Adempas 1 mg (Riociguat)

Adult dose

1) Adults o Initial dose The initial dose is 1.0 mg per dose, 3 times daily for 2 weeks. This medicine should be taken 3 times daily at approximately 6-8-hour intervals, regardless of food intake. To minimize the potential for hypotension, the initial dose may be started at 0.5mg 3 times daily. o Dose titration • If systolic blood pressure is 95 mmHg or higher and there are no signs or symptoms of hypotension, increase the dose by 0.5 mg per dose up to a maximum of 2.5 mg; dose titration should be performed at 2-week intervals. • If systolic blood pressure is less than 95 mmHg and there are no signs or symptoms of hypotension, maintain the dose. • If systolic blood pressure is less than 95 mmHg and signs or symptoms of hypotension are observed, withhold the next 3 doses at any time and, after 24 hours, if clinically acceptable, resume treatment at a dose reduced by 0.5 mg per dose. o Maintenance dose The individualized maintenance dose established for each patient should be maintained provided that no signs or symptoms of hypotension occur. The maximum daily dose of this medicine is 7.5 mg. If a dose is missed, continue with the next scheduled dose. If tolerability is poor, dose reduction may be considered at any time. o Interruption of treatment If treatment must be interrupted for 3 days or more, restart at the initial dose, administered 3 times daily for 2 weeks, and then continue treatment according to the dose titration method described above. o For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or soft food such as applesauce, and administered orally. 2) Administration in special populations (1) Elderly patients Exposure to this medicine is increased in elderly patients aged 65 years or older; therefore, special care is needed when individually titrating the dose. (2) Patients with hepatic impairment Exposure to this medicine is increased in patients with moderate hepatic impairment (Child Pugh B); therefore, special care is needed when individually titrating the dose. This medicine has not been studied in patients with severe hepatic impairment (Child Pugh C) and should not be administered to them. (3) Patients with renal impairment Exposure to this medicine is increased in patients with mild, moderate, or severe renal impairment (creatinine clearance 15-80 mL/min); therefore, special care is needed when individually titrating the dose. This medicine has not been studied in patients with a creatinine clearance of 15 mL/min or in patients on dialysis and should not be administered to them. (4) Patients taking strong dual or multiple pathway CYP and P-gp (P-glycoprotein) / BCRP (Breast cancer resistance protein) inhibitors When initiating this medicine in patients taking a stable dose of strong dual or multiple pathway CYP and P-gp/BCRP inhibitors [e.g., azole antifungals (ketoconazole, itraconazole, etc.), HIV protease inhibitors (e.g., ritonavir, etc.)], consider a starting dose of 0.5mg 3 times daily to reduce the risk of hypotension. Monitor for signs and symptoms of hypotension at the start of treatment and during treatment (see section ‘3. Patients for whom administration requires caution’ under Precautions for Use). (5) Smokers Smoking cessation is recommended for smokers. Blood concentrations of this medicine were lower in smokers than in nonsmokers. Dose adjustment of this medicine may be necessary in patients who stop smoking or start smoking during treatment. 3) Switching medications · Discontinue sildenafil at least 24 hours before starting this medicine. · Discontinue tadalafil at least 48 hours before starting this medicine. For patients at risk of hypotension, consider starting this medicine at an initial dose of 0.5mg. When switching medications, observation for signs or symptoms of hypotension is recommended initially. · Discontinue this medicine at least 24 hours before administering a PDE-5 inhibitor. When switching medications, observation for signs or symptoms of hypotension is recommended initially.

This medication should not be administered to pregnant women as it may be harmful to the fetus. Women of childbearing potential must confirm their pregnancy status before taking this medication and should use effective contraception during treatment and for one month after stopping the medication. This medication should not be given to certain patients. For example, individuals who are allergic to this medication, pregnant or potentially pregnant women, breastfeeding women, patients with certain low blood pressure conditions, and those with severe liver or kidney diseases may be at risk if they take this medication. Additionally, patients with pulmonary venous obstructive disease, recent serious respiratory hemorrhage, or those at risk of hypotension should use this medication cautiously. As this medication can cause vasodilation and lower blood pressure, special caution is warranted for patients with low blood pressure. Patients with impaired liver or kidney function, as well as the elderly, require careful dosage adjustment and monitoring. There may be interactions with other medications, and consultation with a physician or pharmacist is essential when taking this medication with others. During treatment with this medication, side effects such as headache, dizziness, dyspepsia, nausea, vomiting, diarrhea, peripheral edema may occur. If severe bleeding or symptoms of hypotension occur, immediate medical attention is needed. There are no specific food interactions, but smoking may reduce the effectiveness of this medication, so quitting smoking is recommended. Additionally, this medication can cause dizziness, so caution is needed when driving or operating machinery. This medication may have enhanced effects or increased side effects when combined with other antihypertensives or certain antifungals and antivirals, hence it should be taken strictly according to professional guidance. Pregnant or breastfeeding women should not take this medication, and if pregnancy occurs during treatment, immediate consultation with a physician is necessary. Safety and efficacy in pediatric populations have not been adequately established, hence it is not recommended. In case of overdose, symptoms of hypotension may appear, necessitating immediate medical care for appropriate treatment. This medication must be kept out of reach of children and should not be transferred to other containers. Furthermore, long-term use may affect bone metabolism, necessitating regular check-ups.

• Headache
• dizziness
• indigestion
• peripheral edema
• nausea
• diarrhea
• vomiting
• anemia
• palpitations
• hypotension

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best kept at room temperature, between 1 to 30 degrees Celsius. Proper storage can help maintain the medication's efficacy over time.

Appearance

This is a round, yellowish film-coated tablet with a convex shape on both sides. One side is imprinted with "R 1" and the other side bears the Bayer cross.

Package unit

42 tablets (21 tablets in PTP packaging x 2)