Topstatin F Tablets 10/5 milligrams

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, a starting dose of 10/5mg once daily is recommended. The dosage range is from 10/5mg to 10/20mg per day, and for patients requiring more LDL cholesterol reduction, the dosage may be adjusted accordingly. After initiating treatment or adjusting the dose, blood lipid levels should be checked at intervals of 4 weeks or more before adjusting the dosage.

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can result in serious muscle damage. Particularly, for patients at risk of rapid deterioration of kidney function due to acute infections, hypotension, major surgeries or trauma, severe metabolic abnormalities, the use of this medication should be temporarily suspended or discontinued. Additionally, this medication should not be administered to patients with allergies to the active ingredient or components, patients with severe liver dysfunction, patients with muscle diseases, patients taking certain immunosuppressants, patients with severe kidney function impairment, pregnant women or women who may become pregnant, and nursing mothers. Patients who are prone to myopathy or rhabdomyolysis, such as those with moderate or severe renal impairment, hypothyroidism, a family history of muscle diseases, previous experiences of muscle toxicity from other statins or fibrates, patients with alcohol addiction, and Asian patients should use this medication with caution. This medication contains lactose and should not be given to patients with lactose intolerance or related genetic disorders. Regular liver function tests should be conducted while taking this medication, and treatment may be discontinued if liver enzyme levels become abnormally elevated. Additionally, if symptoms such as myalgia, muscle spasms, muscle weakness, fatigue, fever, etc. occur, the healthcare provider should be informed immediately, and blood tests should be performed to check for muscle damage if necessary. This medication may interact with other drugs; therefore, if the patient is taking other medications, they must inform their healthcare provider. Women who are pregnant or planning to become pregnant should not take this medication and must use appropriate contraceptive methods during treatment. The safety and efficacy in children and adolescents have not been sufficiently established, so its use is not recommended. Caution is needed when administering to the elderly as the risk of myopathy may increase. When storing this medication, it should be kept out of reach of children and should not be transferred to other containers.

Serious side effects

Hives, swelling (severe edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis,

Mild side effects

• Pharyngitis
• arthralgia
• headache
• ALT elevation
• AST elevation
• myalgia
• edema
• elevated bilirubin levels
• acne-like dermatitis
• itching

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness for a longer time.

Appearance

White to almost white round film-coated tablets

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle, PTP - 30 tablets/box [10 tablets/PTP x 3]