Medication info
Lipitan Tablets 20 mg (Atorvastatin Calcium Hydrate)

Lipitan Tablets 20 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201803145 · Approved 2018.07.30 · Insurance code 641502840

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of high cholesterol
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended initial dose is 10 mg once daily, and for patients requiring greater LDL cholesterol reduction, it can be initiated at 20 mg or 40 mg once daily. Generally, it is administered within a range of 10 to 80 mg once daily, with dosing individualized according to treatment goals and patient characteristics. Lipid levels should be assessed 2 to 4 weeks after the start of therapy to determine if dosage adjustments are necessary. The goal of treatment is to lower LDL cholesterol levels, so using LDL cholesterol levels during treatment initiation and response evaluation is recommended. However, if LDL cholesterol levels cannot be used, total cholesterol levels should be monitored for treatment response. For patients with homozygous familial hypercholesterolemia, the dosing regimen is 10 to 80 mg once daily, used in conjunction with other lipid-lowering therapies (e.g., LDL apheresis), or when such therapies are not possible. 2. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, with a maximum recommended dose of 20 mg once daily (there is no clinical data on dosing this medication above 20 mg in the pediatric population). The dosage should be adjusted to meet the recommended treatment goals for each individual patient. Adjustments should be made at intervals of 4 weeks or more. ○ For patients with renal impairment: Renal disease does not affect atorvastatin plasma concentration or LDL cholesterol-lowering efficacy, so dosage adjustments are not necessary. ○ For the elderly: The efficacy and safety for patients over 70 years old are similar to those of the general adult population.
Children's dosage
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum dose of 20 mg once daily. The dosage should be adjusted at intervals of at least 4 weeks.

Ingredients

Manufacturer
맥널티제약(주)

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, improvement of high cholesterol

  • Coronary artery heart disease
  • myocardial infarction
  • stroke
  • vascular revascularization
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hyperlipidemia
  • hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases. Specifically, it decreases the risk of myocardial infarction and stroke in adults with multiple risk factors such as hypertension, smoking, and family history, as well as in patients with type 2 diabetes. It also reduces the likelihood of hospitalization due to vascular revascularization, angina, and congestive heart failure. For patients with hyperlipidemia, it lowers total cholesterol and LDL cholesterol while raising HDL cholesterol, making it a useful adjunct to dietary therapy. It is particularly effective in pediatric patients with heterozygous familial hypercholesterolemia, helping to improve blood lipid levels. This medication is used to improve cardiovascular health and reduce the risk of disease.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg once daily, and for patients requiring greater LDL cholesterol reduction, it can be initiated at 20 mg or 40 mg once daily. Generally, it is administered within a range of 10 to 80 mg once daily, with dosing individualized according to treatment goals and patient characteristics. Lipid levels should be assessed 2 to 4 weeks after the start of therapy to determine if dosage adjustments are necessary. The goal of treatment is to lower LDL cholesterol levels, so using LDL cholesterol levels during treatment initiation and response evaluation is recommended. However, if LDL cholesterol levels cannot be used, total cholesterol levels should be monitored for treatment response. For patients with homozygous familial hypercholesterolemia, the dosing regimen is 10 to 80 mg once daily, used in conjunction with other lipid-lowering therapies (e.g., LDL apheresis), or when such therapies are not possible. 2. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, with a maximum recommended dose of 20 mg once daily (there is no clinical data on dosing this medication above 20 mg in the pediatric population). The dosage should be adjusted to meet the recommended treatment goals for each individual patient. Adjustments should be made at intervals of 4 weeks or more. ○ For patients with renal impairment: Renal disease does not affect atorvastatin plasma concentration or LDL cholesterol-lowering efficacy, so dosage adjustments are not necessary. ○ For the elderly: The efficacy and safety for patients over 70 years old are similar to those of the general adult population.

Children's dosage

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum dose of 20 mg once daily. The dosage should be adjusted at intervals of at least 4 weeks.

Precautions

This medication may cause muscle-related side effects, so if severe muscle pain or weakness occurs or there is a significant rise in creatine kinase levels, discontinue use immediately and consult a doctor. Do not take this medication if there is active liver disease or if liver function test values are very high. Patients with muscle diseases, pregnant women, children under 10 years old, or those taking certain medications should not use this medication. Patients with a history of alcohol abuse or liver disease, impaired renal function, hypothyroidism, and the elderly should exercise extra caution when using this medication. During treatment, liver function and muscle status should be regularly monitored, and if any unusual symptoms arise, medical personnel should be notified immediately. This medication may interact with various drugs, so if you are taking other medications, inform your doctor or pharmacist, particularly when using certain antibiotics, antifungals, antiviral agents, some antihypertensives, and fibrate class drugs. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use appropriate contraception while taking it. The elderly and patients with impaired renal function are at higher risk of myopathy and should be monitored closely during treatment. There is no specific antidote for overdose, so visit a medical institution immediately for treatment according to symptoms. Keep this medication out of reach of children and store it safely in its original container.

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 high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urination issues

Mild side effects

  • Weakness
  • fatigue
  • 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
  • throat and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste distortion
  • 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 should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the drug's efficacy for a longer period.

Appearance and packaging

Appearance

White round 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.

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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.