Medication info
Simvast Tablets 40 mg (Simvastatin)

Simvast Tablets 40 mg (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›40mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Oval film-coated tablet of red brick color
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200402617 · Notified 2004.03.19 · Insurance code 643501470

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
1. Reduction of cardiovascular disease risk: The recommended starting dose is 40 mg once daily. 2. Hyperlipidemia: - The usual starting dose is 20 mg once daily in the evening. - Patients with mild to moderate hypercholesterolemia may start with 10 mg. - 5 to 40 mg once daily in the evening is recommended. - Patients with heterozygous familial hypercholesterolemia may receive 1 daily dose of
Child dose
Children with heterozygous familial hypercholesterolemia (ages 10 to 17): The recommended starting dose is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg daily, with a maximum dose of 1

Ingredients

Manufacturer
한미약품(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. It specifically decreases the risk of death due to coronary heart disease in adult patients with a history of coronary artery disease, diabetes, peripheral vascular disease, or stroke, while reducing the risk of non-fatal myocardial infarctions and strokes, as well as risks associated with vascular surgeries. It also aids in managing cholesterol and triglyceride levels in patients with hyperlipidemia, maintaining healthy blood lipid levels. It can be used alongside dietary therapy in patients with primary hypercholesterolemia and dyslipidemia and is also beneficial for certain types of familial hypercholesterolemia. In children aged 10 to 17 who meet specific conditions, it serves as an adjunct to dietary therapy. This medication is used to improve cardiovascular health and treat hyperlipidemia.

How to take

Adult dose

1. Reduction of cardiovascular disease risk: The recommended starting dose is 40 mg once daily. 2. Hyperlipidemia: - The usual starting dose is 20 mg once daily in the evening. - Patients with mild to moderate hypercholesterolemia may start with 10 mg. - 5 to 40 mg once daily in the evening is recommended. - Patients with heterozygous familial hypercholesterolemia may receive 1 daily dose of

Child dose

Children with heterozygous familial hypercholesterolemia (ages 10 to 17): The recommended starting dose is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg daily, with a maximum dose of 1

Precautions

This medication may cause muscle-related side effects such as myopathy or rhabdomyolysis, so caution is advised, especially when taking high doses. Patients with an allergy to this medication or its ingredients, those with liver dysfunction, pregnant or breastfeeding women, and those taking certain medications should not take this drug. Patients with impaired liver function or kidney issues, those with hypothyroidism or a history of muscle disorders, elderly patients, and women should use this medication with care. If muscle pain, muscle weakness, or unexplained muscle soreness occurs during treatment, consult your physician immediately, as discontinuation may be necessary in some cases. Since this medication is metabolized in the liver, patients with liver dysfunction should undergo regular liver function tests, and those with a history of liver disease should be particularly cautious. This medication may interact with multiple drugs, so inform your physician or pharmacist if you are taking other medications, especially when combined with certain antifungals, antibiotics, immunosuppressants, calcium channel blockers, or niacin. Women who are pregnant or may become pregnant should not take this medication, and if pregnancy occurs during treatment, it should be stopped immediately, and a physician should be consulted. This drug is also used in children and adolescents, but safety in children under 10 has not been established, hence it should not be administered to this age group. Elderly patients may have higher blood levels of this medication, necessitating dosage adjustments and careful monitoring. In case of overdose, specific antidotes are not available; general treatment is required, and this medication should be stored out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), generalized malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory tract infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • laryngitis
  • eczema
  • urinary tract infection
  • alopecia
  • itching
  • skin changes
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • erectile dysfunction
  • progression of cataracts
  • ophthalmoplegia
  • anemia
  • thyroid dysfunction
  • transient liver enzyme abnormalities
  • anxiety
  • sleep disturbances
  • restlessness

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. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Oval film-coated tablet of red brick color

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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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.