Medication info
Lobetin Tablet 10mg (Rosuvastatin Calcium)

Lobetin Tablet 10mg (Rosuvastatin Calcium)

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

MFDS item code 201310589 · Approved 2013.12.09 · Insurance code 642904970

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken any time of the day, regardless of meals. The initial dose is 5 mg once daily; for those needing more significant reductions in LDL-cholesterol levels, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, which most patients are regulated at. The maintenance dosage should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.
Child dose
The usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to individual treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used as an adjunct to diet when dietary and exercise alone are inadequate to control elevated cholesterol levels, such as primary hypercholesterolemia and mixed hyperlipidemia. It is also helpful in patients with homozygous familial hypercholesterolemia when used in conjunction with diet or other lipid-lowering therapies. This drug is effective in lowering total cholesterol and LDL-cholesterol levels, helping to delay the progression of atherosclerosis. It is also used in some pediatric patients aged 10 to 17 years to reduce LDL-cholesterol levels. It can also be used as an adjunct to diet for patients with primary dysbetalipoproteinemia. Additionally, it helps to lower the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged or older patients with cardiovascular risk factors. Overall, it is used to control cholesterol levels and enhance cardiovascular health.

How to take

Adult dose

This medication can be taken any time of the day, regardless of meals. The initial dose is 5 mg once daily; for those needing more significant reductions in LDL-cholesterol levels, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, which most patients are regulated at. The maintenance dosage should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to individual treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to this drug, severely impaired liver function, muscle disorders, or those taking certain immunosuppressants. Women who are pregnant or breastfeeding should not take this medication and women of childbearing age should use appropriate contraception. Additionally, since this medication can cause muscle-related side effects, any symptoms of muscle pain or weakness should be reported to healthcare professionals immediately. Special caution is needed in patients with poor renal function, low thyroid function, the elderly, and those who consume excessive alcohol. Patients on this medication should have regular liver function tests, and should discontinue use if symptoms of liver damage appear. This medication can interact with various medications, so patients taking other medications should inform their healthcare providers, especially when taking certain antivirals, immunosuppressants, or fibrate-class medications. In case of an overdose, as there is no specific antidote, treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Caution should be exercised while driving or operating machinery as dizziness may occur. Finally, this medication may show higher blood concentrations in Asians, thus dosage adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, pancreatitis, myopathy, rhabdomyolysis, polyneuropathy, memory loss, peripheral neuropathy, severe muscle weakness, dyspnea, ophthalmoplegia, thrombocytopenia, jaundice, hepatitis, increased transaminases, Stevens-Johnson syndrome, eosinophilia, and drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, edema, acute renal failure, oliguria, blood dyscrasia

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • chest discomfort
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  • loss of appetite
  • abdominal bloating
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • altered sensation
  • fainting
  • body aches
  • joint pain
  • hematuria

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 exposure to air or moisture, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer duration.

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.