and if pregnancy is confirmed, they should stop taking it immediately. It is also recommended to avoid taking this drug while breastfeeding, and if necessary, cease breastfeeding for safety. Caution is warranted as the safety and efficacy have not been adequately established in children and adolescents. In case of overdose, as there is no specific antidote, appropriate treatment should be received immediately at a hospital.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling (edema), anaphylaxis, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions
  • Severe skin reactions such as high fever with severe rash, blisters, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), erythema multiforme and other severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attacks, cough + fever

Mild side effects

Headache, diarrhea, influenza, upper respiratory infection, muscle pain, limb pain, fatigue, abdominal pain, nausea, constipation, dyspepsia, cough, dizziness, paresthesia, depression, cholelithiasis, cholecystitis, alopecia, pruritus, increased serum creatine phosphokinase (CPK), weight loss, edema, thirst, facial swelling, syncope, insomnia, gastritis, atrophic gastritis, mucus stool, irritable bowel syndrome, sore throat, nocturia, hematuria, weakness, chest pain

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

Storage

This drug is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it should be kept at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold locations.

Appearance and packaging

Appearance

White to off-white, double-convex, rectangular tablet

Package unit

30 tablets (10 tablets/PTPX3)

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.