Traclear Tablet 62.5 Milligrams (Bosentan Monohydrate)

Adult dose

< Pulmonary arterial hypertension > The initial dose is 62.5 mg twice daily for the first 4 weeks of treatment. Starting in week 5, the maintenance dose is 125 mg twice daily. This medicine should be taken in the morning and evening, regardless of meals. The risk of liver injury increases at doses exceeding 250 mg per day. < Active digital ulcers associated with systemic sclerosis > The initial dose is 62.5 mg twice daily for the first 4 weeks of treatment, followed by a maintenance dose of 125 mg twice daily. This medicine should be taken in the morning and evening, regardless of meals. The treatment period in clinical trials conducted for this indication was 6 months. < Special populations > *Dose adjustment and monitoring for abnormal aminotransferase levels 3 x ULN < liver enzyme levels ≤ 5 x ULN If repeat aminotransferase testing confirms the abnormality, reduce the daily dose or discontinue treatment and monitor aminotransferase levels every 2 weeks. If aminotransferase levels return to pretreatment values, continue treatment or restart treatment using an appropriate regimen. 5 x ULN < liver enzyme levels ≤ 8 x ULN If repeat aminotransferase testing confirms the abnormality, discontinue treatment and monitor aminotransferase levels every 2 weeks. If aminotransferase levels return to pretreatment values, restart treatment using an appropriate regimen. > 8 x ULN Treatment must be discontinued, and this medicine must not be restarted. If this medicine is restarted, resume treatment at the initial dose, check AST and ALT values within 3 days after administration, and recheck them after 2 weeks. Thereafter, administer the medicine with reference to the regimen and timing of liver function tests described above. If elevated aminotransferase levels are accompanied by clinical symptoms of liver injury (e.g., nausea, vomiting, fever, abdominal pain, jaundice, lethargy, malaise, or fatigue) and elevated bilirubin (≥ 2 x ULN), treatment must be discontinued. ㆍ Women of childbearing potential Perform a pregnancy test before administering this medicine. Administer it only if the test is negative and the patient is using an appropriate contraceptive method. Women of childbearing potential receiving this medicine should have a pregnancy test every month. (See Warnings under Precautions for Use.) ㆍ Patients with renal impairment No dose adjustment is necessary in patients with renal impairment. ㆍ Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment, but use with caution. This medicine should not be administered to patients with moderate to severe hepatic impairment. ㆍ Elderly patients There is insufficient clinical experience with use in patients aged 65 years and older. Because physiological function is generally reduced in elderly patients, use caution when selecting the dose. ㆍ Underweight patients Systemic sclerosis with active digital ulcers: Experience in patients weighing less than 40 kg is limited. < Discontinuation of treatment > Experience with abrupt discontinuation of this medicine is limited. No acute rebound effects have been observed, but gradual dose reduction should be considered to prevent clinical worsening due to potential rebound effects (reduce the dose to 1/2 over 3~7 days). Careful monitoring is recommended during the period of discontinuation. If discontinuation of this medicine is decided, it should be stopped gradually while alternative treatment is initiated.

Child dose

Pulmonary arterial hypertension: The safety and efficacy in children under 12 years of age have not been established. Active digital ulcers associated with systemic sclerosis: There are no data on the safety and efficacy in patients under 18 years of age. Pulmonary arterial hypertension: For patients weighing less than 40 kg (aged 12 years or older), an initial and maintenance dose of 62.5 mg twice daily is recommended.

This medication poses a risk of liver damage, so routine liver function tests should be conducted before starting treatment and during therapy. It is especially recommended to check liver enzyme levels every 2 weeks for the first 3 months. If liver enzyme levels become abnormally elevated or symptoms of liver damage appear, it may be necessary to consult a doctor regarding dosage adjustment or discontinuation of the medication. During pregnancy, this medication can cause congenital defects in the fetus; therefore, women of childbearing potential should confirm a negative pregnancy test before taking this medication and should use reliable contraception. Additionally, this medication may reduce the effectiveness of single hormone contraceptives, so alternative contraceptive methods must be used. This medication should not be administered to patients with moderate to severe liver dysfunction, those taking certain medications, or individuals allergic to this drug or its components. Elderly patients or those with hypotension must use this medication with greater caution, and administration should be avoided if blood pressure is too low. This medication has a high potential for drug interactions, especially with anticoagulants, antifungals, antivirals, and certain immunosuppressants, so consultation with a healthcare provider is necessary before concurrent use. During the administration of this drug, symptoms such as dizziness, blurred vision, and fainting may occur; therefore, caution is advised when driving or operating machinery. In case of overdose, symptoms such as severe hypotension may occur, thus strict adherence to the prescribed dose is essential, and if overdose is suspected, medical attention should be sought immediately. This medication should be kept out of reach of children, and stored in its original container to prevent misuse or quality deterioration.

• Headache
• edema
• fluid retention
• abnormal liver function tests
• anemia
• decreased hemoglobin
• thrombocytopenia
• neutropenia
• leukopenia
• hypersensitivity reactions

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best to store the medication at room temperature between 1 and 30 degrees Celsius, away from extreme heat or cold.

Appearance

A pale apricot-colored, biconvex, round, film-coated tablet engraved with '62.5'.

Package unit

60 tablets (10 tablets/PTP × 6)