Pitaterol Tablets 4 mg (Pitavastatin Calcium Hydrate)

Adult dose

In adults, the usual initial dosage is 1 to 2 mg of pitavastatin calcium once daily. If the LDL-cholesterol lowering effect is insufficient, the dose may be increased to a maximum of 4 mg per day. The dosage should be appropriately adjusted at intervals of 4 weeks or more, based on the LDL-cholesterol levels, therapeutic targets, and the patient's response. The therapeutic effect of this medication is maintained with continuous administration.

This medication should not be used in certain patients. For example, patients who are allergic to this medication, those with active liver disease, severe hepatic impairment, biliary obstruction, and those taking cyclosporine should not take this medication. Additionally, this medication should not be used in patients with myopathy, pregnant women or those who may become pregnant, nursing women, and children. This medication contains lactose, so lactose-intolerant patients should also avoid its use. Patients with kidney function abnormalities or a history of liver impairment should use this medication with caution. Especially when taken with fibrates or niacin, there can be a risk of muscle damage and kidney function deterioration, so caution is required. Caution is also warranted for patients who consume alcohol excessively or have a history of hypothyroidism or muscle disorders. Elderly patients and those with allergies to specific dye components also require careful monitoring. This medication can cause various adverse reactions, including muscle pain, weakness, liver function abnormalities, and allergic reactions. Rhabdomyolysis, which involves the breakdown of muscle tissue, can occur; therefore, if muscle pain or weakness occurs, one should immediately discontinue use. Regular liver function tests should be performed, and if abnormalities are detected, the medication should be stopped, and appropriate action should be taken. Since this medication is used for the treatment of hypercholesterolemia, it is important to conduct thorough examinations and dietary and exercise regimens prior to administration. During treatment, blood lipid levels should be monitored regularly, and if no effect is observed, use should be discontinued. Patients with impaired liver function should adjust the dosage, and liver function tests should also be performed periodically after medication use. This medication interacts with certain drugs, increasing the risk of kidney damage and muscle injury when used together. In particular, it should not be taken with cyclosporine, fibrates, or niacin, and a sufficient interval should be maintained from the use of cholestyramine. Additionally, co-administration of this medication with fusidic acid is not recommended, and if unavoidable, strict monitoring is necessary. Elderly patients have a higher risk of experiencing adverse reactions due to decreased bodily function, so dosage adjustments and caution are required. Pregnant women, women who may become pregnant, and nursing women should not take this medication. It can have serious effects on the fetus, so administration should be discontinued immediately if pregnancy occurs. The safety and efficacy of this medication in children have not been established, so its use is not recommended. When taking this medication, it is advisable not to split the tablets but to swallow them whole, and to store them out of reach of children. Furthermore, medications should not be transferred from their original container to another container, as this is to prevent misuse or deterioration in quality.

Serious side effects

• Urticaria
• erythema
• angioedema
• rhabdomyolysis
• acute renal failure
• liver function disorder
• jaundice
• severe muscle weakness
• ophthalmoplegia

Mild side effects

• Abdominal pain
• rash
• fatigue
• paralysis
• itching
• stiffness
• drowsiness
• insomnia
• headache
• heaviness in the head

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, it is best to store the medication at room temperature between 1°C and 30°C. This way, the medication's efficacy and safety can be maintained.

Appearance

Yellow round film-coated tablet with a line in the center

Package unit

30 tablets/bottle, 100 tablets/bottle