Basic Information
ADEMPAS FILM-COATED TABLET 0.5mg
TABLET, FILM COATED
Regulatory Information
SIN14678P
November 24, 2014
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
XC02KX05
Company Information
BAYER (SOUTH EAST ASIA) PTE LTD
BAYER (SOUTH EAST ASIA) PTE LTD
Active Ingredients
Strength: 0.50mg
Detailed Information
Contraindications
**4.3 Contraindications** Adempas is contraindicated during pregnancy _(see section ‘pregnancy and lactation’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated _(see section ‘Interaction with other medicinal products and other forms of interaction’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. Co-administration of riociguat with PDE-5-inhibitors (such as sildenafil, tadalafil, vardenafil) is contraindicated _(see section ‘Interaction with other medicinal products and other forms of interaction’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. Co-administration of Adempas with other soluble guanylate cyclase stimulators is contraindicated _(see section ‘Interaction with other medicinal products and other forms of interaction’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Adempas is contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) _(see section ‘Pharmacodynamic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)_.
Indication Information
**4.1 Indication(s)** Chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4): Adempas is indicated for the treatment of adult patients with WHO functional Class II to III symptoms - Inoperable CTEPH, - Persistent or recurrent CTEPH after surgical treatment to improve exercise capacity (see section 5.1.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Pulmonary arterial hypertension (PAH, WHO Group 1): Adempas is indicated for the treatment of adult patients with WHO functional class II to III PAH to improve exercise capacity (see section 5.1.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Efficacy was shown in patients on riociguat monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II-III and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.