Medication info

TGP Simvastatin 20 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
해태에이치티비(주)
Appearance
Yellowish-brown oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201307299 · Approved 2013.05.10

This product's status changed to Approval withdrawn on 2025.05.29. 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 dosage for adults is 5 to 40 mg once daily in the evening. The initial starting dose of Simvastatin is 40 mg per day, with a common initial starting dose being 20 mg, and for patients with mild to moderate hypercholesterolemia, it can begin at 10 mg. Certain patient groups may have different dosages; for example, the elderly should start with 20 mg per day, while those taking verapamil or diltiazem or dronedarone should start with 10 mg per day.
Child dose
The recommended initial dose for pediatric patients (aged 10 to 17 years) with heterozygous familial hypercholesterolemia is to take 10 mg once daily in the evening, with a recommended dosage range of 10 to 40 mg per day, and the recommended maximum dose is 40 mg per day.

Ingredients

Manufacturer
해태에이치티비(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medicine helps reduce the risk of cardiovascular disease in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, or stroke. It lowers the risk of death from coronary heart disease, as well as the risk of non-fatal myocardial infarction and stroke, and also reduces the risk of complications related to vascular surgery. Additionally, it effectively lowers high cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia and increases good cholesterol (HDL). It is also used in pediatric patients with familial hypercholesterolemia and is utilized as an adjunct to improve blood lipid levels in conjunction with dietary therapy. Thus, this drug is used to improve various risk factors associated with cardiovascular diseases and enhance cardiovascular health.

How to take

Adult dose

The dosage for adults is 5 to 40 mg once daily in the evening. The initial starting dose of Simvastatin is 40 mg per day, with a common initial starting dose being 20 mg, and for patients with mild to moderate hypercholesterolemia, it can begin at 10 mg. Certain patient groups may have different dosages; for example, the elderly should start with 20 mg per day, while those taking verapamil or diltiazem or dronedarone should start with 10 mg per day.

Child dose

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

Precautions

This medication requires caution as it may cause muscle problems. Especially at high doses, there is an increased risk of muscle damage known as myopathy or rhabdomyolysis. Patients who are allergic to this medication or have impaired liver function, as well as pregnant or nursing women, should not use it. Additionally, it can be dangerous when taken with certain strong medications, so consultation with a physician is necessary. Individuals who consume excessive amounts of alcohol or have liver or kidney problems, those with hypothyroidism or a history of muscle disorders, elderly individuals, and women should be particularly cautious when using this medication. If symptoms such as muscle pain, muscle weakness, or pain occur while taking this medication, it is essential to notify a physician immediately, and sometimes it may be necessary to discontinue the medication. Regular liver function tests are important as liver function abnormalities may occur. If symptoms of hepatitis or jaundice appear, notify a physician immediately. This medication may interact with other drugs, so if you are taking other medications, be sure to inform healthcare providers, particularly when used with certain antibiotics, antifungals, immunosuppressants, calcium channel blockers, etc., dosage adjustment or discontinuation may be necessary. Women who are planning to become pregnant or are potentially pregnant should use contraception and must discontinue the medication immediately if pregnancy is confirmed. Use in children aged 10 years and older, especially between the ages of 10 and 17, should be limited, and consultation with healthcare providers regarding effects on growth and maturation is necessary. Elderly patients may respond differently to the medication, so caution is required during use. In case of overdose, seek immediate medical attention for appropriate treatment. This medication must be stored out of reach of children, and it should be kept in its original container to maintain its quality.

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, peeling skin, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory issues with coughing+fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, impaired vision, paralysis, urination

Mild side effects

  • Abdominal pain
  • fatigue
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • edema
Show 26 more
  • atrial fibrillation
  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle cramps
  • arthralgia
  • taste disturbance
  • ocular movement disorder
  • facial paresis
  • tremor
  • sensory disturbance
  • peripheral neuropathy
  • peripheral nerve paralysis
  • mental disorders
  • anxiety
  • sleep disturbances
  • depression
  • cognitive impairment
  • cataract progression
  • ocular muscle paralysis

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 the ingress of air or moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help keep the medication effective for a longer period.

Appearance and packaging

Appearance

Yellowish-brown 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.