Topstatin F Tablets 10/10 mg

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. The dosage range is between 10/5 mg to 10/20 mg once daily. For patients who require more significant reductions in LDL cholesterol, the dosage may be adjusted accordingly. Blood lipid levels should be checked at intervals of more than 4 weeks after starting administration or adjusting the dosage.

This medication can cause adverse reactions in muscles, so immediate consultation with a physician is necessary if severe muscle pain or weakness occurs. It can also affect the liver, so liver function tests should be done before starting treatment, and liver function should be monitored regularly during treatment. Patients with specific liver diseases or persistent elevations in liver enzyme levels should not take this medication. Patients with muscle diseases or those taking certain medications like cyclosporine, and patients with significantly impaired kidney function should not use this medication. Women who are pregnant, possibly pregnant, or breastfeeding should avoid this medication, and fertile women should use appropriate contraception while taking it. Patients who consume excessive alcohol or have a history of liver disease should use this medication cautiously, and the elderly are also at risk for muscle adverse reactions, so caution is needed. This medication may interact with other drugs, so it’s essential to inform the healthcare provider or pharmacist of any other medications being taken. Dizziness or headaches may occur during the use of this medication; therefore, caution should be exercised when driving or operating machinery. This medication contains lactose, so patients with lactose intolerance should not take it. In case of overdose, there is no specific antidote, so immediate medical attention should be sought for appropriate treatment. Safety and efficacy in children have not been established, so it is not recommended for use in this population. This medication should be stored away from direct sunlight and out of the reach of children.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty in breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormality with cough + fever, jaundice (yellowing of skin or eyes), severe malaise, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

• Pharyngitis
• arthralgia
• headache
• dizziness
• upper respiratory infection
• myalgia
• fatigue
• constipation
• nausea
• abdominal pain

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication’s effectiveness and safety over time.

Appearance

White to almost white round film-coated tablet

Package unit

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