Medication info
Rotajet Tablet 10/5 mg

Rotajet Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
White to almost white round film-coated tablet
Packaging
30 tablets/bottle, 30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 202004130 · Approved 2020.05.29 · Insurance code 653805820

Summary

Main use
Reduction of cholesterol in primary and mixed hypercholesterolemia and dyslipidemia, and inhibition of the risk of atherosclerotic vascular disease through increased HDL.
Who takes it
Adults
Adult dose
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, it is administered at a dose ranging from 10/5 mg to 10/20 mg daily, with the initial dose being 10/5 mg once daily. If further reduction of LDL cholesterol is required, the dosage can be adjusted, and may be increased up to a maximum of 10/20 mg daily. After starting treatment or adjusting the dose, lipid levels should be assessed at intervals of more than 4 weeks.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Reduction of cholesterol in primary and mixed hypercholesterolemia and dyslipidemia, and inhibition of the risk of atherosclerotic vascular disease through increased HDL.

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

This medication is used as an adjunct to diet to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia while raising HDL cholesterol levels. In patients at high risk for atherosclerotic vascular disease due to hypercholesterolemia, it should be used considering various risk factors, and it must be administered alongside appropriate dietary therapy. Additionally, it is important to identify and treat other secondary causes and periodically check lipid levels to evaluate treatment effectiveness. This medication is administered when dietary and non-pharmacological measures are insufficient, improving blood lipid levels to help prevent cardiovascular diseases. Therefore, it is used for the treatment of hypercholesterolemia and for improving related blood lipid levels.

How to take

Adult dose

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, it is administered at a dose ranging from 10/5 mg to 10/20 mg daily, with the initial dose being 10/5 mg once daily. If further reduction of LDL cholesterol is required, the dosage can be adjusted, and may be increased up to a maximum of 10/20 mg daily. After starting treatment or adjusting the dose, lipid levels should be assessed at intervals of more than 4 weeks.

Precautions

This medication can cause serious muscle problems, so if symptoms of muscle pain or weakness occur, inform your doctor immediately. Serious myopathy or rhabdomyolysis can occur and may affect kidney function, requiring caution. This medication can affect liver function, so liver function tests should be performed regularly before and during treatment. Patients with liver disease or those who consume alcohol heavily should be especially cautious when using this medication. This medication should not be administered to patients with specific genetic issues or poor kidney function, and should be avoided in pregnant or potentially pregnant women and nursing mothers. Additionally, this medication may interact with other drugs, so inform your doctor or pharmacist of any concomitant medications. Use of this medication is not recommended in children and elderly patients, as elderly patients are at higher risk for myopathy. In case of overdose, there is no specific antidote, so seek appropriate medical care immediately and undergo liver function and muscle-related tests. Dizziness may occur while taking this medication, so caution is required during driving or operating machinery. Finally, this medication should be stored out of reach of children, and it is safe not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, facial swelling, rhabdomyolysis, acute renal failure, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, breathing problems, skin or eyes turning yellow (jaundice), overall extreme fatigue.

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • increased ALT
  • increased AST
  • myalgia
  • edema
  • elevated blood bilirubin
  • acneiform dermatitis
  • pruritus
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  • dizziness
  • upper respiratory infection
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • abnormalities in liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • itching
  • rash
  • urticaria
  • cough
  • sputum
  • runny nose
  • limb pain
  • low back pain
  • tremors
  • vomiting

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering and should be kept at room temperature between 1 and 30 degrees Celsius. This helps maintain the drug's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

Package unit

30 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.