Medication info
Baisib Tablets 10/10 mg

Baisib Tablets 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
A white to light yellow, double convex, rectangular tablet
Packaging
30 tablets (10 tablets/PTP packaging x 3)
Approval status
Active

MFDS item code 201601731 · Approved 2016.03.31 · Insurance code 693902150

Summary

Main use
Lipid control effect through reduction of LDL cholesterol and increase of HDL cholesterol in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia.
Who takes it
Adults
Adult dose
This medication should be taken once daily in the evening without regard to meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with the generally recommended starting dose being 10/20 mg per day. Patients who need less reduction in LDL cholesterol may start at 10/10 mg once daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40 mg once daily.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Lipid control effect through reduction of LDL cholesterol and increase of HDL cholesterol in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia.
View approved original text

This medication effectively lowers cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed hyperlipidemia, and helps raise levels of good cholesterol (HDL). It is used in combination with a diet for patients with familial hypercholesterolemia or as an adjuvant therapy when other treatments are not effective. Additionally, it supports cardiovascular health when used with appropriate dietary management in patients at high risk for atherosclerotic vascular disease. Before use, one should evaluate for underlying secondary causes such as diabetes and hypothyroidism, and treat those conditions if necessary. To assess treatment efficacy, cholesterol and triglyceride levels should be monitored regularly. In summary, this drug is used for treating hypercholesterolemia and helps improve blood lipid levels.

How to take

Adult dose

This medication should be taken once daily in the evening without regard to meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with the generally recommended starting dose being 10/20 mg per day. Patients who need less reduction in LDL cholesterol may start at 10/10 mg once daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40 mg once daily.

Precautions

This drug has the potential to cause muscle-related disorders such as myopathy and rhabdomyolysis. Myopathy may present with muscle pain and weakness, and in severe cases, may lead to renal damage, thus caution is warranted. The risk is particularly heightened when taken at high doses or in conjunction with certain medications. This drug should not be used in patients who are allergic to its ingredients, severely impaired liver function, pregnant or breastfeeding women. Additionally, patients with a genetic problem concerning lactose in this drug should not take it. Patients with severe muscle weakness or ocular myasthenia gravis should use this drug cautiously and discontinue immediately if symptoms worsen. Patients on this medication should consult their doctor immediately if they experience muscle pain, weakness, tenderness, etc., and should verify their condition through muscle enzyme tests if necessary. Patients with liver dysfunction should have regular liver function tests before and during the use of this drug; if liver damage symptoms arise, administration should be halted immediately. This drug may interact with several other medications, so if you are taking other medications, you must inform your doctor or pharmacist. The risk of myopathy increases when used with specific antifungals, antibiotics, antivirals, anticoagulants, calcium channel blockers, thus caution is advised. Women who are planning to become pregnant or are of childbearing potential must consult healthcare professionals before taking this drug, and should discontinue immediately if pregnancy is confirmed. Women who are breastfeeding should also refrain from nursing while taking this drug. For children and adolescents, sufficient data regarding safety and efficacy of this drug is lacking, thus it is not recommended for children under 10 years of age. Elderly patients require special caution and should discuss potential adverse reactions with healthcare professionals. In cases of overdose, there is no specific antidote, so one must seek immediate medical care for appropriate treatment. This drug may cause rare respiratory side effects like interstitial lung disease during long-term use. Therefore, if difficulty breathing or persistent cough occurs, consult a doctor immediately. Lastly, it is important to monitor liver function and muscle condition through regular blood tests and clinical assessments during the course of this treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, severe allergic reactions, severe skin adverse reactions, myopathy, rhabdomyolysis, elevated liver aminotransferase levels, hepatitis, liver abnormalities (jaundice), cholelithiasis, cholecystitis, pancreatitis, severe edema, significantly reduced urine output, severe edema or urinary disturbances.

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus stool
  • irritable bowel syndrome
  • sore throat
  • dizziness
  • sensory disturbance
  • depression
  • insomnia
  • cataract progression
  • alopecia
  • pruritus
  • dryness of skin and mucous membranes
  • changes in hair and nails
  • gynecomastia
  • decreased libido
  • erectile dysfunction
  • weakness
  • thrombocytopenia
  • blood creatine phosphokinase elevation.

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

Storage

This drug is sensitive to air and moisture, so it should be stored in a sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

A white to light yellow, double convex, rectangular tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)

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.