Effects of CENFORCE on Blood Pressure When Nitroglycerin is Subsequently Administered.

Effects of CENFORCE on Blood Pressure When Nitroglycerin is Subsequently Administered.

Effects of CENFORCE on Blood Pressure. Cenforce 100 was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound Cenforce 100 and its major metabolite of 29-and 42-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg. Cenforce 100 was not carcinogenic when administered to mice for 18-21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.6 times the MRHD on a mg/m² basis. Physicians should inform patients not to take CENFORCE with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing Cenforce 100.

 

Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of CENFORCE. Therefore, when CENFORCE is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating CENFORCE treatment and CENFORCE should be initiated at the lowest dose see WARNINGS AND PRECAUTIONS. Physicians should advise patients of the potential for CENFORCE to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

 

Concomitant Use with Drugs Which Lower Blood Pressure. CENFORCE has systemic vasodilatory properties and may further lower blood pressure in patients taking antihypertensive medications. In some patients, concomitant use of these two drug classes can lower blood pressure significantly see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY leading to symptomatic hypotension (e.g., dizziness, lightheadedness , fainting ).

 

PDE5 inhibitors, including CENFORCE, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including CENFORCE - those with left ventricular outflow obstruction (e.g., aortic stenosis , idiopathic hypertrophic subaortic stenosis ) and those with severely impaired autonomic control of blood pressure. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

 

In a drug-drug interaction study Cenforce 100 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, Cenforce 100 did not potentiate the hypotensive effect of alcohol in healthy volunteers see CLINICAL PHARMACOLOGY. When CENFORCE 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic see WARNINGS AND PRECAUTIONS , CLINICAL PHARMACOLOGY. When CENFORCE is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating CENFORCE treatment and CENFORCE should be initiated at the lowest dose see DOSAGE AND ADMINISTRATION , WARNINGS AND PRECAUTIONS , CLINICAL PHARMACOLOGY.

 

Use caution when co-administering alpha-blockers with CENFORCE because of potential additive blood pressure-lowering effects. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis ), and patients with severe renal impairment (creatinine clearance < 30 mL/minute) because administration of CENFORCE in these patients resulted in higher plasma levels of Cenforce 100 see Use in Specific Populations and CLINICAL PHARMACOLOGY.http://cenforce.org/es/http://mycenforce.com/