Medication info

Simvastatin/Ezetimibe 10/20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
White to off-white, bilaterally convex rectangular tablets
Packaging
PTP - 30 tablets/PTP[(10 tablets/PTP*3)]
Approval status
Expired

MFDS item code 201905983 · Approved 2019.08.23

This product's status changed to Expired on 2024.08.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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, and the generally recommended starting dose is 10/20mg per day. Patients who require less reduction of LDL cholesterol may start with 10/10mg per day. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40mg per day, administered once daily in the evening.

Ingredients

Manufacturer
(주)휴비스트제약

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 cardiovascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used in combination with dietary regulation to lower elevated total cholesterol, LDL cholesterol, apo B protein, and triglycerides in patients with primary hypercholesterolemia and mixed hyperlipidemia, while increasing good cholesterol (HDL cholesterol). It is particularly used as an adjunct to other lipid-lowering therapies or in cases where other treatments are ineffective for patients with homozygous familial hypercholesterolemia. This medication is applied as a lipid-modulating agent for patients at high risk of atherosclerotic cardiovascular disease due to hypercholesterolemia and is used when proper diet and non-drug measures are insufficient. It is important to confirm and adequately treat secondary causes, such as diabetes and hypothyroidism, before administration of this medication. This medication effectively improves blood lipid levels and helps reduce the risk of cardiovascular diseases.

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, and the generally recommended starting dose is 10/20mg per day. Patients who require less reduction of LDL cholesterol may start with 10/10mg per day. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40mg per day, administered once daily in the evening.

Precautions

This medication is primarily used to lower blood cholesterol levels to reduce the risk of cardiovascular diseases. However, when taking this medication, muscle-related adverse effects such as muscle pain or weakness may occur, so caution is advised. Especially when taking high doses or when combined with certain medications, the risk of muscle damage may increase, so consultation with a doctor is necessary. This medication can affect liver function; therefore, it should not be taken by patients with liver diseases or abnormal liver function tests. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should check for pregnancy possibilities and use it cautiously. Additionally, when combined with specific medications such as certain antifungal drugs, antibiotics, and antiviral agents that interfere with the metabolism of this medication in the liver, the risk of side effects can increase. If sudden muscle pain, muscle weakness, or changes in urine color occur while taking this medication, it is essential to inform healthcare professionals immediately. Elderly patients or those with impaired renal function need to be particularly cautious, and regular blood tests to check liver function and muscle enzyme levels are recommended. This medication may increase blood glucose levels in some patients, so careful management of blood glucose is necessary for those at risk of diabetes. During treatment, it is crucial to inform healthcare professionals about the use of this medication when starting any new medications, and to avoid certain foods such as grapefruit juice. In case of overdose, there are no specific antidotes, so treatment will be symptom-based. This medication is only used restrictively in children and adolescents, as safety and efficacy have not been adequately established. Therefore, strict adherence to physician instructions is essential while taking this medication, and immediate consultation is advised if any suspected adverse effects occur.

Side effects and when to seek care immediately

Serious side effects

Myopathy/rhabdomyolysis (severe muscle pain, weakness, elevation of creatine kinase over 10 times), angioedema, rash, pancreatitis, cholelithiasis, cholecystitis, anaphylaxis, urticaria, severe swelling (edema), chest tightness, difficulty breathing, severe skin reactions (rash, blisters, skin peeling, mucosal pain in mouth/eyes), respiratory problems (asthma attacks, cough accompanied by fever), liver abnormalities (jaundice, yellowing of skin or eyes)

Mild side effects

Headache, diarrhea, influenza-like symptoms, upper respiratory tract infections, muscle pain, limb pain, fatigue, nausea, abdominal pain, constipation, epigastric discomfort, vomiting, chest pain, chest discomfort, sensory loss, cough, edema, thirst, facial swelling, fainting, insomnia, gastritis, atrophic gastritis, dyspepsia, mucus stools, irritable bowel syndrome, sore throat, hematuria, itching, weight loss, malaise, increased serum creatine phosphokinase (CPK), nocturia, cataract, abdominal pain,

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is essential to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Following these guidelines helps maintain the medication's effectiveness and safety for a longer duration.

Appearance and packaging

Appearance

White to off-white, bilaterally convex rectangular tablets

Package unit

PTP - 30 tablets/PTP[(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.