Medication info

New Shubatine 20mg (Rosuvastatin Calcium)

Prescription medicationExpired
Ingredient · strength
Rosuvastatin Calcium›Strength being verified
Manufacturer / importer
안국뉴팜(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/Alu-Alu x 3)
Approval status
Expired

MFDS item code 201802675 · Approved 2018.06.27

This product's status changed to Expired on 2023.06.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For patients with primary hypercholesterolemia, combined hyperlipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, it can be administered at any time of day without regard to meals. The initial dose is 5 mg once daily and can be adjusted to a maintenance dose as needed. The maintenance dose is 10 mg once daily, and LDL-cholesterol levels and treatment goals should be assessed at intervals of 4 weeks or more.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The dose may be adjusted according to the treatment goals for each individual patient over intervals of 4 weeks or longer.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

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

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

This medicine is used as an adjunct in cases of primary hypercholesterolemia, heterozygous familial hypercholesterolemia, and combined hyperlipidemia where diet and exercise alone are insufficient to control levels. It is also used in combination with other treatments for patients with homozygous familial hypercholesterolemia to enhance effectiveness. It lowers total cholesterol and LDL cholesterol levels, slows the progression of atherosclerosis, and helps improve hypercholesterolemic conditions in some pediatric patients. It is also used as an adjunct to dietary measures for patients with primary dysbetalipoproteinemia. Furthermore, it contributes to a decrease in the risk of stroke, myocardial infarction, and arterial revascularization procedures in patients at high risk for cardiovascular disease. This medicine effectively improves hyperlipidemia and the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

For patients with primary hypercholesterolemia, combined hyperlipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, it can be administered at any time of day without regard to meals. The initial dose is 5 mg once daily and can be adjusted to a maintenance dose as needed. The maintenance dose is 10 mg once daily, and LDL-cholesterol levels and treatment goals should be assessed at intervals of 4 weeks or more.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The dose may be adjusted according to the treatment goals for each individual patient over intervals of 4 weeks or longer.

Precautions

This medication should not be used in certain patients. For example, individuals allergic to any components of this drug, those with severe liver dysfunction, individuals with muscle disorders, and women who are pregnant or breastfeeding should not take this drug. This medication can affect liver health; thus, individuals with a history of liver disease or those who consume alcohol excessively should undergo regular liver function tests before and during treatment. Patients with specific conditions such as hypothyroidism or nephrotic syndrome should treat those conditions prior to taking this medication. Muscle-related symptoms may occur, so if symptoms such as myalgia, muscle weakness, or cramps arise, immediate consultation with a doctor is necessary. Caution is especially required in the elderly, those with impaired kidney function, or individuals who abuse alcohol, as they have a higher risk of muscle adverse reactions. This medication can interact with other drugs, increasing blood concentration and the risk of side effects; therefore, it is essential to consult a doctor or pharmacist when taking other medications, especially certain antivirals, immunosuppressants, antifungals, some antibiotics, and fibrate-class medications. Women of childbearing age should use appropriate contraception while taking this drug, and if pregnancy occurs, they must stop taking it immediately. Additionally, this medication may be excreted in breast milk, so it's advisable not to use it while breastfeeding. In the case of overdose, there is no specific antidote; hence, treatment according to symptoms and tests for liver and muscle function may be required. Finally, dizziness may occur during the usage of this drug, so caution should be exercised when driving or operating machinery. It is important to consult medical personnel immediately if abnormal reactions occur during the use of this drug.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, severe swelling, tightness in the chest, difficulty breathing, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, Stevens-Johnson syndrome, dyspnea, jaundice, hepatitis, severe liver damage, fatal and non-fatal liver failure, sudden and severe headache, lightning headache, seizures, confusion, vision disturbances, paralysis, myopathy, rhabdomyolysis, severe edema

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, hematuria, cough, diarrhea, thrombocytopenia, increase in transaminases, eosinophilia, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), lupus-like syndrome, arthralgia, fatigue, numbness, paresthesia, chest discomfort, anorexia, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disturbances, sexual dysfunction,

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering and kept in a cool place below 30 degrees Celsius. Proper storage can help maintain effectiveness over time and prevent deterioration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu x 3)

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.