Medication info
Rosuvastatin Calcium Tablets 5mg

Rosuvastatin Calcium Tablets 5mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
Yellow round film-coated tablets
Packaging
28 tablets/Alu-Alu, 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201803162 · Approved 2018.07.31 · Insurance code 628901100

Summary

Main use
Treatment of hypercholesterolemia and familial hypercholesterolemia (reduction of cardiovascular disease risk)
Who uses it
Adults · Children
Adult dosage
This drug can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is usually 10 mg once daily, which most patients are adjusted to. The maintenance dose may be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient responses after 4 weeks or longer, and can be increased to a maximum of 20 mg per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to individual treatment goals.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Treatment of hypercholesterolemia and familial hypercholesterolemia (reduction of cardiovascular disease risk)

  • Hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
  • risk of arterial revascularization
View approved original text

This medication is used as an adjunct therapy when diet and exercise are insufficient to control primary hypercholesterolemia and mixed hyperlipidemia in patients. It is also used as an adjunct to diet and other treatments in patients with homozygous familial hypercholesterolemia to lower cholesterol levels. In patients with hypercholesterolemia, it effectively lowers total cholesterol and LDL cholesterol to desired levels, slowing the progression of atherosclerosis. Additionally, in pediatric patients aged 10 to 17 years who meet specific criteria, it is used as an adjunct to diet to lower cholesterol levels in cases of heterozygous familial hypercholesterolemia. It can also be used as adjunctive therapy in patients with primary dysbetalipoproteinemia. Finally, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 years and women over 60 years with certain cardiovascular risk factors. Overall, this medication is used to control cholesterol levels and improve cardiovascular health.

Dosage and Administration

Adult dosage

This drug can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is usually 10 mg once daily, which most patients are adjusted to. The maintenance dose may be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient responses after 4 weeks or longer, and can be increased to a maximum of 20 mg per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to individual treatment goals.

Precautions

This drug should not be used in certain patients. It is contraindicated in patients with an allergy to the ingredients of this drug, persistent unexplained liver dysfunction, muscle diseases, patients taking certain medications, patients with severe renal impairment, pregnant or breastfeeding women, and women of childbearing age not using appropriate contraception. Additionally, high-dose use of this drug is prohibited in patients at high risk for muscle diseases. Patients with genetic lactose intolerance should also avoid taking this drug. This medication should be used cautiously in patients with impaired liver function or those consuming alcohol excessively, and it is recommended to repeat liver function tests before and during treatment. Muscle pain, myopathy, and, rarely, a severe muscle degradation condition called rhabdomyolysis may occur; any symptoms related to muscles should be immediately reported to a healthcare provider. If there is a significant increase in muscle enzyme levels, the medication should be discontinued, and it may be restarted after the symptoms improve based on the doctor's judgment. In cases of acute renal failure or severity, the administration of this drug should be stopped, and if severe muscle weakness symptoms arise, it should be stopped immediately. Caution should be exercised as this medication may increase plasma concentrations when combined with certain drugs, leading to a higher risk of muscle disease; consult with healthcare providers regarding concomitant medications. This medication should not be taken during pregnancy or breastfeeding, and women who may become pregnant should use appropriate contraceptive methods. There is no specific antidote for overdose, so treatment based on symptoms and monitoring of liver function and muscle enzyme levels is necessary. This medication does not significantly affect driving or machine operation, but caution is advised as dizziness may occur. Lastly, if any unusual symptoms appear, such as liver dysfunction, muscle pain, or skin rashes while taking this medication, inform healthcare providers immediately.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, jaundice, hepatitis, severe muscle weakness, ocular myasthenia, acute renal failure, oliguria, chest tightness, difficulty breathing, dyspnea, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • thrombocytopenia
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  • memory loss
  • peripheral neuropathy
  • cough
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature. Proper storage will help prolong the medication's effectiveness.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets/Alu-Alu, 30 tablets/bottle, 300 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.