Medication info
Samtocet Tablet 10/40 Milligrams

Samtocet Tablet 10/40 Milligrams

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
White or whitish oval film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu × 3]
Approval status
Active

MFDS item code 202101550 · Approved 2021.02.18 · Insurance code 642308490

Summary

Main use
Lipid-modulating effect by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. An initial dosage of 10/10 mg or 10/20 mg daily is recommended. For patients requiring more significant (over 55%) reduction in LDL cholesterol, an initial dosage of 10/40 mg daily is recommended. After starting treatment or adjusting the dosage, check the blood lipid levels after an interval of at least 2 weeks before adjusting the dosage.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Lipid-modulating effect by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used as an adjunct to diet for the treatment of high total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia or mixed dyslipidemia. It is also used in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering therapies or when other therapies are not effective. This medication helps control lipid levels to reduce the risk of cardiovascular disease, and it is important to combine it with proper dietary measures. Before using the medication, other causes of dyslipidemia such as diabetes and hypothyroidism should be identified and treated. Regular lipid tests are necessary to monitor treatment effectiveness, especially during acute coronary events when lipid levels should be quickly checked. In conclusion, this medication is used to reduce the risks associated with hypercholesterolemia and to improve dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. An initial dosage of 10/10 mg or 10/20 mg daily is recommended. For patients requiring more significant (over 55%) reduction in LDL cholesterol, an initial dosage of 10/40 mg daily is recommended. After starting treatment or adjusting the dosage, check the blood lipid levels after an interval of at least 2 weeks before adjusting the dosage.

Precautions

This medication can affect muscle tissue and may rarely cause severe muscle damage and renal dysfunction, so immediately inform your doctor if acute muscle pain or weakness occurs. Patients with serious infections, hypotension, major surgery or trauma, metabolic disorders, etc., may need to temporarily discontinue this medication. Patients allergic to any of the ingredients, those with liver diseases, muscle diseases, pregnant or nursing women should not use this medication. Patients with alcohol addiction or liver dysfunction, elderly patients, patients with impaired renal function, or patients with hypothyroidism should be careful when using this medication. If taken with certain specific medications, the risk of muscle damage may increase, so if you are taking other medications, make sure to consult your doctor or pharmacist. While on this medication, you should regularly undergo liver function tests and muscle enzyme tests, and immediately inform healthcare professionals if you experience signs of liver dysfunction or persistent muscle pain. Be cautious of dizziness when driving or operating machinery. Women of childbearing age should use appropriate contraceptive methods while taking this medication, and should immediately discontinue if pregnancy is confirmed. Safety in children has not been established and is not recommended. There is no specific antidote for overdose, and treatment should be based on symptoms along with liver function and muscle enzyme tests. Keep out of reach of children and take care not to transfer to other containers.

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, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual abnormalities, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • nausea
  • diarrhea
  • headache
  • fatigue
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • cough
  • flushing
  • weakness
  • lethargy
  • chest pain
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • throat and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • altered perception
  • sensory impairment
  • altered taste
  • memory loss
  • peripheral neuropathy

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to keep the effectiveness and safety of the medication for a long time.

Appearance and packaging

Appearance

White or whitish oval film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu × 3]

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.