Medication info
Bipito Tablet 20mg (Atorvastatin Calcium Trihydrate)

Bipito Tablet 20mg (Atorvastatin Calcium Trihydrate)

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

MFDS item code 201603463 · Approved 2016.06.15 · Insurance code 643104840

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia: The recommended initial dose is 10 mg of atorvastatin once daily. For patients requiring a larger reduction in LDL-cholesterol levels, treatment may start at 20 mg or 40 mg once daily. This medication is administered within a dosage range of 10 mg to 80 mg once daily. Dosage should be individualized according to treatment goals and responses, with lipid levels analyzed and adjusted within 2 to 4 weeks. The goal of treatment is to lower LDL-cholesterol levels, and it is recommended to use LDL-cholesterol levels for assessing the start of treatment and treatment response. However, if LDL-cholesterol levels cannot be utilized, total cholesterol levels may be used to monitor treatment response. In patients with homozygous familial hypercholesterolemia, the dosage is 10 mg to 80 mg once daily, used either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not feasible. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17): The recommended initial dosage of this medication is 10 mg per day, with a recommended maximum dosage of 20 mg per day (there are no clinical data administering over 20 mg for this age group). Dosage should be appropriately adjusted based on the recommended treatment goals for individual patients and should be adjusted at intervals of 4 weeks or more. ○ In patients with kidney disease: Kidney disease does not affect the plasma concentration of atorvastatin or its LDL-cholesterol lowering effects, so dosage adjustment is unnecessary. ○ In elderly patients: The efficacy and safety in patients over 70 years of age are similar to those observed in the general adult patient population.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17): The recommended initial dosage is 10 mg once daily, with a maximum dosage of 20 mg once daily. The dosage should be adjusted at intervals of at least 4 weeks.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia

  • Myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
  • hypercholesterolemia
View approved original text

This medication is used to reduce the risk of cardiovascular diseases. In particular, it lowers the risk of myocardial infarction and stroke in adults with multiple risk factors or in patients with type 2 diabetes. It helps lower the risk of non-fatal myocardial infarction, stroke, revascularization procedures, hospitalization due to heart failure, and angina in patients with clinically evident heart disease. In addition, it reduces total cholesterol, LDL-cholesterol, Apo-B protein, and triglycerides, and increases HDL-cholesterol levels to improve the serum lipid profile in patients with hyperlipidemia. It is used as an adjunct therapy in patients with dyslipidemia unresponsive to diet and those with elevated triglyceride levels in serum. It also assists in the treatment of familial hypercholesterolemia in pediatric patients.

Dosage and Administration

Adult dosage

For hyperlipidemia: The recommended initial dose is 10 mg of atorvastatin once daily. For patients requiring a larger reduction in LDL-cholesterol levels, treatment may start at 20 mg or 40 mg once daily. This medication is administered within a dosage range of 10 mg to 80 mg once daily. Dosage should be individualized according to treatment goals and responses, with lipid levels analyzed and adjusted within 2 to 4 weeks. The goal of treatment is to lower LDL-cholesterol levels, and it is recommended to use LDL-cholesterol levels for assessing the start of treatment and treatment response. However, if LDL-cholesterol levels cannot be utilized, total cholesterol levels may be used to monitor treatment response. In patients with homozygous familial hypercholesterolemia, the dosage is 10 mg to 80 mg once daily, used either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not feasible. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17): The recommended initial dosage of this medication is 10 mg per day, with a recommended maximum dosage of 20 mg per day (there are no clinical data administering over 20 mg for this age group). Dosage should be appropriately adjusted based on the recommended treatment goals for individual patients and should be adjusted at intervals of 4 weeks or more. ○ In patients with kidney disease: Kidney disease does not affect the plasma concentration of atorvastatin or its LDL-cholesterol lowering effects, so dosage adjustment is unnecessary. ○ In elderly patients: The efficacy and safety in patients over 70 years of age are similar to those observed in the general adult patient population.

Children's dosage

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

Precautions

This medication may cause muscular symptoms; if there is severe muscle pain or weakness or if creatine kinase levels are significantly elevated, discontinue immediately and consult with a doctor. This medication should not be used in patients with certain liver diseases or muscle disorders, in pregnant or potentially pregnant women, in breastfeeding women, in children under 10 years of age, or in patients taking certain other medications. Patients with a history of alcohol abuse or liver disease, patients with impaired kidney function, hypothyroidism patients, and the elderly need to be especially cautious while using this medication and must undergo regular check-ups as directed by their physician. This medication can cause various side effects such as liver dysfunction, gastrointestinal symptoms, headaches, muscle pain, and allergic reactions; if any abnormal symptoms occur, inform a healthcare professional immediately. This medication is metabolized in the liver, hence, dosage adjustments may be necessary for patients with liver dysfunction, and treatment should be discontinued if symptoms of hepatitis (nausea, vomiting, lethargy, etc.) occur. While taking this medication, if symptoms like muscle pain, weakness, or fever appear, consult a physician immediately and get tested. This medication may interact with other drugs; therefore, caution is necessary, particularly when taken with certain antibiotics, antifungals, antivirals, immunosuppressants, grapefruit juice, etc. Women of childbearing age should use appropriate contraception while taking this medication, and must discontinue if pregnancy occurs. This medication is not recommended for breastfeeding women; breastfeeding should be stopped. Elderly patients or those with kidney disorders may have a higher risk of muscle-related side effects while taking this medication; careful monitoring is required. In case of overdose, there is no specific antidote available, and treatment should be symptomatic; regular checks of liver function and muscle-related tests are necessary. This medication should be stored out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema, allergic edema), chest tightness, difficulty breathing, cold sweats, pallor, acute and severe myopathy, rhabdomyolysis, kidney failure, severe skin reactions (with fever, severe rashes, blisters, peeling skin, pain in oral/eye mucous membranes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), breathing problems (dyspnea, asthma attacks, cough accompanied by fever)

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disorder
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is safe to store at temperatures between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White 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.

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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.