Tadalafil Sandoz

Tadalafil

Erectile dysfunction in adult males.

10 mg taken at least 30 min prior to anticipated sexual activity, may be increased to 20 mg if 10 mg does not produce an adequate effect. Max dose frequency: Once per day. Men w/ severe renal impairment Max: 10 mg for on-demand treatment.

May be taken with or without food.

Hypersensitivity. Must not be used in men w/ cardiac disease for whom sexual activity is inadvisable. Patients w/ MI w/in the last 90 days; unstable angina or angina occurring during sexual intercourse; NYHA class 2 or greater heart failure in the last 6 mth; uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled HTN; a stroke w/in the last 6 mth. Patients who have loss of vision in 1 eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether in connection or not w/ previous PDE5 inhibitor exposure. Concomitant use w/ any form of organic nitrate; guanylate cyclase stimulators eg, riociguat.

Consider CV status of patient prior to treatment initiation. May induce a BP decrease. Reports of serious CV events; visual defects & cases of NAION; sudden hearing loss. Caution in patients w/ anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma, or leukaemia). Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ antihypertensives, α₁ blockers; potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin). Not recommended w/ doxazosin. Do not take w/ other PDE5 inhibitors or other treatments for erectile dysfunction. Patient w/ severe renal or hepatic impairment. Not indicated for use by women.

Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity.

Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, ritonavir, saquinavir, erythromycin, clarithromycin, itraconazole, grapefruit juice. Potential interaction w/ transporter inhibitors. Decreased plasma conc w/ CYP3A4 inducers eg, rifampicin, phenobarb, phenytoin, carbamazepine. Augmented hypotensive effects of nitrates/organic nitrates. Increased BP-lowering effect of α-blocker doxazosin. In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a BP decrease. Additive systemic BP-lowering effect w/ riociguat. Exercise caution when tadalafil is co-administered w/ 5-α reductase inhibitors. Increased oral bioavailability of ethinylestradiol; terbutaline (oral administration).

Drugs for Erectile Dysfunction & Ejaculatory Disorders

G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.

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