Medication info

Colesnon 40mg (Simvastatin)

Prescription medicationTablet경구Expired
Ingredient · strength
Simvastatin›40mg / 1 tablet
Manufacturer / importer
동아에스티(주)
Appearance
It is an oval-shaped film-coated tablet with a pale rose color.
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 200400165 · Notified 2004.02.03

This product's status changed to Expired on 2024.10.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial starting dose for this medication is 40 mg per day, typically taken once daily in the evening as 5 to 40 mg. Dosage should be adjusted based on pre-treatment LDL cholesterol levels, treatment goals, and patient response. In the elderly, a dose of 20 mg per day can achieve maximum effects. When used in conjunction with verapamil, diltiazem, or dronedarone, the dose should not exceed 10 mg per day. For amiodarone, amlodipine
Child dose
The recommended initial dosage for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, administered in the evening. The recommended dosage range is 10 to 40 mg once daily, with a maximum dosage of 40 mg per day.

Ingredients

Manufacturer
동아에스티(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular disease in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, and stroke. Specifically, it reduces the risks of death from coronary heart disease, non-fatal myocardial infarction, stroke, and vascular interventions. It is also used to lower total cholesterol, LDL cholesterol, Apo-B proteins, and triglyceride levels while increasing HDL cholesterol levels in patients with primary hyperlipidemia and dyslipidemia. This drug is effective in patients with mixed dyslipidemia and type III and IV dyslipidemia, as well as in patients with homozygous familial hypercholesterolemia. For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia who meet certain criteria, it is used as an adjunct to diet to reduce total cholesterol and LDL cholesterol levels. This medication effectively improves cardiovascular health and treats hyperlipidemia.

How to take

Adult dose

The recommended initial starting dose for this medication is 40 mg per day, typically taken once daily in the evening as 5 to 40 mg. Dosage should be adjusted based on pre-treatment LDL cholesterol levels, treatment goals, and patient response. In the elderly, a dose of 20 mg per day can achieve maximum effects. When used in conjunction with verapamil, diltiazem, or dronedarone, the dose should not exceed 10 mg per day. For amiodarone, amlodipine

Child dose

The recommended initial dosage for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, administered in the evening. The recommended dosage range is 10 to 40 mg once daily, with a maximum dosage of 40 mg per day.

Precautions

This medication is primarily used to lower cholesterol levels. Muscle-related issues may occur during treatment, especially when taking high doses or concomitant medications, increasing the risk of serious muscle damage known as myopathy or rhabdomyolysis. Therefore, patients taking this medication at high doses should immediately inform their doctor if they experience muscle pain or weakness, and dosage adjustments or a switch to another medication may be necessary. This drug is not to be administered to patients with poor liver function or active liver disease. Moreover, women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Co-administration with potent CYP3A4 inhibitors, certain lipid-lowering medications, some antibiotics, and other drugs may elevate the risk of muscle damage; hence, consultation with a physician is essential. Special precautions are necessary for the elderly, patients with impaired kidney function, or those with hypothyroidism. Regular liver function tests and muscle-related examinations during treatment are recommended, and it is crucial to notify medical staff of any abnormal symptoms. Additionally, specific foods like grapefruit juice may increase the plasma concentration of this medication and raise the risk of side effects, so they should be avoided. The use of this medication in children and adolescents is limited because it can affect growth and development, and it should be taken under the guidance of a specialist. In case of overdose, prompt medical attention should be sought, and this medication should be stored out of reach of children.

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 fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever-associated respiratory abnormalities, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary disturbances

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle cramps
  • myalgia
  • arthralgia
  • dysgeusia
  • ocular motility disorders
  • facial paresis
  • tremors
  • sensory disturbances
  • peripheral neuropathy
  • peripheral nerve palsy
  • mental disorders
  • anxiety
  • sleep disturbances
  • depression
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion
  • alopecia

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and ensure safe use.

Appearance and packaging

Appearance

It is an oval-shaped film-coated tablet with a pale rose color.

Package unit

30 tablets/bottle, 300 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.