Medication info
Ibatin Tablet 4 mg (Pitavastatin Calcium Hydrate)

Ibatin Tablet 4 mg (Pitavastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›4.409mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
Light yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202103366 · Approved 2021.04.26 · Insurance code 628902020

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia
Who takes it
Adults
Adult dose
For adults, the usual initial dose of pitavastatin calcium is 1 to 2 mg once daily. If the LDL-cholesterol lowering effect is insufficient, the dose may be increased up to a maximum of 4 mg per day. Dosage adjustments should be made at appropriate intervals of 4 weeks or more depending on LDL-cholesterol levels, treatment goals, and patient response.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia

  • Hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo-B protein
  • elevated triglycerides
View approved original text

This medication helps lower total cholesterol, LDL-cholesterol, Apo-B protein, and triglyceride levels while raising HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, thus improving the lipid profile. It is particularly used as an adjunct to dietary therapy in cases of familial and non-familial hypercholesterolemia and Fredrickson classification type IIa and IIb, contributing to vascular health and prevention of cardiovascular diseases.

How to take

Adult dose

For adults, the usual initial dose of pitavastatin calcium is 1 to 2 mg once daily. If the LDL-cholesterol lowering effect is insufficient, the dose may be increased up to a maximum of 4 mg per day. Dosage adjustments should be made at appropriate intervals of 4 weeks or more depending on LDL-cholesterol levels, treatment goals, and patient response.

Precautions

This medication should not be used by individuals who have had allergic reactions to it. Patients with active liver disease or consistently high liver function test results should not take it. Those with severe liver impairment or bile duct obstruction, as well as biliary obstruction, should also avoid this medication. Individuals currently taking cyclosporine should not use it concurrently. Those with myopathy-related muscle disorders should refrain from use. This medication is not recommended for pregnant women, women who may become pregnant, or nursing mothers. Safety and efficacy in children have not been established, so it should not be used in this population. This medication contains lactose, which should be avoided by those with lactose intolerance or certain genetic metabolic disorders. Allergies to soybean oil, soy, or peanuts also warrant avoidance. Individuals with renal function abnormalities should be cautious when taking this medication with other specific drugs, as muscle damage and renal function deterioration may occur. Patients with weakened liver function or a history of liver disease should use this medication cautiously, as it may burden the liver. Excessive alcohol consumption during treatment requires caution. Individuals with hypothyroidism, a family history of muscle disorders, elderly patients, and those with lipid metabolism abnormalities should also use it with care. In individuals with severe myasthenia, symptoms may worsen during use, necessitating caution. If muscle pain, weakness, or dark-colored urine occurs while taking this medication, consult a physician immediately. Regular liver function tests and blood tests are required, and if abnormalities are detected, medication should be discontinued. This medication is used for the treatment of hypercholesterolemia, so a thorough examination is necessary prior to use to confirm the condition. Dietary adjustments, exercise, and management of other risk factors should also be considered. There may be interactions with other medications, so patients must inform their healthcare provider of any concurrent medications. In particular, caution is needed when used with cyclosporine, fibrate medications, and niacin, as severe side effects may occur. This medication may have a higher incidence of side effects in older individuals, requiring potential dose adjustments. Pregnant or nursing women should avoid use due to potential risks to the fetus and infants. The tablets should be swallowed whole without chewing or splitting and kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, muscle pain due to rhabdomyolysis, weakness, elevated CPK levels, acute renal failure, liver dysfunction, jaundice, thrombocytopenia, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing, asthma attacks, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, significantly reduced urine output, severe generalized edema, elevated blood pressure, chest tightness, chest discomfort, respiratory distress

Mild side effects

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

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

Storage

This medication is sensitive to light, so it should be stored in a special container that does not allow light to enter. Additionally, when storing the medication, it is important to maintain a temperature between 1 and 30 degrees Celsius to preserve its effectiveness.

Appearance and packaging

Appearance

Light yellow round film-coated tablets

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.