Medication info
Impactwin Tablet 10/10mg

Impactwin Tablet 10/10mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
A white to light yellow, double convex rectangular tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201601721 · Approved 2016.03.31 · Insurance code 698503420

Summary

Main use
Lipid improvement by reducing LDL cholesterol and increasing 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. For patients with primary hypercholesterolemia: The dosage range is 10/10mg to 10/40mg per day, with a generally recommended initial dose of 10/20mg daily. Patients for whom LDL cholesterol reduction is less critical may start at 10/10mg daily. After initiation of treatment or dose adjustment, blood lipid levels should be checked at intervals of more than 4 weeks.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Lipid improvement by reducing LDL cholesterol and increasing 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 diseases due to hypercholesterolemia
  • dyslipidemia.
View approved original text

This medication is used as an adjunct to diet to lower elevated total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides and to increase HDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. In patients with homozygous familial hypercholesterolemia, it can be used as an adjunct to other lipid-lowering treatments, or alone when other treatments are insufficient. This medication should be used in conjunction with an appropriate diet, including restriction of saturated fat and cholesterol intake, and is administered when responses to non-drug treatments are inadequate. Furthermore, it should be used after confirming and treating secondary causes (such as diabetes, hypothyroidism), and it is important to regularly check blood lipid levels. It is also referenced for the treatment initiation after rapid lipid measurement in patients with acute coronary events. This medication is used to effectively improve lipid abnormalities associated with hypercholesterolemia.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia: The dosage range is 10/10mg to 10/40mg per day, with a generally recommended initial dose of 10/20mg daily. Patients for whom LDL cholesterol reduction is less critical may start at 10/10mg daily. After initiation of treatment or dose adjustment, blood lipid levels should be checked at intervals of more than 4 weeks.

Precautions

This medication is primarily used to lower cholesterol, and serious muscle-related side effects such as myopathy or rhabdomyolysis may occur, so caution is advised. Myopathy may be accompanied by symptoms of muscle pain or weakness, and blood tests may show a significant increase in creatine kinase levels indicating muscle damage. Particularly, the risk of muscle side effects increases with high dosage; thus, patients taking high doses require more careful monitoring. This medication can affect liver function, so it should not be taken by patients with liver disease or abnormal liver enzyme levels. Women who are pregnant or breastfeeding should not take this medication, and women who may become pregnant should confirm their pregnancy status before taking it. Additionally, the risk of muscle side effects may be increased when this medication is taken with other drugs that inhibit specific enzymes (CYP3A4); consult a physician if on such medications. Medications that should not be used in conjunction with this medication include certain antifungals, antibiotics, immunosuppressants, and specific heart medications. If muscle pain, weakness, or unexplained pain occurs during treatment, inform a doctor immediately, and if necessary, discontinue the medication. This medication may elevate blood glucose levels, so patients at risk of diabetes should monitor their blood sugar regularly. Elderly patients or those with impaired kidney function may experience side effects more readily, so caution is advised. This medication contains lactose, and lactose-intolerant patients should not take it. Routine blood tests during treatment are recommended to monitor liver function and muscle condition, and if abnormal symptoms appear, consult medical personnel immediately. If prescribed a new medication during treatment, inform medical personnel that you are taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues with cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden severe headache, thunderclap headache, seizures, consciousness disturbance, visual disturbances, paralysis, urination issues.

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • epigastric pain
  • vomiting
  • chest pain
  • discomfort in the chest
  • weakness
  • sensory impairment
  • cough
  • nocturia
  • hematuria
  • itching
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus stools
  • irritable bowel syndrome
  • sore throat
  • alopecia
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataracts
  • dizziness
  • sensory disturbances
  • depression.

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 or moisture. Moreover, avoid areas that are too hot or too cold and store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A white to light yellow, double convex 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.