Medication info

GL Jet Tablets 10/40 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Prescription medicationApproval withdrawn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/PVC[X3]
Approval status
Approval withdrawn

MFDS item code 202101401 · 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This product's status changed to Approval withdrawn on 2023.04.19.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 hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg once daily is recommended. In patients requiring a greater reduction in LDL cholesterol (greater than 55%), an initial dose of 10/40 mg once daily is recommended. After starting treatment or adjusting the dose, blood lipid levels should be monitored at least every 2 weeks, and the dose may be adjusted based on the results.

Ingredients

Manufacturer
지엘파마(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
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication helps reduce 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 (good cholesterol). It is also used alone or in combination with other lipid-lowering treatments to manage cholesterol levels in patients with homozygous familial hypercholesterolemia. This medication is administered alongside an appropriate diet, serving as an adjunctive treatment when dietary control alone is insufficiently effective. Before treatment, it is important to evaluate for other causes of dyslipidemia such as diabetes or hypothyroidism, and treat if necessary. Continuous monitoring of cholesterol and triglyceride levels through blood tests is recommended, and lipid testing is also advised during acute cardiovascular events. This medication is used to lower the risk of atherosclerotic vascular diseases and improve overall blood lipid status.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg once daily is recommended. In patients requiring a greater reduction in LDL cholesterol (greater than 55%), an initial dose of 10/40 mg once daily is recommended. After starting treatment or adjusting the dose, blood lipid levels should be monitored at least every 2 weeks, and the dose may be adjusted based on the results.

Precautions

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can lead to severe muscle damage. Patients exhibiting severe muscle disease symptoms or those with renal function issues should temporarily discontinue or stop using this medication. Individuals with allergies to the active ingredient or other components, those with severe liver dysfunction, patients with muscular diseases, women who are pregnant or may become pregnant, nursing mothers, and those taking certain other medications should not take this medication. Caution should be exercised in patients with a history of alcoholism or liver disease, severe liver dysfunction, those at risk for muscle disease such as impaired renal function or hypothyroidism. This medication may cause side effects including muscle pain, abdominal pain, elevation of liver enzymes, and rarely symptoms such as headache, dizziness, cough, diarrhea, and others. If muscle pain, weakness, fatigue, or fever occurs during treatment, the doctor should be notified immediately, and blood tests may be conducted to assess for muscle damage. If any liver function abnormalities arise, discontinuation of this medication is necessary, and regular liver function tests are important. This medication may interact with various other drugs; therefore, patients should inform their healthcare provider of any other medications they are taking. Women of childbearing potential must use appropriate contraceptive methods to prevent pregnancy while taking this medication and should discontinue use immediately upon confirmation of pregnancy. This medication is not recommended for children due to lack of proven safety and efficacy, and caution is required for elderly patients due to the higher risk of muscle disease. Patients with active liver disease or persistent elevations of liver enzymes of unknown origin should not take this medication. In case of overdose, there is no specific antidote, and symptomatic treatment and supportive care should be sought, monitoring liver function and muscle damage.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blistering, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • arthralgia
  • muscle weakness
  • musculoskeletal pain
Show 26 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • headache
  • pharyngitis
  • sinusitis
  • upper respiratory infection
  • low back pain
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • vomiting
  • belching
  • pancreatitis
  • sore throat/voice
  • nosebleeds
  • insomnia
  • nightmares
  • perceptual disturbances
  • sensory loss

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 exposure to air and moisture, and it is best kept in a cool place below 30 degrees Celsius. This is to maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

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

Package unit

30 tablets/box - 10 tablets/PVC[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.