Medication info
SimbaDuet Tablet 10/10mg

SimbaDuet Tablet 10/10mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
White to light yellow, bilaterally convex, rectangular tablet
Packaging
30 tablets per box [30 tablets (10 tablets/PTPX3)]
Approval status
Active

MFDS item code 201907684 · Approved 2019.11.04

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is taken once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, and the generally recommended starting dose is 10/20mg daily. Patients who require less reduction in LDL cholesterol can start with 10/10mg once daily. After dosage adjustment, lipid levels should be checked at intervals of four weeks or more to modify the dosage.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

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

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

This medication is used in conjunction with a diet to lower total cholesterol, LDL cholesterol, Apo B protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed hyperlipidemia, while increasing HDL cholesterol. It is particularly used as an adjunct in patients with homozygous familial hypercholesterolemia when other lipid-lowering therapies are insufficient. This medication is used with consideration of risk factors in patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, and dietary and lifestyle modifications are necessary. Prior to administration, potential secondary causes such as diabetes or hypothyroidism should be identified and treated. During treatment, regular monitoring of cholesterol and triglyceride levels is conducted. This medication is indicated for the effective treatment of hypercholesterolemia.

How to take

Adult dose

This medication is taken once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, and the generally recommended starting dose is 10/20mg daily. Patients who require less reduction in LDL cholesterol can start with 10/10mg once daily. After dosage adjustment, lipid levels should be checked at intervals of four weeks or more to modify the dosage.

Precautions

This medication can cause serious muscle-related side effects such as myopathy and rhabdomyolysis, so patients must notify their doctor immediately if they experience muscle pain, weakness, or tenderness. This medication should not be administered to patients with poor liver function or active liver disease, and liver function tests should be conducted regularly. Women who are pregnant or breastfeeding should not take this medication, and women planning to become pregnant should consult with a doctor before use. This medication may interact with certain drugs, increasing the risk of muscle side effects, so if taking other medications, patients must inform their doctor or pharmacist, particularly when taking strong CYP3A4 inhibitors, some antibiotics, antifungals, immunosuppressants, and certain heart medications. Elderly patients, those with hypothyroidism, or impaired kidney function are at higher risk for myopathy and should exercise extra caution when taking this medication. This medication can raise blood sugar levels and increase the risk of diabetes, so patients with risk factors for diabetes should regularly monitor their blood sugar levels. Patients taking this medication who experience unexplained muscle pain, weakness, or changes in urine color should notify healthcare professionals immediately, and medication may need to be discontinued if these symptoms occur. This medication should not be administered to patients with certain genetic lactose intolerance, and there is no specific antidote for overdose, so immediate medical attention is necessary in the event of an overdose. Patients taking this medication should inform healthcare professionals of any current medications when being prescribed new ones and must be cautious about drugs that cannot be combined with this medication.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • skin peeling
  • pain in oral/ocular mucosa
  • severe allergic reactions
  • severe skin adverse reactions
  • difficulty breathing
  • respiratory distress
  • asthma attacks
  • visual disturbances
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  • paralysis
  • severe neurological symptoms
  • jaundice
  • liver abnormalities
  • decreased urine output
  • severe edema
  • elevated blood pressure
  • severe edema or urination abnormalities
  • myopathy
  • rhabdomyolysis
  • anaphylaxis
  • angioedema
  • Stevens-Johnson syndrome (SJS)

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
Show 28 more
  • indigestion
  • flatulence
  • vomiting
  • itching
  • thrombocytopenia
  • dizziness
  • sensory disturbances
  • depression
  • cholelithiasis
  • cholecystitis
  • fever
  • chills
  • flushing
  • malaise
  • weakness
  • photophobia
  • insomnia
  • sore throat
  • nocturia
  • hematuria
  • alopecia
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataracts
  • ocular muscle paralysis
  • anemia
  • weight loss

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. To maintain the drug's efficacy, it is advised to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to light yellow, bilaterally convex, rectangular tablet

Package unit

30 tablets per box [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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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.