Medication info
Lobasto Tablet 5 mg (Rosuvastatin Calcium)

Lobasto Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201502973 · Approved 2015.05.18 · Insurance code 647303070

Summary

Main use
Effects for treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk.
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if more reduction of LDL cholesterol is needed, the maintenance dose may be adjusted accordingly. The maintenance dose is 10 mg once daily, and most patients are managed at this dosage. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or longer based on LDL cholesterol levels, therapeutic targets, and patient response, with a maximum dose of 20 mg per day.
Children's dosage
The usual dosage range is 5 mg to 20 mg once daily. The administered dosage should be adjusted individually based on the recommended therapeutic target for each patient. Dosage should be adjusted at intervals of 4 weeks or longer.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Effects for treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is effectively used for hypercholesterolemia, a condition characterized by high cholesterol levels in the blood. It helps in cases where cholesterol control is difficult due to genetic factors, such as familial hypercholesterolemia. It is also recommended for patients with mixed hyperlipidemia who cannot manage their condition with diet and exercise alone, and it lowers total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. It is used as an adjunct to dietary therapy in children aged 10 to 17 years who meet specific criteria. Additionally, it helps reduce the risk of stroke and myocardial infarction in patients with dysbetalipoproteinemia and those at high risk for cardiovascular disease. In summary, this medication is used for various forms of hypercholesterolemia and to reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if more reduction of LDL cholesterol is needed, the maintenance dose may be adjusted accordingly. The maintenance dose is 10 mg once daily, and most patients are managed at this dosage. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or longer based on LDL cholesterol levels, therapeutic targets, and patient response, with a maximum dose of 20 mg per day.

Children's dosage

The usual dosage range is 5 mg to 20 mg once daily. The administered dosage should be adjusted individually based on the recommended therapeutic target for each patient. Dosage should be adjusted at intervals of 4 weeks or longer.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this drug, those with liver function problems, or those with muscle disorders should avoid taking it. Additionally, it is not safe to administer to patients with severely impaired kidney function, pregnant or nursing women, and women of childbearing age who do not use appropriate contraception. Individuals at higher risk of muscle-related side effects, such as those with slightly impaired kidney function, hypothyroidism, family history of muscle disorders, alcohol abuse, Asian descent, and those taking certain other medications, should avoid taking this drug in high doses and should exercise caution during use. This medication contains lactose and should not be used by patients with lactose intolerance or genetic lactose metabolism disorders. Patients who consume a lot of alcohol or have a history of liver disease should have liver function tests before taking this medication and should monitor their liver status regularly during treatment. If symptoms such as muscle pain, weakness, or cramps occur, notify healthcare professionals immediately, and blood tests may be necessary to check for muscle damage. Particularly, if muscle damage markers are elevated or if muscle symptoms are severe, it is advisable to discontinue the medication and consult a physician. This drug may raise blood sugar levels in some patients, so those at a risk for diabetes should regularly monitor their blood glucose levels. Additionally, rare side effects such as skin rashes, itching, severe allergic reactions, liver function abnormalities, and myopathy may occur during use, and if these symptoms appear, patients should inform their healthcare provider promptly. This medication can interact with many other drugs, so it is crucial to inform the doctor or pharmacist if taking other medications. Women who are pregnant or planning to become pregnant should not take this medication, and if pregnancy occurs while using it, treatment should be immediately discontinued. In the case of overdose, since there is no specific antidote, patients should go to the hospital immediately for appropriate treatment and assessment of liver function and muscle damage. Finally, this medication is known to have little effect on driving or operating machinery, but caution is advised due to the possibility of dizziness.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions including urticaria and angioedema
  • Pancreatitis
  • Myopathy, rhabdomyolysis
  • Severe allergic reactions
  • Severe skin adverse reactions (Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms)
  • Respiratory distress accompanied by cough and fever
  • Liver abnormalities (jaundice, hepatitis)
  • Serious neurological symptoms (memory loss, peripheral neuropathy, polyneuropathy, severe muscle weakness)
  • Severe edema or urinary issues.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • cough
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  • diarrhea
  • hematuria
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • paresthesia.

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is essential to maintain the storage temperature between 1 to 30 degrees Celsius to keep the medication effective for an extended period.

Appearance and packaging

Appearance

Yellow 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.

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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.