Medication info
Kvastin Tablets 10mg (Rosuvastatin Calcium)

Kvastin Tablets 10mg (Rosuvastatin Calcium)

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

MFDS item code 201400382 · Approved 2014.01.28 · Insurance code 670103510

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Regardless of meals, administer 5mg once daily at any time of the day. If a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted to 10mg once daily. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response over a period of 4 weeks or more, with a maximum daily dose of 20mg.
Child dose
For children aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage ranges from 5mg to 20mg once daily. The dosage should be adjusted based on the individual patient's treatment goals over a period of 4 weeks or more.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary artery disease
View approved original text

This medication is primarily used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia for cases where dietary management and exercise alone are insufficient. It is also used as an adjunct to other lipid-lowering therapies, such as dietary management or LDL apheresis, in patients with homozygous familial hypercholesterolemia. For patients with hypercholesterolemia, it is effective in lowering total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis, and notably for adolescents with familial hypercholesterolemia, it helps reduce total cholesterol, LDL cholesterol, and Apo-B protein levels. It also serves as an adjunct to dietary management in patients with primary dysbetalipoproteinemia and effectively reduces the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged individuals with cardiovascular risk factors. It is used for the treatment and prevention of various lipid disorders, cardiovascular risks, and related diseases.

How to take

Adult dose

Regardless of meals, administer 5mg once daily at any time of the day. If a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted to 10mg once daily. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response over a period of 4 weeks or more, with a maximum daily dose of 20mg.

Child dose

For children aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage ranges from 5mg to 20mg once daily. The dosage should be adjusted based on the individual patient's treatment goals over a period of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For instance, it should not be administered to those allergic to its ingredients, patients with active liver disease, those with muscle disorders, patients with severe renal impairment, or pregnant or breastfeeding women. Additionally, high-dose administration is prohibited in patients at risk for muscle disorders. This medication contains lactose and is not recommended for patients with lactose intolerance. Liver function and muscle condition should be monitored regularly during administration. Patients who consume large amounts of alcohol or have a history of liver disease need to be particularly cautious. If symptoms of muscle pain or weakness occur, inform a physician immediately, and medication may need to be discontinued if necessary. This medication can interact with various drugs, so it is crucial to consult a physician or pharmacist if you are taking other medications. Special caution is required when combined with certain antiviral drugs, immunosuppressants, antifungals, and antibiotics. Women who may become pregnant should practice adequate contraception during treatment with this medication, and if pregnancy is confirmed, the use of this medication should be discontinued immediately. Breastfeeding women should also refrain from using this medication for safety. In cases of overdose, there is no specific antidote; therefore, symptomatic treatment and monitoring of liver function and muscle enzyme levels are necessary. Rarely, side effects such as headaches, dizziness, dyspepsia, rashes, muscle pain, weakness, hematuria, diarrhea, chest discomfort, loss of appetite, abdominal bloating, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, fatigue, numbness, and sensory disturbances may occur, and consultation with a physician is advised if symptoms arise. Caution is advised when driving or operating machinery as dizziness may occur. Lastly, this medication may accumulate more in Asian individuals, necessitating dosage adjustments.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria, angioedema, severe edema, chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, exfoliative dermatitis, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, serious liver damage, acute renal failure, oliguria, thrombocytopenia, severe muscle weakness, ocular myopathy

Mild side effects

  • Headaches
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • rashes
Show 13 more
  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory disturbances

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture and should ideally be kept at room temperature, between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

100 tablets/bottle, 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.

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.