Medication info
Rosutinem Tablet 5mg (Rosuvastatin Calcium)

Rosutinem Tablet 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
Yellow round film-coated tablet
Packaging
100 tablets/box [(10 tablets/Alu-Alu) x 10], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906242 · Approved 2019.09.03 · Insurance code 622804040

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and dyslipidemia, and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
The initial dose is 5 milligrams once daily, and if more reduction in LDL cholesterol is required, the maintenance dose can be adjusted accordingly. The maintenance dose is usually 10 milligrams once daily, and most patients are adjusted at this dose. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum of 20 milligrams per day.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary Dysbetalipoproteinemia
  • coronary heart disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medication is used as an adjunct when dietary modification and exercise alone are insufficient to control primary hypercholesterolemia and mixed dyslipidemia. It can also be used in combination with dietary therapy or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. This drug helps reduce total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thus slowing the progression of atherosclerosis. It is also used as an adjunctive treatment in patients with primary Dysbetalipoproteinemia and has been shown to reduce the risks of stroke, myocardial infarction, and restenosis in middle-aged patients at high risk for cardiovascular disease. Thus, this medication is effectively used for various types of dyslipidemia and the reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

The initial dose is 5 milligrams once daily, and if more reduction in LDL cholesterol is required, the maintenance dose can be adjusted accordingly. The maintenance dose is usually 10 milligrams once daily, and most patients are adjusted at this dose. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum of 20 milligrams per day.

Precautions

This medication may not be suitable for certain patients. Firstly, those allergic to any components of this medication should not take it. Secondly, patients with severely impaired liver function or active liver disease should avoid this medication. Thirdly, patients with muscle diseases or issues related to muscles should also avoid this medication. Fourthly, patients taking the immunosuppressant cyclosporine should not use this medication. Fifthly, patients with significantly impaired kidney function are prohibited from taking this medication. Sixthly, women who are pregnant or breastfeeding should avoid this medication, and fertile women should use appropriate contraception. Seventhly, high-dose (40mg) administration is prohibited in patients at risk of myopathy. Eighthly, patients with lactose intolerance or genetic lactose metabolism disorders should not take this medication. Caution is advised when taking this medication. Individuals with poor liver function or those who consume alcohol heavily should undergo regular liver function tests both before and during treatment. If symptoms like muscle pain, muscle weakness, or cramps occur, patients should notify their doctor immediately, as muscle enzyme level tests may be required. The medication may need to be discontinued in cases of acute severe illness. Additionally, this medication can rarely cause severe muscle weakness or ocular muscle weakness, and if these symptoms occur, it should be discontinued immediately. This medication may interact with other drugs, thus it is mandatory to consult a doctor or pharmacist if you are taking other medications. Particularly, caution is needed when used with certain antiviral drugs, immunosuppressants, antifungals, antibiotics, and fibrate medications. If taken with oral contraceptives, it could affect contraceptive efficacy, so consultation with a physician is recommended. It is safest to avoid this medication during pregnancy or breastfeeding. Women who may become pregnant must use effective contraception while taking this medication. In case of overdose, since there is no specific antidote, immediate medical attention is necessary, as well as checks on liver function and muscle enzyme levels. Dizziness may occur while taking this medication, so caution is needed when driving or operating machinery. Lastly, this medication can rarely cause serious skin reactions; therefore, if symptoms like skin rash, itching, or swelling occur, use should be stopped immediately and medical attention sought.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, hives, severe muscle weakness, rhabdomyolysis, severe skin adverse reactions (Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms), jaundice, hepatitis, acute renal failure, thrombocytopenia, severe swelling, dyspnea, cough, ocular muscle weakness, severe allergic reactions, severe liver damage and hyperbilirubinemia, hepatic failure, immune-mediated necrotizing myopathy, multifocal

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • muscle pain
  • weakness
  • thrombocytopenia
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  • diarrhea
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion
  • hematuria

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

Storage

This medication should be stored in a tightly sealed container away from air and moisture, ideally at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

100 tablets/box [(10 tablets/Alu-Alu) 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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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.