Medication info
Rosutanjat Tablet 10/5 mg

Rosutanjat Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 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 201606050 · Approved 2016.10.12 · Insurance code 653403750

Summary

Main use
Improvement of hypercholesterolemia (primary and mixed type) and inhibition of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended. In patients who require more reduction of LDL cholesterol, the dose may be adjusted. After initiation of treatment or after appropriate dose adjustment, blood lipid levels should be confirmed with intervals of more than 4 weeks, and the dose should be adjusted accordingly, with a maximum daily dose of 10/20 mg.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary and mixed type) and inhibition of the risk of atherosclerotic vascular disease

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

This medication helps to improve blood cholesterol and lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Specifically, it reduces levels of total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol while increasing levels of good HDL cholesterol. This medication is used in conjunction with diet and is administered when there is insufficient response to non-pharmacological treatments such as dietary restriction of saturated fat and cholesterol intake. Prior to treatment, it is important to investigate and manage other causes of dyslipidemia such as diabetes and hypothyroidism. This medication helps to reduce the risk of atherosclerotic vascular diseases caused by hypercholesterolemia. Therefore, it is used to improve cardiovascular disease risk by controlling blood lipid levels.

How to take

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended. In patients who require more reduction of LDL cholesterol, the dose may be adjusted. After initiation of treatment or after appropriate dose adjustment, blood lipid levels should be confirmed with intervals of more than 4 weeks, and the dose should be adjusted accordingly, with a maximum daily dose of 10/20 mg.

Precautions

This medication carries a rare risk of rhabdomyolysis, which can lead to serious kidney dysfunction due to muscle tissue damage. Therefore, if severe muscle pain or weakness symptoms occur, consult a physician immediately. Furthermore, patients with liver dysfunction or severely reduced kidney function should not use this medication. Women who are pregnant or may become pregnant, as well as breastfeeding women, should also avoid this medication. If there is a history of muscle disease or if certain medications are being taken, a physician should be consulted before using this medication. It is important to regularly monitor liver and muscle health during treatment. Patients with a history of alcohol dependency or liver disease should use this medication with caution, and elderly patients should also be aware of muscle-related reactions. This medication may interact with certain drugs, so it is essential to inform your healthcare provider of any other medications being taken. Additionally, this medication contains lactose, so patients with specific genetic lactose metabolism disorders should not take it. Caution is necessary as dizziness may occur during driving or operating machinery. If symptoms such as muscle pain, weakness, fever, etc. occur during treatment, inform healthcare personnel immediately and undergo testing. Regular liver function tests and muscle enzyme tests are recommended before and during treatment. This medication is not recommended for children as safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, mental confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Nasopharyngitis
  • joint pain
  • headache
  • elevated ALT
  • elevated AST
  • muscle pain
  • swelling
  • increased blood bilirubin
  • acne-like dermatitis
  • itching
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  • dizziness
  • upper respiratory infection
  • cough
  • diarrhea
  • constipation
  • nausea
  • abdominal pain
  • fatigue
  • numbness
  • paresthesia
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • rash
  • sweating
  • pruritus
  • conjunctival hyperemia
  • chest

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

Storage

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication'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.