SPEDRA TABLET 50MG

Basic Information

Product Name

SPEDRA TABLET 50MG

Dosage Form

TABLET

Regulatory Information

Approval Number

SIN15880P

Approval Date

January 24, 2020

Forensic Classification

Prescription Only

Drug Type

Therapeutic

Route of Administration

ORAL

Record Created

August 10, 2023

Last Updated

June 3, 2025

ATC Business ID

XG04BE10

Active Ingredients

AVANAFIL

Strength: 50MG

Detailed Information

Contraindications

**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite) (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra. The use of avanafil is contraindicated in: - Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; - Patients with resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg); - Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater. Patients with severe hepatic impairment (Child-Pugh C). Patients with severe renal impairment (creatinine clearance < 30 mL/min). Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with known hereditary degenerative retinal disorders. Patients who are using potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (see sections 4.2, 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

Indication Information