CAVERTA Tablet

For most patients, the recommended dose is 50mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil may be taken anywhere from 4 hours to 0.5 hour before sexual activity.

1. Patient with a known hypersensitive to any component of the tablet.

2. Patient who are currently using nitric oxide donors, organic nitrate or organic nitrites in any form (Sildenafil was shown to potentiate the hypotensive effects of acute and chronic nitrates)

3. Co-administration with guanylate cyclase stimulators, such as riociguat (This may potentially lead to symptomatic hypotension.

Headache, dizziness, hot flush, nasal congestion, altered vision, nausea, heart rate increased, hypotension, rhinitis, etc.

- The following factors are associated with increased plasma levels of sildenafil: age >65, hepatic impairment (e.g. cirrhosis), severe renal impairment (creatinine clearance <30mL/min), and concomitant use of poten CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir). A starting dose of 25mg should be considered in these patients.

- If prescribed to the following groups, this should be done with caution.

Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.

Patients with resting hypotension (BP<90/50) or hypertension (BP>170/110)

Patients with cardiac failure or coronary artery disease causing unstable angina

Patients with retinitis pigmentosa

- Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration): In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

- Serious cardiovasucular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage and transient ischemic attack have been reported post-marketing in temporal association with the use of sildenafil. Most, but not all, of these patients had pre-existing cardiovascular risk factors.

- Acute onset of NAION, a rare condition and a cause of decreased vision or loss of vision. In case of sudden visual loss, patients should be advised to stop taking sildenafil and consult a physician immediately.

- Decrease or loss of hearing. In case of sudden decrease or loss of hearing, patients should be advised to stop taking sildenafil and consult a physician promptly.

Ritonavir, CYP3A4 inhibitors (e.g. erythromycin, saquinavir, ketoconazole, itraconazole)

- Alpha-blocker: In order to minimize the potential for developing postural hypotension, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment, and start with a low dose. However, other classes of antihypertensive medication (diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonist, Calcium channel blockers, etc) were reported to produce no difference in the side effect profile in patients taking sildenafil compared to placebo treatment.

PDE5 inhibitor

- The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation, producing smooth muscle relaxation and allowing inflow of blood to the corpus cavernosum.