Medication info
Simvarotin Tablets 20 mg (Simvastatin)

Simvarotin Tablets 20 mg (Simvastatin)

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

MFDS item code 200300639 · Notified 2003.05.31 · Insurance code 656000680

Summary

Main use
Reduction of risk for cardiovascular diseases and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
Adult patients at high risk for cardiovascular disease: 40 mg once daily. For hyperlipidemia: 5-40 mg once daily in the evening, initial dose is 20 mg (mild to moderate patients may start at 10 mg). For homozygous familial hypercholesterolemia: 40 mg once daily in the evening. Elderly: 20 mg once daily. When combined with verapamil, diltiazem, or dronedarone: do not exceed 10 mg daily. Amiodarone, amlodipine,
Child dose
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17): 10 mg once daily in the evening. Recommended dosage range is 10-40 mg once daily, maximum 40 mg. Adjust dosage at intervals of 4 weeks or more.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Reduction of risk for cardiovascular diseases and improvement of hyperlipidemia

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

This medication helps reduce the risk of cardiovascular diseases. It lowers the risk of mortality from coronary heart disease and the risk of non-fatal myocardial infarction and stroke in adult patients with a history of coronary heart disease, diabetes, peripheral artery disease, and stroke. It also reduces the risk due to vascular interventions. For the treatment of hyperlipidemia, it improves cardiovascular health by controlling cholesterol and triglyceride levels. It is particularly effective in patients with familial hypercholesterolemia or dyslipidemia and is used as an adjunct to dietary therapy. It helps lower total cholesterol and LDL cholesterol levels in pediatric patients with familial hypercholesterolemia. Overall, it is used for managing the risk of cardiovascular diseases.

How to take

Adult dose

Adult patients at high risk for cardiovascular disease: 40 mg once daily. For hyperlipidemia: 5-40 mg once daily in the evening, initial dose is 20 mg (mild to moderate patients may start at 10 mg). For homozygous familial hypercholesterolemia: 40 mg once daily in the evening. Elderly: 20 mg once daily. When combined with verapamil, diltiazem, or dronedarone: do not exceed 10 mg daily. Amiodarone, amlodipine,

Child dose

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17): 10 mg once daily in the evening. Recommended dosage range is 10-40 mg once daily, maximum 40 mg. Adjust dosage at intervals of 4 weeks or more.

Precautions

This medication helps lower blood cholesterol levels to reduce the risk of cardiovascular disease. When taking this medication, it may cause muscle abnormalities, so if muscle pain, weakness, or tenderness occurs, consult a doctor immediately. Particularly, if taking a high dose of this medication, the risk of serious muscle injury such as myopathy or rhabdomyolysis increases, so caution is necessary. When taken with other medications that interact with this drug, the risk of muscle injury may increase, so be sure to notify your doctor and take appropriate measures. As it may affect liver function, it is better not to take this medication if there is liver disease or abnormal liver function test results. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication, and those planning a pregnancy should consult a doctor. Patients who consume alcohol excessively, have a history of liver or kidney disease, have hypothyroidism, or are elderly or female should be especially cautious when taking this medication. Regular blood tests are recommended to monitor liver function and muscle-related indicators while taking this medication. Avoid grapefruit juice as it may increase blood concentration and risk of side effects. If a new medication is prescribed or taken while using this medication, inform the prescribing doctor or pharmacist about the medications being taken. In case of overdose, visit a medical facility immediately for appropriate treatment and store the medication out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, wheezing or difficulty breathing, asthma attacks, breathing difficulties accompanied by cough and fever, yellowing of skin or eyes (jaundice), systemic malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, significantly decreased urine output,

Mild side effects

  • Abdominal pain
  • fatigue
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
Show 26 more
  • gastritis
  • insomnia
  • dizziness
  • bronchitis
  • eczema
  • urinary tract infection
  • muscle pain
  • muscle cramps
  • joint pain
  • taste disturbances
  • eye movement disorders
  • facial paresis
  • tremor
  • sensory disorders
  • peripheral neuropathy
  • peripheral nerve paralysis
  • psychiatric disorders
  • anxiety
  • sleep disturbances
  • depression
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • alopecia
  • pruritus
  • skin changes

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

Storage

Store this medication in a tightly closed container to prevent air or moisture from entering, at room temperature between 1°C and 30°C. This way of storage can help maintain the efficacy of the medication.

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

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.