Medication info

Seltojet Tablets 10/40 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202100210 · Approved 2021.01.08

This product's status changed to Approval withdrawn on 2025.10.20. 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 and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/40 mg per day. A starting dose of 10/10 mg or 10/20 mg per day is recommended. For patients who require greater LDL cholesterol reduction, the dosage may be adjusted. After starting treatment or adjusting the dosage, lipid levels in the blood should be checked after intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia and dyslipidemia

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

This medication can be used in conjunction with diet for patients with primary hypercholesterolemia or mixed dyslipidemia. It lowers elevated levels of total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in the blood while increasing HDL cholesterol levels. It is particularly beneficial for individuals at risk of atherosclerotic vascular diseases, and it should be used appropriately along with a dietary regimen that includes restrictions on saturated fats and cholesterol. Before starting treatment, it is important to confirm and treat any other causes of dyslipidemia, such as diabetes and hypothyroidism, if necessary. The treatment effect will be assessed by regularly checking blood lipid levels. This medication effectively acts on dyslipidemia to improve cholesterol and lipid levels.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/40 mg per day. A starting dose of 10/10 mg or 10/20 mg per day is recommended. For patients who require greater LDL cholesterol reduction, the dosage may be adjusted. After starting treatment or adjusting the dosage, lipid levels in the blood should be checked after intervals of more than 2 weeks.

Precautions

This medication can cause a rare side effect, rhabdomyolysis, which can lead to serious muscle problems. If severe muscle pain or weakness occurs, you should immediately notify a doctor. This medication should not be administered to individuals with certain diseases or to pregnant women, nursing mothers, or patients with liver or muscle diseases. Furthermore, patients taking specific medications should not use this drug. Caution should be exercised when administering this medication to patients with impaired liver function, alcohol dependence, elderly patients, or those with kidney problems, and regular checks on liver function and muscle condition are necessary. While taking this medication, liver enzyme levels may rise, or signs of liver damage may appear, so regular liver function tests should be performed, and any abnormal symptoms should be reported to healthcare professionals immediately. This medication may raise blood sugar levels, so diabetic patients should manage their blood sugar carefully and may require additional treatment if necessary. During treatment, skin reactions such as rash or itching, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome may occur. In such cases, treatment should be discontinued immediately, and consultation with a physician is required. This medication may interact with other drugs, so it is essential to inform your doctor or pharmacist of any medications you are currently taking, especially those that inhibit or activate the enzymes that break down drugs in the liver. Women of childbearing potential should use appropriate birth control methods while taking this medication and should not take it if they are pregnant or may become pregnant. The safety and efficacy of this medication in children have not been established, and it is not recommended for use in this age group. In case of overdose, no specific antidote exists, so treatment should be symptomatic, and liver function and muscle condition should be monitored. 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, paleness, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning bolt headache, seizures, disorientation, visual disturbances, paralysis, urination changes.

Mild side effects

  • Decreased sensation
  • abnormal perception
  • hypertension
  • increased ALT
  • increased GGT
  • nasopharyngitis
  • cough
  • itching
  • dizziness
  • diabetes
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  • weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • rhinosinusitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • abnormal perception
  • sensory reduction
  • mild.

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 important to store it at a temperature between 1 degree and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White 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.