Pitacuzet Tablets 1/10 mg (Pitavastatin Calcium Hydrate, Ezetimibe)

Adult dose

This drug is administered once daily at a dose of 1/10 mg regardless of meals.

This drug should not be used in certain patients. For example, patients with allergic reactions to this medication or a history of such experiences, patients with active liver disease or persistently elevated liver enzyme levels, patients with severe liver dysfunction, and those taking cyclosporine should not be treated with this medication. Additionally, patients with myopathy, women who are pregnant or may become pregnant, nursing mothers, and children should not be administered this drug as there is no experience of use. This drug contains lactose and should not be taken by patients with lactose intolerance or related genetic diseases. This drug should be used with caution in patients with slightly reduced liver function, those who consume excessive alcohol, patients with renal dysfunction, hypothyroid patients, patients with genetic muscle diseases, or the elderly. In particular, when taken with fibrate drugs or niacin, there is an increased risk of muscle damage and renal dysfunction, so caution is necessary. During treatment with this drug, side effects such as muscle pain, weakness, abdominal pain, skin rash, itching, and abnormal liver function may occur, and patients should consult a doctor immediately if these symptoms occur. Regular liver function tests and muscle-related tests should be performed, and treatment may be discontinued if abnormal findings are detected. This medication is not to be administered to pregnant or nursing women, and women who may become pregnant should consult a doctor before taking it. Safety and efficacy in children have not been confirmed, so it is not used. No special dosage adjustments are needed for the elderly; however, they should use the drug with caution due to the higher likelihood of adverse reactions. This drug may interact with other medications, so especially when taken with cyclosporine, fibrate drugs, niacin, or erythromycin, prescribing should follow a physician's advice, as concurrent use may increase the risk of muscle damage. In cases of overdose, there is no specific antidote, so appropriate treatment and supportive therapy should be provided based on symptoms, and liver function and muscle enzyme levels should be monitored periodically. Finally, this drug should be stored out of reach of children and not transferred to another container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash accompanied by high fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty in breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention

Mild side effects

• Abdominal pain
• rash
• pruritus
• muscle pain
• fatigue
• paralysis
• itching
• headache
• thirst
• indigestion

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is at room temperature between 1 and 30 degrees Celsius. This helps maintain the drug's effectiveness over time.

Appearance

Pale green round film-coated tablet

Package unit

30 tablets per bottle