Medication info
Rosuemjet Tablet 10/10 mg (Ezetimibe, Rosuvastatin)

Rosuemjet Tablet 10/10 mg (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
Pale pink, oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 202004140 · Approved 2020.05.29 · Insurance code 622804330

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This drug is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring a greater reduction in LDL cholesterol, the dose may be adjusted, and it may be increased up to a maximum of 10/20 mg per day. Blood lipid levels should be checked at intervals of more than 4 weeks after starting treatment or after dose adjustments to adjust the dosage accordingly.

Ingredients

Manufacturer
(주)마더스제약

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
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This drug helps reduce high total cholesterol and LDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing the good cholesterol, HDL cholesterol. In particular, this drug is used in conjunction with dietary therapy, as a supplementary treatment when dietary control limiting saturated fat and cholesterol intake is insufficient. It is used in patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, and it is important to first identify and treat secondary causes such as diabetes or hypothyroidism depending on the patient's condition. Regular checks of lipid levels are necessary, and if triglycerides are very high, accurate LDL cholesterol levels should be measured through ultracentrifugation. Lipid tests should also be quickly conducted in cases of acute coronary events to establish appropriate treatment plans. Overall, this drug is used effectively to improve dyslipidemic conditions.

How to take

Adult dose

This drug is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring a greater reduction in LDL cholesterol, the dose may be adjusted, and it may be increased up to a maximum of 10/20 mg per day. Blood lipid levels should be checked at intervals of more than 4 weeks after starting treatment or after dose adjustments to adjust the dosage accordingly.

Precautions

This drug can cause a rare side effect called rhabdomyolysis, which can lead to serious problems with muscles. Since it may rapidly worsen kidney function, patients should stop taking the drug immediately and consult a doctor if they experience severe muscle pain or weakness. Patients should undergo liver function tests before taking this drug, and it should not be administered if there are abnormal symptoms or persistently high liver enzyme levels. Regular liver function tests should be conducted if liver abnormalities are suspected, and the medication should be stopped if liver enzymes rise significantly. Patients consuming large amounts of alcohol or with a history of liver disease, those with severe kidney dysfunction, and patients with muscle disorders should take this drug with caution. In particular, patients with poor kidney function or hypothyroidism are at higher risk of muscle problems and should be monitored closely. This drug should not be given to pregnant or potentially pregnant women, or nursing mothers, and women of childbearing age should ensure appropriate contraception while taking it. During treatment, if symptoms such as muscle pain, cramping, weakness, or fever arise, immediate medical attention should be sought and blood tests conducted to assess for muscle damage if necessary. There may be interactions with other medications, so all current medications should be disclosed to healthcare professionals, especially when taken with cyclosporine, fibric acid derivatives, certain antifungals, and antivirals. Symptoms such as dizziness or headache may occur, so caution is advised during driving or operating machinery. This drug is generally not recommended for children as safety and efficacy have not been established. In case of overdose, there is no specific antidote available; treatment should be symptomatic and supportive, and liver function and muscle damage should be closely monitored. This drug contains lactose, so it should not be given to patients with lactose intolerance, and it should be discontinued immediately if serious skin reactions occur.

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, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, vision problems, paralysis, difficult urination

Mild side effects

  • Headache
  • arthralgia
  • myalgia
  • pharyngitis
  • dizziness
  • fatigue
  • nausea
  • abdominal pain
  • constipation
  • diarrhea
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  • pruritus
  • rash
  • itching
  • muscle cramps
  • weakness
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • urticaria
  • alopecia
  • vomiting
  • upper respiratory tract infection
  • sensory disturbances
  • depression
  • palpitations
  • flushing
  • nasal congestion
  • cough
  • sputum
  • facial swelling
  • tremors
  • erectile dysfunction
  • dizziness
  • somnolence
  • migraine
  • orthostatic dizziness
  • cold sweat
  • dermatitis
  • skin

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

Storage

This drug should be stored in a sealed container to protect it from air and moisture, and storage temperatures should be maintained between 1 to 30 degrees Celsius. Proper storage will maintain the drug's efficacy for a longer time.

Appearance and packaging

Appearance

Pale pink, oblong film-coated tablet

Package unit

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.