Medication info
Rosugrine 20 mg (Rosuvastatin Calcium)

Rosugrine 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)시어스제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets (15 tablets/PTP x 2)
Approval status
Active

MFDS item code 201903039 · Approved 2019.05.10 · Insurance code 689000760

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time during the day, irrespective of meals. The initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily, which most patients will adjust to. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, with increments up to a maximum of 20 mg per day after intervals of 4 weeks or more.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage can be administered once daily in the range of 5 mg to 20 mg. The administered dosage should be adjusted based on individual treatment goals.

Ingredients

Manufacturer
(주)시어스제약

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • hyperlipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • cardiovascular disease risk
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunctive therapy when diet and exercise alone are insufficient to manage patients with hyperlipidemia such as primary hypercholesterolemia or mixed hyperlipidemia. It also helps in the treatment of patients with homozygous familial hypercholesterolemia and primary dysbetalipoproteinemia. Notably, it effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It is also used as an adjunct to dietary therapy in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, and it reduces the risk of stroke, myocardial infarction, and vascular reconstructions in adults at high risk for cardiovascular diseases. Overall, this medication is effectively used for the treatment of various types of dyslipidemia associated with hyperlipidemia and the reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time during the day, irrespective of meals. The initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily, which most patients will adjust to. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, with increments up to a maximum of 20 mg per day after intervals of 4 weeks or more.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage can be administered once daily in the range of 5 mg to 20 mg. The administered dosage should be adjusted based on individual treatment goals.

Precautions

This medication should not be used in patients with allergies to certain components. It should also not be administered to patients with active liver disease or severe liver function abnormalities. It may pose risks to patients with muscular diseases or myopathy. Patients taking cyclosporine and those with severe renal failure should not use this medication. Pregnant or breastfeeding women, as well as fertile women who are not using appropriate contraception, should avoid using it. Women of childbearing age should only use it after explaining the low likelihood of pregnancy and the potential risks to the fetus. Dosages greater than 40 mg are contraindicated in patients at high risk of myopathy. This medication includes lactose, so it should not be administered to patients with certain genetic disorders such as lactose intolerance. Patients with a history of liver disease or excessive alcohol intake should undergo regular liver function tests. If symptoms of muscle pain or weakness occur, the patient should immediately inform their doctor and undergo evaluation, and in severe cases, the medication should be discontinued. In acute severe conditions, the use of this medication should be halted, and should myasthenia gravis develop, the administration should cease. Caution is advised as concomitant use with specific other medications may increase the risk of muscle-related side effects. Renal function tests may be necessary when taking high doses. Asian patients may exhibit increased drug concentration, necessitating dosage adjustment. This medication can be used in children and adolescents; however, evaluations concerning growth and sexual maturation are limited. Severe skin reactions may occur, so medical attention should be sought immediately if skin changes are observed. Due to numerous medications interacting with this drug, patients must consult their doctor or pharmacist about any concomitant medications. It should not be used during pregnancy or breastfeeding, and women planning a pregnancy should ensure adequate contraception. In case of overdose, there are no specific antidotes; treatment according to symptoms and tests for liver and muscle function are required. This medication does not significantly affect driving or the operation of machinery, but caution is necessary due to the possibility of dizziness.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including hives, angioedema, severe allergic reactions, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions, dyspnea, difficulty breathing, asthma attacks, respiratory issues, jaundice (yellowing of skin or eyes), hepatitis, liver abnormalities (jaundice), acute renal failure, severe edema with elevated blood pressure (swelling), urinary disturbances, sudden

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • fatigue
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  • numbness
  • paresthesia
  • chest discomfort
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hematuria
  • thrombocytopenia
  • forgetfulness
  • peripheral neuropathy
  • cough
  • sexual dysfunction
  • gynecomastia
  • depression
  • sleep disturbance

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

Storage

This medication should be stored in a tightly closed container to protect it from exposure to air and moisture, and it is safe to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP 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.