Medication info
Rosubjet Tablet 10/10 Milligrams

Rosubjet Tablet 10/10 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Yellow oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004603 · Approved 2020.06.23 · Insurance code 650304190

Summary

Main use
Lipid control for hypercholesterolemia (primary, mixed type) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. The dosage range is from 10/5mg to 10/20mg per day. A starting dose of 10/5mg daily is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dose may be adjusted accordingly. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of more than 4 weeks, and the dosage can be modified accordingly. The maximum daily dose is 10/20mg.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Lipid control for hypercholesterolemia (primary, mixed type) and suppression of the risk of atherosclerotic vascular disease

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

This medicine is used as an adjunct to diet to lower total cholesterol, LDL-cholesterol, Apo B protein, triglyceride, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase the level of good cholesterol, HDL-cholesterol. It is especially important for patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia to take lipid-lowering drugs along with it, considering multiple risk factors. Before using the medication, other causes of dyslipidemia, such as diabetes and hypothyroidism, must be identified and treated. It should be administered when there is insufficient response to dietary and non-pharmacological measures. During treatment, it is necessary to regularly check total cholesterol and lipid levels to evaluate the appropriate therapeutic effect. This medication helps prevent cardiovascular disease by improving the blood lipid concentrations in patients.

How to take

Adult dose

This medication is administered once daily, regardless of meals. The dosage range is from 10/5mg to 10/20mg per day. A starting dose of 10/5mg daily is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dose may be adjusted accordingly. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of more than 4 weeks, and the dosage can be modified accordingly. The maximum daily dose is 10/20mg.

Precautions

This medication may cause abnormal reactions in muscles, so if muscle pain or weakness appears, you must inform your doctor immediately. Serious myopathy or rhabdomyolysis may occur, so if these symptoms are suspected, treatment should be stopped, and consultation with a specialist should be sought. This medication may affect liver function, so regular liver function tests should be performed before and during treatment. It is advisable not to use this medication if there is liver disease or if liver enzyme levels are abnormally high. Patients with impaired kidney function should also be cautious, and this product should not be administered in the case of severe kidney dysfunction. Women who are pregnant, potentially pregnant, or breastfeeding should not use this medication, and women of childbearing age should use appropriate contraceptive methods during treatment. The safety and efficacy of this medication in children and adolescents have not been sufficiently established, so it is not recommended. It is advisable to avoid alcohol consumption during this medication treatment, particularly if there is a history of liver disease. There may be drug interactions; therefore, if you are currently taking any medications, be sure to inform your doctor or pharmacist. Particular caution is needed when combined with cyclosporine, fibrate-type medications, certain antibiotics, and antifungal agents. This medication can rarely cause severe skin reactions or allergic reactions, so if symptoms such as skin rash, itching, or swelling appear, inform medical personnel immediately. Caution is needed as dizziness may occur during driving or operation of machinery. In case of overdose, there is no specific antidote, so one should go to the hospital immediately for appropriate treatment, and tests related to liver function and muscle should be conducted. Lastly, this medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosa pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormality accompanied by cough + fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nasopharyngitis
  • indigestion
  • dry mouth
  • pruritus
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • muscle pain
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  • weakness
  • fatigue
  • sensory disturbances
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • joint pain
  • itching
  • alopecia
  • palpitations
  • congestive heart failure
  • cough
  • phlegm
  • nasal congestion
  • oropharyngeal pain
  • positional dizziness
  • migraine
  • somnolence
  • tremors
  • increased blood lactate dehydrogenase
  • elevated CPK
  • thrombocytopenia
  • increased serum creatinine

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

Storage

This medicine should be stored in a tightly closed container to protect it from air and moisture. It is essential to maintain the storage temperature between 1 degree and 30 degrees Celsius to keep the medicine's efficacy and safety for a long time.

Appearance and packaging

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 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.