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Generic Tadalafil Tadalafil
Physical causes of erectile dysfunction
Data source: The Impotence Resource Center, Boston University.
How is erectile dysfunction diagnosed?
Your doctor will probably start by asking you some questions and doing a physical exam. Samples of your blood and urine may be tested for diseases and disorders. Other tests may also be needed. Your doctor will determine which tests are right for you.
Feelings that can lead to erectile dysfunction
How erectile dysfunction is treated depends on what things are causing it. After your doctor checks you for medical problems and medicines that might cause erectile dysfunction, he or she may have you try a medicine like Tadalafil to help with erectile dysfunction. Tadalafil is taken by mouth.
Tadalafil is a member of a family of drugs known as PDE5 enzyme inhibitors.
Tadalafil is known as the " 36 hour pill" or the "weekend pill" because unlike other similar drugs, Tadalafil has a long duration of action.
Tadalafil blocks an enzyme that causes an erection to go flaccid. Although Tadalafil is similar to Levitra and Viagra, its dose, onset of action, and duration of action is unique.
However not everyone can use Tadalafil. Your doctor will help you decide if you can try Tadalafil.
What other options do you have?
If the medicines aren't right for you, you could also try using vacuum pump devices, or you could have surgery. Your doctor may send you to an urologist to talk about these options.
Tadalafil is taken orally. Tadalafil is available in 10 mg and 20 mg tablets.
Tadalafil works as fast as 16-30 minutes and can work up to 24-36 hours.
It has been observed through study that 595 of previously impotent men were able to have sex 36 hours after taking Tadalafil.
The recommended dose of Tadalafil is 10 mg taken prior to anticipated sexual activity and without regard to food. In those patients in whom Tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. Tadalafil can be taken from 30 minutes to 12 hours prior to sexual activity. The efficacy of Tadalafil may persist up to 24 hours post-dose.
Tadalafil is readily absorbed from the bloodstream following oral administration. 16% of the total drug is available for activity. Tadalafil is about 94% bound to plasma protein. Maximum plasma concentration of Tadalafil was achieved 2 hours post dose. The Tadalafil label states that It can be taken from 30 minutes to 12 hours prior to sexual activity. Efficacy of Tadalafil may persist up to 24 hours post-dose.
Tadalafil is broken down in the liver by an enzyme known as CYP3A4 and to a lesser extent CYPC2. Tadalafil breakdown products are excreted in the feces (61%) and in the urine (36%).
17.5 hours are required for the quantity of Tadalafil in the body to be reduced to half of its original level through various elimination processes in a healthy man.
5.Tadalafil EFFECTS ON SPECIAL POPULATION
How do different people react to Tadalafil?
Geriatric - Healthy male elderly subjects (65 years or over) have a lower oral clearance of Tadalafil, resulting in 25% higher exposure of Tadalafil relative to that observed in healthy subjects 19 to 45 years of age. No dose adjustment is warranted based on age alone. However, greater sensitivity to medications in some older individuals should be considered.
Pediatric - Tadalafil has not been evaluated in individuals less than 18 years old.
6.Tadalafil EFFECTS ON MEDICAL CONDITIONS
How does Tadalafil affect your existing condition/ailment?
Hepatic Impairment - In clinical pharmacology studies, Tadalafil exposure in subjects with mild or moderate hepatic impairment was comparable to exposure in healthy subjects when a dose of 10 mg was administered. There are no available data for doses higher than 10 mg of Tadalafil in patients with hepatic impairment. Insufficient data are available for subjects with severe hepatic impairment. Therefore, for patients with mild or moderate hepatic impairment, the maximum dose should not exceed 10 mg, and use in patients with severe hepatic impairment is not recommended.
Renal Insufficiency- In patients on hemodialysis taking 10-or 20-mg Tadalafil (tadalafil), there were no reported cases of back pain. The dose of Tadalafil, tadalafil should be limited to 5 mg not more than once daily in patients with severe renal insufficiency or end-stage renal disease. A starting dose of Tadalafil 5 mg not more than once daily is recommended for patients with moderate renal insufficiency; the maximum recommended dose of Tadalafil is 10 mg not more than once in every 48 hours. No dose adjustment is required in patients with mild renal insufficiency.
Diabetes Mellitus- In male patients with diabetes mellitus after a 10 mg Tadalafil (tadalafil) dose, exposure to the drug was reduced approximately 19% and maximum concentration was 5% lower than that observed in healthy subjects. No dose adjustment is warranted.
Effects on Blood Pressure-Tadalafil 20 mg administered to healthy male subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (difference in the mean maximal decrease of 1.6/ 0.8 mm Hg, respectively) and in standing systolic and diastolic blood pressure (difference in the mean maximal decrease of 0.2/ 4.6 mm Hg, respectively). In addition, there was no significant effect on heart rate.
Effects on Sperm Characteristics- There were no clinically relevant effects on sperm concentration, sperm count, motility, or morphology in humans in placebo-controlled studies of daily doses of Tadalafil 10 mg or 20 mg for 6 months. In addition, Tadalafil had no effect on serum levels of testosterone, luteinizing hormone, or follicle stimulating hormone.
7.OTHER/ALTERNATE USES OF Tadalafil
What else does Tadalafil treat?
Tadalafil is undergoing Phase II Clinical trials for sexual dysfunction in women.
Tadalafil was administered to over 5700 men (mean age 59, range 19 to 87 years) during clinical trials worldwide. Over 1000 patients were treated for 1 year or longer and over 1300 patients were treated for 6 months or more.
In placebo-controlled Phase 3 clinical trials (A placebo is a medical treatment (operation, therapy, chemical solution, pill, etc.), which is administered as if it were a therapy, but which has no therapeutic value other than the placebo effect), the discontinuation rate due to adverse events in patients treated with Tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo-treated patients. When Tadalafil was taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported (see Table below):
Back pain or myalgia was reported at incidence rates described in Table 7. In Tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/ myalgia associated with Tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort.
Overall, approximately 0.5% of all tadalafil-treated subjects discontinued treatment as a consequence of back pain/ myalgia. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology.
Across all studies with any Tadalafil dose, reports of changes in color vision were rare (< 0.1% of patients).
The other adverse effects include
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
9. USEFUL SITES
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