Medication info
Rotajet Tablet 10/10 mg

Rotajet Tablet 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP × 3], 30 tablets/bottle
Approval status
Active

MFDS item code 202004129 · Approved 2020.05.29 · Insurance code 653805810

Summary

Main use
Treatment for improving cholesterol and lipid levels in hypercholesterolemia (primary, mixed type) and dyslipidemia
Who takes it
Adults
Adult dose
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, it can start at 10/5 mg once daily and can be increased to 10/20 mg. The initial dose is 10/5 mg once daily, and after checking lipid levels with an interval of more than 4 weeks, the dosage should be adjusted. The maximum daily dosage is 10/20 mg.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Treatment for improving cholesterol and lipid levels in hypercholesterolemia (primary, mixed type) and dyslipidemia

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

This medication helps improve elevated total cholesterol and abnormal lipid levels, including LDL-cholesterol, in patients with primary hypercholesterolemia and mixed dyslipidemia. It is specifically designed to lower Apo B protein, triglycerides, and non-HDL-cholesterol levels while increasing HDL-cholesterol levels. This medication is used alongside an appropriate diet and is administered as an adjunct when lipid level improvements are insufficient. Moreover, when applied to patients at high risk of atherosclerotic cardiovascular disease due to hypercholesterolemia, various risk factors should be considered. It is important to identify other causes of dyslipidemia prior to treatment and to address secondary causes if necessary. With such management, it is effectively used for improving blood lipids.

How to take

Adult dose

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, it can start at 10/5 mg once daily and can be increased to 10/20 mg. The initial dose is 10/5 mg once daily, and after checking lipid levels with an interval of more than 4 weeks, the dosage should be adjusted. The maximum daily dosage is 10/20 mg.

Precautions

This medication has been reported to have rare side effects that may cause serious muscular problems, so if symptoms such as muscle pain or weakness occur, consult a doctor immediately. In particular, patients with severe conditions, such as acute infections, hypotension, major surgeries, or trauma, may need to temporarily stop or discontinue the use of this medication. Patients with allergies to any component of this medication, or with liver disease, muscle disease, or severe kidney dysfunction should not use it. Pregnant or potentially pregnant women and nursing mothers should also avoid using this medication. Furthermore, patients with a high risk of specific myopathies, such as those with moderately impaired kidney function or hypothyroidism, and those with a history of muscle-related drug side effects should prefer to avoid this medication. Since this medication contains lactose, patients with lactose intolerance or related genetic disorders should not take it. Alcoholics or patients with a history of liver disease need to be cautious when administering this, and it is recommended not to administer it if there is severe liver dysfunction. Elderly patients over 70 years of age should also use this carefully due to a higher risk of muscular issues. During the use of this medication, liver function and muscle condition should be regularly monitored, and if any abnormal symptoms occur, inform a doctor immediately and get tested. In particular, if symptoms such as muscle pain, muscle cramps, or muscle weakness occur, it is essential to inform healthcare professionals, and medication should be discontinued if necessary. This medication may interact with other drugs, so if you are taking any other medications, you must inform your healthcare professionals, especially caution is needed when taking other fibrate drugs, anticoagulants, antibiotics, and antifungals. Pregnant women or women planning to become pregnant should not take this medication, and if pregnancy is confirmed during treatment, it should be discontinued immediately. Nursing mothers should also avoid taking this medication. The safety of this medication in children and adolescents has not been adequately verified, so it should be avoided except in special cases. When administering to the elderly, careful observation is required considering the risk of muscle-related side effects. This medication should be stored out of reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, swelling, chest discomfort, cold sweat, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), acute kidney failure, thrombocytopenia, hepatitis, acute hepatitis, toxic hepatitis, jaundice, rhabdomyolysis, myopathy, liver disorders, severe allergic reactions, severe skin reactions, serious neurological symptoms, respiratory issues, kidney dysfunction, severe swelling or urinary abnormalities

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • increased ALT
  • increased AST
  • myalgia
  • elevated blood bilirubin
  • acneiform dermatitis
  • pruritus
  • dizziness
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  • upper respiratory tract infection
  • itching
  • rash
  • asthenia
  • fatigue
  • numbness
  • sensory disturbances
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • cough
  • sputum
  • runny nose
  • limb pain
  • low back pain

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

Storage

This medication should be kept in a tightly sealed container to protect it from air and moisture, and it is preferable to store it at room temperature between 1 degrees and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

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