Medication info
Bitorin Table 10/10

Bitorin Table 10/10

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›10mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한국오가논(주)
Appearance
A capsule-shaped tablet with a white to off-white color, marked with '311' on one side and convex on both sides
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 200511262 · Approved 2005.01.31 · Insurance code 073100120

Summary

Main use
Reduction of cholesterol in hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk through increasing HDL.
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. Primary hypercholesterolemia patients: 10/10mg to 10/40mg daily, with the generally recommended initial dose being 10/20mg daily. It can be started at 10/10mg daily if needed. Homozygous familial hypercholesterolemia patients: 10/40mg daily administered once in the evening. Chronic kidney disease patients (estimated glomerular filtration rate

Ingredients

Importer
한국오가논(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk through increasing HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
View approved original text

This medication helps lower elevated total cholesterol, LDL-cholesterol, apoB protein, and triglyceride levels in patients with primary hypercholesterolemia or mixed hyperlipidemia, and raises good cholesterol levels such as HDL-cholesterol. It is particularly used in conjunction with or as an alternative to other treatments in patients with homozygous familial hypercholesterolemia, and should be taken alongside appropriate dietary regimens to reduce the risk of atherosclerotic vascular disease. It is important to check for other causes, such as diabetes and hypothyroidism, before use and to conduct necessary treatments simultaneously. This medication is used as an adjunctive therapy when dietary and non-pharmacological measures are insufficient, and lipid levels should be continuously monitored for patient safety. In this way, this medication is used to manage hyperlipidemia and improve the risk of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. Primary hypercholesterolemia patients: 10/10mg to 10/40mg daily, with the generally recommended initial dose being 10/20mg daily. It can be started at 10/10mg daily if needed. Homozygous familial hypercholesterolemia patients: 10/40mg daily administered once in the evening. Chronic kidney disease patients (estimated glomerular filtration rate

Precautions

This medication is primarily used to lower blood cholesterol levels. Caution is required as muscle issues may arise when taking this medication. If muscle pain or weakness occurs, consult a physician immediately. Patients with impaired liver function or active liver disease should not use this medication. Pregnant or breastfeeding women should not take this medication as it may be harmful to the fetus or infant. Due to potential drug interactions, especially with certain antifungals, antibiotics, immunosuppressants, and some heart medications, it is essential to consult a physician when taking this medication with other drugs. This medication contains lactose, so those with lactose intolerance should avoid taking it. Elderly patients and children under 10 years of age are not recommended to use it, and adolescents over 10 years should take it under the guidance of a physician. It is advisable to undergo regular liver function tests and muscle-related tests during the course of this medication. There is no specific antidote for overdose; if suspected, seek medical treatment immediately. If unexplained muscle pain, muscle weakness, or changes in urine color occur while taking this medication, inform healthcare personnel immediately. This medication may slightly raise blood sugar levels, so patients at risk of diabetes should manage their blood sugar carefully. Exercise caution when taking this medication with certain foods like grapefruit juice, as it may increase drug concentration and the risk of side effects.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, high fever with severe rash, blisters, skin peeling, oral/ocular mucosa pain, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • upper abdominal pain
  • vomiting
  • chest pain
  • chest discomfort
  • weakness
  • sensory impairment
  • sore throat
  • nocturia
  • hematuria
  • itching
  • weight loss
  • dizziness
  • insomnia
  • dyspepsia
  • mucous stools
  • irritable bowel syndrome
  • hair loss
  • diverse skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataracts
  • eye muscle paralysis
  • anemia
  • elevated serum creatinine

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

Storage

This medication is sensitive to air and humidity, so it should be stored in a sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness over time.

Appearance and packaging

Appearance

A capsule-shaped tablet with a white to off-white color, marked with '311' on one side and convex on both sides

Package unit

30 tablets (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.