Medication info
Seltocet Tablet 10/20 milligrams

Seltocet Tablet 10/20 milligrams

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202100211 · Approved 2021.01.08 · Insurance code 693903390

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 meal times. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg per day. A starting dose of 10/10mg or 10/20mg per day is recommended. For patients requiring a greater reduction in LDL cholesterol, the dosage may be adjusted accordingly. After starting treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than two weeks.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)

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

This medication helps lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases beneficial HDL cholesterol levels. It is particularly effective when used in conjunction with dietary modifications, and establishing a treatment plan that considers other risk factors is important. Additionally, any secondary causes such as diabetes or hypothyroidism should be identified and treated as necessary, and lipid levels should be monitored regularly. This medication contributes to reducing the risk of cardiovascular disease, but its effectiveness has not been proven for certain types of dyslipidemia, so it is recommended to take it under the guidance of a healthcare professional. For safe and effective treatment, it is important to consistently use this medication while improving lifestyle habits. This medication is used for the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meal times. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg per day. A starting dose of 10/10mg or 10/20mg per day is recommended. For patients requiring a greater reduction in LDL cholesterol, the dosage may be adjusted accordingly. After starting treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than two weeks.

Precautions

This medication may rarely cause rhabdomyolysis, a condition that can result in severe kidney problems due to muscle tissue damage. Patients with severe myopathy symptoms or impaired kidney function should temporarily discontinue or stop using this medication. This medication should not be used in certain patients. For instance, individuals who are allergic to this medication, have severe liver dysfunction, have muscle disorders, are pregnant or nursing females, are taking specific antiviral medications, or have genetic problems such as lactose intolerance should not take this medication. Alcoholics or individuals with a history of liver disease, those with impaired kidney function, patients with hypothyroidism, those with a family history of muscle disorders, and elderly individuals over 70 years of age, who are at high risk of myopathy, should use this medication with caution. If symptoms such as muscle pain, muscle cramps, fatigue, or muscle pain accompanied by fever occur while taking this medication, it is essential to inform a doctor immediately, and blood tests may be necessary to check for muscle damage. Liver function abnormalities may occur, thus regular liver function tests should be conducted before starting this medication and during treatment. Particularly, if liver function levels rise significantly above normal, the medication should be discontinued. Pregnant women or those who may become pregnant should not take this medication as it could harm the fetus, and fertile women should use appropriate contraception methods. This medication may cause symptoms like dizziness, so caution is needed when driving or operating machinery. As there are numerous interactions with other medications, co-administration with certain drugs may increase the blood concentration of this medication, increasing the risk of side effects, so it is crucial to inform a doctor or pharmacist of any other medications being taken. Safety in pediatrics has not been established, thus it is not recommended for children. Elderly patients are at higher risk of myopathy; caution is needed during administration, but no specific dosage adjustment is necessary. In cases of overdose, there is no specific antidote, and symptomatic treatment and supportive care should be provided, with liver function and muscle damage being assessed. This medication should be kept out of reach of children, and caution should be taken as transferring it to another container may deteriorate its quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory difficulty accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe overall malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual abnormalities, paralysis, urination

Mild side effects

  • Reduced sensation
  • dysesthesia
  • hypertension
  • increased ALT
  • increased GGT
  • nasopharyngitis
  • cough
  • itching
  • dizziness
  • diabetes
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  • headache
  • fatigue
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • throat/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • dysesthesia
  • sensory loss
  • dysgeusia
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue

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. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the effectiveness of the medication.

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.