Medication info
KVAJET Tablet 10/20 mg

KVAJET Tablet 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets/box (10 tablets/PTPX3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004134 · Approved 2020.05.29 · Insurance code 670104910

Summary

Main use
Lipid improvement for hypercholesterolemia (primary, mixed) and risk reduction of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is taken once daily without regard to meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring further reduction of LDL cholesterol, the dosage may be adjusted up to a maximum of 10/20 mg daily. Following the initiation of therapy or dosage adjustment, lipid levels should be checked at intervals of four weeks or longer.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Lipid improvement for hypercholesterolemia (primary, mixed) and risk reduction of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It is administered together with a proper diet particularly for patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia. This medication is effective as an adjunct when dietary or other non-pharmacological methods are insufficient for cholesterol control. It is also important to identify and possibly treat secondary causes of dyslipidemia, such as diabetes or hypothyroidism, before treatment. Regular monitoring of the patient's lipid levels is essential to evaluate treatment effectiveness, and especially for patients with acute coronary events, measuring lipid levels during hospitalization or within 24 hours of admission is recommended. This medication is used for improving hypercholesterolemia and dyslipidemia.

How to take

Adult dose

This medication is taken once daily without regard to meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. For patients requiring further reduction of LDL cholesterol, the dosage may be adjusted up to a maximum of 10/20 mg daily. Following the initiation of therapy or dosage adjustment, lipid levels should be checked at intervals of four weeks or longer.

Precautions

This medication may cause a rare serious side effect known as rhabdomyolysis, which can lead to rapid deterioration of kidney function; therefore, patients should inform their healthcare provider immediately if they experience severe muscle pain or weakness. This medication should not be used in patients with allergies to its ingredients, severe liver dysfunction, myopathy, significantly impaired kidney function, pregnant women or women who may become pregnant, and breastfeeding mothers. Additionally, caution should be exercised in patients with certain genetic disorders or those with a history of alcoholism, hypothyroidism, elderly patients, and when used in combination with other lipid-lowering agents due to an increased risk of muscle problems. Prior to administration, liver function tests and muscle enzyme tests should be performed, and regular monitoring should continue during treatment. Patients should immediately report any symptoms of muscle pain, fatigue, or fever to their healthcare provider for testing. This medication can cause liver dysfunction, so it should be discontinued immediately if signs of liver damage appear, and extra caution is warranted for patients with a history of excessive alcohol use or liver disease. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should employ appropriate contraception. Because the safety and efficacy for children and elderly individuals have not been sufficiently confirmed, caution is advised for their use. As this medication can interact with other drugs, patients should inform their healthcare provider or pharmacist of any medications they are currently taking, particularly when used with anticoagulants, certain antibiotics, antifungal agents, and immunosuppressants. Patients should be cautious during driving or operating machinery, as dizziness and other symptoms may occur while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucous membranes, shortness of breath or breathing difficulty, asthmatic attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), marked lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

  • Pharyngitis
  • arthralgia
  • headache
  • dizziness
  • upper respiratory infection
  • itching
  • rash
  • pruritus
  • constipation
  • nausea
Show 28 more
  • abdominal pain
  • myalgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • vomiting
  • gastritis
  • epigastric discomfort
  • belching
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorders
  • urticaria
  • hyperhidrosis
  • alopecia
  • bronchitis
  • rhinitis
  • cystitis
  • ingrown toenails

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets/box (10 tablets/PTPX3), 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.