Medication info
Letova Tablet 10 mg (Atorvastatin Calcium Hydrate)

Letova Tablet 10 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Hydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)바스칸바이오제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201903183 · Approved 2019.05.16 · Insurance code 656205050

Summary

Main use
Reduction of risks of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
The recommended initial dosage for the treatment of hyperlipidemia is 10 mg once daily. Patients requiring greater reductions in LDL cholesterol levels may start at 20 mg or 40 mg once daily. The dosage range is 10-80 mg once daily. After initiating treatment and adjusting the dosage, lipid levels should be analyzed within 2-4 weeks to adjust the dosage accordingly. The goal of treatment is to reduce LDL cholesterol levels; therefore, LDL cholesterol levels should be used to evaluate treatment response. However, if LDL cholesterol levels cannot be obtained, total cholesterol levels should be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosage is 10-80 mg once daily, administered concomitantly with other lipid-lowering therapies (e.g., LDL apheresis) or if such therapies are not possible. 2. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dosage is 10 mg once daily, with a recommended maximum dosage of 20 mg once daily (there are no clinical data supporting doses higher than 20 mg in this population). The dosage should be adjusted appropriately based on the recommended treatment goals for individual patients. Dosage should be adjusted at intervals of 4 weeks or more. ○ In patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering effects of atorvastatin, so dosage adjustments are not necessary. ○ In elderly patients: The efficacy and safety in elderly patients over 70 years old is similar to that in the general adult population.
Children's dosage
The recommended initial dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a recommended maximum dosage of 20 mg once daily. The dosage should be adjusted appropriately at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)바스칸바이오제약

Efficacy & effects

Reduction of risks of myocardial infarction and stroke, improvement of hypercholesterolemia

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

This medication is used to reduce the risk of cardiovascular diseases. It is particularly useful in reducing the risk of myocardial infarction and stroke, and is effective in adults with various risk factors for coronary heart disease and patients with type 2 diabetes. It also contributes to the prevention of complications after vascular interventions and reduces the risk of hospitalization due to congestive heart failure. Additionally, it lowers total cholesterol, LDL cholesterol, and triglyceride levels in patients with hyperlipidemia while increasing HDL cholesterol levels, thereby improving blood lipid balance. In pediatric patients with heterozygous familial hypercholesterolemia, it is used as an adjunct to diet to control cholesterol levels. Overall, it is used for improving cardiovascular health and reducing the risk of related diseases.

Dosage and Administration

Adult dosage

The recommended initial dosage for the treatment of hyperlipidemia is 10 mg once daily. Patients requiring greater reductions in LDL cholesterol levels may start at 20 mg or 40 mg once daily. The dosage range is 10-80 mg once daily. After initiating treatment and adjusting the dosage, lipid levels should be analyzed within 2-4 weeks to adjust the dosage accordingly. The goal of treatment is to reduce LDL cholesterol levels; therefore, LDL cholesterol levels should be used to evaluate treatment response. However, if LDL cholesterol levels cannot be obtained, total cholesterol levels should be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosage is 10-80 mg once daily, administered concomitantly with other lipid-lowering therapies (e.g., LDL apheresis) or if such therapies are not possible. 2. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dosage is 10 mg once daily, with a recommended maximum dosage of 20 mg once daily (there are no clinical data supporting doses higher than 20 mg in this population). The dosage should be adjusted appropriately based on the recommended treatment goals for individual patients. Dosage should be adjusted at intervals of 4 weeks or more. ○ In patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering effects of atorvastatin, so dosage adjustments are not necessary. ○ In elderly patients: The efficacy and safety in elderly patients over 70 years old is similar to that in the general adult population.

Children's dosage

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

Precautions

This medication may cause abnormal reactions in the muscles, so if there is severe muscle pain or weakness or if creatine kinase levels rise significantly, discontinue use immediately and consult a physician. It may affect liver function, therefore patients with liver disease or elevated liver enzyme levels should not use this medication, and liver function tests should be conducted regularly during treatment. Pregnant women and women who may become pregnant, as well as nursing mothers, should not take this medication, and appropriate contraceptive methods must be used during treatment. Children under 10 years old and certain genetically lactose-intolerant patients should not take this medication. Patients with a history of alcohol abuse or liver disease, those with impaired kidney function, and those with hypothyroidism should use this medication cautiously, as the risk of myopathy is higher and careful monitoring is required. There may be interactions with other drugs, so consult a physician especially when using with CYP3A4 inhibitors, cyclosporine, some antibiotics, antifungals, and antivirals, as dosage adjustments or discontinuation may be necessary. Consumption of grapefruit juice may increase the blood concentration of this medication, leading to a higher risk of side effects, so excessive intake should be avoided. If muscle pain, fatigue, or fever occur during treatment, notify medical personnel immediately and get tested; if these symptoms are severe, discontinue the medication. This medication may cause various side effects including hepatitis, hives, skin rashes, and allergic reactions, so if any abnormal symptoms occur, consult a physician immediately. Elderly patients or those with kidney impairment are at a higher risk of myopathy, so care should be taken when administering, along with regular monitoring. In cases of overdose, there is no specific antidote, so treatment should be symptom-based, and liver function tests and blood tests should be performed to check the condition. This medication should be kept out of reach of children and stored in its original container to maintain efficacy and prevent misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormality accompanied by cough + fever, respiratory problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • decreased appetite
  • constipation
  • abdominal distention
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • abnormal sensation
  • decreased sensation
  • altered taste
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • arthritis

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 air or moisture ingress. It is also important to keep it at room temperature between 1 and 30 degrees Celsius to maintain its efficacy.

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.