Medication info
Combijet Tablet 10/20 mg

Combijet Tablet 10/20 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP packaging (Alu-Alu) x3]
Approval status
Active

MFDS item code 202101514 · Approved 2021.02.18 · Insurance code 657203790

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and suppression of cardiovascular disease risk by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is taken once daily regardless of meals. The dosage range is from 10/10 mg to 10/80 mg per day. A starting dose of either 10/10 mg or 10/20 mg per day is recommended. For patients requiring more significant reduction of LDL cholesterol (55% or more), a starting dose of 10/40 mg per day is recommended. After starting treatment or adjusting the dosage, blood lipid levels should be checked with an interval of at least 2 weeks.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and suppression of cardiovascular disease risk by increasing HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • hypercholesterolemia
  • atherosclerotic vascular disease
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 levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase levels of HDL cholesterol, which is good cholesterol. Additionally, it may be used alone in patients with homozygous familial hypercholesterolemia or in combination with other lipid-lowering therapies when those therapies are ineffective. This medication should be taken alongside a proper diet that includes restrictions on saturated fats and cholesterol when treating dyslipidemia and should be used when other non-pharmacological therapies have not been effective. It is essential to identify and treat secondary causes such as diabetes and hypothyroidism for safe administration. Blood lipid measurements should be carried out to check total cholesterol, LDL, HDL, triglycerides, aiding in treatment to reduce the risk of cardiovascular disease. This medication is used to lower the risk of vascular disease associated with hypercholesterolemia and improve lipid levels.

Dosage and Administration

Adult dosage

This medication is taken once daily regardless of meals. The dosage range is from 10/10 mg to 10/80 mg per day. A starting dose of either 10/10 mg or 10/20 mg per day is recommended. For patients requiring more significant reduction of LDL cholesterol (55% or more), a starting dose of 10/40 mg per day is recommended. After starting treatment or adjusting the dosage, blood lipid levels should be checked with an interval of at least 2 weeks.

Precautions

This medication can affect the muscles, so if muscle pain or weakness occurs, you must inform a doctor immediately. Patients at risk for severe myopathy or rhabdomyolysis may need to temporarily stop or discontinue this medication. As this medication may affect liver function, liver function tests should be conducted before and regularly during treatment. Patients with active liver disease or persistently elevated liver enzyme levels should not take this medication. There may be drug interactions that increase the risk of side effects when taken with certain medications, so it is crucial to inform the doctor or pharmacist of any currently taken medications. Pregnant women or those who may become pregnant should not take this medication, and women of childbearing age should use appropriate contraception while taking it. Breastfeeding women are also advised not to take this medication. Elderly patients, those with renal impairment, or those with liver impairment should take caution and may require dosage adjustments or regular monitoring. Dizziness may occur when driving or operating machinery, so take care. In case of overdose, there is no specific antidote, so seek appropriate treatment and monitoring by visiting a medical institution immediately. Safety has not been established for children, and it is not recommended for them. During treatment with this medication, adverse reactions such as muscle pain, abdominal pain, elevated liver enzymes, etc., may occur; if symptoms persist or worsen, consult a doctor.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Muscle pain, abdominal pain, headache, dizziness, fatigue, nausea, vomiting, diarrhea, constipation, musculoskeletal pain, joint pain, muscle weakness, muscle cramps, rash, itching, hair loss, hives, elevated serum aminotransferases (increased ALT, AST), hepatitis, cholestasis, liver dysfunction, blurred vision, tinnitus, hearing loss, depression, insomnia, nightmares, thrombocytopenia, anemia, hyperkalemia, malaise, chest pain, chest discomfort

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 air and moisture from entering, and should be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaging (Alu-Alu) x3]

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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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.