Medication info
Roze K Tablets 10/10 mg

Roze K Tablets 10/10 mg

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

MFDS item code 202004561 · Approved 2020.06.23 · Insurance code 641806920

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 administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage is between 10/5 mg and 10/20 mg per day. A starting dose of 10/5 mg daily is recommended. For patients who require more significant LDL cholesterol reduction, the dosage can be adjusted. Lipid levels should be checked at intervals of at least 4 weeks after starting treatment or adjusting the dosage.

Ingredients

Manufacturer
광동제약(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
  • increased apolipoprotein B
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication helps improve cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. In particular, it lowers total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels while increasing HDL cholesterol. This medication should be used in conjunction with a dietary regimen and is administered when diet control alone is not sufficient. It is also important to confirm and treat other causes of dyslipidemia such as diabetes or hypothyroidism prior to using this medication. Since hypercholesterolemia can increase the risk of atherosclerotic vascular disease, it is necessary to manage risk factors appropriately. Thus, this medication is used to regulate patients' cholesterol and lipid levels to improve health.

How to take

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage is between 10/5 mg and 10/20 mg per day. A starting dose of 10/5 mg daily is recommended. For patients who require more significant LDL cholesterol reduction, the dosage can be adjusted. Lipid levels should be checked at intervals of at least 4 weeks after starting treatment or adjusting the dosage.

Precautions

There is a risk of severe muscle problems associated with this medication; thus, if symptoms such as muscle pain or weakness occur, the physician should be notified immediately. In particular, in cases of severe infection, hypotension, major surgery or trauma, or serious metabolic or electrolyte abnormalities, the use of this medication may need to be temporarily suspended or discontinued. It should not be used by individuals with allergies to the ingredients, active liver disease, muscle disorders, or severe renal function impairment. It should also not be administered to pregnant women or women who may become pregnant, or to nursing mothers. Patients with a history of alcohol dependence or liver disease, as well as those with severe liver dysfunction, should use this medication with caution. Additionally, elderly patients or those with hypothyroidism, a genetic history of muscle disease, or patients taking certain other medications should also exercise caution. This medication contains lactose, so patients with genetic issues such as lactose intolerance should not take it. Regular monitoring of liver function and muscle enzyme levels should be performed before and during administration, and appropriate measures should be taken if abnormalities are found. Adverse symptoms such as liver damage, skin rashes, severe muscle pain, muscle weakness, dizziness, dyspepsia may occur; if these symptoms develop, healthcare personnel should be consulted immediately. As this medication can interact with other drugs, particularly anticoagulants, fibrate drugs, and certain antibiotics and antifungals, it is essential to inform the physician if you are taking these medications. This medication is not recommended for children due to established safety and efficacy concerns, and caution is needed for the elderly as the risk of myopathy is increased. In the case of overdose, there is no specific antidote, and treatment should be symptomatic with liver and muscle function testing as necessary. Finally, when storing this medication, keep it out of reach of children and do not transfer it 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, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination issues.

Mild side effects

  • Pharyngitis
  • dyspepsia
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • dry mouth
  • pruritus
  • fatigue
Show 25 more
  • weakness
  • elevated blood sugar
  • increased blood lactate dehydrogenase
  • increased serum creatinine
  • myalgia
  • arthralgia
  • itching
  • rash
  • alopecia
  • cough
  • nausea
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • dry mouth
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorders
  • drowsiness
  • sensory disturbances
  • tremors
  • depression
  • sleep disturbances

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 it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP * 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.