Medication info

Megasimvastatin Tablets (Simvastatin)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Brownish-yellow oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001045 · Approved 2020.02.17

This product's status changed to Approval withdrawn on 2024.07.02. 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
1. The recommended initial starting dosage for the reduction of cardiovascular disease risk is 40 mg once daily. 2. For the treatment of hyperlipidemia, the typical initial starting dosage is 20 mg administered once daily in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg, adjusting the dosage to 5 to 40 mg taken once daily in the evening. The dosage should be adjusted based on LDL cholesterol levels and treatment objectives.
Child dose
The recommended initial dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily in the evening, with a recommended dosage range of 10 to 40 mg per day and a maximum dosage of 40 mg per day.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • hyperlipidemia
  • primary hypercholesterolemia
  • dyslipidemia
  • abetalipoproteinemia
  • high triglyceridemia
  • homozygous familial hypercholesterolemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps reduce the risk of death from coronary heart disease, as well as the risk of non-fatal myocardial infarction and stroke, in adult patients who are at high risk of cardiovascular disease. It also reduces the risk of complications after vascular surgery and is used to treat various types of hyperlipidemia. It is particularly used as an adjunct to diet in children with heterozygous familial hypercholesterolemia who have a family history or other risk factors. It effectively lowers total cholesterol and LDL cholesterol levels while increasing HDL cholesterol, improving cardiovascular health. This medication is effectively used for the treatment and prevention of heart disease and dyslipidemia.

How to take

Adult dose

1. The recommended initial starting dosage for the reduction of cardiovascular disease risk is 40 mg once daily. 2. For the treatment of hyperlipidemia, the typical initial starting dosage is 20 mg administered once daily in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg, adjusting the dosage to 5 to 40 mg taken once daily in the evening. The dosage should be adjusted based on LDL cholesterol levels and treatment objectives.

Child dose

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

Precautions

This medication is used to lower blood cholesterol levels. Caution is needed as muscle-related side effects such as muscle pain or weakness may occur during use. Particularly, if taken at high doses or in combination with other specific medications, the risk of muscle damage may increase. Patients with liver disease or abnormal liver function test results should not take this medication as it can affect liver function. Women who are pregnant or may become pregnant and breastfeeding women should not take this medication. This medication may interact with certain antifungal drugs, antibiotics, and immunosuppressants, increasing the risk of muscle damage when taken together, so consultation with a physician is necessary. Special attention is required for the elderly, patients with impaired kidney function, and those with hypothyroidism. If unexplained muscle pain, tenderness, or weakness occurs during use, patients should inform their doctors immediately, and if symptoms are severe, they should discontinue the medication. Symptoms indicating liver function abnormalities or allergic reactions should also prompt immediate consultation with healthcare professionals. This medication is not recommended for children under 10 years old, and adolescents aged 10 and older should take it under the guidance of a physician. It is advisable to avoid taking this medication with certain foods such as grapefruit juice. This medication must be taken strictly according to a physician's prescription and instructions, and patients should inform other physicians about taking this medication when receiving treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor, high fever, severe rash, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • abdominal pain
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  • atrial fibrillation
  • constipation
  • gastritis
  • diabetes
  • myalgia
  • headache
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle cramps
  • myalgia
  • arthralgia
  • taste disturbance
  • oculomotor disorder
  • facial weakness
  • tremor
  • sensory disturbance
  • peripheral neuropathy
  • peripheral nerve palsy
  • mental disorders
  • anxiety
  • sleep disturbance
  • depression
  • cognitive impairment
  • cataract

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air and moisture, and it is best kept at temperatures between 1 degree to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Brownish-yellow oval film-coated tablets

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.