Statjet Tablet 4/10 mg (Pitavastatin Calcium, Ezetimibe)

Adult dose

This medication is taken once daily without regard to meals. The recommended initial dose is 2/10 mg once daily. If the effect of lowering LDL cholesterol is insufficient, the dose may be increased up to a maximum of 4/10 mg once daily. In the case of patients with liver dysfunction, an initial dose of 1 mg once daily is recommended, with a maximum dosage of 2/10 mg daily. This medication is not recommended for patients with moderate to severe liver dysfunction.

This drug should not be used in patients with allergies or history of hypersensitivity to certain components. It is also contraindicated in patients with active liver disease or unexplained elevation of liver enzyme levels, severe liver impairment, or biliary obstruction. Patients taking cyclosporine, those with myopathy, pregnant women or women who may become pregnant, nursing mothers, and children should not use this medication. This drug contains lactose, so it should not be administered to patients with lactose intolerance or related genetic disorders. Caution should be exercised when administering to patients with mild to moderate liver function impairment, excessive alcohol consumption, renal impairment, hypothyroidism, and the elderly. Particularly, patients taking fibrates or niacin are at higher risk for muscle-related side effects, and it is advisable to avoid concomitant administration of these medications if possible. While using this drug, any muscle-related symptoms such as myalgia, weakness, or muscle tenderness should lead to prompt consultation with a physician, and liver function tests should be performed regularly. Serious muscle-related side effects such as myopathy or rhabdomyolysis can occur, and if such symptoms are suspected, the medication should be discontinued immediately. If signs of impaired liver function appear, treatment should be halted, and appropriate measures should be taken, including regular blood tests to monitor liver enzyme levels. This medication is not to be used in pregnant or nursing women, and women planning to become pregnant should consult a physician before use. Safety and efficacy in children have not been established, thus it should not be used in pediatric patients. In the elderly, dosage adjustment is generally not necessary, but caution is required in case of adverse reactions. If an overdose occurs, there is no specific antidote, and treatment should be symptomatic and supportive, with monitoring of liver function and muscle-related tests. This medication should be kept out of reach of children and should not be transferred to another container to maintain quality.

Serious side effects

Hives, chest discomfort, difficulty breathing, rhabdomyolysis, myopathy, liver dysfunction, jaundice, thrombocytopenia, severe allergic reaction, severe edema, renal failure, interstitial lung disease, severe skin adverse reactions, severe neurological symptoms, renal function deterioration, severe muscle weakness, ocular myasthenia, anaphylaxis, elevated blood pressure (in severe cases)

Mild side effects

• Abdominal pain
• diarrhea
• dry mouth
• bloating
• gastroesophageal reflux disease
• dental pain
• weakness
• fatigue
• myalgia
• altered taste

This medication is sensitive to light and should be stored in a container that protects it from light. Furthermore, to maintain the effectiveness of the drug, it is important to store it at a temperature between 1°C and 30°C.

Appearance

Pink oval film-coated tablets

Package unit

30 tablets/bottle