Rosutanjet Tablet 10/10 mg

Adult dose

This medication is administered once daily irrespective of meals. For primary hypercholesterolemia, a starting dose of 10/5 mg per day is recommended, with a dosage range of 10/5 mg to 10/20 mg per day. For patients who require more significant LDL-cholesterol reduction, the dosage may be adjusted, with the maximum daily dosage being 10/20 mg. After initiation of treatment or dosage adjustment, a gap of at least 4 weeks should be maintained before further evaluation.

This medication can rarely cause serious damage to muscle tissue, resulting in acute renal failure; therefore, if severe muscle pain or weakness occurs, it is essential to consult a physician immediately. This medication should not be administered to individuals allergic to the active ingredient or any components, those with active liver disease or persistently elevated liver function tests, those with muscle disorders, individuals taking certain immunosuppressants, those with severe renal impairment, pregnant women or women who may become pregnant, and nursing mothers. Additionally, patients with moderate or severe liver dysfunction, alcohol dependence, hypothyroidism, a history of genetic muscle disease, and elderly individuals who are at increased risk of muscle damage should use this medication cautiously and notify healthcare professionals if muscle pain or weakness symptoms arise. This medication contains lactose and should not be administered to patients with lactose intolerance or specific genetic metabolic disorders. While on this medication, liver function and muscle state should be regularly monitored, and if liver enzyme levels rise abnormally or muscle-related indicators significantly increase, administration should be discontinued. During treatment, care should be taken to avoid intense exercise or other activities that put strain on muscles; if symptoms such as muscle pain, fatigue, or fever occur, medical attention must be sought immediately. Pregnant or nursing women should not take this medication, and fertile women should use appropriate contraception during treatment. This medication may interact with some drugs; therefore, it is crucial to inform healthcare providers about any other medications being taken, especially anticoagulants, fibrate class drugs, certain antibiotics, and antifungal agents due to the need for caution. Safety in children and adolescents has not been sufficiently established and is not recommended; the risk of myopathy in elderly patients necessitates careful use. There is no specific antidote in case of overdose; symptomatic treatment and supportive care are required, monitoring liver function and muscle state. This medication should be kept out of the reach of children and should not be transferred to other containers.

Serious side effects

Hives, edema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver dysfunction (jaundice), sudden and severe symptoms

Mild side effects

• Nasopharyngitis
• arthralgia
• headache
• ALT elevation
• AST elevation
• myalgia
• edema
• increased blood bilirubin
• acneiform dermatitis
• pruritus

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to keep it at room temperature between 1°C and 30°C. Following these instructions helps maintain the medication's effectiveness for a longer time.

Appearance

White to nearly white round film-coated tablets

Package unit

30 tablets (15 tablets/blister × 2)