Medication info
Apito Tablet 20 Milligrams (Atorvastatin Calcium Trihydrate)

Apito Tablet 20 Milligrams (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201602931 · Approved 2016.05.25 · Insurance code 662503460

Summary

Main use
Effectiveness in reducing the risk of myocardial infarction and stroke, and improving hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients requiring greater reduction of LDL-cholesterol, it may start at 20 mg or 40 mg once daily. Dosing is within a range of 10 to 80 mg once daily, individualized based on treatment goals and patient characteristics. Analyze lipid levels 2 to 4 weeks after starting treatment and adjust the dose accordingly. The treatment goal is to reduce LDL-cholesterol levels, so it's recommended to use LDL-cholesterol levels for evaluating treatment response. If LDL-cholesterol levels cannot be used, monitor treatment response using total cholesterol levels. For patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, administered in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when these treatments are not feasible.
Children's dosage
The recommended initial dose for pediatric patients (10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg per day, with a maximum dose of 20 mg per day. The dosing should be adjusted according to treatment goals.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Effectiveness in reducing the risk of myocardial infarction and stroke, and improving hyperlipidemia

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

This medication reduces the risk of myocardial infarction and stroke in adults with risk factors for coronary heart disease and in patients with type 2 diabetes. It also helps to prevent hospitalization due to vascular procedures, chronic stable angina, and congestive heart failure. In patients with hyperlipidemia, it decreases total cholesterol, LDL-cholesterol, and triglyceride levels while increasing HDL-cholesterol levels. It is particularly effective in pediatric patients with heterozygous familial hypercholesterolemia, reducing the risk of cardiovascular diseases. This medication is used for the improvement of cardiovascular diseases and hyperlipidemia.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients requiring greater reduction of LDL-cholesterol, it may start at 20 mg or 40 mg once daily. Dosing is within a range of 10 to 80 mg once daily, individualized based on treatment goals and patient characteristics. Analyze lipid levels 2 to 4 weeks after starting treatment and adjust the dose accordingly. The treatment goal is to reduce LDL-cholesterol levels, so it's recommended to use LDL-cholesterol levels for evaluating treatment response. If LDL-cholesterol levels cannot be used, monitor treatment response using total cholesterol levels. For patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, administered in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when these treatments are not feasible.

Children's dosage

The recommended initial dose for pediatric patients (10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg per day, with a maximum dose of 20 mg per day. The dosing should be adjusted according to treatment goals.

Precautions

If symptoms of muscular issues occur, this medication should be discontinued immediately. Particularly, if muscle pain or weakness is severe or if blood tests show significantly elevated muscle damage markers, medical consultation is necessary. Patients with liver dysfunction or liver diseases should not take this medication and should undergo regular liver function tests during treatment. This medication should not be used by pregnant women, women who may become pregnant, or breastfeeding women. It should not be administered to children, especially those under 10 years of age. Patients with a history of alcoholism, liver disease, impaired kidney function, and elderly patients should use this medication with extra caution. This medication may have an increased risk of side effects when taken with certain drugs, so inform healthcare providers of any other medications being taken. In particular, dosage adjustments may be required when taken with medications that interfere with the metabolism of this drug in the liver. If sudden symptoms such as muscle pain, weakness, or fever occur during treatment, contact a physician immediately for evaluation. This medication should be stored out of reach of children and kept in its original container for safety. There is no specific antidote for overdose, so treatment should involve monitoring liver function and muscle damage and addressing symptoms as they arise.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, yellowing of the skin or eyes (jaundice), severe overall weakness, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, significant reduction in urine output, severe swelling across the body with increased blood pressure, anaphylaxis

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
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  • constipation
  • abdominal distension
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • 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 protect it from air and moisture, preferably at room temperature between 1°C and 30°C. This will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.