Lipitab 4 mg (Pitavastatin Calcium Hydrate)

Adult dose

For adults, the usual initial dose is 1 to 2 mg of pitavastatin calcium, taken once daily. If the LDL cholesterol lowering effect is insufficient, the dosage may be increased to a maximum of 4 mg per day. The dosage should be adjusted appropriately at intervals of 4 weeks or more depending on the LDL cholesterol level, treatment goals, and the patient’s response.

This drug should not be used in patients with allergies to specific ingredients. It should also be avoided in patients with active liver disease or persistently elevated liver function tests. It is contraindicated in patients with severe liver dysfunction or bile duct obstruction, as well as those with cholestasis. Patients taking cyclosporine must not use this medication. Patients with myopathy or pregnant women, women who may become pregnant, and breastfeeding women should also not use this drug. Safety and efficacy have not been established in children, so it should not be administered to them. This drug contains lactose; therefore, it should not be taken by patients with lactose intolerance or related genetic disorders. Patients with allergies to soybean oil, soy, or peanuts should exercise caution. Patients with impaired kidney function or who are taking fibrate medications or niacin should be cautious as there is a risk of muscle damage and worsening kidney function. Patients with weakened liver function should use this medication cautiously as it may exacerbate liver function. Excessive alcohol consumption may also pose risks. Patients with hypothyroidism or genetic muscle disorders, elderly patients, patients with hyperlipoproteinemia, or diabetic dyslipidemia should also proceed with caution. Patients with severe myasthenia gravis or ocular muscle weakness may experience worsening of their condition when using this drug. During the course of this medication, symptoms such as muscle pain, weakness, liver function abnormalities, skin rashes, and blood abnormalities may occur, and any concerning symptoms should prompt immediate consultation with a physician. In particular, severe muscle pain or weakness may indicate a serious side effect called rhabdomyolysis, necessitating discontinuation of the medication. Liver function tests should be performed regularly before and during treatment; if abnormalities are detected, the drug should be discontinued. Like other statins, this drug may slightly increase the risk of diabetes; however, the cardiovascular disease prevention benefits outweigh this risk, so it is not considered a reason to discontinue. Rare cases of immune-mediated necrotizing myopathy, an autoimmune muscle disorder, have been reported, and if symptoms persist, specialized treatment is needed. When used in conjunction with other lipid-lowering agents, the risk of muscle damage may increase; therefore, caution is advised during concomitant use. Elderly patients may experience side effects more readily, so dose adjustment and careful monitoring are necessary. Pregnant and breastfeeding women should not use this drug as it may pose risks to the fetus or newborn. This medication should be swallowed whole and not divided, and it must be stored out of reach of children. It is safer to keep it in its original container and not transfer it to another container.

Serious side effects

• Hives
• rhabdomyolysis
• myopathy
• liver dysfunction
• jaundice
• thrombocytopenia
• severe allergic reactions
• liver abnormalities (jaundice)
• severe edema or urinary disturbances

Mild side effects

• Abdominal pain
• rash
• fatigue
• paralysis
• itching
• thrombocytopenia
• stiffness
• drowsiness
• insomnia
• headache

This drug is sensitive to light, so it should be stored in an opaque container, and the temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Storing it this way helps safely maintain the drug's effectiveness.

Appearance

Pale yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle