Medication info
Simpex Duo Tablet 10/10mg

Simpex Duo Tablet 10/10mg

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

MFDS item code 201601736 · Approved 2016.03.31 · Insurance code 644309050

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. The dose range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, with a commonly recommended starting dose of 10/20mg per day. Patients with less need for LDL cholesterol reduction may start with 10/10mg per day. After starting this treatment or adjusting the dose, blood lipid levels should be checked at least 4 weeks later before making any dose adjustments.

Ingredients

Manufacturer
한국유나이티드제약(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
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is administered in conjunction with dietary therapy to reduce total cholesterol, LDL cholesterol, ApoB protein, and triglycerides in patients with primary hypercholesterolemia, particularly in heterozygous familial and non-familial patients, as well as patients with mixed hyperlipidemia. It is used as an adjunct to other therapies (e.g., LDL apheresis) for patients with homozygous familial hypercholesterolemia or in cases where other treatments are ineffective. This medication is given to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, particularly when there is inadequate response to appropriate dietary and non-pharmacological treatments. Prior to administration, it is essential to identify and treat other causes of dyslipidemia (such as diabetes and hypothyroidism) if necessary, and lipid levels should be monitored periodically during treatment. This medication helps to improve the patient's blood lipid profile, thereby lowering the risk of atherosclerotic disease.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. The dose range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, with a commonly recommended starting dose of 10/20mg per day. Patients with less need for LDL cholesterol reduction may start with 10/10mg per day. After starting this treatment or adjusting the dose, blood lipid levels should be checked at least 4 weeks later before making any dose adjustments.

Precautions

This medication is used to lower cholesterol. Caution should be exercised as muscle problems may occur when taking this medication. If muscle pain or weakness occurs, inform a doctor immediately. The risk of muscle damage may increase, especially when taking high doses or in conjunction with certain other drugs. This medication may affect liver function; therefore, it should not be used in patients with liver disease or elevated liver enzymes. Women who are pregnant or breastfeeding must not use this medication, and women of childbearing potential should only take it after confirming the possibility of pregnancy. This medication may interact with specific drugs; if taking other medications, always inform your doctor or pharmacist. It is not recommended for children or patients under 10 years old, and caution is required when given to the elderly. If any unusual symptoms occur while taking this medication, consult healthcare professionals immediately, and regular blood tests to monitor liver and muscle status are advisable. There is no specific antidote for overdose; therefore, you will receive general treatment according to the symptoms. It is advisable to avoid certain foods, such as grapefruit juice, while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, rash, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, severe skin reactions, hepatitis, liver abnormalities (including jaundice), liver failure, cholecystitis, pancreatitis, severe edema, severe allergic reactions, severe skin reactions, severe symptoms related to cardiovascular disease, rhabdomyolysis, myopathy, increased creatine kinase (CK), severe

Mild side effects

Headache, diarrhea, influenza, upper respiratory infection, muscle pain, limb pain, fatigue, nausea, abdominal pain, constipation, vomiting, itching, dizziness, paraesthesia, insomnia, weakness, increased serum creatine phosphokinase (CPK), weight loss, nocturia, hematuria, epigastric pain, sore throat

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

Storage

This medication is sensitive to air and moisture and should be stored in a tightly sealed container. Additionally, it is important to maintain its effectiveness by storing it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White to pale yellow, bilaterally 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.

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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.