Medication info
Rosumjet Tablet 10/2.5 mg (Ezetimibe, Rosuvastatin)

Rosumjet Tablet 10/2.5 mg (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›2.6mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202301091 · Approved 2023.03.31 · Insurance code 622805050

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. The dose range is from 10/2.5 mg to 10/20 mg per day, with a recommended starting dose of 10/2.5 mg or 10/5 mg per day. In patients requiring a greater reduction in LDL cholesterol, the dose can be adjusted. Check blood lipid levels at least 4 weeks after starting treatment or dose adjustment, and the maximum daily dose can be increased to 10/2.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication helps reduce high total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and it helps increase levels of HDL cholesterol, known as 'good cholesterol.' It plays an important role in managing blood lipid levels healthily when used in conjunction with dietary therapy. This action contributes to the prevention of cardiovascular disease and improves the overall lipid profile of patients. Therefore, this medicine is used for the improvement of lipid metabolism disorders.

How to take

Adult dose

This medication is administered once daily, regardless of meals. The dose range is from 10/2.5 mg to 10/20 mg per day, with a recommended starting dose of 10/2.5 mg or 10/5 mg per day. In patients requiring a greater reduction in LDL cholesterol, the dose can be adjusted. Check blood lipid levels at least 4 weeks after starting treatment or dose adjustment, and the maximum daily dose can be increased to 10/2.

Precautions

This drug has rare side effects that may cause muscle problems, so if severe muscle pain or myopathy occurs, use should be discontinued immediately. Patients with liver dysfunction or liver disease should not use this drug and should undergo regular liver function tests. This drug is contraindicated in patients with severely impaired renal function or myopathy. Women who are pregnant, may become pregnant, or are breastfeeding should not use this drug. This medication contains lactose, so patients with lactose intolerance should not take it. Caution is required for alcoholics or patients with a history of liver disease when using this drug and should be administered more carefully if factors for myopathy risk are present. Drug interactions can occur when combined with other medications, so it is advisable to consult a doctor, especially when taking cyclosporine, fibrate drugs, certain antifungals, and antivirals. If symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, and fever occur while taking this medication, patients should notify medical personnel immediately, and blood tests may be needed to check for muscle damage. If liver enzyme levels increase in blood tests, dose adjustment or discontinuation may be necessary, so regular liver function tests are recommended. Elderly patients are at higher risk for myopathy, so caution is needed when administering. While taking this medication, patients should be careful as dizziness may occur when driving or operating machinery. There is no specific antidote for overdose, so treatment and supportive care should be given based on symptoms, and liver function and muscle damage should be monitored. This drug is not recommended for children as safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

Mild side effects

  • Headache
  • dizziness
  • tooth discomfort
  • chest pain
  • joint pain
  • microvascular coronary artery disease
  • lower extremity fractures
  • orthostatic dizziness
  • diabetes
  • hypoglycemia
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  • chronic cholecystitis
  • gallstones
  • nasopharyngitis
  • dyspepsia
  • elevated ALT
  • edema
  • muscle pain
  • elevated AST
  • acute pyelonephritis
  • dry mouth
  • elevated liver enzymes
  • abnormal liver function tests
  • increased serum lactate dehydrogenase
  • pruritus
  • cough
  • fatigue
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite

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 air or moisture from entering, ideally at a temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain its effectiveness and prevents deterioration.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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.