Medication info
Lipistat Tablets 20 mg (Atorvastatin Calcium Hydrate)

Lipistat Tablets 20 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Hydrate›21.7mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603432 · Approved 2016.06.14 · Insurance code 661904670

Summary

Main use
Reduction of risks for myocardial infarction and stroke, improvement of hypercholesterolemia, treatment of familial hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
Atorvastatin is administered once daily in a dosage range of 10-80 mg, at any time of day regardless of food. The recommended initial dose for hyperlipidemia patients is 10 mg once daily; if greater reductions in LDL-cholesterol are needed, it may be started at 20 mg or 40 mg once daily. Within 2-4 weeks after initiation and/or dose adjustment, lipid levels should be analyzed to guide further dose adjustments.
Children's dosage
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a recommended maximum dose of 20 mg daily. Dose adjustments should be made at intervals of at least 4 weeks based on treatment goals.

Ingredients

Manufacturer
영풍제약(주)

Efficacy & effects

Reduction of risks for myocardial infarction and stroke, improvement of hypercholesterolemia, treatment of familial hypercholesterolemia

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • hyperlipidemia
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
View approved original text

This medication helps reduce the risk of myocardial infarction, stroke, vascular procedures, stable angina, and hospitalization due to congestive heart failure in adults with cardiovascular risk factors and patients with type 2 diabetes. It is also used to lower total cholesterol and LDL-cholesterol, while increasing HDL-cholesterol, in patients with primary hypercholesterolemia and mixed dyslipidemia, thus improving blood lipid profiles. It is effective even in cases where hyperlipidemia is poorly controlled and is particularly useful as an adjunct therapy for lowering cholesterol levels in children with heterozygous familial hypercholesterolemia. In summary, this medication is effectively used for hyperlipidemia and reducing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

Atorvastatin is administered once daily in a dosage range of 10-80 mg, at any time of day regardless of food. The recommended initial dose for hyperlipidemia patients is 10 mg once daily; if greater reductions in LDL-cholesterol are needed, it may be started at 20 mg or 40 mg once daily. Within 2-4 weeks after initiation and/or dose adjustment, lipid levels should be analyzed to guide further dose adjustments.

Children's dosage

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a recommended maximum dose of 20 mg daily. Dose adjustments should be made at intervals of at least 4 weeks based on treatment goals.

Precautions

This medication may cause adverse muscle reactions, so if severe muscle pain or weakness occurs, discontinue use immediately and consult a physician. Due to potential effects on liver function, do not take this medication if you have liver disease or elevated liver enzyme levels. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication and should use appropriate contraception while on it. This medication should not be administered to children, especially those under 10 years of age. Individuals with alcoholism or a history of liver disease should use this medication with caution and undergo regular liver function tests. This medication may interact with certain drugs, so inform a physician or pharmacist if you are taking other medications. Be cautious when taking this medication with foods or drugs that inhibit the CYP3A4 enzyme, like grapefruit juice, as it may increase blood concentrations of this medication, raising the risk of side effects. If you experience severe muscle pain, weakness, fatigue, accompanied by fever or malaise, contact a physician immediately for testing. If symptoms of hepatitis such as nausea, vomiting, fatigue, or jaundice occur while taking this medication, discontinue use immediately and seek medical attention. Elderly patients or those with renal function impairment are at higher risk for myopathy, requiring additional caution during use. In the event of an overdose, there are no specific antidotes, so seek medical treatment immediately for symptomatic care and undergo liver and muscle-related testing. Store in a place out of reach of children, and keep in the original container tightly sealed.

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 mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, altered consciousness, visual disturbances, paralysis, urination changes.

Mild side effects

  • Fatigue
  • malaise
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. Additionally, it is recommended to store the medication at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold conditions.

Appearance and packaging

Appearance

White round 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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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.