Vidalista is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia ( BPH ). In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with tadalafil was 3.6% compared to 1.6% in placebo-treated patients. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications ( amlodipine , angiotensin II receptor blockers, bendrofluazide, enalapril , and metoprolol). Ritonavir (200 mg twice daily), increased tadalafil 20-mg singledose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone.
Vidalista is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of Vidalista. As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure.
Vidalista should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia , multiple myeloma , or leukemia ), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). Therefore, PDE5 inhibitors, including Vidalista, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Physicians should discuss with patients the potential for Vidalista to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY.
In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. The efficacy of the coadministration of an alpha-blocker and Vidalista for the treatment of BPH has not been adequately studied, and due to the potential vasodilatory effects of combined use resulting in blood pressure lowering, the combination of Vidalista and alpha-blockers is not recommended for the treatment of BPH. Vidalista should be limited to 5 mg not more than once in every 72 hours in patients with creatinine clearance less than 30 mL/min or end-stage renal disease on hemodialysis The starting dose of Vidalista in patients with creatinine clearance 30 - 50 mL/min should be 5 mg not more than once per day, and the maximum dose should be limited to 10 mg not more than once in every 48 hours - https://vidalista.biz/
Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Vidalista for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min.
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