Medication info
Rojet Tablet 10/5 mg

Rojet Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
White to nearly white round film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3), 30 tablets/bottle
Approval status
Active

MFDS item code 201601216 · Approved 2016.02.29 · Insurance code 649807100

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. The dosage range is between 10/5 mg and 10/20 mg per day, adjusted according to the patient's response. After starting treatment or adjusting the dose, cholesterol levels should be verified after a minimum of 4 weeks, and the dosage can be increased up to a maximum of 10/20 mg per day.

Ingredients

Manufacturer
명문제약(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
  • elevated LDL-cholesterol
  • elevated apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
View approved original text

This medication is administered to patients with primary hypercholesterolemia, especially heterozygous familial and non-familial, and mixed dyslipidemia. The treatment aims to lower elevated total cholesterol, LDL-cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels, while increasing HDL cholesterol, known as good cholesterol. This drug is primarily used as an adjunct to dietary therapy and is managed in conjunction with non-pharmacological methods such as restrictions on saturated fat and cholesterol intake. It is also mainly prescribed for individuals at high risk of atherosclerotic vascular disease due to hypercholesterolemia. Before administering this medication, it is important to identify other causes of dyslipidemia and provide necessary treatments. This medication helps to improve lipid levels into the normal range, aiding in the prevention of cardiovascular disease.

How to take

Adult dose

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. The dosage range is between 10/5 mg and 10/20 mg per day, adjusted according to the patient's response. After starting treatment or adjusting the dose, cholesterol levels should be verified after a minimum of 4 weeks, and the dosage can be increased up to a maximum of 10/20 mg per day.

Precautions

This medication may rarely cause muscle damage, resulting in muscle pain or weakness, which could lead to severe renal damage in extreme cases; therefore, if severe muscle pain or weakness occurs, consult a physician immediately. This medication can affect liver function, so it should not be administered or should be used with caution in patients with liver disease or elevated liver enzyme levels, and liver function tests should be conducted regularly during treatment. This medication should not be used in patients with certain genetic disorders, severely impaired kidney function, or in women who are pregnant or breastfeeding. Patients with a history of alcohol abuse, liver disease, elderly patients, and those with hypothyroidism should be especially cautious when administering this medication, and dosage adjustments or monitoring may be necessary as directed by a physician. During the use of this medication, if symptoms such as muscle pain, fever, or fatigue occur, inform the medical staff immediately, and if necessary, blood tests should be performed to check for muscle damage. This medication may interact with other drugs, so it is essential to inform the physician or pharmacist about any currently taken medications, particularly in combination with anticoagulants, certain antibiotics, and fibrate drugs, caution is required. Safety and efficacy of this medication in children or adolescents have not been established, hence it is not recommended. During the use of this medication, dizziness may occur while driving or operating machinery, therefore caution is advised.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blistering, skin peeling, oral/ocular mucosal pain, severe skin adverse reaction, shortness of breath or breathing difficulty, asthma attack, respiratory distress accompanied by cough and fever, hepatic issues (jaundice), severe and sudden headache, extreme drowsiness

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • dizziness
  • upper respiratory infection
  • myalgia
  • weakness
  • pruritus
  • rash
  • itching
Show 25 more
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • fatigue
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • bronchitis
  • rhinitis
  • cystitis
  • onychomycosis
  • soft tissue infection
  • dizziness
  • somnolence
  • neurodegenerative disorder
  • orthostatic dizziness
  • migraine
  • diabetic neuropathy

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 and moisture from entering, at a temperature between 1 degree and 30 degrees Celsius, preferably at room temperature. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White to nearly white round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 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.