Medication info
Rosvatran 5mg (Rosuvastatin Calcium)

Rosvatran 5mg (Rosuvastatin Calcium)

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

MFDS item code 201702134 · Approved 2017.04.26 · Insurance code 657307080

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, the maintenance dose can be adjusted to achieve that. The maintenance dose is typically 10 mg once daily, which most patients can manage on this dosage. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum of 20 mg per day.
Children's dosage
The typical dosage range for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 5mg to 20mg, administered once daily. The administration dosage should be individually adjusted based on the recommended treatment goals for each patient.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol level
  • smoking
View approved original text

This medication is used as an adjunct when dietary changes and exercise are not sufficient to control primarily hypercholesterolemia and mixed dyslipidemia patients. It is particularly suitable for patients with primary hypercholesterolemia and familial hypercholesterolemia, lowering LDL-cholesterol levels and delaying the progression of atherosclerosis. It can also be safely used in pediatric and adolescent patients meeting specific criteria for familial hypercholesterolemia. It is recommended as a dietary adjunct for patients with primary dysbetalipoproteinemia. Additionally, it reduces the risk of stroke, myocardial infarction, and arterial revascularization in adult patients with elevated high-sensitivity C-reactive protein levels and risk factors for cardiovascular disease. Therefore, this medication is effectively used for various dyslipidemias and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, the maintenance dose can be adjusted to achieve that. The maintenance dose is typically 10 mg once daily, which most patients can manage on this dosage. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum of 20 mg per day.

Children's dosage

The typical dosage range for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 5mg to 20mg, administered once daily. The administration dosage should be individually adjusted based on the recommended treatment goals for each patient.

Precautions

This medication should not be administered to certain patients. Patients with allergies to the ingredients of this medication, severely impaired liver function, muscle diseases, those taking certain immunosuppressants, patients with severe renal impairment, pregnant or breastfeeding women, and fertile women not using appropriate contraception should not take this medication. Moreover, patients at high risk of muscle-related conditions are prohibited from taking high doses, which includes those with moderate renal impairment, hypothyroidism, a history of hereditary muscle diseases, alcohol dependence, and concomitant use of certain drugs. This medication contains lactose, so it should not be administered to patients with lactose intolerance or related genetic disorders. During treatment with this medication, liver function abnormalities or symptoms like muscle pain and weakness should be carefully monitored, and if any adverse symptoms occur, medical personnel should be informed immediately. Patients with significant alcohol consumption or a history of liver disease should have regular liver function tests, and treatment of underlying conditions is prioritized in cases of hypothyroidism or nephrotic syndrome. This medication may interact with other drugs, so patients should inform healthcare providers of any other medications they are taking, as combining with certain medications may increase the risk of muscle diseases. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant should use appropriate contraception. In case of overdose, there is no specific antidote, so appropriate treatment based on symptoms and liver and muscle enzyme tests is necessary. This medication does not significantly affect driving or operating machinery; however, caution should be taken due to possible symptoms like dizziness. During treatment, rare occurrences of interstitial lung disease, severe skin reactions, and serious liver damage may happen, so immediate discontinuation and consultation with healthcare personnel should be sought if any unusual symptoms occur. Lastly, this medication may show higher blood concentration in Asians, so dosage adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, severe muscle weakness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, fatal and non-fatal liver failure, immune-mediated necrotizing myopathy, edema, acute renal failure, oliguria, severe skin reaction, interstitial lung disease, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
Show 26 more
  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • dysesthesia
  • headache
  • dizziness
  • increased ALT
  • increased CK
  • increased AST
  • thrombocytopenia
  • increased transaminases
  • amnesia
  • peripheral neuropathy
  • cough
  • diarrhea
  • ocular myasthenia
  • lupus-like symptoms

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best stored at a cool room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.