Xarelto XL Sustained Release Tablet (Fluvastatin Sodium)

Adult dosage

1) In clinical trials in adult patients with primary hypercholesterolemia and coronary artery disease, administration of 40 mg of fluvastatin daily delayed the progression of coronary atherosclerosis. 2) For patients with coronary artery disease who have undergone percutaneous coronary intervention, the appropriate dose is 80 mg daily. The recommended initial dose is 20 ～ 40 mg of this medicine once daily in the evening. Most patients require 20 ～ 40 mg once daily; however, depending on baseline LDL cholesterol levels and the treatment target, the dose may be individually increased to 80 mg daily (fluvastatin extended-release tablets 80 mg once daily or fluvastatin immediate-release capsules 40 mg twice daily). The maximum daily dose is 80 mg. Fluvastatin extended-release tablets 80 mg may be taken at any time of day, at the same time each day, regardless of food intake.

Children's dosage

Males: Ages 9 through 16 years — Before treatment with this medicine, patients must have followed a standard cholesterol-lowering diet for 6 months, and the diet must be continued during treatment. The recommended starting dose is 20 mg of this medicine. The maximum daily dose is 40 mg per dose twice daily or 80 mg extended-release tablets once daily. Females: Ages 10 through 16 years after menarche — Before treatment with this medicine, patients must have followed a standard cholesterol-lowering diet for 6 months, and the diet must be continued during treatment. The recommended starting dose is 20 mg of this medicine. The maximum daily dose is 40 mg per dose twice daily or 80 mg extended-release tablets once daily.

This medication carries a risk of muscle-related issues. If symptoms like muscle pain or weakness occur, inform a doctor immediately and stop treatment. It should not be taken by patients with severe renal impairment or liver disease, or by women who are pregnant or breastfeeding. Use caution in individuals with alcohol dependence, poor liver function, or hypothyroidism as they are at a higher risk for muscle issues. Mild side effects like indigestion, diarrhea, headache, and insomnia may occur during treatment, and monitoring muscle enzyme levels through blood tests is important if muscle-related side effects are suspected. Consult with a doctor before taking this medication to check for possible drug interactions, particularly with certain antibiotics or immunosuppressants. Women of childbearing potential should use effective contraception, and if pregnancy is confirmed, medication should be stopped immediately. Special caution is required for children and the elderly, and the safety and efficacy may not be sufficiently studied, so expert guidance should be followed. There is no specific antidote for overdose, so treatment should be based on symptoms, and liver function and muscle enzyme levels should be monitored. Store the medication out of reach of children and keep it in its original container to prevent misuse.

Myopathy, rhabdomyolysis, myalgia, arthritis, arthropathy, sinusitis, bronchitis, dyspepsia, diarrhea, abdominal pain, nausea, abdominal distension, dental disorders, insomnia, urinary tract infection, headache, influenza-like symptoms, accidental injury, fatigue, allergy, thrombocytopenia, rash, urticaria, anaphylactic reaction, paresthesia associated with hyperlipidemia, sensory disturbances, hypoesthesia, vasculitis, pancreatitis, hepatitis, other skin reactions (eczema, dermatitis, vesicular rash), facial edema, angioedema, muscle weakness, myositis, lupus erythematosus-like reaction, elevated aminotransferase levels, hyperlipidemia, specific cranial nerve dysfunction (taste changes, ocular movement ataxia, facial paralysis), tremors, dizziness, memory loss, peripheral neuropathy, peripheral nerve paralysis, mental confusion, anxiety disorders, depression, angioedema, erythematosus lupus-like syndrome, polymyalgia rheumatica, purpura, leukopenia, hemolytic anemia, positive ANA, increased ESR, eosinophilia, arthralgia, myasthenia, photosensitivity reaction, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, mucocutaneous syndrome, erythema multiforme, chronic active hepatitis, cholestatic jaundice, hepatic steatosis, cirrhosis, fulminant hepatic necrosis, liver cancer, anorexia, vomiting, liver failure, alopecia, pruritus, gynecomastia, loss of libido, erectile dysfunction, cataract progression, ocular muscle paralysis, sweating, tinnitus, urinary disorders, myocardial infarction, esophageal ulcer, chest pain, mild dyspnea, sleep disorder, nightmares, amnesia, interstitial lung disease, sexual dysfunction, hyperglycemia, immune-mediated necrotizing myopathy, myoglobinemia, acute renal failure, muscle tenderness, myasthenia gravis, elevated creatine kinase levels, liver dysfunction, weight gain, dizziness, pruritus, rash, vesicular dermatitis, eczema, perivascular hemorrhage, edema, perivascular space mononuclear cell infiltration, exophytic squamous papilloma, exophytic carcinoma, thyroid follicular cell adenoma, thyroid follicular cell carcinoma, exophytic squamous cell papilloma, axoplasmic perivascular vacuolization in the medulla, epididymitis, testicular swelling, tubular degenerative changes, testicular azoospermia

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. Furthermore, it is important to maintain room temperature between 1 and 30 degrees Celsius when storing this medication to ensure prolonged effectiveness.

Appearance

Yellow round film-coated sustained release tablet

Package unit

28 tablets (14 tablets/PTP packaging X2)