Medication info
Rosutinem Tablet 20mg (Rosuvastatin Calcium)

Rosutinem Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
Pink round film-coated tablet
Packaging
100 tablets/box [(10 tablets/PTP) X 10], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201904801 · Approved 2019.07.18 · Insurance code 622803640

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
This medication may be taken once daily at any time of day, with or without food. The initial dose is 5 milligrams once daily, followed by a maintenance dose of 10 milligrams once daily. The maintenance dose should be adjusted based on LDL-cholesterol levels and patient response, with intervals of 4 weeks or more, and can be increased up to a maximum of 20 milligrams per day.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • early family history of coronary artery disease
  • risk of stroke
  • risk of myocardial infarction
  • risk of arterial revascularization
View approved original text

This medication is used as an adjunct when dietary measures and exercise have not been sufficient in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct therapy in patients with homozygous familial hypercholesterolemia. It lowers total cholesterol and LDL-cholesterol in hypercholesterolemic patients, effectively delaying the progression of atherosclerosis. Additionally, it is used as an adjunct to diet in patients with primary dysbetalipoproteinemia. This medication helps reduce the risk of cardiovascular diseases, supporting a decrease in the risk of stroke, myocardial infarction, and post-arterial revascularization. Therefore, it is effectively used for the prevention of hypercholesterolemia and related cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication may be taken once daily at any time of day, with or without food. The initial dose is 5 milligrams once daily, followed by a maintenance dose of 10 milligrams once daily. The maintenance dose should be adjusted based on LDL-cholesterol levels and patient response, with intervals of 4 weeks or more, and can be increased up to a maximum of 20 milligrams per day.

Precautions

This medication should not be used in certain patients. For example, those with allergies to any of its ingredients, severe liver impairment, muscle diseases, and women who are pregnant or breastfeeding should not take this medication. Additionally, individuals with severe kidney impairment or those taking certain immunosuppressants should be cautious. Since this medication can affect liver function, individuals with a history of heavy alcohol use or liver disease should undergo liver tests before taking it and check their liver condition regularly during treatment. It is advisable to use this medication after treating underlying conditions, such as hypothyroidism or nephrotic syndrome. Muscle pain or weakness may occur, and rarely, severe muscle damage may result, so any unusual muscle symptoms should be reported to a doctor immediately. Special caution is necessary for the elderly, individuals with reduced kidney function, those who consume excessive alcohol, and those with a family history of muscle disease. This medication contains lactose, so individuals with lactose intolerance should avoid taking it. Furthermore, this medication can interact with many other drugs, so it is essential to inform healthcare providers about any medications currently being taken. In particular, taking it with certain antiviral agents, immunosuppressants, antifungals, antibiotics, and lipid-lowering drugs may increase the risk of muscle damage. Women who are pregnant or may become pregnant should practice appropriate contraception when taking this medication due to potential risks to the fetus, and they should stop taking it immediately if pregnancy is confirmed. It is also advised that lactating women do not take this medication. In the case of an overdose, there are no specific antidotes, so treatment should be symptomatic, and liver and muscle conditions should be monitored regularly. Caution is advised while driving or operating machinery as dizziness may occur. Lastly, this medication can rarely cause severe skin reactions, liver damage, or kidney problems, so if any unusual symptoms occur, medical advice should be sought immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, thrombocytopenia, severe renal failure, elevated transaminases, jaundice, severe rash, blisters, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, eosinophilia with systemic symptoms associated with drug reaction syndrome (DRESS), immune-mediated necrotizing myopathy, myopathy, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, acute renal failure,

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • myalgia
  • muscle cramps
  • gout
  • erectile dysfunction
  • headache
  • dizziness
  • increased ALT
  • increased CK
  • increased AST
  • increased serum creatinine
  • paresthesia
  • erectile dysfunction
  • sleep disturbances
  • depression

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

Storage

Store this medication in a tightly closed container to prevent exposure to air or moisture. Store the medicine at room temperature, between 1°C and 30°C, away from extreme heat or cold.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP) X 10], 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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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.