Medication info
Kvastin Tablet 5 mg (Rosuvastatin Calcium)

Kvastin Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202002303 · Approved 2020.04.02 · Insurance code 670104730

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if more LDL-cholesterol reduction is needed, it can be titrated to the maintenance dose. The maintenance dose is typically 10 mg once daily, and most patients are controlled at this dose. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg per day.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 5 mg to 20 mg once daily. The administration dosage should be adjusted individually based on the recommended therapeutic goals for each patient.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • stroke risk
  • myocardial infarction risk
  • arterial revascularization risk
View approved original text

This medication is primarily used as an adjunct therapy in patients with primary hypercholesterolemia and mixed hyperlipidemia who cannot be controlled by diet and exercise. It is also utilized as an adjunct to diet in patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. This drug lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and is effective in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. Additionally, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged patients with elevated high-sensitivity C-reactive protein levels and additional cardiovascular disease risk factors. Overall, this medication is used to reduce cardiovascular risk associated with hyperlipidemia and improve cholesterol levels.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if more LDL-cholesterol reduction is needed, it can be titrated to the maintenance dose. The maintenance dose is typically 10 mg once daily, and most patients are controlled at this dose. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg per day.

Children's dosage

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

Precautions

This drug should not be used in certain patients. For example, it is contraindicated in patients who are allergic to this drug, have severely impaired liver function, have muscle disorders, have severe renal impairment, are pregnant or breastfeeding women, and in fertile women not using adequate contraception. Moreover, in patients at increased risk for muscle disorders, or when used in conjunction with certain medications, caution should be exercised in deciding the dosage or whether to administer this drug. For instance, patients with moderate to severe renal impairment, those with hypothyroidism, alcoholics, and those with a history of genetic muscle disorders or family history should be cautious. This drug contains lactose, so it should not be given to patients with genetic problems such as lactose intolerance. It is important to perform regular liver function tests and muscle-related tests while taking this drug. Specifically, patients with a history of liver disease or excessive alcohol consumption should regularly monitor liver enzyme levels. In case of symptoms such as myalgia, muscle weakness, or cramps, notify healthcare professionals immediately, and treatment with this drug can be discontinued if necessary. Furthermore, since muscle enzyme levels may increase due to exercise or other causes, caution is needed during testing. This drug can rarely cause severe skin reactions or liver damage, so if symptoms such as rash, fever, or jaundice occur, treatment should be stopped immediately, and healthcare professionals should be consulted. When used in conjunction with other medications, interactions may occur, so all medications being taken should be reported to healthcare professionals with caution. Especially, the risk of muscle injury may increase when combined with certain antiviral agents, immunosuppressants, and fibrate medications. Pregnant or breastfeeding individuals should not use this drug, and women who might become pregnant should use appropriate contraception. In cases of overdose, specific antidotes are not available, so treatment must follow the symptoms, and liver function and muscle enzyme tests are required. Caution is advised during driving or operation of machinery, as dizziness may occur. The drug's concentration may be higher in Asian individuals, so dosage adjustment may be necessary. Overall, this drug should be used with careful monitoring of liver and muscle health status, and it must be taken according to the physician's instructions.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including hives and angioedema, severe allergic reactions, rash, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin adverse reactions, pancreatitis, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular myasthenia, respiratory difficulties, breathing problems, jaundice, hepatitis, liver abnormalities, acute renal failure, oliguria, sudden and severe headache,

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • fatigue
  • thrombocytopenia
  • diarrhea
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  • paresthesia
  • chest discomfort
  • decreased appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • hematuria
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is also recommended to store the medication at room temperature between 1°C and 30°C. This helps to maintain the effectiveness of the medication for a longer period.

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.