Medication info
Schvastin Tablets 10mg (Rosuvastatin Calcium)

Schvastin Tablets 10mg (Rosuvastatin Calcium)

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

MFDS item code 201504202 · Approved 2015.06.29 · Insurance code 658202850

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The starting dose is 5 mg once daily, and if greater reduction in LDL-cholesterol is required, the maintenance dose can be adjusted accordingly. The maintenance dosage is 10 mg once daily, which is suitable for most patients. It should be appropriately adjusted at intervals of four weeks or more based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum dose of up to 20 mg per day.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosing should be individually adjusted based on the recommended treatment goals for each patient.

Ingredients

Manufacturer
(주)비보존제약

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 hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as an adjunctive treatment in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary changes and exercise alone are not sufficient. It is also effective as an adjunct to diet for patients with homozygous familial hypercholesterolemia or primary dysbetalipoproteinemia. This drug lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and is considered safe for pediatric patients between the ages of 10 and 17 with familial hypercholesterolemia. In middle-aged and older patients at high risk for cardiovascular disease, it helps to reduce the risks of stroke, myocardial infarction, and vascular revascularization procedures. Overall, this medication is used to improve blood lipid levels and reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

The starting dose is 5 mg once daily, and if greater reduction in LDL-cholesterol is required, the maintenance dose can be adjusted accordingly. The maintenance dosage is 10 mg once daily, which is suitable for most patients. It should be appropriately adjusted at intervals of four weeks or more based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum dose of up to 20 mg per day.

Children's dosage

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

Precautions

This medication should not be taken by individuals who are allergic to any of its components. Persons with severely impaired liver function or liver disease should also avoid using this medication. Individuals with muscle-related diseases or a history of muscle problems should not take this drug. Caution should be exercised when taken with certain immunosuppressants as it may pose risks. Patients with severely impaired kidney function should avoid this medication. Pregnant or nursing women, as well as women of childbearing potential, should consult a doctor before taking this medication. The 40mg dose is contraindicated for individuals at high risk for muscle disease. People with lactose intolerance or certain genetic metabolic disorders should not take this drug. Individuals who consume large amounts of alcohol or have a history of liver disease should undergo liver function tests before starting this medication and receive regular monitoring during treatment. If symptoms of myalgia or muscular weakness occur, inform healthcare professionals immediately, and in severe cases, the medication may need to be discontinued. Careful monitoring is required for patients at high risk for muscle disease when taking this drug. Patients with hypothyroidism or nephrotic syndrome should treat the respective conditions before administering this medication. Severe myasthenia gravis or ocular myasthenia may occur, and if these symptoms arise, the medication should be stopped. This drug may interact with other medications, which may necessitate dosage adjustments or contraindications depending on the drugs taken concurrently. Particularly, when used in conjunction with fibrate medications, the risk of myopathy increases, so caution is warranted. Regular kidney function tests may be required for those on high doses. In Asians, this medication may show higher blood concentrations, potentially requiring dosage adjustments. For pediatric patients aged 10 to 17, careful use is necessary considering effects on growth and sexual development. This medication contains yellow dye, so caution is advised for individuals allergic to this component. Severe skin reactions may rarely occur, so if a skin rash or allergic symptoms occur, discontinue use immediately and consult a physician. Pregnant or nursing women should not take this medication, and women planning to become pregnant should use appropriate contraceptive methods. In cases of overdose, specific antidotes are not available; hence, treatment should be symptomatic, with liver function and muscle enzyme tests performed as needed. Dizziness may occur during treatment, requiring caution while driving or operating machinery. This medication may impact the liver and muscles; thus, regular check-ups are recommended, and any unusual symptoms should be discussed with healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, hematuria, edema, acute kidney failure, oliguria, severe myasthenia gravis, dyspnea, ophthalmoplegia, polyneuropathy, amnesia, peripheral neuropathy, seizures

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
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  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory disturbances
  • joint pain

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius room temperature to preserve its efficacy and safety.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

100 tablets/box [10 tablets/Alu-Alu×10], 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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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.