Medication info
Lowrose Tablet 10/2.5 mg (Ezetimibe, Rosuvastatin Calcium)

Lowrose Tablet 10/2.5 mg (Ezetimibe, Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›2.6mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
애드파마(주)
Appearance
Yellow rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP X 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202204606 · Approved 2022.12.21 · Insurance code 076800010

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed type) and treatment of dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/2.5 mg to 10/20 mg per day. An initial dose of 10/2.5 mg or 10/5 mg per day is recommended. Patients requiring more significant reductions in LDL cholesterol may adjust their dosage. After starting the treatment or adjusting the dosage, blood lipid levels should be checked at intervals of at least 4 weeks.

Ingredients

Manufacturer
애드파마(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed type) and treatment of 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
View approved original text

This medication aids in lowering elevated total cholesterol, LDL-cholesterol, apo B protein, triglyceride, and non-HDL cholesterol levels, while increasing HDL cholesterol levels, when used in conjunction with dietary therapy in patients with primary hypercholesterolemia and mixed dyslipidemia. This helps regulate blood lipid levels and is effective in reducing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/2.5 mg to 10/20 mg per day. An initial dose of 10/2.5 mg or 10/5 mg per day is recommended. Patients requiring more significant reductions in LDL cholesterol may adjust their dosage. After starting the treatment or adjusting the dosage, blood lipid levels should be checked at intervals of at least 4 weeks.

Precautions

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can lead to serious muscle damage. This may result in a rapid decline in kidney function, so if symptoms of severe muscle pain or weakness occur, consult a physician immediately. This medication should not be administered to patients with certain diseases. For example, those allergic to the components contained in this medication, with severe liver impairment, having muscular diseases, taking specific immunosuppressants, experiencing severe kidney dysfunction, pregnant or nursing women, should not use this medication. Additionally, patients at high risk for myopathy or rhabdomyolysis should use this medication cautiously. Risk factors include reduced kidney function, hypothyroidism, family or personal history of muscular diseases, previous muscle toxicity experience with other lipid-lowering agents, excessive alcohol consumption, certain racial groups (e.g., Asian), and co-administration with other drugs that may interact with this medication. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Liver function tests should be performed before taking this medication, and any symptoms of liver damage during treatment should be reported to a physician immediately. If liver enzyme levels rise significantly, discontinuation of the medication may be necessary. If symptoms such as muscle pain or weakness occur, muscle enzyme levels in the blood should be tested, and if levels rise significantly, the medication should be stopped. Caution is needed when administering this medication to patients with a history of alcohol dependence or liver disease, and elderly patients are also at risk for myopathy and should be monitored closely. Women who are pregnant or who might become pregnant should not take this medication, and if pregnancy occurs during treatment, it should be discontinued immediately. Additionally, nursing mothers are advised not to take this medication. This medication can interact with other drugs, so anyone taking other medications must inform their physician. Particularly caution is required when taken with certain antibiotics, immunosuppressants, fibrates, anticoagulants, etc. Regular blood tests and liver function tests should be conducted during the course of this medication, and if any unusual symptoms occur, consult a physician immediately. The use of this medication in children is not recommended as safety and efficacy have not been adequately established for this population. This medication should be stored out of reach of children and care should be taken to avoid transferring it to other containers, as this can cause degradation of quality or accidents.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe allergic reactions
  • Severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucosa, severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever
  • Yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice)
  • Sudden and severe headaches

Mild side effects

Constipation, diverticulitis, dyspepsia, COVID-19, arthralgia, contusion, elevated CPK, hematoma, iron deficiency anemia, nasopharyngitis, indigestion, edema, myalgia, headache, acute pyelonephritis, dry mouth, elevated liver enzymes, abnormal liver function tests, increased serum lactate dehydrogenase levels, pruritus, dizziness, drowsiness, neurodegenerative disorders, orthostatic dizziness, migraine, depression, bronchitis, rhinitis, cystitis, skin on hands and feet

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at a temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow rectangular 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.