【藥品庫存】 本藥品為臨時採購藥品，經院長核可後，限定特定科別、病人使用。

Chronic thromboembolic pulmonary hypertension: Treatment of persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class in adults.
Pulmonary arterial hypertension: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening in adults.

Soluble Guanylate Cyclase (sGC) Stimulator

Distribution: ~30 L
Protein binding: Plasma: ~95%
Metabolism: Mainly cleared by metabolism by CYP1A1, CYP3A, CYP2C8 and CYP2J2. Formation of the major active metabolite, M1, is catalyzed by CYP1A1, which is inducible by polycyclic aromatic hydrocarbons such as those present in cigarette smoke. M1 is only 1/3 to 1/10 as potent as the parent drug and is further metabolized to the inactive N-glucuronide. Plasma concentrations of M1 in patients with pulmonary arterial hypertension are about half those for riociguat.
Bioavailability: ~94%
Half-life elimination: Patients: 12 hours; Healthy subjects: 7 hours
Time to peak, plasma: 1.5 hours
Excretion: Feces (~53%); urine (~40%)

1. Pregnancy
2. Coadministration with nitrates, nitric oxide donors, phosphodiesterase (PDE) inhibitors (eg, sildenafil, tadalafil, vardenafil), or nonspecific PDE inhibitors (eg, dipyridamole, theophylline)
3. Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)

Use is contraindicated during pregnancy.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.

1. Cardiovascular: Hypotension, palpitations, peripheral edema
2. Central nervous system: Headache, dizziness
3. Gastrointestinal: Dyspepsia, nausea, diarrhea, vomiting, gastritis, constipation, gastroesophageal reflux disease, abdominal distention, dysphagia
4. Hematologic & oncologic: Anemia, major hemorrhage (including vaginal hemorrhage, catheter site hemorrhage, subdural hematoma, hematemesis, and intra-abdominal hemorrhage)
5. Respiratory: Hemoptysis, epistaxis, nasal congestion

1. Initial: 1 mg 3 times daily, may initiate 0.5 mg 3 times daily in patients at higher risk of hypotension.
2. Increase: If systolic BP remains >95 mm Hg and the patient has no signs or symptoms of hypotension, increase the dose by 0.5 mg 3 times daily at intervals of >2 weeks to a maximum dose of 2.5 mg 3 times daily.
3. Transitioning from a PDE-5 inhibitor to riociguat:
1) Discontinue sildenafil >24 hours prior to administering riociguat.
2) Discontinue tadalafil ?48 hours prior to administering riociguat.
4. Transitioning from riociguat to a PDE-5 inhibitor: Discontinue riociguat ?24 hours prior to administering sildenafil or tadalafil.

CrCl >15 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling.
CrCl <15 mL/minute, Dialysis: Use is not recommended (has not been studied)

Mild to moderate hepatic impairment (Child-Pugh class A and B): There are no dosage adjustments provided in the manufacturer's labeling.
Severe hepatic impairment (Child-Pugh class C): Use is not recommended (has not been studied).