Medication info
Rosuzet Tablets 10/5 mg

Rosuzet Tablets 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
This medication is a pale yellow, rectangular film-coated tablet.
Packaging
30 tablets/box [10 tablets/PTP x 3], 100 tablets/bottle
Approval status
Active

MFDS item code 201503658 · Approved 2015.06.08 · Insurance code 643507280

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and prevention of the risk of atherosclerotic vascular diseases.
Who takes it
Adults
Adult dose
This medication is taken once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg daily, with an initial recommended dose of 10/5 mg daily. For patients requiring a greater reduction in LDL cholesterol, the dosage can be adjusted. Lipid levels should be checked at intervals of at least 4 weeks after starting treatment or adjusting the dosage, and the dosage can be increased to a maximum of 10/20 mg daily.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and prevention of the risk of atherosclerotic vascular diseases.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • elevated Apo B levels
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
View approved original text

This medication helps reduce total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. It is used in conjunction with dietary control and is administered as an adjunctive treatment when dietary therapy alone is inadequate. It is particularly recommended for patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia. Before administration, secondary causes of dyslipidemia such as diabetes and hypothyroidism should be identified and treated if necessary. Furthermore, lipid levels should be monitored regularly to assess appropriate treatment effects. This medication is used effectively to improve lipid levels and reduce the risk of cardiovascular diseases.

How to take

Adult dose

This medication is taken once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg daily, with an initial recommended dose of 10/5 mg daily. For patients requiring a greater reduction in LDL cholesterol, the dosage can be adjusted. Lipid levels should be checked at intervals of at least 4 weeks after starting treatment or adjusting the dosage, and the dosage can be increased to a maximum of 10/20 mg daily.

Precautions

This medication can rarely cause serious muscle damage that may affect kidney function, so if sudden severe muscle pain or weakness occurs, a doctor should be notified immediately. This medication should not be used in patients with certain diseases, particularly those with poor liver function or muscle disorders should avoid its use. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication. Patients with a history of alcohol addiction or liver disease, as well as elderly patients or those with decreased kidney function should exercise special caution when using this medication. During treatment, liver function and muscle condition should be periodically monitored, and if abnormalities are found, appropriate actions should be taken. When taking this medication with other drugs, the risk of side effects from this medication may increase due to interactions, so all medications should be disclosed to healthcare providers. This medication contains lactose, so patients with lactose intolerance should not take it. Caution is advised when driving or operating machinery, as dizziness may occur. The safety of this medication in children and adolescents has not been sufficiently established, so it is advisable to avoid use except in special circumstances. In case of overdose, the patient should visit a medical institution immediately and receive appropriate treatment, including liver function and muscle-related tests depending on symptoms. This medication should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, cold sweat, difficulty breathing, severe allergic reactions
  • Severe rash accompanied by high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions
  • Shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanying respiratory abnormalities
  • Yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice)
  • Sudden and severe headaches, thunderclap headache.

Mild side effects

  • Headache
  • dyspepsia
  • itching
  • nausea
  • joint pain
  • dizziness
  • cough
  • diarrhea
  • weakness
  • fatigue
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  • constipation
  • abdominal pain
  • loss of appetite
  • vomiting
  • insomnia
  • paresthesia
  • hives
  • rash
  • increased serum creatinine
  • abnormal liver function tests
  • increased blood pressure
  • thrombocytopenia
  • paresthesia
  • myalgia
  • joint pain
  • dizziness
  • drowsiness
  • cough
  • rhinitis
  • cystitis
  • dermatitis
  • cold sweats
  • skin burning sensations
  • hair loss
  • chest discomfort
  • syncope
  • generalized.

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is best to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will ensure the safety and effectiveness of the medication.

Appearance and packaging

Appearance

This medication is a pale yellow, rectangular film-coated tablet.

Package unit

30 tablets/box [10 tablets/PTP x 3], 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.