Medication info
Taeguk Simvastatin Tablets

Taeguk Simvastatin Tablets

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

MFDS item code 200401145 · Notified 2004.05.03 · Insurance code 644802220

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial starting dose of this medication as simvastatin is 40 mg once daily. In cases of hyperlipidemia, the general initial starting dose is 20 mg taken once daily in the evening, while mild to moderate hypercholesterolemia patients may start with 10 mg. This medication should be taken at a dose of 5 to 40 mg once daily in the evening, with dosage adjustments made according to treatment goals and patient response. The dosage for specific patient groups is as follows:
Child dose
For pediatric patients with homozygous familial hypercholesterolemia (ages 10-17), the recommended dose is 10 mg once daily in the evening, with a recommended dosage range of 10 to 40 mg per day and a maximum dose of 40 mg per day.

Ingredients

Manufacturer
태극제약(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
  • familial hypercholesterolemia
  • early risk factors for cardiovascular disease
View approved original text

This medication helps reduce the risk of cardiovascular diseases. It particularly lowers the risk of death from heart disease and the likelihood of myocardial infarction and stroke in individuals with a history of coronary heart disease, diabetes, peripheral vascular disease, and stroke. Additionally, it reduces the risks associated with other vascular surgeries. It is also used in the treatment of hyperlipidemia, improving blood lipid levels by decreasing total cholesterol, LDL-cholesterol, Apo-B protein, and triglycerides while increasing HDL-cholesterol levels. Specifically, it is used as an adjunct to diet in children with familial hypercholesterolemia to help manage cholesterol levels. Therefore, this medication improves overall cardiovascular health through the prevention of cardiovascular diseases and management of hyperlipidemia.

How to take

Adult dose

The recommended initial starting dose of this medication as simvastatin is 40 mg once daily. In cases of hyperlipidemia, the general initial starting dose is 20 mg taken once daily in the evening, while mild to moderate hypercholesterolemia patients may start with 10 mg. This medication should be taken at a dose of 5 to 40 mg once daily in the evening, with dosage adjustments made according to treatment goals and patient response. The dosage for specific patient groups is as follows:

Child dose

For pediatric patients with homozygous familial hypercholesterolemia (ages 10-17), the recommended dose is 10 mg once daily in the evening, with a recommended dosage range of 10 to 40 mg per day and a maximum dose of 40 mg per day.

Precautions

This medication is primarily used to lower blood cholesterol levels. However, caution is required as muscle abnormalities may occur while taking this medication. Particularly, co-administration with certain drugs or high doses may significantly increase the risk of serious muscle damage such as myopathy or rhabdomyolysis. Symptoms like muscle pain or weakness should be reported to a physician immediately, and medication should be discontinued if necessary. Individuals with liver function problems or liver disease should not take this medication and should have regular liver function tests. Pregnant women or those who may become pregnant, as well as nursing mothers, should not take this medication and must consult a physician if planning to become pregnant. This medication may interact with various drugs, so patients taking other medications must inform their physician or pharmacist. Specifically, co-administration with certain antifungal agents, antibiotics, immunosuppressants, calcium channel blockers, and some lipid-lowering agents may increase the risk of side effects. Elderly patients, those with kidney or thyroid issues, or those who consume alcohol regularly should use this medication with extra caution. It is only used in pediatric patients aged 10 years and older who meet specific conditions, and its effects on growth and sexual maturation will be evaluated by a doctor. While taking this medication, symptoms such as muscle pain, liver function abnormalities, neurological symptoms, and allergic reactions may present; any symptoms should be consulted with healthcare professionals immediately. In the event of an overdose, general emergency measures should be taken, and medication use should always follow a physician's instructions. Lastly, this medication should be stored out of reach of children and kept in its original container, and consumption with specific foods such as grapefruit juice should be avoided.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, peeling skin, pain in oral/conjunctival mucous membranes, shortness of breath or breathing difficulties, asthma attacks, cough with fever, respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle cramps
  • myalgia
  • arthralgia
  • taste disturbances
  • extraocular muscle disorders
  • facial weakness
  • tremor
  • sensory disturbances
  • peripheral neuropathy
  • peripheral nerve paralysis
  • psychological disorders
  • anxiety
  • sleep disorders
  • depression
  • cognitive impairment
  • severe muscle weakness or ocular muscle.

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

Storage

This medication should be stored in a tightly sealed container that is well-ventilated, at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the medication's effectiveness 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.