Medication info
Simba Medi Tablet (Simvastatin)

Simba Medi Tablet (Simvastatin)

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

MFDS item code 201402515 · Approved 2014.06.03 · Insurance code 625800130

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial starting dose of this medication is 40 mg daily, and for patients with hyperlipidemia, 20 mg is recommended once nightly. Patients with mild to moderate hypercholesterolemia may start with 10 mg. The dosage of 5 to 40 mg is recommended for administration once nightly, adjusting the dosage appropriately based on cholesterol levels measured at 4 weeks and thereafter after treatment initiation. For certain patient populations, the dosage should be reviewed.
Child dose
The recommended initial dose for pediatric patients aged 10 to 17 years is 10 mg once daily, with a recommended dosage range of 10 to 40 mg daily. The maximum dose is 40 mg daily. The dosage should be adjusted according to the treatment goals.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular-related death, myocardial infarction, and stroke in adult patients at high risk of cardiovascular diseases, such as coronary heart disease, diabetes, peripheral vascular disease, and stroke. It is also used to reduce the risk of complications following coronary and non-coronary vascular interventions. In the treatment of hyperlipidemia, it contributes to maintaining a healthy lipid balance by controlling blood cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Particularly, it effectively lowers cholesterol levels in pediatric patients with heterozygous familial hypercholesterolemia when used in conjunction with dietary modification. This medication plays an important role in protecting patients' health by preventing and improving cardiovascular diseases.

How to take

Adult dose

The recommended initial starting dose of this medication is 40 mg daily, and for patients with hyperlipidemia, 20 mg is recommended once nightly. Patients with mild to moderate hypercholesterolemia may start with 10 mg. The dosage of 5 to 40 mg is recommended for administration once nightly, adjusting the dosage appropriately based on cholesterol levels measured at 4 weeks and thereafter after treatment initiation. For certain patient populations, the dosage should be reviewed.

Child dose

The recommended initial dose for pediatric patients aged 10 to 17 years is 10 mg once daily, with a recommended dosage range of 10 to 40 mg daily. The maximum dose is 40 mg daily. The dosage should be adjusted according to the treatment goals.

Precautions

This medication is primarily used to lower blood cholesterol levels by inhibiting an enzyme involved in cholesterol production in the liver. When taking this medication, there may be muscle-related abnormalities, so if symptoms like muscle pain or weakness occur, consult a doctor immediately. The risk of serious muscle damage, such as myopathy or rhabdomyolysis, can increase, especially when taking high doses or in conjunction with certain drugs. As it may affect liver function, this medication is not recommended for individuals with liver disease or elevated liver enzymes. Also, pregnant or potentially pregnant women and breastfeeding women should not take this medication. Taking this medication with strong CYP3A4 inhibitors such as certain antifungals, antibiotics, and HIV treatments can increase the drug concentration and the risk of side effects. Therefore, it is crucial to inform the doctor if you are taking any of these medications, as co-administration may need to be avoided or dosage adjustments may be necessary. Special caution is required for alcohol abusers, patients with poor kidney function, and patients with hypothyroidism when taking this medication. While taking this medication, avoid combining it with grapefruit juice or certain drugs, and always inform your doctor or pharmacist about this medication when starting new drugs. Elderly patients and children also require dosage adjustments and careful monitoring, and this medication is not to be used in children under 10 years. Regular monitoring of liver function tests and muscle-related tests is recommended during treatment, and consult healthcare providers if any unusual symptoms occur. Possible side effects of this medication include dyspepsia, headache, constipation, and muscle pain, and in severe cases, hepatitis, muscle damage, and allergic reactions may occur. In the event of an overdose, seek appropriate treatment immediately, and it is important to store this medication out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory problems accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis,

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
Show 27 more
  • gastritis
  • diabetes
  • muscle pain
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle cramp
  • joint pain
  • taste distortion
  • oculomotor dysfunction
  • facial palsy
  • tremors
  • sensory disturbance
  • peripheral neuropathy
  • peripheral nerve palsy
  • mental disorders
  • anxiety
  • sleep disturbances
  • nightmares
  • depression
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • alopecia

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain a storage temperature in a range of 1 to 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness.

Appearance and packaging

Appearance

Brownish yellow oval film-coated tablet

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.