Medication info
Rosuzet Tablet 10/10 mg

Rosuzet Tablet 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
This medicine is a pale yellowish pink, oblong, film-coated tablet.
Packaging
30 tablets/box [10 tablets/PTP x 3], 100 tablets/bottle
Approval status
Active

MFDS item code 201503659 · Approved 2015.06.08 · Insurance code 643507260

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed) and inhibition of the risk of atherosclerotic vascular disease.
Who takes it
Adults
Adult dose
This medicine is administered once daily without regard to meals. For primary hypercholesterolemia, the recommended initial dose is 10/5 mg once daily, within the dosage range of 10/5 mg to 10/20 mg daily. If a greater reduction in LDL cholesterol is required, the dosage can be adjusted. Blood lipid levels should be checked at intervals of more than 4 weeks after initiation or dose adjustment to control the dosage.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed) and inhibition of the risk of atherosclerotic vascular disease.

  • 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
  • dyslipidemia.
View approved original text

This medicine is used in conjunction with dietary therapy to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels while raising HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is particularly suitable for patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia and is administered when there is inadequate response to diet and other non-pharmacological treatments. Prior to use, secondary causes such as diabetes or hypothyroidism should be confirmed, and necessary treatments must be provided. Treatment effects should be monitored through lipid tests, and if triglyceride levels are high, advanced testing may be required. In patients with acute coronary events, lipid levels should be measured upon admission or within 24 hours of admission and incorporated into the treatment plan. This medicine effectively improves cholesterol and lipid levels.

How to take

Adult dose

This medicine is administered once daily without regard to meals. For primary hypercholesterolemia, the recommended initial dose is 10/5 mg once daily, within the dosage range of 10/5 mg to 10/20 mg daily. If a greater reduction in LDL cholesterol is required, the dosage can be adjusted. Blood lipid levels should be checked at intervals of more than 4 weeks after initiation or dose adjustment to control the dosage.

Precautions

This medicine carries a risk of muscle problems; therefore, if symptoms such as muscle pain, muscle weakness, or fever occur, you should immediately inform your doctor. Serious muscle damage, such as rhabdomyolysis, can occur rarely, so if muscle-related symptoms are severe or if CPK levels are significantly elevated, the medication should be discontinued. Additionally, it may affect liver function, so liver function tests should be performed regularly before and during medication use, and it should not be administered in cases of liver abnormalities. Patients who consume large amounts of alcohol or have liver disease should use this medicine cautiously. This medicine should not be administered to patients with severely reduced kidney function, and patients with weak kidney function should be monitored for possible muscle problems. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medicine, and women of childbearing age should use appropriate contraception while on this medication. Safety for children and adolescents has not been sufficiently established, therefore it is not recommended. When taking this medicine, there may be interactions with other drugs, so you must inform your doctor or pharmacist of any medications you are taking. Caution is advised while driving or operating machinery as dizziness may occur. If severe skin reactions such as rash or swelling occur, immediately stop taking the medication and consult a healthcare professional. In the event of overdose, since there is no specific antidote, treatment should be based on symptoms while monitoring liver function and muscle condition. This medicine 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, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination changes.

Mild side effects

  • Nasopharyngitis
  • headache
  • dyspepsia
  • hypertension
  • itching
  • rash
  • nausea
  • arthralgia
  • dizziness
  • cough
Show 28 more
  • fatigue
  • constipation
  • diarrhea
  • myalgia
  • weakness
  • thrombocytopenia
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • chest pain
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia
  • anemia
  • splenomegaly
  • hyperhidrosis

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

Storage

This medicine is sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

This medicine is a pale yellowish pink, oblong, 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.