Medication info
Ibatin Tablets 1 mg (Pitavastatin Calcium Hydrate)

Ibatin Tablets 1 mg (Pitavastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›1.102mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202102718 · Approved 2021.03.29 · Insurance code 628901990

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, familial) and dyslipidemia
Who takes it
Adults · Children
Adult dose
For adults, the usual initial dose is 1 to 2 mg of pitavastatin calcium once daily. If the LDL cholesterol-lowering effect is insufficient, it can be increased up to a maximum of 4 mg daily. The dosage should be appropriately adjusted every 4 weeks or more, based on LDL cholesterol levels, treatment goals, and patient response.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 16), take 1 mg of pitavastatin calcium once daily. If the LDL cholesterol-lowering effect is insufficient, the maximum daily dosage can be increased to 2 mg.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, familial) and dyslipidemia

  • Hypercholesterolemia
  • dyslipidemia
  • increased total cholesterol
  • increased LDL cholesterol
  • increased Apo-B protein
  • increased triglycerides
  • decreased HDL cholesterol
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels, and increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is particularly used in pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 16 years, where it is effective as an adjunct therapy to control cholesterol levels along with dietary therapy. This drug is especially recommended for pediatric patients with a family history of early cardiovascular disease or those with cardiovascular risk factors, contributing to reducing the risk of cardiovascular disease and maintaining health by improving blood lipid levels. Patients can expect good effects if taken consistently along with dietary modifications. This drug is used to improve abnormal blood lipid levels.

How to take

Adult dose

For adults, the usual initial dose is 1 to 2 mg of pitavastatin calcium once daily. If the LDL cholesterol-lowering effect is insufficient, it can be increased up to a maximum of 4 mg daily. The dosage should be appropriately adjusted every 4 weeks or more, based on LDL cholesterol levels, treatment goals, and patient response.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 16), take 1 mg of pitavastatin calcium once daily. If the LDL cholesterol-lowering effect is insufficient, the maximum daily dosage can be increased to 2 mg.

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to this drug, have liver function issues, are taking cyclosporine, or are pregnant or breastfeeding should not take this drug. Patients with impaired kidney or liver function, the elderly, children, and those with hypothyroidism should use this drug cautiously, and special attention is needed when taken with other medications due to increased risk of side effects. During the use of this drug, symptoms such as muscle pain, weakness, and abnormal liver function may occur, and if any of these symptoms arise, immediate consultation with a physician is necessary. Regular liver function tests and blood lipid level checks should be conducted to evaluate therapeutic effects, and any abnormal findings should lead to discontinuation of the medication. This drug may interact with other medications, so it is important to inform your doctor or pharmacist if you are taking any other drugs. The elderly may experience side effects more easily due to decreased physical function, and special caution is needed when taking this drug. Pregnant women or those who may become pregnant should not take this drug, and if pregnancy is confirmed during treatment, it should be discontinued immediately. In children, this drug should only be used under the guidance of an experienced physician for the treatment of familial hypercholesterolemia, and care should be taken as there is a risk of muscle-related side effects if they have a high level of physical activity. This drug should be kept out of reach of children and stored in its original container to prevent degradation or misuse. Finally, this drug may rarely cause serious side effects such as severe muscle diseases, interstitial lung diseases, and diabetes, so if any unusual symptoms occur during treatment, immediate consultation with healthcare personnel is necessary.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe renal impairment
  • liver dysfunction
  • jaundice
  • rhabdomyolysis
  • severe edema
  • thrombocytopenia
  • severe allergic reactions
  • serious neurological symptoms
  • respiratory problems

Mild side effects

  • Abdominal pain
  • rash
  • fatigue
  • numbness
  • itching
  • headache
  • muscle pain
  • stiffness
  • drowsiness
  • insomnia
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  • heaviness in the head
  • dizziness
  • thirst
  • dyspepsia
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • discomfort in the stomach
  • diarrhea
  • thrombocytopenia
  • agranulocytosis
  • leukopenia
  • eosinophilia
  • leukocytosis
  • increase in globulin
  • positive Coombs test
  • anemia
  • increased urination
  • elevated BUN
  • elevated serum creatinine
  • decreased aldosterone

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

Storage

This drug is sensitive to light and should be stored in a container that can block light. Additionally, it is recommended to store the medication at room temperature, between 1 and 30 degrees Celsius, to maintain its 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.

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.