Medication info

GLjet Tablet 10/20 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›Strength being verifiedEzetimibe›Strength being verified
Manufacturer / importer
지엘파마(주)
Appearance
White to off-white, oval-shaped biconvex film-coated tablet
Packaging
30 tablets/box - 10 tablets/PTP[X3]
Approval status
Approval withdrawn

MFDS item code 202101402 · Approved 2021.02.18

This product's status changed to Approval withdrawn on 2023.04.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of lipid levels through cholesterol reduction and HDL increase in primary hypercholesterolemia (homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the recommended initial dose is 10/10 mg or 10/20 mg once daily. For patients needing greater LDL cholesterol reduction (55% or more), the recommended initial dose is 10/40 mg once daily. After starting treatment or adjusting doses, check blood lipid levels at intervals of at least 2 weeks before making further adjustments.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Improvement of lipid levels through cholesterol reduction and HDL increase in primary hypercholesterolemia (homozygous familial) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used as an adjunct to dietary therapy to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, and to increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. For patients with homozygous familial hypercholesterolemia, it may be administered as an adjunct to other lipid-lowering therapies or used alone when other treatments are ineffective. This medication helps reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia. During treatment, it is important to follow a diet, verify any underlying causes of dyslipidemia, and treat them if necessary. Moreover, continuous monitoring of lipid levels through testing is essential. This medication is effectively used for the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the recommended initial dose is 10/10 mg or 10/20 mg once daily. For patients needing greater LDL cholesterol reduction (55% or more), the recommended initial dose is 10/40 mg once daily. After starting treatment or adjusting doses, check blood lipid levels at intervals of at least 2 weeks before making further adjustments.

Precautions

This medication carries a risk of serious problems with muscles, so immediately notify a doctor if sudden muscle pain, muscle weakness, fatigue, or fever occurs. Since muscle damage can lead to kidney function deterioration, it may be necessary to temporarily discontinue the medication after serious infections, major surgery, or in patients with kidney disease. This medication can affect liver function, so liver function tests should be performed before administering it, and liver health should be monitored regularly during use. Patients with liver disease or significantly elevated liver enzyme levels should not use this medication. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication, and effective contraception should be utilized during treatment. This medication may have an increased risk of muscle damage when taken with certain drugs, so if other medications are being taken, inform your doctor or pharmacist. It is not recommended for children as safety and effectiveness have not been established. Caution is necessary when administering to the elderly due to the risk of myopathy, but no specific dose adjustment is needed. In case of overdose, as there is no specific antidote, appropriate treatment and monitoring of liver and muscle-related tests should be conducted based on symptoms. Dizziness may occur during the use of this medication, so caution is advised when driving or operating machinery. This medication should be stored out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/eye mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and very severe headache, lightning headache, seizure, confusional state, vision disturbances, paralysis, urination issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • dizziness
  • joint pain
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
  • sinusitis
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  • flushing
  • fatigue
  • headache
  • constipation
  • hyperglycemia
  • hypoglycemia
  • loss of appetite
  • dyspepsia
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • sensory disturbances
  • sensory loss
  • taste disturbance
  • amnesia
  • peripheral neuropathy
  • urticaria
  • skin rash
  • itching
  • hair loss
  • angioedema
  • erythema multiforme
  • gynecomastia

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 exposure, and it is recommended to keep it at a cool temperature below 30 degrees Celsius. This will help maintain the effectiveness of the medication for an extended period.

Appearance and packaging

Appearance

White to off-white, oval-shaped biconvex film-coated tablet

Package unit

30 tablets/box - 10 tablets/PTP[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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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.