Medication info

Ezistar Tablets 10/20 Milligrams

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)보령
Appearance
White to off-white, biconvex rectangular tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Expired

MFDS item code 201007222 · Notified 2010.11.26

This product's status changed to Expired on 2024.10.01. 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 medication is taken once daily in the evening without regard to meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with a commonly recommended starting dose of 10/20 mg per day. Patients with lower needs for reducing LDL cholesterol may start with 10/10 mg once daily. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40 mg once daily in the evening.

Ingredients

Manufacturer
(주)보령

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
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used as an adjunct to diet for patients with primary hypercholesterolemia and mixed hyperlipidemia to lower high total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, and to raise HDL cholesterol. It is administered to patients with homozygous familial hypercholesterolemia either alone or in combination with other treatments when those treatments are not effective. This medication should be used in conjunction with an appropriate diet, particularly in cases where dietary control or other non-drug therapies have not yielded sufficient response. Before treatment, it is important to identify underlying causes of dyslipidemia such as diabetes or hypothyroidism and treat them if necessary. Furthermore, lipid tests should be conducted to assess cholesterol and triglyceride levels, which will inform the treatment plan. This medication helps reduce the risk of atherosclerotic vascular diseases associated with hypercholesterolemia.

How to take

Adult dose

This medication is taken once daily in the evening without regard to meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with a commonly recommended starting dose of 10/20 mg per day. Patients with lower needs for reducing LDL cholesterol may start with 10/10 mg once daily. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40 mg once daily in the evening.

Precautions

This medication may cause serious side effects such as myopathy and rhabdomyolysis. These side effects can include muscle pain and weakness, accompanied by a significant increase in specific blood enzyme levels. The risk may be higher when taking high doses of this medication or when used in conjunction with certain other drugs. Thus, if you experience muscle pain or weakness, you should inform your doctor immediately, and discontinue the medication if necessary. This medication should not be administered to patients with allergies to its components, severely impaired liver function, or to women who are pregnant or breastfeeding. Additionally, caution is required when used in conjunction with certain antifungals, antibiotics, and immunosuppressants, as the risk of side effects may increase. It should be administered with caution to patients with severe muscle weakness or ocular myasthenia; if these symptoms worsen, medication use should be discontinued. This medication may cause liver function abnormalities, so regular liver function tests should be conducted, particularly for patients with a history of liver disease. If you experience unexplained muscle pain, tenderness, or weakness while taking this medication, inform healthcare personnel immediately; when receiving a prescription for new medications, be sure to inform them that you are taking this medication. Special care is required when using this medication in the elderly or children, especially as it is not recommended for children under 10 years of age. This medication may raise blood sugar levels, thus patients at risk for diabetes should monitor their blood glucose levels regularly. In case of overdose, as there is no specific antidote, general treatment according to symptoms will be administered. Finally, patients taking this medication should limit consumption of certain foods like grapefruit juice, and exercise caution to avoid drug interactions with other medications.

Side effects and when to seek care immediately

Serious side effects

  • Myopathy/rhabdomyolysis
  • angioedema
  • rash
  • urticaria
  • pancreatitis
  • hepatitis
  • cholestatic jaundice
  • severe fatigue
  • severe muscle weakness
  • ocular muscle weakness
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  • urticaria
  • angioedema
  • lupus-like syndrome
  • polymyositis
  • dermatomyositis
  • vasculitis
  • purpura
  • thrombocytopenia
  • leukopenia
  • hemolytic anemia
  • positive antinuclear antibodies
  • increased erythrocyte sedimentation rate
  • eosinophilia
  • arthritis
  • arthralgia
  • photosensitivity

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
Show 23 more
  • epigastric pain
  • vomiting
  • chest pain
  • chest discomfort
  • paresthesia
  • cough
  • edema
  • thirst
  • facial swelling
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucous stools
  • irritable bowel syndrome
  • sore throat
  • nocturnal polyuria
  • hematuria
  • pruritus
  • weight loss
  • weakness
  • syncope
  • sensory disturbance

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. This helps to preserve the efficacy of the medication for an extended period.

Appearance and packaging

Appearance

White to off-white, biconvex rectangular tablet

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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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.