Medication info
Vaisib Tablet 10/20 Milligrams

Vaisib Tablet 10/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White to off-white, bilaterally convex, rectangular tablet
Packaging
30 tablets/Alu-Alu
Approval status
Active

MFDS item code 201600853 · Approved 2016.02.15 · Insurance code 693902090

Summary

Main use
Improvement of cholesterol and lipids in patients with hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication should be taken once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day. The generally recommended starting dose is 10/20 mg once daily. Patients with less need for LDL cholesterol reduction may start with 10/10 mg once daily. For patients with homozygous familial hypercholesterolemia, the recommended dosage is 10/40 mg per day.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement of cholesterol and lipids in patients with hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
View approved original text

This medication is used as an adjunct to diet in patients with primary hypercholesterolemia, particularly in those with heterozygous familial and non-familial hypercholesterolemia and mixed hyperlipidemia to lower total cholesterol, LDL cholesterol, ApoB protein, and triglycerides, and increase HDL cholesterol. Additionally, it is administered as an adjunct or alternative to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia for effective reduction of serum lipid levels. This drug is used in cases of insufficient response to dietary and other non-drug therapies, and patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia require appropriate management. It is important to identify and treat secondary causes such as diabetes and hypothyroidism before using the medication. Lipid tests should include total cholesterol, LDL, HDL, and triglycerides, and special measurement methods may be required for patients with severe hypertriglyceridemia. Thus, this drug is used as a safe and effective management option for improving serum lipid levels in the treatment of hyperlipidemia.

How to take

Adult dose

This medication should be taken once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day. The generally recommended starting dose is 10/20 mg once daily. Patients with less need for LDL cholesterol reduction may start with 10/10 mg once daily. For patients with homozygous familial hypercholesterolemia, the recommended dosage is 10/40 mg per day.

Precautions

This medication can cause serious muscle-related side effects such as myopathy and rhabdomyolysis. These side effects may manifest as muscle pain, muscle weakness, and significantly elevated creatine kinase levels in the blood. The risk is particularly greater with high doses, so dosage adjustment is crucial. This medication should not be administered to patients with poor liver function or active liver disease. Pregnant or breastfeeding women should not take this medication, and women planning to become pregnant must consult a doctor. Furthermore, caution is needed when combined with potent CYP3A4 inhibitors such as certain antifungals, antibiotics, and antivirals as the risk of muscle side effects may increase. There may also be interactions with other lipid-lowering agents, immunosuppressants, and certain anticoagulants, so patients must inform their healthcare provider of all medications they are currently taking. If symptoms of muscle pain or weakness occur during the use of this medication, patients should contact their doctor immediately, and regular blood tests should monitor muscle condition and liver function. Elderly patients or those with decreased kidney function should also use this medication with caution. Additionally, this medication may raise blood sugar levels in some patients, so those at risk for diabetes must manage their blood sugar carefully. Lastly, specific food intake such as grapefruit juice must be limited during the use of this medication, and patients should always inform their healthcare providers of this medication when starting new drugs.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, severe allergic reactions, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe skin adverse reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, breathing problems, shortness of breath or difficulty breathing, asthma attacks, cough with fever associated respiratory problems, liver abnormalities (jaundice), yellowing of the skin or eyes, severe body reaction

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • upper abdominal pain
  • vomiting
  • chest pain
  • discomfort in the chest
  • weakness
  • sensory loss
  • cough
  • edema
  • thirst
  • facial swelling
  • fainting
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus stools
  • irritable bowel syndrome
  • sore throat
  • joint pain
  • lower back pain
  • itching
  • hair loss
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture, and it is safest to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy and prevents degradation.

Appearance and packaging

Appearance

White to off-white, bilaterally convex, rectangular tablet

Package unit

30 tablets/Alu-Alu

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.