Medication info

Simvastatin CR Tablets (Simvastatin)

Prescription medication경구Approval withdrawn
Ingredient · strength
Simvastatin›20mg
Manufacturer / importer
한미약품(주)
Appearance
White to whitish round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 200708762 · Approved 2007.07.27 · Insurance code 643501450

This product's status changed to Approval withdrawn on 2024.05.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hyperlipidemia (cholesterol, triglycerides)
Who takes it
Adults
Adult dose
The initial dose is 20 mg of Simvastatin extended-release tablets taken once daily, with a maximum of 40 mg. It can be taken at any time of the day. This medication should not be crushed, divided, or chewed; the whole tablet must be swallowed. Cholesterol levels should be measured regularly after 4 weeks of starting treatment and thereafter to adjust the dosing. If cholesterol levels fall below the target level, the dose should be reduced.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improvement of hyperlipidemia (cholesterol, triglycerides)

  • Hyperlipidemia
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apo-B protein
  • elevated triglycerides
View approved original text

This medication helps to lower elevated total cholesterol, LDL cholesterol, apo-B protein, and triglyceride levels in patients with hyperlipidemia, particularly those with primary hypercholesterolemia and mixed dyslipidemia, while raising good HDL cholesterol levels. It is more effective when used in conjunction with dietary therapy. Before starting treatment, the underlying causes of secondary hyperlipidemia should be identified, and total cholesterol, HDL cholesterol, and triglyceride levels must be measured. This process allows for appropriate individualized treatment. Therefore, this drug is used to improve blood lipid levels and reduce the risk of cardiovascular diseases.

How to take

Adult dose

The initial dose is 20 mg of Simvastatin extended-release tablets taken once daily, with a maximum of 40 mg. It can be taken at any time of the day. This medication should not be crushed, divided, or chewed; the whole tablet must be swallowed. Cholesterol levels should be measured regularly after 4 weeks of starting treatment and thereafter to adjust the dosing. If cholesterol levels fall below the target level, the dose should be reduced.

Precautions

This drug can cause serious muscle-related side effects such as myopathy and rhabdomyolysis, with the risk being higher when taken at high doses, thus caution is needed. This medication should not be taken by individuals who have an allergic reaction to it, have severe liver dysfunction, or are pregnant or breastfeeding. Additionally, the risk of muscle damage may increase when taken with certain medications; therefore, patients should inform their doctor or pharmacist of other medications they are taking. People with impaired liver function or excessive alcohol consumption, reduced kidney function, hypothyroidism, a history of muscle disorders, the elderly, and women should use this medication cautiously. Symptoms such as muscle pain, weakness, or tenderness should be reported to healthcare professionals immediately during treatment, and the medication should be stopped if necessary. Liver dysfunction symptoms have also been reported, so regular liver function tests before and during treatment are important. It should be avoided during pregnancy, as it may harm the fetus, and women planning to become pregnant should use appropriate contraception. Breastfeeding should be avoided while taking this medication, as side effects may occur in nursing infants. This medication is not recommended for children under 10 years old or females before menarche. For the elderly, dose adjustments may be necessary because their response to the medication could differ. Caution must be taken to avoid coadministration with certain foods or drugs such as grapefruit juice, and any side effects should be reported to a physician immediately. In the event of overdose, immediate medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, respiratory distress, respiratory difficulties with fever, severe edema accompanied by hypertension, skin peeling, pain in oral/ocular mucosa, toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome (skin-mucosal syndrome), severe allergic reaction, severe skin reaction, liver abnormalities (jaundice), yellowing of skin or eyes (jaundice), hepatitis

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, dyspepsia, bloating, nausea, headache, upper respiratory tract infection, edema, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchiolitis, gout, eczema, urinary tract infection, muscle cramps, arthralgia, some cranial nerve disorders (taste disorders, extraocular muscle dysfunction, facial paralysis, etc.), tremors, sensory abnormalities, peripheral neuropathy, mental instability, anxiety, depression, alopecia, itching, hives, gynecomastia, sexual

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to whitish round film-coated tablets

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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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.