Medication info
Rostone Tablet 10 mg (Rosuvastatin Calcium)

Rostone Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu x 2)
Approval status
Active

MFDS item code 201400386 · Approved 2014.01.28 · Insurance code 670606760

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The medication can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and if greater LDL cholesterol reduction is needed, it can be adjusted to the maintenance dose. The maintenance dose is typically 10 mg once daily, where most patients are adjusted at this dose. The maintenance dose should be appropriately adjusted 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 individually according to the recommended treatment goals for each patient. Dose adjustments should be made at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • excess LDL cholesterol
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is mainly used to control hypercholesterolemia and hyperlipidemia. It is prescribed as an adjunctive treatment when dietary changes and exercise alone are insufficient for patients with primary hypercholesterolemia or mixed hyperlipidemia. Additionally, it is used together with other treatments to help lower cholesterol levels in patients with homozygous familial hypercholesterolemia. In pediatric patients with hypercholesterolemia exceeding certain criteria, it is used as an adjunct to dietary changes. This medication lowers total cholesterol and LDL-cholesterol levels, delays the progression of atherosclerosis, and contributes to the reduction of cardiovascular disease risk. Thus, it is effectively used for the prevention of hypercholesterolemia and related cardiovascular diseases.

How to take

Adult dose

The medication can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and if greater LDL cholesterol reduction is needed, it can be adjusted to the maintenance dose. The maintenance dose is typically 10 mg once daily, where most patients are adjusted at this dose. The maintenance dose should be appropriately adjusted 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 individually according to the recommended treatment goals for each patient. Dose adjustments should be made at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients with allergies to its components, patients with persistent unknown liver function abnormalities, patients with muscle disorders, patients taking specific immunosuppressants, patients with severe kidney impairment, pregnant or lactating women, and patients at high risk for muscle-related disorders. This medication contains lactose and should not be given to patients with genetic conditions such as lactose intolerance. Patients with a history of liver disease or excessive alcohol intake should undergo liver function tests before taking this medication, and liver function should be regularly monitored during treatment. If symptoms related to myalgia, muscle weakness, or muscle damage occur, the doctor should be notified immediately, and blood tests may be necessary to check for muscle damage. Especially, patients at high risk for muscle damage should be closely monitored before and during treatment. This medication can rarely cause severe skin reactions or liver damage; therefore, if symptoms like skin rash, jaundice, or severe fatigue occur, treatment should be stopped immediately, and the doctor should be consulted. The concentration of this medication in the blood may change when used with other drugs, which can increase the risk of muscle damage; therefore, always consult with a doctor or pharmacist about concomitant medications. Pregnant or lactating women should not use this medication, and women of childbearing potential should use appropriate contraception methods. There is no specific antidote for overdose; therefore, treatment should be symptomatic, and liver and muscle-related tests should be conducted. Caution is needed as dizziness may occur while driving or operating machinery. This medication may present higher blood concentrations in Asians; therefore, dose adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe allergic reactions, severe skin reactions, breathing problems, liver abnormalities (jaundice), severe neurological symptoms, severe discomfort

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • cough
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  • diarrhea
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • abdominal bloating
  • decreased appetite
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • discomfort in the chest

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu x 2)

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.