Medication info

Simtami Tablets 10/10 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
White to pale yellow, double convex, rectangular tablet
Packaging
30 tablets/PTP [10 tablets/PTP X 3]
Approval status
Expired

MFDS item code 201905598 · Approved 2019.08.08

This product's status changed to Expired on 2024.08.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg daily, and the generally recommended initial dose is 10/20mg daily. Patients with a lower need for LDL cholesterol reduction may start at 10/10mg daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg daily, taken once in the evening.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease resulting from hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps reduce total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. In particular, it is used as an adjunct therapy for patients with homozygous familial hypercholesterolemia or as an alternative treatment when other treatments are ineffective. This medication is used in conjunction with an appropriate diet and is administered when dietary treatment alone is insufficient. It is important to identify and treat other causes such as diabetes and hypothyroidism before treatment. Additionally, blood lipid levels should be checked regularly to monitor treatment effectiveness and condition. This medication is used to maintain healthy blood lipid levels and reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg daily, and the generally recommended initial dose is 10/20mg daily. Patients with a lower need for LDL cholesterol reduction may start at 10/10mg daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg daily, taken once in the evening.

Precautions

This medication is primarily used to treat hyperlipidemia and is responsible for lowering cholesterol levels. However, care should be taken as serious muscle diseases such as myopathy or rhabdomyolysis may occur while taking this medication. Particularly, the risk of muscle-related side effects increases with higher doses, so it is important to adjust the dosage and take it according to the physician's instructions. This medication should not be taken by those who have allergies to its components, have active liver disease, or have elevated liver enzyme levels. Women who are pregnant or breastfeeding should not take this medication, and women who may become pregnant must consult a doctor before taking it. Additionally, this medication may interact with certain drugs; therefore, if you are taking other medications, be sure to inform your doctor or pharmacist. The risk of muscle side effects increases when combined with strong CYP3A4 inhibitors, certain antibiotics, antifungals, immunosuppressants, fibrates, niacin, etc. If unexplained muscle pain, weakness, tenderness, etc., occur while taking this medication, inform a healthcare professional immediately and discontinue use if necessary. Regular liver function tests and muscle enzyme tests may be necessary as there may be abnormal liver function. Elderly patients or those with reduced kidney function should also be cautious when taking this medication and consult a healthcare professional immediately if symptoms occur. This medication may increase drug concentration when taken with grapefruit juice, therefore, it is advisable to avoid grapefruit juice. There is no specific antidote for overdose of this medication; therefore, appropriate treatment should be sought immediately at a hospital if an overdose occurs. Patients taking this medication should inform healthcare professionals of its use when starting new medications, and should discontinue if they are planning to become pregnant or are already pregnant.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, rash, pancreatitis, chest tightness, difficulty breathing, cold sweat, paleness, toxic epidermal necrolysis (Lyell syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), hepatitis, cholestatic jaundice, cirrhosis, liver failure, liver damage, jaundice, severe rash, blisters, skin peeling, mucosal pain in mouth/eyes, sudden and severe headache, seizures, confusion, vision changes, paralysis, serious neurological symptoms

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • indigestion
  • flatulence
  • itching
  • rash
  • nocturia
  • hematuria
  • facial edema
  • insomnia
  • gastritis
  • atrophic gastritis
  • mucus stool
  • irritable bowel syndrome
  • sore throat
  • weight loss
  • weakness
  • sensory loss
  • cough

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, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a long time.

Appearance and packaging

Appearance

White to pale yellow, double convex, rectangular tablet

Package unit

30 tablets/PTP [10 tablets/PTP X 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.