Tadalafil Stella

Tadalafil

Erectile dysfunction.

Adult 10 mg once daily at least 30 min prior to anticipated sexual activity, may be increased to 20 mg once daily if 10 mg does not produce adequate effect. Patient who anticipate frequent use eg, at least twice wkly 5 mg once daily, may be decreased to 2.5 mg once daily. Hepatic & severe renal impairment Max recommended dose: 10 mg.

May be taken with or without food.

Hypersensitivity. Not to be used in men w/ cardiac disease for whom sexual activity is inadvisable. CV disease eg, MI w/in last 90 days, unstable angina or angina occurring during sexual intercourse, NYHA class ≥2 heart failure in last 6 mth, uncontrolled arrhythmias, hypotension (<90/50 mmHg) or uncontrolled HTN, stroke w/in last 6 mth. Loss of vision in 1 eye due to non-arteritic anterior ischaemic optic neuropathy (NAION). Co-administration w/ guanylate cyclase stimulators eg, riociguat; organic nitrates.

Discontinue use if sudden vision defect, decreased or hearing loss occur. Increased risk of acute NAION. Anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions predisposing to priapism eg, sickle cell anaemia, multiple myeloma or leukaemia. Serious CV events eg, MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations, tachycardia. Assess CV status prior to treatment; patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Not to be used in combination w/ other PDE5 inhibitors or other treatments for erectile dysfunction. Not recommended in combination w/ doxazosin. Concomitant use w/ α₁-blockers, potent CYP3A4 inhibitors eg, ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe hepatic insufficiency (Child-Pugh class C). Not recommended for once-daily dosing in severe renal impairment. Not to be used in women. Avoid use during pregnancy. Not to be used during lactation.

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

Increased AUC & C_max w/ CYP3A4 inhibitors. Increased plasma conc w/ other PIs eg, saquinavir, other CYP3A4 inhibitors (eg, erythromycin, clarithromycin, itraconazole), grapefruit juice. Potential drug interactions mediated by transport inhibitors. Decreased efficacy w/ CYP3A4 inducers eg, rifampicin. Decrease plasma conc w/ other CYP3A4 inducers eg, phenobarb, phenytoin, carbamazepine. Augmented hypotensive effects of nitrates. Increased BP-lowering effect of doxazosin. Augmented hypotensive effects w/ riociguat. Increased oral bioavailability of ethinylestradiol, terbutaline. Concomitant use w/ α-blockers, 5α-reductase inhibitors, CYP1A2 substrates eg, theophylline.

Drugs for Erectile Dysfunction & Ejaculatory Disorders

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

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