Medication info
Pitarotin Tablets 4mg (Pitavastatin Calcium)

Pitarotin Tablets 4mg (Pitavastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium›4mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Yellowish round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603045 · Approved 2016.05.30 · Insurance code 693902300

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia
Who takes it
Adults
Adult dose
For adults, the usual initial dosage of pitavastatin calcium is 1 to 2 mg once daily. If the LDL-cholesterol lowering effect is not sufficient, the dosage may be increased up to a maximum of 4 mg per day. The dosage should be adjusted appropriately at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and the patient's response.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • LDL-cholesterol
  • apo-B protein
  • triglyceride levels
View approved original text

This medication lowers total cholesterol, LDL-cholesterol, apo-B protein, and triglyceride levels in the blood of patients with primary hypercholesterolemia and mixed dyslipidemia. It also increases HDL-cholesterol levels, helping to raise good cholesterol. It is primarily used as an adjunct to diet, improving these lipid levels to support cardiovascular health. As a result, it is effectively used in the management of hyperlipidemia.

How to take

Adult dose

For adults, the usual initial dosage of pitavastatin calcium is 1 to 2 mg once daily. If the LDL-cholesterol lowering effect is not sufficient, the dosage may be increased up to a maximum of 4 mg per day. The dosage should be adjusted appropriately at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and the patient's response.

Precautions

This medication should not be used in certain patients. For example, patients who have had an allergic reaction to this drug, those with severely impaired liver function, pregnant women or women who may become pregnant, and children should not receive this medication. Additionally, this drug should be used cautiously in patients with impaired kidney function, a history of liver disease, elderly patients, and patients with muscle disorders. During treatment, symptoms such as muscle pain, weakness, or liver function abnormalities may occur, and immediate consultation with a physician is required if these symptoms arise. Regular liver function tests should be performed, and if liver enzyme levels become abnormally high, administration should be discontinued. This medication can cause muscle-related side effects, including rhabdomyolysis, so caution is needed if muscle pain or weakness occurs. Moreover, it may interact with other medications, so caution is advised, especially when taken with cyclosporine, fibrate drugs, or niacin. Pregnant or breastfeeding women should not take this medication as it may affect the fetus or newborn. The safety of this medication in children has not been established, so it should not be used in pediatric patients. It is important to swallow the tablet whole without splitting it, and during storage, it should be kept out of reach of children. Before taking this medication, ensure that hypercholesterolemia is confirmed through thorough testing and consider non-drug treatments such as diet and exercise.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain of oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

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

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 container that does not allow light to enter. Additionally, it should be stored at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Yellowish 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.