Medication info
J-Bastat 10 mg (Rosuvastatin Calcium)

J-Bastat 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/box [(10 tablets/Alu-Alu X 3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707148 · Approved 2017.09.19

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Can be taken at any time during the day, regardless of meals. The starting dose is 5 mg once daily and can be adjusted to the maintenance dose as required. The maintenance dose is 10 mg once daily, and after evaluation at intervals of at least 4 weeks, can be increased to a maximum of 20 mg per day.
Children's dosage
For pediatric patients aged 10 to 17, the dose is 5 to 20 mg once daily. The dosage should be individually adjusted based on treatment goals and can be modified at intervals of at least 4 weeks. Safety and efficacy in children under 10 years of age have not been established.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • familial type of heterozygous hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medicine is primarily used as an adjunct when dietary modifications and exercise alone do not adequately control cholesterol levels in patients with hypercholesterolemia and hyperlipidemia. It particularly lowers blood cholesterol levels in patients with familial hypercholesterolemia or type III hyperlipoproteinemia, delaying the progression of atherosclerosis. It also aids in dietary therapy for pediatric patients aged 10 to 17 who meet specific criteria for heterozygous familial hypercholesterolemia. Additionally, this medication is utilized to reduce the risk of cardiovascular events such as stroke and myocardial infarction in certain high-risk groups. Overall, it effectively improves blood cholesterol levels and associated risk factors.

Dosage and Administration

Adult dosage

Can be taken at any time during the day, regardless of meals. The starting dose is 5 mg once daily and can be adjusted to the maintenance dose as required. The maintenance dose is 10 mg once daily, and after evaluation at intervals of at least 4 weeks, can be increased to a maximum of 20 mg per day.

Children's dosage

For pediatric patients aged 10 to 17, the dose is 5 to 20 mg once daily. The dosage should be individually adjusted based on treatment goals and can be modified at intervals of at least 4 weeks. Safety and efficacy in children under 10 years of age have not been established.

Precautions

This medication should not be administered to certain patients. For example, individuals who are allergic to this medication, have severe liver dysfunction, have muscle disorders, or are pregnant or breastfeeding should not take this medication. Furthermore, this medication may affect liver function; therefore, patients with a history of liver disease must undergo regular liver function tests before and during treatment. Symptoms such as muscle pain or weakness may appear, so it is essential to inform the physician immediately if these symptoms occur. Particularly, if muscle problems worsen, discontinuation of the medication may be necessary. This medication should be used with caution in patients who excessively consume alcohol or have hypothyroidism. In addition, the risk of muscle toxicity may increase when used in combination with other specific medications, so patients must inform their doctor or pharmacist of any other medications they are taking. This medication contains lactose, so it is advisable for patients with lactose intolerance not to take it. Women who can become pregnant should ensure adequate contraception while taking this medication and must stop taking it immediately if they become pregnant. There is no specific antidote for overdose; therefore, treatment according to symptoms and liver function and muscle enzyme testing may be necessary. Dizziness may occur while driving or operating machinery, so caution is needed. This medication can rarely cause severe skin reactions or liver damage; hence, if a rash, jaundice, or severe fatigue occurs, it is critical to consult healthcare professionals immediately. Lastly, this medication may also be used in children and adolescents, but monitoring for impacts on growth and development is necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ophthalmoplegia, jaundice, hepatitis, acute kidney failure, oliguria, thrombocytopenia, increased creatinine levels, severe allergic reactions, severe skin reactions, dyspnea, severe edema or urinary issues

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
Show 17 more
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal bloating
  • abnormal liver function test
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria

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 is best kept at room temperature between 1 and 30 degrees Celsius. By storing it this way, the medication's efficacy and safety can be maintained for an extended period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [(10 tablets/Alu-Alu X 3)], 30 tablets/bottle, 100 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.