Medication info
Rovitane Tablet 5 mg (Rosuvastatin Calcium)

Rovitane Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
삼일제약(주)
Appearance
Yellow, round film-coated tablets
Packaging
14 tablets/blister X 2
Approval status
Active

MFDS item code 201001007 · Approved 2010.01.28 · Insurance code 643902800

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer 5 mg once daily at any time of the day, regardless of meals. If a greater reduction in LDL cholesterol is needed, maintain a dose of 10 mg once daily, and can be increased up to a maximum of 20 mg daily based on the patient's response at intervals of 4 weeks or more.
Child dose
For pediatric patients aged 10 to 17 years, administer 5 mg to 20 mg once daily, adjusting the dosage individually according to treatment goals with an interval of at least 4 weeks. For patients under 10 years

Ingredients

Manufacturer
삼일제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • excess LDL cholesterol
  • excess total cholesterol
  • high Apo-B protein levels
  • primary dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • hypertension
View approved original text

This medication is used as an adjunct when dietary management and exercise are not enough to control primary hypercholesterolemia and mixed dyslipidemia patients. It is also used in conjunction with dietary restrictions or LDL apheresis in patients with homozygous familial hypercholesterolemia. This medication helps lower total cholesterol and LDL cholesterol levels in hypercholesterolemia patients and delays the progression of atherosclerosis. It is also administered as an adjunct to diet for pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. This medication also acts as an adjunct to diet in patients with primary dysbetalipoproteinemia, reducing cardiovascular disease risk, as well as the risk of stroke, myocardial infarction, and recurrence after arterial revascularization. This medication improves blood cholesterol and cardiovascular disease risk factors, thereby enhancing patient health.

How to take

Adult dose

Administer 5 mg once daily at any time of the day, regardless of meals. If a greater reduction in LDL cholesterol is needed, maintain a dose of 10 mg once daily, and can be increased up to a maximum of 20 mg daily based on the patient's response at intervals of 4 weeks or more.

Child dose

For pediatric patients aged 10 to 17 years, administer 5 mg to 20 mg once daily, adjusting the dosage individually according to treatment goals with an interval of at least 4 weeks. For patients under 10 years

Precautions

This medication should not be used in certain patients. For example, patients with an allergy to the ingredients of this medication, severely impaired liver function, muscle disorders, severe kidney dysfunction, and women who are pregnant or breastfeeding should not take this medication. Additionally, this medication should be used cautiously in patients at high risk for muscle disorders or those taking certain medications. Because this medication can affect liver function, patients with a history of liver disease or excessive alcohol consumption should undergo liver function tests before taking it and periodically during treatment. If symptoms such as muscle pain or weakness occur, medical personnel should be informed immediately, and blood tests should be conducted to check for muscle damage. If muscle damage is severe, medication may need to be discontinued. This medication may elevate blood sugar levels in some people; therefore, patients at risk for diabetes should monitor their blood sugar levels periodically. Additionally, the response to this medication and its side effects can vary based on genetic factors, so dosage adjustments may be necessary in consultation with medical personnel. Serious skin reactions may occur during treatment; if skin rashes, swelling, or severe itching develop, medication should be discontinued immediately, and medical personnel should be consulted. This medication may interact with other drugs; if other medications are being taken, it is essential to inform medical personnel. Caution is needed when used with medications that affect liver function or increase the risk of muscle damage. Women of childbearing potential should use appropriate contraception to avoid becoming pregnant while taking this medication, and should discontinue use immediately if pregnancy occurs. Nursing women should also avoid taking this medication. In case of overdose, since there is no specific antidote, it is important to receive symptomatic treatment and conduct liver function and muscle-related tests. This medication is known not to significantly affect the ability to drive or operate machinery, but caution is advised due to potential dizziness. Finally, this medication may show higher concentrations in Asian individuals, requiring dosage adjustments.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), tightness in the chest, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular myasthenia, thrombocytopenia, acute renal failure, oliguria, fatal and non-fatal liver failure, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), severe neurological issues

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • increased ALT
  • increased CK
  • increased AST
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • syncope
  • 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 should be stored in a tightly closed container to protect it from air and moisture, and it should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way ensures the effectiveness of the medication is maintained safely.

Appearance and packaging

Appearance

Yellow, round film-coated tablets

Package unit

14 tablets/blister 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.

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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.