Does food affect the absorption of tadalafil?

Neither the extent nor the rate of absorption of  tadalafil are affected by food, including a highfat  meal [42,43]. A ‘‘high-fat’’ meal can be  defined as any meal that contains at least  59 g of fat, which roughly equates to a large  cheeseburger sandwich and large french fries. 

Can tadalafil be taken with alcohol (ethanol)?

Yes. Alcohol can be consumed with tadalafil.  PDE5 inhibitors, including tadalafil, and alcohol  are both mild systemic vasodilators. When  mild vasodilators are taken in combination,  blood pressure-lowering effects of each individual  compound may be increased. The substantial  consumption of alcohol (e.g., 5 units  or greater) in combination with tadalafil can  increase the potential for orthostatic signs and  symptoms, including increase in heart rate,  decrease in standing blood pressure, dizziness,  and headache.

When should I adjust the dose of tadalafil?

No dosing adjustment are needed for the following  parameters: age, bodymass index (BMI),  smoking, or concurrent diabetes mellitus.  Dosing needs to be adjusted for the following:  Renal insufficiency: (USA Label) No dose adjustment  is required in patients with mild renal  insufficiency. For patients with moderate (creatinine  clearance 31 to 50 mL/min) renal insufficiency,  a starting dose of 5 mg not more than  once daily is recommended, and the maximum  dose should be limited to 10 mg not  more than once in every 48 hours.

Why do dosing instructions vary from country to country?

Variations in label language among countries  are common for most drugs, including tadalafil,  and are in general due to differences in  interpretation of data regarding medications  by the different regulatory agencies. The label  language (prescribing instructions) for tadalafil  in a given country is based on the core data  regarding the drug and the interpretation of  local regulatory authorities. 

What is the recommended starting dose for tadalafil?

In approximately 60% (56/90) of countries including  the USA, the recommended starting  dose for most men is 10 mg. The dose may be  increased to 20 mg or decreased to 5 mg, based  on individual efficacy and tolerability. In approximately  40% (34/90) of countries, the recommended  starting dose is 20 mg. Please refer to  the package insert pertaining to your locale to  determine the recommended starting dose. 

Is the half-life of tadalafil long in comparison to other commonly prescribed pharmaceutical agents?

The half-life of tadalafil is 17.5 hours. For comparison,  the half-lives of other commonly used  drugs in primary practice include 14 hours for  atorvastatin (Lipitor1), about 15 hours for tamsulosin  (Flomax1), 15 hours for naproxen  sodium (Anaprox1), about 22 hours for doxazosin  (Cardura1), 24 to 26 hours for sertraline  (Zoloft1), and 5 weeks for dutasteride (Avodart1). 

Does tadalafil work in older men with ED?

 Yes. In an analysis of 11 integrated studies  where 23% of men were over age 65 [23], the  mean change in IIEF EF Domain scores from  baseline to endpoint for men [1]65 taking tadalafil  20 mg was 8.8. For men >65, the mean  change from baseline was 8.0. For men taking  tadalafil 10 mg, the mean change from baseline  to endpoint was 6.6 ([1]65 y) and 6.3 (>65 y)  (p < 0.001 for all comparisons of tadalafil to  placebo). The mean changes from baseline to  endpoint for the two age groups were not  significantly different (p = 0.74). Thus, the  response to tadalafil was not influenced by age.  Supplement  148 Vol. 2, No. 1, pp. 141–157, March 2005  III. Maximizing Tadalafil Therapy 

Is tadalafil efficacious in treating ED following nerve-sparing radical prostatectomy?

Yes. Erectile dysfunction following bilateralnerve  sparing retropubic radical prostatectomy  results from smooth muscle degeneration secondary  to neurapraxia and hypoxia [38]. Even  with nerve-sparing surgical techniques, nerve  injury may result from the unintentional surgical  severing of nerve tissue, nerve stretching  during prostate retraction, thermal or ischemic  injury to nerves, or local inflammatory effects.  [39] Tadalafil 20 mg has been shown to improve  erectile function in men following bilateral  nerve-sparing radical retropubic prostatectomy  (BNSRRP) [40]. The mean percentage of successful  intercourse attempts (SEP3) was41% formen  taking tadalafil compared to 19% on placebo  (p < 0.001). The improvements in IIEF, SEP, and  GAQ scores were higher overall for a subgroup  of men with evidence of tumescence ability  after prostatectomy (i.e., less severe ED). This  study evaluatedmenwhohadED12–48months  post-surgery. PDE5 inhibitor therapy administered  on a daily basis within 30 days of radical  prostatectomy is being studied to determine if  this facilitates the earlier return of erectile  function.