Medication info
RosuMjet Tablets 10/5 mg (Ezetimibe, Rosuvastatin)

RosuMjet Tablets 10/5 mg (Ezetimibe, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
Pale yellow, oblong film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 202004138 · Approved 2020.05.29 · Insurance code 622804310

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed) and suppression of the risk of atherosclerotic vascular diseases
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. In the case of primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg once daily. A starting dose of 10/5 mg once daily is recommended. Patients requiring greater reductions in LDL cholesterol may have their dosage adjusted. After initiation of therapy or dosage adjustment, lipid levels should be checked with an interval of more than four weeks, and the dosage may be adjusted accordingly.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed) and suppression of the risk of atherosclerotic vascular diseases

  • 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 medication is used to improve cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It particularly helps lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels while increasing HDL cholesterol, the good cholesterol. This medication is taken along with dietary management and is administered when there is insufficient response to dietary control or non-drug treatment. Additionally, it is used in patients with a high risk of atherosclerotic vascular diseases caused by hypercholesterolemia, while confirming other underlying conditions or medications. Regular lipid testing is conducted to evaluate treatment effects, and the treatment plan is adjusted as needed. This systematic management improves cholesterol levels.

How to take

Adult dose

This medication is administered once daily regardless of meals. In the case of primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg once daily. A starting dose of 10/5 mg once daily is recommended. Patients requiring greater reductions in LDL cholesterol may have their dosage adjusted. After initiation of therapy or dosage adjustment, lipid levels should be checked with an interval of more than four weeks, and the dosage may be adjusted accordingly.

Precautions

This medication can cause serious muscle problems, so severe muscle pain or weakness symptoms should be reported to a doctor immediately. Particularly, in cases where there is a risk of renal function impairment due to severe infections, hypotension, major surgery, trauma, or metabolic disorders, the use of this medication should be temporarily suspended or stopped. Do not use if you are allergic to any ingredients in this medication, have liver or muscle diseases, or have severe renal impairment. Women who are pregnant, potentially pregnant, or breastfeeding should not use this medication. Patients with a history of alcohol dependence or liver disease, the elderly, and those with hypothyroidism, who are at higher risk of muscle diseases, should use this medication with caution. This medication contains specific dyes, so people with allergies to these should be cautious. In case of liver function abnormalities, liver test results should be checked regularly, and treatment should be stopped immediately if liver damage is suspected. This medication may increase blood glucose levels, but since the cardiovascular disease risk reduction effect outweighs this, it is advisable not to discontinue. It may interact with other drugs, so make sure to inform your doctor or pharmacist if you are taking other medications, especially when used with anticoagulants or fibrate drugs. Caution is advised when driving or operating machinery as dizziness may occur. Do not use this medication during pregnancy or breastfeeding, and fertile women should use appropriate contraceptive methods. Safety for children and adolescents has not been sufficiently established so it is not recommended. In case of overdose, there is no specific antidote, so symptomatic treatment along with liver function and muscle enzyme tests should be conducted. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, facial swelling, cold sweat, chest tightness, difficulty breathing, jaundice, severe edema, renal failure, acute renal failure, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, severe skin reactions (Stevens-Johnson syndrome, DRESS), liver toxicity, acute hepatitis, toxic hepatitis, liver failure, severe liver damage, thrombocytopenia, anaphylaxis, polyneuropathy, peripheral neuropathy, Stevens-Johnson syndrome, h

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • dizziness
  • upper respiratory infection
  • myalgia
  • fatigue
  • nausea
  • abdominal pain
  • diarrhea
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  • constipation
  • pruritus
  • rash
  • urticaria
  • increased bilirubin in the blood
  • increased creatinine in the blood
  • chest discomfort
  • weakness
  • chest pain
  • muscle cramps
  • fainting
  • general pain
  • paresthesia
  • loss of appetite
  • abdominal distension
  • alopecia
  • paresthesia
  • tremor
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in epigastrium
  • belching
  • gastrointestinal disturbance
  • gastroesophageal reflux

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. The suitable storage temperature is room temperature between 1 to 30 degrees Celsius. Avoid extremely hot or cold places, and store in a cool place away from direct sunlight.

Appearance and packaging

Appearance

Pale yellow, oblong film-coated tablets

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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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.