Medication info
Schwasta Tablet (Rosuvastatin Calcium)

Schwasta Tablet (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
조아제약(주)
Appearance
Pink round film-coated tablet
Packaging
28 T / PTP
Approval status
Active

MFDS item code 201404134 · Approved 2014.09.04 · Insurance code 644602960

Summary

Main use
Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and cardiovascular disease risk reduction effect
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily. If greater reductions in LDL cholesterol are required, the maintenance dose can be adjusted accordingly. The maintenance dose is usually 10 mg once daily, with most patients being managed at this dosage. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or longer, based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.
Child dose
The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals.

Ingredients

Manufacturer
조아제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and cardiovascular disease risk reduction effect

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol level
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used for various diseases related to hypercholesterolemia. It is used as an adjunctive treatment when dietary changes and exercise are insufficient to control primary hypercholesterolemia or mixed hyperlipidemia. It is also used as an adjunct to the diet or other lipid-lowering therapy for patients with homozygous familial hypercholesterolemia. Additionally, it effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It is also used as an adjunct to diet for children and adolescents in high-risk groups with heterozygous familial hypercholesterolemia. It aids patients with primary dysbetalipoproteinemia and contributes to reduced cardiovascular disease risk, lowering the risks of stroke, myocardial infarction, and arterial revascularization. Overall, it is effectively used for managing hyperlipidemia and cardiovascular risk.

How to take

Adult dose

The initial dose is 5 mg once daily. If greater reductions in LDL cholesterol are required, the maintenance dose can be adjusted accordingly. The maintenance dose is usually 10 mg once daily, with most patients being managed at this dosage. The maintenance dose should be appropriately adjusted at intervals of 4 weeks or longer, based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Child dose

The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals.

Precautions

This medication should not be used in certain patients. For example, those who are allergic to this medication, have severely impaired liver function, have muscle disorders, or are taking certain immunosuppressants should not take this medication. Patients with significantly reduced kidney function and women who are pregnant or breastfeeding should also avoid this drug. Because this medication can cause muscle problems, individuals with a history of muscle disorders or those susceptible to muscle toxicity should exercise particular caution. It is also advisable for individuals with genetic issues such as lactose intolerance to avoid this medication. This medication can affect liver function, so 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 hypothyroidism or nephrotic syndrome should treat the underlying condition before taking this medication. If symptoms such as muscle pain or weakness occur, it is crucial to inform a healthcare professional immediately, and the medication should be discontinued if necessary. If muscle enzyme levels rise significantly, therapy should be discontinued and the condition monitored. This medication can increase blood concentration when taken with certain drugs, raising the risk of muscle side effects; thus, it is essential to consult a doctor before combining it with other medications. Additionally, taking it with antacids may reduce its effectiveness, so timing of doses should be adjusted accordingly. Women of childbearing potential should ensure effective contraceptive methods are used, and this medication should not be taken during pregnancy. In cases of overdose, there is no specific antidote, so treatment should be symptomatic and liver function and muscle enzyme checks should be performed. Caution is needed while driving or operating machinery as dizziness may occur. This medication may show higher blood concentrations in Asians, so dosage adjustments may be necessary. In children and adolescents, it should be used cautiously considering its potential impact on growth and development.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myasthenia, jaundice, liver failure, acute renal failure, oliguria, thrombocytopenia, dyspnea, interstitial lung disease, severe skin adverse reactions.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • rash
  • chest discomfort
  • cold sweat
  • pallor
  • fatigue
  • numbness
  • dysesthesia
  • nausea
  • abdominal bloating
  • loss of appetite
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • transaminase elevation
  • hepatitis
  • lupus-like syndrome
  • muscle rupture
  • increased serum creatinine levels.

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It should also be safely stored at room temperature, between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 T / PTP

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.