Medication info
Rostin Tablet 10mg (Rosuvastatin Calcium)

Rostin Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets / bottle, 300 tablets / bottle
Approval status
Active

MFDS item code 201000967 · Approved 2010.01.28 · Insurance code 654003750

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For the treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia), mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, this medication can be taken at any time of the day, with or without food. The initial dose is 5mg once daily, which can be adjusted to a maintenance dose of up to 10mg once daily as needed for further LDL cholesterol reduction. The maintenance dose should be adjusted periodically every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, up to a maximum of 20mg per day.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose between 5mg to 20mg once daily. Doses should be individually adjusted according to therapeutic goals with intervals of 4 weeks or more.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dysbetalipoproteinemia
  • increase in 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 therapy for patients with primary hypercholesterolemia and mixed dyslipidemia when dietary changes and exercise are insufficient. It is also beneficial for patients with homozygous familial hypercholesterolemia in conjunction with diet or other lipid-lowering therapies. It effectively controls total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients with heterozygous familial hypercholesterolemia. It assists in the treatment of primary dysbetalipoproteinemia and helps reduce the risk of cardiovascular disease. In particular, it improves health by lowering the risk of stroke, myocardial infarction, and arterial revascularization procedures.

How to take

Adult dose

For the treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia), mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, this medication can be taken at any time of the day, with or without food. The initial dose is 5mg once daily, which can be adjusted to a maintenance dose of up to 10mg once daily as needed for further LDL cholesterol reduction. The maintenance dose should be adjusted periodically every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, up to a maximum of 20mg per day.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose between 5mg to 20mg once daily. Doses should be individually adjusted according to therapeutic goals with intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, individuals allergic to any component of this medication, those with active liver disease, muscle disorders, or severe renal impairment should avoid taking it. Women who are pregnant, nursing, or who may become pregnant should not take this medication unless appropriate contraception is used, as there may be risks to the fetus. Those prone to myopathy or rhabdomyolysis should avoid high doses, including individuals with renal impairment, hypothyroidism, or family history. Periodic liver function tests are required before and during treatment with this medication, especially for individuals with a history of liver disease or excessive alcohol consumption. If symptoms such as muscle pain, weakness, or cramps occur, the patient should inform a physician immediately and seek testing. If severe muscle damage is suspected, the medication should be discontinued. This medication may interact with other drugs, so patients should inform healthcare providers of any other medications they are taking. Special caution is required when used with certain antivirals, immunosuppressants, or fibrate class drugs. The use of this medication during pregnancy or breastfeeding is not recommended, and women planning pregnancy should consult with a healthcare provider before use. In case of overdose, as there is no specific antidote, immediate medical attention should be sought for appropriate treatment, and monitoring of liver function and muscle enzyme levels is necessary. Care should be taken while driving or operating machinery as dizziness may occur. Finally, it is important to consult with healthcare providers if there are changes in physical condition or abnormal symptoms while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, liver failure, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), severe muscle weakness, ocular myasthenia, rhabdomyolysis, immune-mediated necrotizing myopathy, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • chest discomfort
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  • sweating
  • pallor
  • thrombocytopenia
  • hematuria
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • joint pain
  • amnesia
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia

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

Storage

This medication should be stored in a tightly closed container to keep out air and moisture and should be kept at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets / bottle, 300 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.