Medication info
Lopatan Tablets 10 mg (Rosuvastatin Calcium)

Lopatan Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)킵스바이오파마
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201403882 · Approved 2014.08.20 · Insurance code 693201040

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia can take this drug at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and it may be adjusted to maintain a dose of up to 10 mg once daily as needed. The maintenance dose should be adjusted based on LDL cholesterol levels and patient response at intervals of 4 weeks or more, with a maximum of 20 mg per day.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is 5 mg to 20 mg once daily. The dose should be adjusted according to treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dyslipidemia with familial hypercholesterolemia
  • elevated LDL cholesterol
  • family history of early cardiovascular disease
  • cardiovascular disease risk factors
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
View approved original text

This medicine is used as an adjunct in patients with hypercholesterolemia and mixed dyslipidemia that are not adequately controlled by diet and exercise. It is particularly useful for patients with familial hypercholesterolemia and dysbetalipoproteinemia. This drug works by lowering total cholesterol and LDL cholesterol levels, helping to slow the progression of atherosclerosis. It is also effective for pediatric patients aged 10 to 17 with familial hypercholesterolemia under specific conditions. Additionally, it is used to reduce the risk of stroke, myocardial infarction, and vascular revascularization in middle-aged patients at high risk for cardiovascular disease. Overall, this drug is extremely useful for improving blood lipid levels and reducing cardiovascular disease risk.

How to take

Adult dose

Patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia can take this drug at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and it may be adjusted to maintain a dose of up to 10 mg once daily as needed. The maintenance dose should be adjusted based on LDL cholesterol levels and patient response at intervals of 4 weeks or more, with a maximum of 20 mg per day.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is 5 mg to 20 mg once daily. The dose should be adjusted according to treatment goals at intervals of 4 weeks or more.

Precautions

This drug should not be taken by certain patients. For example, it should not be administered to patients who are allergic to its components, patients with severe liver dysfunction, patients with muscle diseases, and patients with significantly impaired kidney function. Pregnant or breastfeeding women, as well as women of childbearing age who are not using adequate contraception, should also avoid taking this drug. It is important to monitor liver function tests and muscle conditions periodically while using this drug. Precautions should be taken, especially for patients with a history of liver disease or heavy alcohol consumption. If symptoms of myalgia, muscle weakness, or muscle damage occur, immediate medical attention should be sought. This drug may exacerbate muscle diseases, so discontinuation may be necessary if such symptoms occur. Additionally, interactions may arise when taken with other medications, so it is essential to inform healthcare providers of all medications being taken, particularly antivirals, immunosuppressants, antibiotics, and fibrates. This drug can elevate blood glucose levels, so patients at risk for diabetes should pay attention to blood glucose management. Pregnant and breastfeeding women should not take this drug, and women planning to become pregnant should use appropriate contraceptive methods. There is no specific antidote for overdose, so immediate medical care and assessment should be sought. This drug may cause symptoms like dizziness, so caution should be exercised when driving or operating machinery. Lastly, it is important to consult healthcare professionals immediately if any adverse reactions occur while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, myopathy (including myositis), immune-mediated necrotizing myopathy, jaundice, hepatitis, severe muscle weakness, oculobulbar weakness, cough, dyspnea, acute renal failure, thrombocytopenia, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • myalgia
  • weakness
  • pruritus
  • rash
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • arthralgia
  • amnesia
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • lichenoid drug eruption
  • lupus-like syndrome
  • muscle rupture
  • increased serum creatinine
  • depression
  • sleepiness

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture, and it is best kept at temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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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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.