Medication info

Meditorin Tablet 10/20 Milligrams

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
메딕스제약(주)
Appearance
A white to off-white, bilaterally convex, rectangular tablet.
Packaging
30 tablets - 10 tablets/Blister, 30 tablets - 3 Blisters/Box
Approval status
Expired

MFDS item code 201901089 · Approved 2019.02.22

This product's status changed to Expired on 2024.02.22. 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, 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 the usual recommended initial dose being 10/20mg daily. Patients with less need for LDL-cholesterol reduction may start at 10/10mg daily. Adjustment of dosage should take place after 4 weeks or more following the initiation of treatment or a dosage adjustment.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and mixed hyperlipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated apolipoprotein B
  • elevated triglycerides
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia.
View approved original text

This medication helps to control cholesterol and lipid levels in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial hypercholesterolemia, as well as mixed hyperlipidemia. It lowers total cholesterol, LDL-cholesterol, apolipoprotein B, and triglyceride levels while increasing levels of HDL-cholesterol, serving as a complement to dietary measures. Additionally, it can be used in patients with homozygous familial hypercholesterolemia when other treatments are ineffective or as adjunct therapy. This drug should be used alongside dietary restrictions such as limiting saturated fat and cholesterol intake, and it is crucial to verify any secondary causes such as diseases or medications before administration. In patients with acute coronary events, treatment may begin based on lipid levels. In summary, this drug effectively improves hypercholesterolemia, which may lead to increased cardiovascular risk.

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 the usual recommended initial dose being 10/20mg daily. Patients with less need for LDL-cholesterol reduction may start at 10/10mg daily. Adjustment of dosage should take place after 4 weeks or more following the initiation of treatment or a dosage adjustment.

Precautions

This medication can cause serious side effects such as myopathy and rhabdomyolysis, thus any symptoms of muscle pain or weakness should be reported to a physician immediately. This medication should not be used in specific patients, such as those allergic to its ingredients, those with active liver disease, pregnant or breastfeeding women, and patients on certain medications. As it can affect liver function, caution is required in patients with a history of liver disease or suspected liver dysfunction, and periodic liver function tests may be necessary. It may interact with multiple drugs, so patients taking other medications should inform their doctor or pharmacist, particularly avoiding co-administration with strong CYP3A4 inhibitors or certain fibrate medications. Pregnant women or those planning to become pregnant should not take this medication and should discontinue it immediately if pregnancy is confirmed. Breastfeeding women should not take this medication and should cease breastfeeding if it is taken. Elderly patients or those with impaired kidney function may be more sensitive to the drug's side effects and should exercise extra caution. During treatment, side effects such as muscle pain, fatigue, dyspepsia, headache, etc., may occur, and any unusual symptoms should be discussed with healthcare personnel immediately. In cases of overdose, there is no specific antidote, and symptomatic treatment will be provided as needed. Prolonged use of this medication may lead to rare pulmonary side effects such as interstitial lung disease, so if symptoms like shortness of breath or persistent cough occur, consultation with a physician is necessary. It is important to regularly monitor muscle and liver function tests when starting or adjusting this medication's dosage. This medication may increase the risk of diabetes, so patients needing blood sugar control should monitor their blood sugar levels regularly.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, rash, toxic epidermal necrolysis (Lyell's syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), erythema multiforme, pancreatitis, hepatitis (including chronic active hepatitis), cholestatic jaundice, cirrhosis, fulminant hepatic necrosis, liver cancer, anemia, cataracts, ocular muscle paralysis, weakness, chest tightness, dyspnea, severe swelling (edema), serious allergic reactions, severe swelling or urinary abnormalities, severe skin reactions.

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infections
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • dyspepsia
  • flatulence
  • itching
  • rash
  • weakness
  • dizziness
  • paresthesia
  • insomnia
  • sore throat
  • hematuria
  • nocturia
  • weight loss.

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly closed container. It is advisable to maintain room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A white to off-white, bilaterally convex, rectangular tablet.

Package unit

30 tablets - 10 tablets/Blister, 30 tablets - 3 Blisters/Box

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.