Medication info
Simvam 20 mg Tablets (Simvastatin)

Simvam 20 mg Tablets (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
맥널티제약(주)
Appearance
Brownish yellow oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603133 · Approved 2016.05.31

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 reducing the risk of cardiovascular disease is 40 mg once daily. For treatment of hyperlipidemia, the typical initial starting dose is 20 mg taken once daily in the evening; mild to moderately elevated cholesterol patients may start with 10 mg. The dosage can vary from 5 to 40 mg taken once daily in the evening, adjusted according to initial LDL cholesterol levels and therapeutic goals.
Child dose
The recommended initial dose for pediatric patients (10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dose of 40 mg.

Ingredients

Manufacturer
맥널티제약(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
  • dysbetalipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This drug helps reduce the risk of mortality from coronary heart disease, non-fatal myocardial infarction, and stroke, and the risk of vascular interventions in adult patients with a high risk of cardiovascular disease. It also lowers total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels in patients with various types of hyperlipidemia and increases HDL cholesterol levels, which is considered the 'good' cholesterol. This medication is used as an adjunct to dietary therapy for various dyslipidemias, including familial hypercholesterolemia. It is particularly effective in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. Thus, it is beneficial for maintaining heart health and improving blood lipid levels, contributing to the overall prevention and treatment of cardiovascular diseases.

How to take

Adult dose

The recommended initial starting dose for reducing the risk of cardiovascular disease is 40 mg once daily. For treatment of hyperlipidemia, the typical initial starting dose is 20 mg taken once daily in the evening; mild to moderately elevated cholesterol patients may start with 10 mg. The dosage can vary from 5 to 40 mg taken once daily in the evening, adjusted according to initial LDL cholesterol levels and therapeutic goals.

Child dose

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

Precautions

This medication may cause muscle-related side effects such as myopathy and rhabdomyolysis, especially when taken at high doses, and therefore caution should be exercised. If unexplained muscle pain, tenderness, or weakness occur during treatment, the physician must be informed immediately. This drug is mainly metabolized in the liver, so patients with poor liver function should avoid or use it cautiously. Women who are pregnant, might become pregnant, or are nursing should not take this medication. When taken with certain specific medications, the blood concentration of this drug may increase, raising the risk of muscle-related side effects; therefore, it is necessary to discuss adjusting the dosage or using an alternative medication with a physician. Special caution should be taken when used in combination with strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol, certain antifungals, antibiotics, calcium channel blockers, etc. Elderly patients, women, patients with reduced renal or thyroid function, and those with a history of muscle diseases need to be more careful while taking this medication. It is advisable to have liver function tests and muscle-related tests regularly while on this drug. In case of overdose, seek medical attention immediately, and this medication should be kept out of the 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 high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion, vision problems, 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
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle cramps
  • joint pain
  • taste disturbance
  • ocular movement disorders
  • facial paralysis
  • tremors
  • sensory abnormalities
  • peripheral neuropathy
  • peripheral nerve paralysis
  • mental disorders
  • anxiety
  • sleep disorders
  • nightmares
  • depression
  • cataract progression
  • ophthalmoplegia
  • anemia
  • alopecia

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

Storage

This drug must be stored in a closed container to prevent exposure to air or light, and it is important to store it at room temperature between 1 and 30 degrees Celsius. Proper storage helps to maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Brownish yellow oval film-coated tablets

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.