Medication info

Ezetimibe/Simvastatin Tablets 10/20mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)라이트팜텍
Appearance
White to pale white, biconvex, rectangular tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Expired

MFDS item code 201906931 · Approved 2019.09.30

This product's status changed to Expired on 2024.09.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medicine is administered once daily in the evening, regardless of meals. The dosing range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, and the generally recommended initial dose is 10/20mg per day. For patients who do not require significant LDL cholesterol reduction, treatment can begin with 10/10mg once daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg per day, taken once daily in the evening.

Ingredients

Manufacturer
(주)라이트팜텍

Efficacy & effects

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

  • Primary hypercholesterolemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medicine helps reduce total cholesterol, LDL cholesterol, apoB protein, and triglycerides, and increase the good cholesterol HDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia as an adjunct to diet therapy. It is especially used as an adjunctive treatment when other therapies are ineffective in patients with homozygous familial hypercholesterolemia. This medicine should be used in conjunction with appropriate dietary therapy, and it is important to identify the cause through expert diagnosis, as other diseases or medications may affect dyslipidemia. Furthermore, patients at high risk of cardiovascular disease should formulate a treatment plan considering multiple risk factors. This medicine is used to effectively control cholesterol levels and improve vascular health.

How to take

Adult dose

This medicine is administered once daily in the evening, regardless of meals. The dosing range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg per day, and the generally recommended initial dose is 10/20mg per day. For patients who do not require significant LDL cholesterol reduction, treatment can begin with 10/10mg once daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg per day, taken once daily in the evening.

Precautions

This medicine is used to lower blood cholesterol levels. Caution should be taken as muscle problems may occur when taking this medicine. If muscle pain or weakness occurs, inform a doctor immediately, and in severe cases, discontinue use. It is safe not to use this medicine in patients with poor liver function or liver disease. Women who are pregnant or breastfeeding should not take this medicine, and women planning to become pregnant should consult a doctor before taking it. There is a risk of muscle damage if this medicine is taken with certain other drugs, so if taking other medications, inform a doctor or pharmacist. Elderly patients or those with decreased renal function also need special caution when taking this medicine. During treatment with this medicine, it is advisable to regularly check liver function and muscle condition through blood tests. Additionally, while taking this medicine, it is safe to avoid certain foods such as grapefruit juice. In case of overdose, there is no specific antidote, so adherence to prescribed dosage is crucial, and if any unusual symptoms occur, visit a medical facility immediately.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including rash, angioedema, pancreatitis, cholelithiasis, cholecystitis, severe muscle weakness, rhabdomyolysis, unexplained muscle weakness or pain with creatine kinase (CK) levels exceeding 10 times the normal upper limit, myoglobinuria, acute renal failure, severe liver dysfunction, hepatitis, cholestatic jaundice, cirrhosis, fulminant hepatic necrosis, liver cancer, fatal liver failure, severe edema, facial swelling, severe

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, muscle pain, limb pain, fatigue, abdominal pain, nausea, constipation, dyspepsia, itching, rash, weakness, sensory loss, cough, nocturia, hematuria, facial swelling, insomnia, gastritis, atrophic gastritis, mucous diarrhea, irritable bowel syndrome, sore throat, alopecia, gynecomastia, decreased libido, sexual dysfunction (including erectile dysfunction), cataract progression, facial paresis, tremor, dizziness, sensory anomalies,

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

Storage

This medicine is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to store it at room temperature between 1 degree and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

White to pale white, biconvex, rectangular tablet

Package unit

30 tablets/box [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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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.