Medication info
Shubastatin Tablets 10 mg (Rosuvastatin Calcium)

Shubastatin Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201603663 · Approved 2016.06.21 · Insurance code 661904690

Summary

Main use
Treatment for hypercholesterolemia and reduced risk of cardiovascular disease
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if lower levels of LDL cholesterol reduction are needed, the maintenance dose can be adjusted. The maintenance dose is 10 mg once daily, and most patients will be managed on this dose. The maintenance dose should be adjusted appropriately every 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosing will be adjusted according to the recommended treatment goals for individual patients.

Ingredients

Manufacturer
영풍제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduced risk of cardiovascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • familial type of 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 medication is used as an adjunct to diet for patients with primary hypercholesterolemia and mixed dyslipidemia who are not able to control cholesterol levels through diet and exercise alone. It may also be prescribed in conjunction with diet or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels to the target range in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It is also used as an adjunct to diet to lower cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, who meet specific criteria. For patients with primary dysbetalipoproteinemia, it is also used as an adjunct to diet, and in adult patients at high risk for cardiovascular disease, it contributes to the reduction of risks for stroke, myocardial infarction, and arterial revascularization. Thus, this medication is an important treatment for managing cholesterol levels and preventing cardiovascular diseases in patients with various dyslipidemia and cardiovascular risk factors.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if lower levels of LDL cholesterol reduction are needed, the maintenance dose can be adjusted. The maintenance dose is 10 mg once daily, and most patients will be managed on this dose. The maintenance dose should be adjusted appropriately every 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosing will be adjusted according to the recommended treatment goals for individual patients.

Precautions

This medication should not be administered to certain patients. For example, patients who are allergic to this drug, have liver dysfunction, have muscle disorders, or have severe renal impairment should not take this medication. The use of this medication is restricted for women who are pregnant or breastfeeding, and for women of childbearing potential who do not use adequate contraception, due to the potential risk to the fetus. Patients at high risk for muscle-related side effects, such as those with hypothyroidism, a history of hereditary muscle disorders, alcohol addiction, or those taking certain medications in combination, should use this medication with caution. This drug contains lactose, so it should not be given to patients with lactose intolerance. Patients who consume large amounts of alcohol or have a history of liver disease should undergo liver function tests before taking this medication and should also have regular liver enzyme tests during treatment. If symptoms related to muscle pain, muscle weakness, or muscle damage occur, patients should promptly inform their doctor and discontinue the use of this medication if necessary. This medication may raise blood glucose levels in some patients, so those at risk of diabetes should manage their blood glucose carefully. This medication may interact with other drugs, so patients should inform their doctor or pharmacist of any other medications they are taking. Special caution is needed when taken with certain antiviral medications, immunosuppressants, antibiotics, and lipid-lowering medications. Pregnant or breastfeeding women should not take this medication, and women who could become pregnant should use adequate contraception. In cases of overdose, there are no specific antidotes, so treatment should be symptomatic, and liver function and muscle enzyme tests should be conducted as needed. This medication does not appear to have a significant effect on driving or operating machinery, but caution is advised due to the possibility of dizziness. Finally, it is important for patients to consult healthcare professionals immediately if any adverse reactions or uncomfortable symptoms occur during treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe skin reactions, acute renal failure, oliguria, myopathy, rhabdomyolysis, severe muscle weakness, oculomotor weakness, serious liver damage, hyperbilirubinemia, severe headache, seizures, confusion, visual disturbances, paralysis, heart

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • amnesia
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • increased transaminases
  • alcohol addiction
  • depression
  • sleep disorders
  • 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 sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius to ensure the drug's efficacy is preserved.

Appearance and packaging

Appearance

Pink 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.

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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.