Medication info

Darim Ezetimibe Tablet 10 mg

Prescription medicationTabletExpired
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
(주)다림바이오텍
Appearance
White to off-white rectangular tablet
Packaging
10 tablets/PTP, 30 tablets (10 tablets/PTP*3), 100 tablets/bottle
Approval status
Expired

MFDS item code 201900323 · Approved 2019.01.22

This product's status changed to Expired on 2024.01.22. 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, familial) and sitosterolemia
Who uses it
Adults
Adult dosage
The recommended dosage for this medication is 10 mg once daily, and it can be taken without regard to meals. When co-administered with HMG-CoA reductase inhibitors, dosage should start at the recommended initial dose or be maintained at the high dose of HMG-CoA reductase inhibitors during combination therapy. When combined with fenofibrate, it should be administered with 160 mg or 200 mg of fenofibrate once daily.

Ingredients

Manufacturer
(주)다림바이오텍

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and sitosterolemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • homozygous familial sitosterolemia
  • homozygous sitosterolemia
  • sitosterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
View approved original text

This medication is primarily used to lower cholesterol and lipid levels in patients with primary hypercholesterolemia, mixed dyslipidemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. It can first be used as an adjunct to dietary therapy to reduce total cholesterol, LDL cholesterol, and apolipoprotein B. Additionally, this medication may enhance the effect by combination with other lipid-lowering agents and is especially used as an adjunct to treatments such as LDL apheresis in familial hypercholesterolemia. In patients with sitosterolemia, it helps to reduce elevated plant sterol levels. Before using this medication, it is important to identify and treat secondary causes such as diabetes and hypothyroidism, and monitor treatment progress through regular lipid tests. Overall, this medication is effectively used to improve hypercholesterolemia and related lipid abnormalities.

Dosage and Administration

Adult dosage

The recommended dosage for this medication is 10 mg once daily, and it can be taken without regard to meals. When co-administered with HMG-CoA reductase inhibitors, dosage should start at the recommended initial dose or be maintained at the high dose of HMG-CoA reductase inhibitors during combination therapy. When combined with fenofibrate, it should be administered with 160 mg or 200 mg of fenofibrate once daily.

Precautions

This medication should not be used by patients with hypersensitivity to specific components. The combination of this medication with certain lipid-lowering agents is contraindicated in patients with severe liver dysfunction or persistently elevated liver enzyme levels of unknown cause. Women who are pregnant or breastfeeding are prohibited from using this medication in combination with certain lipid-lowering agents; therefore, women who may become pregnant should exercise caution. In patients with moderate to severe liver function impairment, this medication's exposure may increase, leading to unexpected adverse effects, so it must be used with caution. In clinical trials, this medication has been safe for most patients; however, side effects such as headache, abdominal pain, diarrhea, fatigue, and myalgia may occur. Particularly when this medication is used in combination with other lipid-lowering agents, there may be more frequent occurrences of elevated liver enzyme levels or muscle-related abnormal symptoms, hence regular testing is required. If symptoms of myalgia or muscle weakness occur, the doctor should be notified immediately, and dosing should be discontinued if necessary. Patients with severe renal impairment also require caution, and kidney function should be monitored before and after dosing. This medication can interact with other drugs, so patients must inform healthcare providers about any medications they are taking. In cases of pregnancy or breastfeeding, the potential risks and benefits of this medication should be carefully considered before use. In children under 6 years old, use is not recommended; however, children and adolescents over 6 years old show responses similar to adults but require caution. Elderly patients can generally use it safely, but individual sensitivity may vary, so caution is warranted. In cases of overdose, there is no specific antidote, so treatment should be based on symptoms, and it is important to keep it out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, hypersensitivity reactions including rash and angioedema, erythema multiforme, hepatitis, pancreatitis, thrombocytopenia, cholecystitis, renal failure (kidney disease), liver dysfunction, urticaria, rhabdomyolysis, myopathy, persistent elevation of aminotransferase levels, rhabdomyolysis, severe edema or urination abnormalities

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • chest pain
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  • dizziness
  • constipation
  • bloating
  • nausea
  • increased AST
  • increased ALT
  • myalgia
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose
  • pain in limbs
  • diabetes
  • hypoglycemia
  • anemia
  • urticaria

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. To maintain its efficacy, it is recommended to store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White to off-white rectangular tablet

Package unit

10 tablets/PTP, 30 tablets (10 tablets/PTP*3), 100 tablets/bottle

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.

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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.