Fildena 100 mg is a brand name medicine for the pill sildenafil and is used to treat men with ED.
Effects of Fildena on Blood Pressure When Nitroglycerin is Subsequently Administered. Effects of Fildena on Blood Pressure. Fildena is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in Fildena and REVATIO, or any component of the tablet.
Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point see DOSAGE AND ADMINISTRATION , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY. Physicians should inform patients not to take Fildena with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Physicians should advise patients of the potential for Fildena to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.
Concomitant Use with Drugs Which Lower Blood Pressure. Fildena has systemic vasodilatory properties and may further lower blood pressure in patients taking antihypertensive medications. PDE5 inhibitors, including Fildena, 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 Fildena - those with left ventricular outflow obstruction (e.g., aortic stenosis , idiopathic hypertrophic subaortic stenosis ) and those with severely impaired autonomic control of blood pressure. In a drug-drug interaction study sildenafil 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers see CLINICAL PHARMACOLOGY. Use caution when co-administering alpha-blockers with Fildena because of potential additive blood pressure-lowering effects.
Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease , vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. When Fildena was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took Fildena at least once weekly, and the following adverse reactions were reported: Fildena is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil.
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 Fildena in these patients resulted in higher plasma levels of sildenafil see Use in Specific Populations and CLINICAL PHARMACOLOGY. Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY. Fildena was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated see CONTRAINDICATIONS , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY.
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