Medication info

Danazen Simvastatin Tablet 20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Oval film-coated tablet with yellowish-brown color
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201907000 · Approved 2019.10.01

This product's status changed to Expired on 2024.10.01. 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 recommended initial dosage is 40 mg once daily. For hypercholesterolemia, the general initial dosage is 20 mg once daily, and mild to moderate hypercholesterolemia patients may start with 10 mg. Administer once daily in the evening 5 to 40 mg. Dosage for specific patient populations should be adjusted; for example, when concomitantly taking verapamil, diltiazem, or dronedarone, it should not exceed 10 mg per day.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dosage of 40 mg per day.

Ingredients

Manufacturer
대원바이오텍주식회사

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 medication is used to reduce the risk of cardiovascular disease. It decreases the risk of cardiovascular mortality and the occurrence of myocardial infarction and stroke in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, and stroke. It also lowers the risk of coronary and non-coronary vascular interventions. It is effective in treating hyperlipidemia, reducing total cholesterol, LDL cholesterol, and Apo-B protein levels while increasing HDL cholesterol, thus improving blood lipid status. It is used for primary and familial hypercholesterolemia as well as various dyslipidemias. Especially in pediatric patients with heterozygous familial hypercholesterolemia, it aids in lowering total cholesterol and LDL cholesterol levels as an adjunct to dietary therapy. This medication is used to improve cardiovascular health and prevent heart-related diseases.

How to take

Adult dose

The recommended initial dosage is 40 mg once daily. For hypercholesterolemia, the general initial dosage is 20 mg once daily, and mild to moderate hypercholesterolemia patients may start with 10 mg. Administer once daily in the evening 5 to 40 mg. Dosage for specific patient populations should be adjusted; for example, when concomitantly taking verapamil, diltiazem, or dronedarone, it should not exceed 10 mg per day.

Child dose

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

Precautions

This medication may pose a risk of muscle problems, particularly at high doses, leading to serious muscle injury such as myopathy or rhabdomyolysis. It should not be used in patients with certain conditions or those taking specific medications; for example, patients with liver dysfunction or pregnant women, and those taking strong CYP3A4 inhibitors should not take this medication. Due to its potential impact on liver function, patients with liver disease or those who consume large amounts of alcohol should use this medication cautiously. Patients with reduced kidney function are also at higher risk for muscle damage, so caution is necessary. This medication should be administered cautiously in women, the elderly, and patients with hypothyroidism. Side effects such as muscle pain, weakness, abdominal pain, headache, and dyspepsia may occur, and if serious abnormal symptoms appear, consultation with a physician should be obtained immediately. Interactions with other drugs may increase the risk of muscle damage; therefore, if any other medications are being taken, patients must inform their doctor or pharmacist. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant must use contraception while taking it. This medication is not to be used in children under 10 years old or pre-menstrual pediatric patients. Elderly patients may have increased blood concentration levels of this medication, necessitating dosage adjustment and careful monitoring. During treatment, liver function and muscle status should be regularly monitored for abnormalities. In case of overdose, immediate medical attention should be sought, and it should be stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • difficulty breathing
  • rhabdomyolysis
  • acute renal failure
  • severe edema
  • hepatitis
  • liver failure
  • cholestatic jaundice
  • fulminant hepatic necrosis
Show 15 more
  • cirrhosis
  • severe liver damage
  • jaundice
  • severe allergic reactions
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • serious neurological symptoms
  • peripheral nerve paralysis
  • acute seizures
  • confusion
  • visual disturbances
  • paralysis
  • rapid decline in kidney function
  • severe headache
  • severe abdominal symptoms

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, dyspepsia, bloating, nausea, headache, upper respiratory infection, edema, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchitis, rhinitis, eczema, urinary tract infection, muscle cramps, arthralgia, taste disturbance, ocular movement disorder, facial incomplete paralysis, tremor, sensory disturbance, peripheral neuropathy, peripheral nerve paralysis, mental disorders, anxiety, sleep disorders, depression, cognitive impairment, severe muscle weakness or ophthalmoplegia

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 and moisture from entering and kept at a temperature between 1°C and 30°C. Storing it this way will maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Oval film-coated tablet with yellowish-brown color

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.