Medication info

Simba-comib Tablet 10/20mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
White to whitish convex rectangular tablets on both sides
Packaging
30 tablets (10 tablets/Alu-Alu*3)
Approval status
Expired

MFDS item code 201007249 · Notified 2010.11.29

This product's status changed to Expired on 2024.10.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the daily dosage ranges from 10/10mg to 10/40mg, with the generally recommended starting dose being 10/20mg once daily. Patients with less need for LDL cholesterol reduction may start with 10/10mg once daily. After initiation or adjustment of dosage, blood lipid levels should be checked at intervals of more than 4 weeks.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Improvement of cholesterol and lipid levels in 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
View approved original text

This medication helps lower elevated total cholesterol and LDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia, while increasing HDL cholesterol. It can be used alone or as an adjunct to other treatments for patients with severe homozygous familial hypercholesterolemia, effectively controlling blood cholesterol levels. This medication should be used in conjunction with a diet and is recommended when dietary treatment alone is insufficient. It is administered cautiously to patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia. Before administration, secondary causes such as diabetes and hypothyroidism should be evaluated and treated if necessary. Treatment efficacy should be monitored by checking total cholesterol, LDL, HDL, and triglyceride levels, and it can also be appropriately applied to patients with cardiovascular events. Therefore, this medication is effective in improving cholesterol levels and enhancing cardiovascular health.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the daily dosage ranges from 10/10mg to 10/40mg, with the generally recommended starting dose being 10/20mg once daily. Patients with less need for LDL cholesterol reduction may start with 10/10mg once daily. After initiation or adjustment of dosage, blood lipid levels should be checked at intervals of more than 4 weeks.

Precautions

This medication is primarily used to lower blood cholesterol levels. Muscle pain or weakness may occur during treatment, and rarely, a serious condition called rhabdomyolysis can develop, resulting in severe muscle damage. The risk can be heightened, especially when taken in high doses or in conjunction with specific medications. Patients with liver function issues or elevated liver enzyme levels should not take this medication, and regular testing is necessary if liver dysfunction is suspected. Women who are pregnant or nursing should not take this medication, and women of childbearing age must confirm pregnancy status before use. This medication can lead to higher blood concentrations when taken with drugs that inhibit certain enzymes (CYP3A4), thus increasing the risk of side effects. Therefore, patients should consult a physician if they are under treatment with such drugs. Additionally, interactions with certain anticoagulants, specific antibiotics, and calcium channel blockers exist; patients taking other medications should notify their healthcare providers. If unexplained muscle pain, muscle weakness, changes in urine color, or other adverse symptoms occur, patients should immediately notify a physician and discontinue treatment. This medication should also be used cautiously in elderly patients or those with reduced kidney function, and regular blood tests to monitor liver and muscle condition are advisable. In cases of overdose, there is no specific antidote, and immediate medical attention is necessary for appropriate treatment. Finally, it is advisable to limit the intake of certain foods, such as grapefruit juice, while taking this medication and to inform other healthcare providers about its use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, respiratory distress, toxic epidermal necrolysis (Lyell syndrome), skin mucosal syndrome (Stevens-Johnson syndrome), severe allergic reactions, severe skin adverse reactions, blood vessel swelling, rash, pancreatitis, hepatitis, cholestatic jaundice, fulminant hepatic necrosis, liver cancer, hepatic failure, skin and mucosal issues, alopecia, liver dysfunction (jaundice), headache, confusion, vision

Mild side effects

Headache, diarrhea, influenza, upper respiratory infection, muscle pain, limb pain, fatigue, nausea, abdominal pain, constipation, indigestion, flatulence, vomiting, itching, alopecia, increased creatine phosphokinase (CPK) in the blood, weight loss, weakness, sensory loss, nocturia, hematuria, insomnia, gastritis, atrophic gastritis, mucoid stools, irritable bowel syndrome, sore throat, cataracts, gynecomastia, decreased libido, sexual dysfunction, anemia, HbA1c and public

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

Storage

This medication 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 at room temperature.

Appearance and packaging

Appearance

White to whitish convex rectangular tablets on both sides

Package unit

30 tablets (10 tablets/Alu-Alu*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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.