Medication info
Combit 10/10 mg Tablet

Combit 10/10 mg Tablet

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White, oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP packaging (Alu-Alu) x 3]
Approval status
Active

MFDS item code 202101515 · Approved 2021.02.18 · Insurance code 657203800

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg per day, with a recommended initial dose of 10/10 mg or 10/20 mg per day. For patients who require a greater reduction in LDL cholesterol, an initial dose of 10/40 mg per day is recommended. After starting therapy or adjusting the dose, serum lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia or mixed dyslipidemia while increasing HDL cholesterol levels. It can also be used as an adjunctive treatment for patients with homozygous familial hypercholesterolemia or administered alone when other treatments are ineffective. This medication is used alongside dietary therapy and is prescribed appropriately after checking for secondary causes of hyperlipidemia. It is particularly effective in patients at high risk of atherosclerotic vascular disease and plays a significant role in lipid control. Due to these properties, it is widely used in the treatment of dyslipidemia related to hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg per day, with a recommended initial dose of 10/10 mg or 10/20 mg per day. For patients who require a greater reduction in LDL cholesterol, an initial dose of 10/40 mg per day is recommended. After starting therapy or adjusting the dose, serum lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication has been reported to cause a rare side effect called rhabdomyolysis, which can lead to serious muscle damage. Therefore, if severe muscle pain or weakness occurs, it is essential to consult a doctor immediately. Additionally, this medication should not be given to patients with liver dysfunction or liver disease, and liver function tests must be conducted before administration. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not use this medication. This drug may increase the risk of side effects when taken with certain medications, so inform your doctor or pharmacist if you are taking other medicines. Elderly patients or those with impaired kidney function also require caution when taking this drug, and regular testing and monitoring are recommended. During treatment, symptoms such as dizziness, muscle pain, abdominal pain, or liver function abnormalities may occur, so inform medical personnel immediately if these symptoms arise. This medication is not recommended for children as its safety and efficacy have not been established.

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, peeling skin, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • malaise
  • chest pain
  • chest discomfort
  • edema
  • weakness
  • angioedema
  • angina
  • facial swelling
  • fever
  • neck stiffness
  • systemic edema
  • headache
  • insomnia
  • nightmares
  • sensory disturbances
  • decreased sensation
  • taste disturbances
  • amnesia
  • peripheral neuropathy
  • thrombocytopenia
  • liver

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to keep the medication at room temperature between 1°C and 30°C, away from extreme heat or cold.

Appearance and packaging

Appearance

White, oblong film-coated tablet

Package unit

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