Medication info

Simvastatin/Ezetimibe Tablets 10/10 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
White to pale yellow, double convex rectangular tablets
Packaging
30 tablets/PTP[(10 tablets/PTPX3)]
Approval status
Expired

MFDS item code 201905982 · 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
Lipid improvement through reduction of LDL cholesterol and increase of HDL cholesterol in patients with 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 10/10 mg to 10/40 mg per day, with a generally recommended starting dose of 10/20 mg per day. For patients with less need for LDL cholesterol reduction, treatment may start at 10/10 mg per day. After starting therapy or after adjusting the dose, blood lipid levels should be checked at an interval of at least 4 weeks.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Lipid improvement through reduction of LDL cholesterol and increase of HDL cholesterol in patients with 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
  • dyslipidemia
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels, and increases HDL cholesterol in patients with primary hypercholesterolemia, especially those with heterozygous familial and non-familial hypercholesterolemia, and mixed hyperlipidemia. It can also be used as an alternative therapy in patients with homozygous familial hypercholesterolemia in conjunction with other lipid-lowering therapies or when other treatments are ineffective. This medication should be used alongside appropriate dietary measures and should be administered when there is insufficient response to non-pharmacological measures. Secondary causes such as diabetes and hypothyroidism should be checked and treated as necessary prior to therapy. It is important to conduct regular blood lipid tests in patients with severe hypercholesterolemia to monitor treatment effectiveness. This medication is effective in reducing the risk of atherosclerotic vascular disease through the treatment of hypercholesterolemia.

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 10/10 mg to 10/40 mg per day, with a generally recommended starting dose of 10/20 mg per day. For patients with less need for LDL cholesterol reduction, treatment may start at 10/10 mg per day. After starting therapy or after adjusting the dose, blood lipid levels should be checked at an interval of at least 4 weeks.

Precautions

This medication helps to lower blood cholesterol levels. However, it is necessary to be cautious as it may cause muscle problems when taking this medication. Especially if muscle pain or weakness occurs, it should be reported to a doctor immediately. This medication can affect liver function, so it should not be taken if there is liver disease or elevated liver function tests. Women who are pregnant or breastfeeding should not use this medication. Taking it alongside certain medications that interact can increase the risk of muscle damage, so it must be discussed with a doctor. Caution is also needed for elderly patients and those with kidney disease. Additionally, regular liver function and muscle-related tests are recommended during treatment with this medication. If unexplained muscle pain, tenderness, or weakness occurs while taking this medication, treatment should be stopped immediately, and medical attention should be sought. It is essential to inform healthcare providers when starting a new medication while on this medication. In case of overdose, there is no specific antidote, and appropriate treatment should be sought at the hospital immediately.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria, angioedema, and rash, pancreatitis, cholelithiasis, cholecystitis, angioedema, erythema multiforme-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia, arthritis, arthralgia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis (Lyell syndrome), skin nodules

Mild side effects

Headache, diarrhea, influenza, upper respiratory infection, myalgia, limb pain, weakness, abdominal pain, constipation, dyspepsia, nausea, pruritus, rash, increased serum creatine phosphokinase (CPK), weight loss, thirst, facial swelling, syncope, sensory abnormalities, insomnia, gastritis, atrophic gastritis, mucus stool, irritable bowel syndrome, sore throat, nocturia, hematuria, alopecia, flatulence, chest pain, discomfort in the chest, sensory loss, cough, fatigue, dizziness

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the drug's efficacy and safety for a long time.

Appearance and packaging

Appearance

White to pale yellow, double convex rectangular tablets

Package unit

30 tablets/PTP[(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.