Pitavastatin Calcium 2 mg Tablets

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, the dose can be increased to a maximum of 4 mg per day. The dosage may be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response.

This medication should not be used in certain patients. First, those who have had an allergy to any of its ingredients should not take it. Patients with active liver disease or ongoing liver dysfunction, and those with severe liver impairment or bile duct obstruction should also avoid its use. Additionally, patients taking cyclosporine, those with myopathy, pregnant or possibly pregnant women, breastfeeding women, and children should not be administered this medication. Since this medication contains lactose, it should also not be given to patients with lactose intolerance or related hereditary disorders. Patients with kidney dysfunction or a history of liver disorders, those who consume alcohol excessively, elderly patients, patients with hypothyroidism, and those with genetic muscle diseases or a history of muscle-related conditions should use this medication with caution. Caution is especially needed when used in conjunction with fibrates or niacin, as this may increase the risk of muscle damage. During treatment, adverse reactions such as muscle pain, weakness, abdominal pain, rash, and itching may occur, and there may be increases in liver function tests or blood abnormalities like thrombocytopenia. If rhabdomyolysis related to muscle damage occurs, medication should be stopped immediately, as it may be accompanied by severe renal impairment. Prior to administration, it is advisable to confirm hypercholesterolemia and to carry out dietary and exercise therapies first. Regular monitoring of blood lipids and liver function tests should be conducted during treatment, and if abnormalities are found, medication should be discontinued. This medication is primarily metabolized in the liver, so dosage adjustments are necessary for patients with reduced liver function, and the risk of muscle-related side effects increases with dose escalation. This medication has many drug interactions, especially with cyclosporine, fibrates, niacin, and erythromycin, which can increase the risk of muscle damage and renal function deterioration; thus, caution should be exercised when co-administered. Elderly patients may have diminished physiological functions, increasing the likelihood of side effects, and dosage adjustments and monitoring are necessary. Pregnant or breastfeeding women should not take this medication as it may harm the fetus or infant, and women planning to become pregnant should also exercise caution. The safety of this medication in children has not been established, so it should not be used. Lastly, this medication should be stored out of reach of children and kept in its original container to prevent deterioration of quality or misuse.

Serious side effects

Hives, angioedema, severe renal impairment, acute renal failure, rhabdomyolysis, liver dysfunction, jaundice, sudden and severe headache, seizures, confusion, paralysis, severe swelling accompanied by increased blood pressure, dyspnea, difficulty breathing, asthma attacks, severe rash with high fever, blisters, skin peeling, oral and ocular mucosal pain.

Mild side effects

• Abdominal pain
• rash
• fatigue
• itching
• muscle pain
• weakness
• headache
• dizziness
• skin tingling
• stiffness

This medication is sensitive to light and should be stored in a container that protects it from light. It is recommended to keep it at room temperature between 1 to 30 degrees Celsius, which helps maintain its efficacy and safety.

Appearance

White, round film-coated tablets with a line.

Package unit

For domestic use) 100 tablets (10 tablets/PTP × 10), 300 tablets/bottle, for export) 30 tablets (10 tablets/PTP x 3)