Medication info
Lopajet Tablet 10/5 Milligrams

Lopajet Tablet 10/5 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
White, biconvex, egg-shaped film-coated tablet
Packaging
30 tablets
Approval status
Active

MFDS item code 201601196 · Approved 2016.02.29 · Insurance code 640006960

Summary

Main use
Reduction of LDL-C and increase in HDL-C in primary hypercholesterolemia (familial, mixed) and dyslipidemia to suppress the risk of cardiovascular disease
Who takes it
Adults
Adult dose
This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended. In patients requiring greater reduction of LDL cholesterol, the dosage may be adjusted up to a maximum of 10/20 mg daily. Blood lipid levels should be checked at intervals of more than 4 weeks after starting treatment or after dosage adjustment for dosage adjustments.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Reduction of LDL-C and increase in HDL-C in primary hypercholesterolemia (familial, mixed) and dyslipidemia to suppress the risk of cardiovascular disease

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • ApoB protein
  • triglycerides
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This drug is used as an adjunct to dietary management to lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia and to increase HDL cholesterol levels. It is particularly administered in conjunction with appropriate dietary management in patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, especially when dietary management alone is insufficient. Prior to administration, it is important to confirm and treat secondary causes such as diabetes and hypothyroidism, and to regularly monitor total cholesterol, LDL, HDL, and triglyceride levels. This drug helps to improve the patient's lipid status to prevent cardiovascular diseases.

How to take

Adult dose

This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended. In patients requiring greater reduction of LDL cholesterol, the dosage may be adjusted up to a maximum of 10/20 mg daily. Blood lipid levels should be checked at intervals of more than 4 weeks after starting treatment or after dosage adjustment for dosage adjustments.

Precautions

This drug may cause rare side effects such as rhabdomyolysis, which can damage muscles; therefore, immediate consultation with a doctor is necessary if severe muscle pain or any unusual symptoms occur during treatment. It is advisable not to use this drug in patients with liver disease or elevated liver enzyme levels, as it may affect liver function. This drug should not be used in patients with very poor kidney function, certain liver diseases, or muscle disorders, nor in women who are pregnant or may become pregnant, or those who are breastfeeding. Patients with a history of alcohol abuse, impaired liver function, the elderly, and those at high risk of myopathy should exercise extra caution when using this drug, and it is important to have regular check-ups as instructed by a doctor. The risk of side effects may increase if this drug is taken with certain other medications, so it is crucial to inform a doctor or pharmacist of all other medications being taken. Regular monitoring of liver function and muscle-related tests is necessary while using this drug, and immediate consultation with healthcare professionals is required if any unusual symptoms arise. This drug is not recommended for children and adolescents, especially those under 10 years of age, as its safety and efficacy have not been sufficiently established. Caution is necessary during driving or operation of machinery as this drug may cause dizziness.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, facial swelling, cold sweat, rash, angioedema, chest discomfort, difficulty breathing, respiratory impairment, severe swelling, severe muscle weakness, ocular muscle weakness, myopathy, rhabdomyolysis, acute kidney failure, kidney dysfunction, hematuria, jaundice, hepatitis, liver toxicity, acute hepatitis, toxic hepatitis, Stevens-Johnson syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • rash
  • myalgia
  • weakness
  • fatigue
  • chest pain
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  • nasopharyngitis
  • diarrhea
  • upper respiratory infection
  • bronchitis
  • rhinitis
  • cystitis
  • dermatitis
  • skin burning sensation
  • alopecia
  • oropharyngeal pain
  • nasal congestion
  • cough
  • sputum
  • runny nose
  • drowsiness
  • tremors
  • paresthesia
  • depression
  • diabetes
  • glucose intolerance
  • palpitations
  • flushing
  • limb pain
  • joint pain
  • back pain
  • sweating
  • itching
  • abdominal distension

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

Storage

This drug must be stored in a tightly sealed container to prevent exposure to air and moisture. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

White, biconvex, egg-shaped film-coated tablet

Package unit

30 tablets

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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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.