Adempas Dosage & Drug Information

Concise Prescribing Info

Contents

Riociguat

Indications/Uses

Chronic thromboembolic pulmonary HTN, pulmonary arterial HTN.

Dosage/Direction for Use

Adult Initially, 1 mg tds for 2 wk, may be increased by 0.5-mg tds every 2 wk to max: 7.5 mg daily.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Co-administration w/ PDE5 inhibitors, nitrates or nitric oxide donors. Patients w/ systolic BP <95 mmHg; pulmonary HTN associated w/ idiopathic interstitial pneumonias. Severe hepatic impairment. Pregnancy.

Special Precautions

Pulmonary veno-occlusive disease. Hypotension. Smokers. Monitor patients receiving anticoagulation therapy. Concomitant use w/ azole antimycotics (eg, ketoconazole, itraconazole) or HIV PIs (eg, ritonavir). Not recommended in patients w/ CrCl <30 mL/min or on dialysis. Mild & moderate renal & moderate hepatic impairment. Childn & adolescents <18 yr.

Adverse Reactions

Dizziness, headache; dyspepsia, diarrhoea, nausea, vomiting; peripheral oedema. Gastroenteritis; anemia; palpitations; hypotension; haemoptysis, epistaxis, nasal congestion; gastritis, GERD, dysphagia, GI & abdominal pains, constipation, abdominal distension.

View ADR Monitoring Form

Drug Interactions

Increased exposure w/ CYP450, UGT1A1 & 1A9, P-gp/BCRP eg, ketoconazole, itraconazole & HIV PIs eg, ritonavir. Potentiated blood lowering effect of SL nitroglycerin. Additive systemic BP lowering effect w/ sildenafil or vardenafil. Caution w/ cyclosporine A. Lowered oral bioavailability w/ drugs increasing upper GI pH. Reduced mean AUC & C_max by antacids eg, Al & Mg hydroxide. Decreased steady-state plasma conc by bosentan & strong CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort.

MIMS Class

Other Antihypertensives

ATC Classification

C02KX05 - riociguat ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.

Regulatory Classification

Presentation/Packing

Form

Adempas FC tab 0.5 mg

Packing/Price

42's

Form

Adempas FC tab 1 mg

Packing/Price

42's

Form

Adempas FC tab 1.5 mg

Packing/Price

42's

Form

Adempas FC tab 2 mg

Packing/Price

42's

Form

Adempas FC tab 2.5 mg

Packing/Price

42's

Adempas

riociguat

Manufacturer:

Bayer

Distributor:

Zuellig Pharma