Medication info
Kvajet Tablet 10/5 mg

Kvajet Tablet 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
White to nearly white round film-coated tablets
Packaging
30 tablets/box (10 tablets/PTPX3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004133 · Approved 2020.05.29 · Insurance code 670104900

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and suppression of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. A starting dose of 10/5 mg once daily is recommended. For patients requiring more significant LDL cholesterol reduction, the dose may be adjusted. After starting treatment or adjusting the dose, check lipid levels after an interval of 4 weeks or more and adjust the dose accordingly, with a maximum of 10/20 mg per day.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and suppression of the risk of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication is used as an adjunct to diet to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia, especially familial or non-familial hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol, the good cholesterol. It also helps control lipid levels in patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia. This medication should be used along with a proper diet that restricts saturated fat and cholesterol intake and is given when non-drug therapies such as dietary adjustment are insufficient. Before treatment, other diseases or medications that may cause dyslipidemia, such as diabetes and hypothyroidism, should be assessed, and secondary disease treatment should be conducted as necessary. During therapy, total cholesterol, LDL, HDL, and triglyceride levels should be regularly monitored. Thus, this medication is used to effectively improve dyslipidemia and reduce the risk of cardiovascular diseases.

How to take

Adult dose

This medication is administered once daily regardless of meals. A starting dose of 10/5 mg once daily is recommended. For patients requiring more significant LDL cholesterol reduction, the dose may be adjusted. After starting treatment or adjusting the dose, check lipid levels after an interval of 4 weeks or more and adjust the dose accordingly, with a maximum of 10/20 mg per day.

Precautions

This medication has been reported to very rarely cause rhabdomyolysis, which can lead to severe kidney damage due to muscle tissue destruction. Patients at high risk for these symptoms should temporarily discontinue or stop taking this medication. This medication should not be used in patients who are allergic to the active ingredient or any component, have severely impaired liver function, have muscular disorders, are taking certain immunosuppressants, have severely impaired renal function, are pregnant or may become pregnant, or are breastfeeding. Patients with a history of muscular disorders, impaired renal function, hypothyroidism, elderly patients, or those taking specific medications should use this medication cautiously. Since this medication can affect liver function, liver function tests should be performed before and during administration, and if signs of liver damage appear, the patient should consult a doctor immediately. If symptoms such as muscle pain, muscle weakness, fatigue, or fever occur, alert a doctor immediately and check for muscle damage through blood tests if necessary. Caution should be exercised when using this medication in patients with a history of excessive alcohol consumption or liver disease. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential should take appropriate contraceptive measures while on this medication. During treatment with this medication, caution is needed as dizziness may occur when driving or operating machinery. There may be interactions with other medications, so all medications being taken should be disclosed to a doctor or pharmacist. In case of overdose, there is no specific antidote, and treatment should be provided according to symptoms while checking liver function and muscle status. Keep this medication out of reach of children, and it is safe not to transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • ALT elevation
  • AST elevation
  • myalgia
  • edema
  • elevated serum bilirubin
  • acneiform dermatitis
  • pruritus
Show 26 more
  • dizziness
  • upper respiratory infection
  • cough
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • asthenia
  • fatigue
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal distention
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • urticaria
  • rash
  • itching
  • alopecia
  • thrombocytopenia
  • depression
  • somnolence
  • nephropathy

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White to nearly 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.