Medication info
Simvastatin 40 mg Tablets (Simvastatin)

Simvastatin 40 mg Tablets (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›40mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Pink oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200301131 · Notified 2003.03.26 · Insurance code 640001040

Summary

Main use
Reduction of risk of cardiovascular diseases (coronary heart disease, stroke) and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
1. For reduction of risk of cardiovascular disease: 40 mg once daily in the evening. 2. For hyperlipidemia: Typically, 20 mg once daily in the evening, while mild to moderate hypercholesterolemia patients may start at 10 mg. 3. Administer 5-40 mg once daily in the evening, and cholesterol levels should be measured at 4 weeks and afterwards to adjust the dosage. 4.
Child dose
Patients aged 10-17 years are recommended an initial dose of 10 mg once daily in the evening, with a recommended dose range of 10-40 mg per day, and a maximum dose of 40 mg per day. Dosage should be adjusted according to treatment needs.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Reduction of risk of cardiovascular diseases (coronary heart disease, stroke) and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • primary dysbetalipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication effectively reduces the risk of cardiovascular disease. It lowers the risk of death from coronary heart disease and the risk of non-fatal myocardial infarction and stroke in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, and stroke. It also reduces the risk after coronary and non-coronary vascular procedures. In patients with hyperlipidemia, it aids in reducing total cholesterol and LDL cholesterol levels, as well as controlling Apo-B protein and triglyceride levels. It is particularly effective in patients with genetic dyslipidemias such as familial hypercholesterolemia when used in conjunction with dietary therapy. It is also used for children over 10 years old with heterozygous familial hypercholesterolemia to improve cholesterol levels. This medication is used to maintain cardiovascular health and improve dyslipidemia.

How to take

Adult dose

1. For reduction of risk of cardiovascular disease: 40 mg once daily in the evening. 2. For hyperlipidemia: Typically, 20 mg once daily in the evening, while mild to moderate hypercholesterolemia patients may start at 10 mg. 3. Administer 5-40 mg once daily in the evening, and cholesterol levels should be measured at 4 weeks and afterwards to adjust the dosage. 4.

Child dose

Patients aged 10-17 years are recommended an initial dose of 10 mg once daily in the evening, with a recommended dose range of 10-40 mg per day, and a maximum dose of 40 mg per day. Dosage should be adjusted according to treatment needs.

Precautions

This medication can cause muscle-related issues, potentially leading to myopathy or rhabdomyolysis. The risk can be increased, particularly when taken at high doses or in combination with certain medications. Patients with hypersensitivity to this medication, liver function impairment, pregnant or nursing women, and those taking powerful CYP3A4 inhibitors or certain medications should not take this medication. Patients with liver dysfunction, reduced kidney function, hypothyroidism, history of muscle disorders, elderly patients, and women should be especially cautious while taking this medication, and regular testing may be required. While taking this medication, if symptoms such as muscle pain, weakness, or tenderness occur, it is important to inform a doctor immediately and have testing done. If adverse symptoms are confirmed, discontinuation of the medication is necessary. Since this medication is metabolized in the liver, regular liver function tests should be conducted, and if symptoms of hepatitis or liver function abnormalities occur, discontinuation of the medication should be immediate. This medication can interact with several other drugs, so it is crucial to inform healthcare providers of the current medications being taken when starting new ones. Women who are pregnant or may become pregnant should avoid taking this medication, and if pregnancy is confirmed while on this medication, it should be discontinued immediately and consultation with healthcare professionals should be sought. In pediatric and adolescent cases, the medication is used restrictively only if specific ages and conditions are met, as it may affect growth and sexual maturation, hence caution is required. Elderly patients may have increased blood concentrations of this medication, leading to a higher possibility of muscle-related adverse reactions; therefore, regular monitoring is needed during use. In cases of overdose, general emergency measures should be implemented, and if suspected, immediate medical attention is necessary. This medication should be kept out of reach of children and stored in its original container to prevent quality deterioration or misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever-joined respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

  • Abdominal pain
  • fatigue
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory tract infection
  • atrial fibrillation
Show 27 more
  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle cramps
  • joint pain
  • taste disturbance
  • oculomotor disorder
  • facial weakness
  • tremors
  • sensory disturbance
  • peripheral neuropathy
  • peripheral nerve paralysis
  • psychiatric disorders
  • anxiety
  • sleep disorders
  • nightmares
  • depression
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • amino

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius. By storing it this way, the medication's effectiveness can be maintained for longer.

Appearance and packaging

Appearance

Pink oval film-coated tablets

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.