Medication info
Ezrosum 10/10 mg

Ezrosum 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle, 30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201601193 · Approved 2016.02.29 · Insurance code 648507560

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This medicine is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg daily. A starting dose of 10/5 mg daily is recommended. For patients requiring a more significant reduction in LDL cholesterol, the dose may be adjusted. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of more than 4 weeks, and the dose should be adjusted accordingly. The maximum daily dose may be increased to 10/20 mg.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia

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

This medicine helps patients with primary hypercholesterolemia and mixed dyslipidemia. It is used to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, and to increase the level of HDL cholesterol, which is good cholesterol. It is recommended as an adjunct therapy along with dietary therapy for those at risk of atherosclerotic vascular disease due to hypercholesterolemia. This medicine is used when dietary control and lifestyle improvements are insufficient, and it is important to confirm and treat secondary causes such as diabetes and hypothyroidism. Cholesterol levels should be periodically checked before and during treatment to monitor the condition. Managing in this way helps improve blood lipid levels and reduce the risk of cardiovascular disease.

How to take

Adult dose

This medicine is administered once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg daily. A starting dose of 10/5 mg daily is recommended. For patients requiring a more significant reduction in LDL cholesterol, the dose may be adjusted. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of more than 4 weeks, and the dose should be adjusted accordingly. The maximum daily dose may be increased to 10/20 mg.

Precautions

This medicine can cause serious problems in muscles, so if muscle pain or weakness occurs, it should be reported to a doctor immediately. Patients with severe infections, hypotension, major surgery or trauma, or severe endocrine disorders may need to temporarily discontinue or permanently stop taking this medicine. Individuals allergic to the active ingredients or constituents of this medicine, those with severely impaired liver function, patients with muscle disorders, and women who are pregnant or breastfeeding should not take this medicine. Additionally, it is prohibited for patients with very poor kidney function or those taking certain medications. Caution is needed for alcoholics, individuals with a history of liver disease, elderly patients over 70 years old, and those with hypothyroidism due to the high risk of myopathy. This medicine can cause liver dysfunction, so liver function tests should be conducted before and during use, and if symptoms of liver damage appear, a doctor should be consulted immediately. This medicine can raise blood sugar levels, so individuals at risk for diabetes require regular blood sugar monitoring. There may be interactions with other medications, so all medications being taken must be reported to a physician or pharmacist, especially when taken with anticoagulants, fibrates, and certain antibiotics. Women who are pregnant or planning to become pregnant must ensure appropriate contraception and should immediately discontinue this medicine if pregnancy is confirmed. The safety of this medicine for children has not been established, so it is not recommended. There is no specific antidote for overdose, so treatment and appropriate testing based on symptoms are necessary. This medicine should be kept out of reach of children, and transferring to other containers should be avoided. Caution is needed when driving or operating machinery as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, tightness in the chest, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, respiratory problems, jaundice, systemic extreme fatigue, liver abnormalities, sudden and very severe headache

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • increased ALT
  • increased AST
  • increased ALP
  • abnormal liver function tests
  • fatigue
  • myalgia
  • rash
Show 26 more
  • pruritus
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • abdominal distention
  • weakness
  • chest pain
  • chest discomfort
  • edema
  • arthralgia
  • numbness
  • paresthesia
  • loss of appetite
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hives
  • hyperhidrosis
  • cold sweat
  • dermatitis
  • skin burning sensation
  • skin disorders
  • alopecia

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

Storage

This medicine is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to preserve the efficacy and safety of the medicine for a longer duration.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle, 30 tablets/box [10 tablets/PTP x 3]

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.