Medication info
ElzeJet Tablet 2/10 mg

ElzeJet Tablet 2/10 mg

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium›2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)보령
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202301674 · Approved 2023.05.25 · Insurance code 641908270

Summary

Main use
Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia
Who takes it
Adults
Adult dose
This medication is to be administered once daily without regard to meals. A starting dose of 2/10 mg once daily is recommended. If the effect on lowering LDL cholesterol is insufficient, the dosage may be increased up to a maximum of 4/10 mg once daily. The dosage should be adjusted appropriately with an interval of 4 weeks or more. For patients with liver dysfunction, an initial dose of 1 mg once daily is recommended, with a maximum dosage of 2/10 mg once daily.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Improvement of hypercholesterolemia (primary, mixed) and treatment of dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication helps to reduce elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing levels of HDL cholesterol, the 'good' cholesterol. It serves as an adjunct to dietary therapy, improving blood lipid levels. Consequently, this is expected to reduce the risk of cardiovascular diseases. Therefore, this drug is effectively used for cholesterol management in patients with hyperlipidemia.

How to take

Adult dose

This medication is to be administered once daily without regard to meals. A starting dose of 2/10 mg once daily is recommended. If the effect on lowering LDL cholesterol is insufficient, the dosage may be increased up to a maximum of 4/10 mg once daily. The dosage should be adjusted appropriately with an interval of 4 weeks or more. For patients with liver dysfunction, an initial dose of 1 mg once daily is recommended, with a maximum dosage of 2/10 mg once daily.

Precautions

This drug should not be used in certain patients. For example, individuals allergic to or hypersensitive to this drug's ingredients, those with active liver disease or persistently elevated liver enzyme levels of unknown cause, or patients with severe liver impairment or biliary obstruction should not be administered the drug. Additionally, it is not administered to patients taking immunosuppressants such as cyclosporine, those with myopathy, pregnant women or women who could become pregnant, nursing mothers, and children. Patients with lactose intolerance or specific metabolic disorders should also exercise caution. This drug should be used cautiously in patients with compromised liver function or those consuming large amounts of alcohol, as well as in patients with renal function abnormalities. Notably, co-administration of fibrates or niacin may increase the risk of muscle damage and kidney function deterioration, so such combinations should be avoided or given cautiously. Elderly patients, patients with hypothyroidism, patients with genetic muscle diseases, or those with a past history of drug-induced myopathy also require caution. Adverse reactions such as muscle pain, weakness, fatigue, gastrointestinal disturbances, headaches, and skin rashes may occur during medication. If pain or weakness in the muscles is felt, immediate consultation with a doctor is necessary, as there is a risk of rhabdomyolysis, a serious side effect related to muscle damage. Abnormal liver function can also occur, so regular liver function tests should be performed before and during treatment. If liver enzyme levels rise significantly, the use of the drug should be discontinued. This drug should not be used in pregnant or nursing women, and should be avoided in cases of planned pregnancy. Care should be taken regarding drug interactions. Especially when taken with cyclosporine, fibrates, niacin, or certain antibiotics, the risk of muscle damage and kidney function deterioration may increase. Therefore, patients taking other medications should definitely consult their doctor or pharmacist. In cases of overdose, there is no specific antidote, so symptom-based treatment and supportive care should be administered while monitoring liver function and muscle enzyme levels. The medication should be stored out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • chest discomfort
  • dyspnea
  • jaundice
  • sudden and severe headache
  • paralysis
  • vision abnormalities
  • rhabdomyolysis
  • myopathy
  • deterioration of kidney function
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  • thrombocytopenia
  • anaphylaxis
  • rash and angioedema
  • erythema multiforme
  • severe muscle weakness
  • ophthalmoplegia
  • interstitial lung disease

Mild side effects

  • Abdominal pain
  • diarrhea
  • dry mouth
  • bloating
  • gastroesophageal reflux disease
  • toothache
  • increased serum creatine phosphokinase
  • increased alanine aminotransferase
  • increased aspartate aminotransferase
  • weakness
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  • fatigue
  • myalgia
  • taste abnormalities
  • headache
  • dizziness
  • decreased appetite
  • insomnia
  • dyspnea
  • constipation
  • dryness
  • malaise
  • itching
  • rash
  • dermalgia
  • burning sensation
  • arthralgia
  • edema
  • blurred vision
  • photophobia
  • hearing loss

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

Storage

This drug is sensitive to light and should be stored in an opaque container that does not allow light in. It is also important to store the medication at a temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 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.

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.