Medication info
Rosutanjett Tablets 10/20 milligrams

Rosutanjett Tablets 10/20 milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets (15 tablets/blister × 2)
Approval status
Active

MFDS item code 201606051 · Approved 2016.10.12 · Insurance code 653403730

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (familial, mixed) and dyslipidemia, and suppression of the risk of atherosclerotic vascular disease through increasing HDL.
Who takes it
Adults
Adult dose
Take this medication once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg per day. The initial recommended dose is 10/5 mg once daily. For patients requiring more significant LDL cholesterol reduction, the dosage can be adjusted. After starting treatment or adjusting the dose, check blood lipid levels at intervals of 4 weeks or longer and adjust the dosage accordingly.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Reduction of cholesterol in primary hypercholesterolemia (familial, mixed) and dyslipidemia, and suppression of the risk of atherosclerotic vascular disease through increasing HDL.

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

This drug lowers total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It is mainly administered as an adjunct to dietary management and is used when there is insufficient response to dietary regimens that restrict saturated fat and cholesterol intake and other non-pharmacological treatments. Since hypercholesterolemia increases the risk of atherosclerotic vascular disease, treatment should consider multiple risk factors for reduction. The secondary causes of dyslipidemia should always be checked and treated if necessary. During treatment, lipid levels including total cholesterol, LDL, HDL, and triglycerides should be periodically tested. This drug effectively improves hypercholesterolemia.

How to take

Adult dose

Take this medication once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg per day. The initial recommended dose is 10/5 mg once daily. For patients requiring more significant LDL cholesterol reduction, the dosage can be adjusted. After starting treatment or adjusting the dose, check blood lipid levels at intervals of 4 weeks or longer and adjust the dosage accordingly.

Precautions

This drug carries a risk of rhabdomyolysis, which can lead to severe kidney dysfunction due to rare muscle tissue damage. Patients who are at high risk of muscle damage, such as those with serious infections, hypotension, major surgery, trauma, metabolic disturbances, or uncontrolled seizures, should suspend or discontinue this medication. Patients with allergies to the active ingredient or any component of this drug, those with severe liver dysfunction, those with muscle diseases, patients taking certain immunosuppressants, those with severe kidney dysfunction, pregnant or potentially pregnant women, and breastfeeding women should not take this medication. Patients with moderate renal dysfunction at high risk for muscle damage, hypothyroidism, a history of genetic muscle disease, muscle toxicity history from other statins or fibrates, alcohol addicts, Asian patients, and those taking fibrates should use this medication with special caution. This drug contains lactose; patients with lactose intolerance or certain hereditary sugar absorption disorders should avoid taking it. If muscle pain, muscle cramps, muscle weakness, fatigue, or fever occur during treatment, contact a doctor immediately for examination, and in severe cases, discontinue the medication. Liver function abnormalities may occur, so liver function tests should be performed both before and during treatment, and if liver enzyme levels are abnormally high or symptoms of liver damage appear, the medication should be discontinued. This medication may slightly elevate blood sugar levels, but its cardiovascular disease prevention benefits outweigh this risk; therefore, patients at risk for diabetes should consult their physician before use. There may be interactions with other medications, so especially if you are taking anticoagulants, fibrates, certain antibiotics, antifungals, or immunosuppressants, you must consult with your doctor or pharmacist. Pregnant or breastfeeding women should not use this medication due to potential risks to the fetus and newborn; women of childbearing age should use appropriate contraception while taking this drug. Safety in children and adolescents has not been adequately established; therefore, it is advisable not to use it except in special cases. Elderly patients should use this medication with caution due to a higher risk of muscle damage, and patients with impaired liver or kidney function also require vigilance. In case of overdose, there is no specific antidote; therefore, treatment should be symptomatic, and liver function and muscle enzyme tests should be monitored.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin sloughing, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthmatic attacks, respiratory distress associated with cough and fever, yellowing of skin or eyes (jaundice), feeling exceptionally lethargic, sudden and severe headache, lightning headache, seizures, confusion, abnormal vision, paralysis, altered urination.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • myalgia
  • edema
  • increased serum bilirubin
  • acneiform dermatitis
  • pruritus
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  • nasopharyngitis
  • arthralgia
  • dizziness
  • upper respiratory infection
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • cough
  • sputum
  • nasal congestion
  • urticaria
  • rash
  • alopecia
  • dermatitis
  • skin burning sensation
  • cold sweat
  • palpitations.

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture, preferably at room temperature between 1 degree and 30 degrees Celsius. This way of storage helps maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets (15 tablets/blister × 2)

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.