Medication info

Simvastatin Tablets 40 mg (Simvastatin)

Prescription medicationTablet경구Expired
Ingredient · strength
Simvastatin›40mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Red brick-colored oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 200300032 · Notified 2003.08.14

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
To reduce the risk of cardiovascular disease, the recommended initial starting dose is 40 mg once daily. For treatment of hyperlipidemia, the general initial starting dose is 20 mg once daily in the evening, and patients with mild to moderate hypercholesterolemia may start at 10 mg. Administer 5 mg to 40 mg once daily in the evening, adjusting the dose before administration based on pre-treatment LDL-cholesterol level, treatment goals, and the patient's response to the medication.
Child dose
The recommended initial dose for pediatric patients (aged 10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily in the evening. The recommended dosage range is 10 mg to 40 mg once daily, with the recommended maximum dose being 1

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • hypercholesterolemia
  • dyslipidemia
  • dysbetalipoproteinemia
  • hypertriglyceridemia
  • hypercholesterolemia
View approved original text

This drug reduces the risk of mortality from coronary heart disease, myocardial infarction, and stroke in adult patients at high risk of cardiovascular disease. It also helps to reduce the risk of complications after coronary and non-coronary vascular procedures. It is used in the treatment of hyperlipidemia, contributing to the lowering of cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia and increasing HDL cholesterol levels. It can effectively manage lipid levels either alone or in combination with other treatments in patients with familial hypercholesterolemia. It is particularly useful in reducing total cholesterol and LDL cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. This medication is used to improve cardiovascular health and treat hyperlipidemia.

How to take

Adult dose

To reduce the risk of cardiovascular disease, the recommended initial starting dose is 40 mg once daily. For treatment of hyperlipidemia, the general initial starting dose is 20 mg once daily in the evening, and patients with mild to moderate hypercholesterolemia may start at 10 mg. Administer 5 mg to 40 mg once daily in the evening, adjusting the dose before administration based on pre-treatment LDL-cholesterol level, treatment goals, and the patient's response to the medication.

Child dose

The recommended initial dose for pediatric patients (aged 10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily in the evening. The recommended dosage range is 10 mg to 40 mg once daily, with the recommended maximum dose being 1

Precautions

This drug may cause serious side effects related to muscles; therefore, if symptoms such as muscle pain or weakness occur, especially when taking high doses, it is essential to inform a doctor immediately. This drug should not be used by individuals with certain liver diseases or by women who are pregnant or breastfeeding, and caution is required in patients with impaired liver function. Additionally, this drug has a high potential for interactions with other medications, so if you are taking other medications, you must inform your doctor or pharmacist. Elderly patients, those with reduced kidney function, and patients with hypothyroidism require closer monitoring while taking this drug. During the use of this drug, regular liver function tests and muscle-related tests must be conducted, and if abnormal symptoms arise, immediate consultation with healthcare providers is required. Taking this drug with grapefruit juice or certain antibiotics, antifungals, and antiviral medications may increase the risk of side effects. Women planning to become pregnant or who may be pregnant must ensure they are using contraception before taking this drug, and if pregnancy is confirmed, the drug must be discontinued immediately. This drug is limited in use for children and adolescents, particularly not used in children under 10 years old. In case of overdose, go to a medical facility immediately for appropriate treatment, and this drug 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 mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Abdominal pain
  • fatigue
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • muscle pain
  • insomnia
  • dizziness
  • bronchitis
  • eczema
  • urinary tract infection
  • alopecia
  • itching
  • skin changes
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • erectile dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • thyroid dysfunction
  • endocrine disorders
  • cognitive impairment
  • tremors
  • sensory abnormalities
  • peripheral neuropathy

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

Storage

This drug may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

Red brick-colored oval film-coated tablet

Package unit

30 tablets/bottle, 100 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.