Medication info
HLB Simvastatin Tablets 20 mg

HLB Simvastatin Tablets 20 mg

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
Brownish-yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200401924 · Notified 2004.06.18 · Insurance code 647300740

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
1. Reduction of the risk of cardiovascular disease - Initial starting dose: 40 mg of Simvastatin daily 2. Hyperlipidemia - General initial starting dose: 20 mg once daily in the evening - Mild to moderate hypercholesterolemia: Can start with 10 mg - Recommended dosage: 5 to 40 mg once daily in the evening - Dosage may be adjusted based on treatment goals and patient response - 80 mg dose requires evidence of muscle toxicity before use
Child dose
3. Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) - Recommended initial dose: 10 mg once daily in the evening - Recommended dose range: 10 to 40 mg once daily - Recommended maximum dose

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medication helps reduce the risk of cardiovascular diseases, particularly in patients with high risks for coronary artery disease, stroke, and peripheral vascular disease, lowering the risk of death from coronary artery disease, myocardial infarction, and stroke. It also reduces the risk of complications after vascular interventions. This drug is used in the treatment of hyperlipidemia, effectively lowering total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels, while increasing HDL cholesterol. It helps improve lipid levels when combined with diet in pediatric patients with heterozygous familial hypercholesterolemia. Thus, this medication is widely used for managing cardiovascular diseases and hyperlipidemia.

How to take

Adult dose

1. Reduction of the risk of cardiovascular disease - Initial starting dose: 40 mg of Simvastatin daily 2. Hyperlipidemia - General initial starting dose: 20 mg once daily in the evening - Mild to moderate hypercholesterolemia: Can start with 10 mg - Recommended dosage: 5 to 40 mg once daily in the evening - Dosage may be adjusted based on treatment goals and patient response - 80 mg dose requires evidence of muscle toxicity before use

Child dose

3. Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) - Recommended initial dose: 10 mg once daily in the evening - Recommended dose range: 10 to 40 mg once daily - Recommended maximum dose

Precautions

This medication is primarily used to lower cholesterol. However, caution is needed as muscle problems may occur while taking this drug. Especially at higher doses, the risk of serious muscle damage known as myopathy or rhabdomyolysis may increase. Patients taking this medication at high doses should inform their doctor immediately if they experience muscle pain or weakness. Additionally, because this drug is metabolized in the liver, it should not be used in patients with poor liver function or liver disease. Women who are pregnant, potentially pregnant, or breastfeeding should not take this medication. This drug should not be taken with other medications that interfere with liver metabolism, such as certain antibiotics, antifungals, and immunosuppressants, as this increases the risk of side effects. Furthermore, individuals who excessively consume alcohol, have poor kidney function, hypothyroidism, the elderly, and females should be especially cautious when taking this medication. Rarely, various side effects such as liver dysfunction, blood abnormalities, skin rashes, digestive disorders, and neurological issues may occur, so any unusual symptoms should prompt immediate consultation with a healthcare provider. It is advisable to regularly check liver function and muscle status through blood tests during treatment. Additionally, it is safe to avoid certain foods like grapefruit juice during the course of this medication. Finally, this medication is not recommended for children, especially females under 10 years old or before menarche.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough + respiratory abnormalities accompanied by fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • muscle pain
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • alopecia
  • itching
  • various skin changes
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • elevated aminotransferases
  • ALP
  • γ-GTP
  • bilirubin levels

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 air ingress, and it is best kept at room temperature between 1 and 30 degrees Celsius. This will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

Brownish-yellow oval film-coated tablet

Package unit

30 tablets/bottle, 300 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.