Medication info
Rosuvastatin Calcium 10mg Tablet

Rosuvastatin Calcium 10mg Tablet

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)킴스제약
Appearance
Pink round film-coated tablet
Packaging
28 tablets per box [28 tablets (14 tablets/PTP x 2)]
Approval status
Active

MFDS item code 201901569 · Approved 2019.03.14 · Insurance code 059600290

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Regardless of meals, start with an initial dose of 5 mg once daily. If further LDL cholesterol reduction is needed, the maintenance dose is adjusted, with most patients being controlled at 10 mg once daily. The maintenance dose should be adjusted every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.
Children's dosage
Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia should receive a dose ranging from 5 mg to 20 mg once daily. The dosage should be adjusted based on individual treatment goals with a minimum interval of 4 weeks.

Ingredients

Manufacturer
(주)킴스제약

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • familial hypercholesterolemia
  • mixed hyperlipidemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as an adjunct when diet and exercise do not adequately control primary hypercholesterolemia and mixed hyperlipidemia patients. It also helps lower cholesterol levels in patients with homozygous familial hypercholesterolemia or pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It lowers total cholesterol and LDL-cholesterol levels to goal levels, delaying the progression of atherosclerosis. It can also be used as an adjunct to dietary control in patients with primary dysbetalipoproteinemia. Additionally, it reduces the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 and women over 60 with elevated high-sensitivity C-reactive protein levels and additional cardiovascular disease risk factors. Thus, this medication is used to improve cholesterol levels and reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

Regardless of meals, start with an initial dose of 5 mg once daily. If further LDL cholesterol reduction is needed, the maintenance dose is adjusted, with most patients being controlled at 10 mg once daily. The maintenance dose should be adjusted every 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Children's dosage

Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia should receive a dose ranging from 5 mg to 20 mg once daily. The dosage should be adjusted based on individual treatment goals with a minimum interval of 4 weeks.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to any ingredient of this medication, those with severe liver dysfunction, or those with muscle diseases should not take this medication. Furthermore, individuals with severely impaired renal function, pregnant or nursing women, and fertile women who are not using adequate contraception should also avoid this medication. This medication contains lactose, making it unsuitable for those with lactose intolerance or certain genetic metabolic disorders. This medication may affect liver function, so individuals who consume large amounts of alcohol or have a history of liver disease should have liver function tests before use and exercise caution. Muscle-related side effects like myalgia or myopathy may occur, thus any symptoms such as muscle pain, weakness, or cramps should be reported to a doctor immediately. Precautions are especially necessary for those with compromised renal function, hypothyroidism, a history of muscle diseases, or the elderly. This medication can rarely cause serious skin reactions or liver damage; if any symptoms such as skin rash, jaundice, or severe fatigue occur, the medication should be stopped immediately and medical advice should be sought. This medication may interact with other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Specifically, the risk of muscle side effects may be increased when used in conjunction with certain antivirals, immunosuppressants, antifungals, some antibiotics, or fibrates. Women who are pregnant or planning a pregnancy should not take this medication, and if pregnancy occurs while taking it, it should be stopped immediately. Nursing women are also advised to avoid this medication. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored regularly. Caution should be exercised when driving or operating machinery, as dizziness may occur. This medication can be used in children and adolescents, but limited information is available regarding its effects on growth and secondary sexual characteristics, so it should be used with caution.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, liver failure, hyperbilirubinemia, severe muscle weakness, ocular myasthenia, rhabdomyolysis, acute renal failure, oliguria, severe edema, thrombocytopenia, severe allergic reactions, severe skin adverse reactions, respiratory distress, serious neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal distension
  • abnormal liver function tests
  • fainting
  • body aches
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • increased serum creatinine
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • post-marketing cases

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

Storage

This medication should be kept in a tightly closed container to avoid exposure to air or moisture, and it is best stored at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets per box [28 tablets (14 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.