Medication info
Bytrin Q Tablet 10/10 mg

Bytrin Q Tablet 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
White to light yellow, double-convex rectangular tablet
Packaging
30 tablets (10 tablets/PTP×3)
Approval status
Active

MFDS item code 201900316 · Approved 2019.01.22 · Insurance code 661905150

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication should be administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day, and the generally recommended initial dose is 10/20 mg once daily. Patients with lesser need for LDL cholesterol reduction may start at 10/10 mg. Dosage adjustments should be made after checking blood lipid levels at intervals of 4 weeks or more.

Ingredients

Manufacturer
영풍제약(주)

Efficacy & effects

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

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

This medication helps lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. It may also be used in combination with other lipid-lowering therapies or alone in patients with familial hypercholesterolemia. This drug is used as an adjunct to appropriate dietary management, especially when dietary therapy alone is insufficient. Before treatment, secondary causes such as diabetes and hypothyroidism should be identified and treated if necessary, and lipid levels should be monitored regularly during treatment. This medication is effective in reducing the risk of vascular disease due to hyperlipidemia and improving cholesterol management.

How to take

Adult dose

This medication should be administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day, and the generally recommended initial dose is 10/20 mg once daily. Patients with lesser need for LDL cholesterol reduction may start at 10/10 mg. Dosage adjustments should be made after checking blood lipid levels at intervals of 4 weeks or more.

Precautions

This medication can cause serious muscle-related side effects, such as myopathy or rhabdomyolysis. These side effects may include muscle pain, muscle tenderness, and muscle weakness, with a significant increase in creatine kinase levels in the blood. The risk is notably higher when taken in high doses, so caution is required. This drug should not be given to certain patients. For example, individuals allergic to its components, those with active liver disease or unexplained persistent elevation of liver enzymes, pregnant or breastfeeding women, and patients taking specific medications should avoid using this drug. Patients with severe muscle weakness or ocular muscle weakness should use this drug with caution as symptoms may worsen. It is important to inform a doctor immediately if muscle pain or weakness occurs while taking this medication. Moreover, liver function abnormalities may occur, so regular liver function tests are necessary, and careful monitoring is essential if there is a history of liver disease. This medication can interact with various drugs; therefore, if taking other medications, it is crucial to inform the doctor or pharmacist. The risk of muscle diseases may increase when this drug is taken in combination with certain antifungals, antibiotics, antivirals, immunosuppressants, or some heart medications, so caution is advised. Pregnant women or women planning to become pregnant must not use this drug, and if pregnancy is confirmed, the medication should be discontinued immediately. Nursing mothers should also stop breastfeeding while taking this medication. The safety and efficacy of this drug have not been sufficiently established in elderly or pediatric patients, hence caution is warranted. In case of overdose, there is no specific antidote; general treatment and supportive care will be provided. Regular blood tests and symptom observation are necessary while taking this medication, and immediate consultation with healthcare personnel is warranted if unexplained muscle pain or weakness, or liver function abnormalities occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in mucous membranes (mouth/eyes), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough+fever, jaundice (skin or eyes turning yellow), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, impaired consciousness, visual disturbances, paralysis, urination issues

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 loss
  • cough
  • edema
  • thirst
  • facial swelling
  • fainting
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus stools
  • irritable bowel syndrome
  • sore throat
  • itching
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataracts
  • anemia
  • alopecia
  • various skin changes
  • flattening

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

Storage

This medication must be stored in a closed container to protect it from exposure to air and moisture. Additionally, keep the medication at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold locations. This helps maintain the drug's effectiveness and safety over time.

Appearance and packaging

Appearance

White to light yellow, double-convex rectangular tablet

Package unit

30 tablets (10 tablets/PTP×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.