Medication info
Boriato Tablets (Atorvastatin Calcium Trihydrate)

Boriato Tablets (Atorvastatin Calcium Trihydrate)

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

MFDS item code 201603144 · Approved 2016.05.31 · Insurance code 660402610

Summary

Main use
Reduces the risk of myocardial infarction and stroke, improves hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended initial dose for the treatment of hyperlipidemia is 10 mg once daily; for patients requiring greater LDL cholesterol reduction, it may begin at 20 mg or 40 mg once daily. Doses should be administered within the range of 10-80 mg once daily, individualized based on treatment goals and responses. Lipid levels should be checked within 2-4 weeks after starting treatment and adjusting doses. The goal of treatment is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol for assessing the response to treatment. If LDL cholesterol levels cannot be measured, total cholesterol levels should be used to monitor the treatment response. For patients with homozygous familial hypercholesterolemia, the dosage should be 10-80 mg once daily, either alongside other lipid-lowering therapies (e.g., LDL apheresis) or if such therapies are not possible. 2. Pediatric patients (aged 10-17 years) with heterozygous familial hypercholesterolemia The recommended initial dose is 10 mg once daily, with a recommended maximum dose of 20 mg daily (there is no clinical data on administering doses greater than 20 mg in the pediatric population). The dose should be adjusted according to the recommended treatment goals for each patient. Doses should be adjusted at intervals of 4 weeks or more. ○ Patients with renal impairment: Renal disease does not affect the plasma concentration of atorvastatin or its LDL cholesterol-lowering effect, so there is no need to adjust dosages. ○ Elderly: Efficacy and safety for patients aged 70 and older are generally similar to those in the regular adult population.
Children's dosage
The recommended initial dose for pediatric patients (aged 10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg daily. Doses should be adjusted at intervals of at least 4 weeks based on treatment goals.

Ingredients

Manufacturer
경진제약(주)

Efficacy & effects

Reduces the risk of myocardial infarction and stroke, improves hyperlipidemia

  • Coronary artery heart disease
  • myocardial infarction
  • stroke
  • vascular intervention
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • congestive heart failure
  • angina
  • hypercholesterolemia
View approved original text

This medication helps to reduce the risk of myocardial infarction, stroke, the need for vascular intervention, angina, and heart failure hospitalization in adults with cardiovascular disease risk factors and in patients with type 2 diabetes. It is also used to lower total cholesterol and LDL cholesterol levels, and to raise HDL cholesterol levels in patients with primary and familial hypercholesterolemia, as well as mixed dyslipidemia. It is useful as an adjunct in certain types of hyperlipidemia that are not controlled by diet. Particularly, it can be used in children aged 10 to 17 years with heterozygous familial hypercholesterolemia, especially in those with a family history of cardiovascular disease or other accompanying risk factors. In summary, this medication helps to enhance cardiovascular health by reducing the risk of cardiovascular disease and improving dyslipidemia.

Dosage and Administration

Adult dosage

The recommended initial dose for the treatment of hyperlipidemia is 10 mg once daily; for patients requiring greater LDL cholesterol reduction, it may begin at 20 mg or 40 mg once daily. Doses should be administered within the range of 10-80 mg once daily, individualized based on treatment goals and responses. Lipid levels should be checked within 2-4 weeks after starting treatment and adjusting doses. The goal of treatment is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol for assessing the response to treatment. If LDL cholesterol levels cannot be measured, total cholesterol levels should be used to monitor the treatment response. For patients with homozygous familial hypercholesterolemia, the dosage should be 10-80 mg once daily, either alongside other lipid-lowering therapies (e.g., LDL apheresis) or if such therapies are not possible. 2. Pediatric patients (aged 10-17 years) with heterozygous familial hypercholesterolemia The recommended initial dose is 10 mg once daily, with a recommended maximum dose of 20 mg daily (there is no clinical data on administering doses greater than 20 mg in the pediatric population). The dose should be adjusted according to the recommended treatment goals for each patient. Doses should be adjusted at intervals of 4 weeks or more. ○ Patients with renal impairment: Renal disease does not affect the plasma concentration of atorvastatin or its LDL cholesterol-lowering effect, so there is no need to adjust dosages. ○ Elderly: Efficacy and safety for patients aged 70 and older are generally similar to those in the regular adult population.

Children's dosage

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

Precautions

This medication may cause muscle-related symptoms, so patients should immediately inform their doctor if they experience muscle pain, weakness, or severe fatigue. Prior to taking this medication, it is essential to check for any allergic reactions or liver and muscle diseases. Women who are pregnant or breastfeeding should not take this medication. As this medication may affect liver function, regular liver function tests should be conducted, and if symptoms of hepatitis or jaundice occur, the medication should be discontinued. The risk of side effects may increase when this medication is taken with certain other drugs, so it is crucial to inform the doctor or pharmacist of any medications currently being taken. Elderly patients or those with impaired renal function are at a higher risk for muscle disease and require caution during use, and should consult healthcare professionals if symptoms arise. Avoid excessive alcohol consumption and limit the intake of certain foods such as grapefruit juice while taking this medication. Women who may become pregnant should use appropriate contraception while taking this medication, and if pregnancy is confirmed, the medication must be discontinued immediately. Children and those under 10 years of age should not use this medication, and adolescents aged 10 years and older should follow professional guidance. This medication can cause severe muscle side effects such as myopathy or rhabdomyolysis, so if significant muscle pain or weakness occurs, healthcare professionals should be informed immediately. In cases of overdose, there is no specific antidote, treatment should depend on symptoms, and liver function and muscle condition should be checked regularly. Store this medication out of reach of children and keep it in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, asthma attacks, difficulty breathing, respiratory issues, jaundice (yellowing of the skin or eyes), extreme lethargy, liver dysfunction (jaundice), sudden and severe headaches, lightning-type headache

Mild side effects

  • Weakness
  • lethargy
  • chest pain
  • peripheral edema
  • fatigue
  • 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 larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste abnormalities
  • amnesia
  • 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 air and moisture from entering, ideally at a temperature between 1°C and 30°C (33.8°F and 86°F). Storing it this way helps maintain the medication's effectiveness and prevents degradation.

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.