One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with CENFORCE 50 mg. This patient had been taking minoxidil, a potent vasodilator, during the study. Twenty subjects received CENFORCE 50 mg, but only 19 subjects received matching placebo. Following at least 14 consecutive days of doxazosin, CENFORCE 50 mg or matching placebo was administered simultaneously with doxazosin 4 mg (17 subjects) or with doxazosin 8 mg (3 subjects).
No dose adjustment is required for mild (CLcr=50-80 mL/min) and moderate (CLcr=30-49 mL/min) renal impairment. Safety and effectiveness have not been established in pediatric patients. A causal relationship between CENFORCE and these events has not been established.
Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients with cardiac failure or coronary artery disease causing unstable angina.
Patients with resting hypotension ( BP < 90⁄50 mmHg) or hypertension (BP > 170⁄110 mmHg); Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (crowded disc”), age over 50, diabetes , hypertension, coronary artery disease, hyperlipidemia and smoking. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently. Over 550 patients were treated for longer than one year. In addition to the active ingredient, Cenforce 100 citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake.
12. Levine LA, Lenting EL. Use of nocturnal penile tumescence and rigidity in the evaluation of male erectile dysfunction. Without suitable controls, the contribution of this variable to treatment outcome is not known. In addition, a high percentage of patients responded to both Cenforce 100 and placebo in Study I (47%) and in the first part of Study II when VSS started 2 h after dosing (42%).
Furthermore, among the nine patients who responded to placebo, seven (78%) did so within 30 min after dosing, similar to the proportion of Cenforce 100 responders (86%, 12⁄14) who responded during the same time interval.