Medication info
Loese Tablet 10/5 mg

Loese Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Pink rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP × 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004568 · Approved 2020.06.23 · Insurance code 694003190

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is taken once daily without regard to meals. The dosage range is from 10/5 mg to 10/20 mg per day. A starting dose of 10/5 mg once daily is recommended. For patients needing more reduction in LDL cholesterol, the dosage may be adjusted. Monitor lipid levels at least 4 weeks after starting or adjusting the dosage to evaluate lipid levels and may increase up to 10/20 mg once daily.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed) and suppression of the risk of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • 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
  • diabetes
View approved original text

This medication is used as an adjunct to diet for the reduction of elevated total cholesterol, LDL cholesterol, ApoB protein, triglycerides, and non-HDL cholesterol levels and for the increase of HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. When administered to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, multiple risk factors should be considered carefully. This medication is used in conjunction with a diet that includes restriction of saturated fats and cholesterol, and is prescribed when sufficient effect is not achieved with diet and non-drug measures. Before administration, other secondary causes of dyslipidemia, such as diabetes, hypothyroidism, liver, and kidney disease, should be checked, and treatment should be combined if necessary. The therapeutic effect should be evaluated through accurate lipid tests and appropriate monitoring, especially, in patients with acute coronary events, lipid levels must be measured at the time of admission or within 24 hours. Thus, this medication is used effectively for the improvement of dyslipidemia.

How to take

Adult dose

This medication is taken once daily without regard to meals. The dosage range is from 10/5 mg to 10/20 mg per day. A starting dose of 10/5 mg once daily is recommended. For patients needing more reduction in LDL cholesterol, the dosage may be adjusted. Monitor lipid levels at least 4 weeks after starting or adjusting the dosage to evaluate lipid levels and may increase up to 10/20 mg once daily.

Precautions

This medication may rarely cause rhabdomyolysis, which can lead to acute kidney failure by damaging muscle tissue; therefore, if severe muscle pain or any muscle symptoms appear during medication, consult a physician immediately. This medication should not be used in patients with allergies to the active ingredient or any component, liver disease, or muscle disorders. Also, women who are pregnant or breastfeeding, or those with severe renal impairment should not take this medication. There is a higher risk of muscle damage in specific circumstances, so caution is required for patients with impaired renal function, hypothyroidism, the elderly, excessive alcohol consumers, or those who are on certain medications. Liver function tests should be conducted before starting medication, and liver function abnormalities and muscle-related symptoms should be checked regularly during treatment. If severe muscle pain, muscle weakness, fatigue, fever, or other symptoms appear during the use of this medication, immediately inform healthcare personnel, and if necessary, assess for muscle damage via blood tests. This medication may interact with some drugs, so if you are taking other medications, make sure to inform your healthcare personnel, particularly if combined with anticoagulants, certain antibiotics, or immunosuppressants. Women who are pregnant or planning to become pregnant should not take this medication, and if they become aware of being on it, they should stop immediately and consult with a physician. Safety in children and adolescents has not been sufficiently established; therefore, it is advisable not to use it except in special cases. This medication can cause dizziness or headache; therefore, caution is required when driving or operating machinery. Store in a place out of the reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, coma

Mild side effects

  • Headache
  • dizziness
  • dyspepsia
  • nasopharyngitis
  • edema
  • myalgia
  • chest discomfort
  • pruritus
  • dry mouth
  • increased blood sugar
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  • increased serum lactate dehydrogenase
  • increased serum creatinine
  • itching
  • rash
  • constipation
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • arthralgia
  • low back pain
  • fatigue
  • numbness
  • paresthesia
  • chest pain
  • cough
  • nasal congestion
  • oropharyngeal pain
  • urticaria

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. By doing so, the medication's effectiveness and safety can be preserved for a long time.

Appearance and packaging

Appearance

Pink rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP × 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.