Medication info
Simpax Duo Tablet 10/20mg

Simpax Duo Tablet 10/20mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
White rectangular tablets
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201601116 · Approved 2016.02.26 · Insurance code 644309030

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 administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, with the generally recommended initial dosage of 10/20mg per day. Patients with less need for LDL-cholesterol reduction may start with 10/10mg per day. After initiating treatment or adjusting the dosage, check blood lipid levels with at least a 4-week interval.

Ingredients

Manufacturer
한국유나이티드제약(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
  • increased risk of atherosclerotic vascular disease caused by hypercholesterolemia
View approved original text

This medication is used as an adjunct to dietary therapy to reduce total cholesterol, LDL-cholesterol, ApoB protein, and triglyceride levels while increasing HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed hyperlipidemia. It is administered to homozygous familial hypercholesterolemia patients when other lipid-lowering therapies are not suitable or available. It is important to conduct appropriate dietary management during use and to verify and treat any secondary causes. This medication helps lower the risk of atherosclerotic vascular disease by improving blood lipid levels. Thus, it is used for the treatment of hypercholesterolemia and related lipid disorders.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, with the generally recommended initial dosage of 10/20mg per day. Patients with less need for LDL-cholesterol reduction may start with 10/10mg per day. After initiating treatment or adjusting the dosage, check blood lipid levels with at least a 4-week interval.

Precautions

This drug is primarily used to lower blood cholesterol levels. While taking this medication, it is important to report any symptoms of muscle pain or weakness to your doctor immediately, as it may cause muscle abnormalities. Caution is especially needed when taking high doses or certain other medications, as the risk of muscle damage may increase. Patients with impaired liver function or liver disease should not take this medication, and regular liver function tests are important. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing age should confirm their pregnancy status before use. Additionally, the risk of side effects may increase due to drug interactions when taken with certain medications, so you must inform your doctor or pharmacist of any other medications you are taking. This medication is limited in use among children and adolescents, and is not recommended for children under 10 years old. Older adults may respond sensitively to this medication, so caution is necessary during use. There is no specific antidote for overdose, so if an overdose occurs, you should immediately seek appropriate treatment from a medical facility.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, severe allergic reactions, severe skin adverse reactions, persistent elevation of aminotransferase levels (liver dysfunction), hepatitis, liver failure, pancreatitis, thrombocytopenia, respiratory distress, asthma attacks, respiratory tract abnormalities, severe edema, increased blood pressure, severe edema or urinary abnormalities,

Mild side effects

Headache, diarrhea, influenza, upper respiratory infection, muscle pain, limb pain, fatigue, nausea, abdominal pain, constipation, indigestion, flatulence, vomiting, facial swelling, itching, dizziness, increase in serum creatine phosphokinase (CPK), weight loss, insomnia, sore throat, nocturia, hematuria, weakness, sensory impairment, mucous stools, gastritis, atrophic gastritis, irritable bowel syndrome

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Also, avoid storing the medication in excessively hot or cold conditions, and it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the effectiveness of the drug for a longer period.

Appearance and packaging

Appearance

White rectangular tablets

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.