Medication info
Simbacrin Tablet (Simvastatin)

Simbacrin Tablet (Simvastatin)

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

MFDS item code 200403084 · Notified 2004.08.23 · Insurance code 669801800

Summary

Main use
Reduction of the risk of cardiovascular diseases and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial dosage for reducing the risk of cardiovascular disease is 40 mg per day. For the treatment of hyperlipidemia, the general initial dosage is 20 mg taken once daily in the evening, and patients with mild to moderate hypercholesterolemia may start at 10 mg. The dosage should be taken in the evening at 5 to 40 mg once daily. Before starting, the initial LDL-cholesterol level, treatment goals, and patient response should guide dosage adjustments.
Child dose
The recommended initial dosage for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily in the evening. The recommended dosage range is from 10 to 40 mg per day, and the maximum dosage is

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Reduction of the risk of cardiovascular diseases and improvement of hyperlipidemia

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

This medication is used to reduce the risk of cardiovascular disease. It particularly lowers the risk for coronary events in adults with a history of coronary artery disease or diabetes, peripheral vascular disease, or cerebrovascular disease. Additionally, it is effective in treating hyperlipidemia by reducing cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia while increasing good cholesterol, HDL. It is also used as an adjunct to dietary therapy in pediatric patients with familial hypercholesterolemia to improve blood lipid levels. Overall, this medication is used to enhance cardiovascular health and reduce the risk of related diseases.

How to take

Adult dose

The recommended initial dosage for reducing the risk of cardiovascular disease is 40 mg per day. For the treatment of hyperlipidemia, the general initial dosage is 20 mg taken once daily in the evening, and patients with mild to moderate hypercholesterolemia may start at 10 mg. The dosage should be taken in the evening at 5 to 40 mg once daily. Before starting, the initial LDL-cholesterol level, treatment goals, and patient response should guide dosage adjustments.

Child dose

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

Precautions

This medication is primarily used to lower blood cholesterol levels. However, caution is needed as it may cause muscle-related abnormalities. Importantly, symptoms such as myalgia or muscle weakness, and in severe cases, rhabdomyolysis, a serious muscle injury, can occur. These muscle issues are more frequent with higher dosages. Therefore, patients on high doses should notify their physician immediately if muscle-related symptoms arise. This medication is mainly metabolized in the liver, thus it should not be administered to patients with liver disease or impaired liver function. Moreover, it should not be used during pregnancy or by women who are possibly pregnant or lactating. There are various drugs that should not be taken with this medication; therefore, patients taking other medications should always consult their doctor or pharmacist. Especially, certain antifungals, antibiotics, immunosuppressants, and calcium channel blockers can interact with this medication, increasing the risk of side effects. Grapefruit juice can also increase the blood concentration of this medication and should be avoided while taking it. The risk of muscle abnormalities is higher in elderly patients, women, individuals with impaired kidney function, and those with hypothyroidism, so this medication should be used with extra caution. Furthermore, patients who consume excessive alcohol should also be cautious. If any unusual symptoms arise while taking this medication, such as liver dysfunction, myalgia, muscle weakness, dyspepsia, headache, or skin rash, immediate medical attention should be sought. Regular blood tests may be necessary to assess liver function and muscle enzyme levels. This medication can also be used in children and adolescents; however, safety has not been established for children under 10 years of age, so it should not be used. Women who are pregnant or planning to become pregnant should consult their physician before taking this medication and should use appropriate contraceptive measures while on it. When storing the medication, keep it out of reach of children, place it back in its original container, and seal it properly. When taking the medicine, adherence to the prescribed dose and method by a physician is essential, and patients should not change dosages or stop medication without consultation.

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 oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

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
  • myopathy
  • arthralgia
  • taste disturbances
  • extraocular muscle dysfunction
  • facial paralysis
  • tremors
  • sensory disturbances
  • peripheral neuropathy
  • peripheral nerve paralysis
  • mental disorders
  • anxiety
  • sleep disturbances
  • depression
  • cognitive impairment
  • severe muscle weakness

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. It is best to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature. Proper storage will help preserve the medication's efficacy and safety for an extended 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.