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How do the medium and higher doses compare? Clinical studies have shown that: In men using the Cialis 20mg dose, an erection prominent enough for vaginal penetration was obtained in 81 per cent of attempted encounters. Across three of the studies in the same report, a level of firmness proficient enough to complete intercourse was kept in 71 per cent of cases. This is compared to respective figures of 73 per cent and 59 per cent in those men who used the middle dose.

Are there people who should not use Cialis 20mg? The clinical significance of the decreased sperm concentrations in the two studies is unknown. There have been no studies evaluating the effect of tadalafil on fertility in men [see Clinical Pharmacology Based on studies in animals, a decrease in spermatogenesis was observed in dogs, but not in rats [see Nonclinical Toxicology Pediatric Use Cialis is not indicated for use in pediatric patients.

Safety and efficacy in patients below the age of 18 years have not been established. A randomized, double-blind, placebo-controlled trial in pediatric patients 7 to 14 years of age with Duchenne muscular dystrophy, who received Cialis 0.

Geriatric Use Of the total number of subjects in ED clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. However, in placebo-controlled studies with Cialis for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Cialis 2.

No dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered. In subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in Cmax and 2. Exposure to total methylcatechol unconjugated plus glucuronide was 2- to 4-fold higher in subjects with renal impairment, compared to those with normal renal function.

In patients on hemodialysis taking or mg tadalafil, there were no reported cases of back pain. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of The structural formula is: It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Cialis is available as almond-shaped tablets for oral administration. Each tablet contains 2. Cialis - Clinical Pharmacology Mechanism of Action Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle.

This response is mediated by the release of nitric oxide NO from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation. The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply.

The mechanism for reducing BPH symptoms has not been established. PDE5 is found in the smooth muscle of the corpus cavernosum, prostate, and bladder as well as in vascular and visceral smooth muscle, skeletal muscle, urethra, platelets, kidney, lung, cerebellum, heart, liver, testis, seminal vesicle, and pancreas. Additionally, tadalafil is fold more potent for PDE5 than for PDE6, which is found in the retina and is responsible for phototransduction. PDE11 is an enzyme found in human prostate, testes, skeletal muscle and in other tissues e.

The physiological role and clinical consequence of PDE11 inhibition in humans have not been defined. In addition, there was no significant effect on heart rate.

Each 20 mg tablet contains 20 mg tadalafil. For the full list of excipients, see section 6. Pharmaceutical form Film-coated tablet tablet. The 5 mg tablets are light yellow and almond shaped tablets, marked 'C 5' on one side. The 10 mg tablets are light yellow and almond shaped tablets, marked 'C 10' on one side. The 20 mg tablets are yellow and almond shaped tablets, marked 'C 20' on one side.

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day.

Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

In these patients, the recommended dose is 5mg taken once a day at approximately the same time of day. The dose may be decreased to 2. The appropriateness of continued use of the daily regimen should be reassessed periodically. Benign prostatic hyperplasia in adult men tadalafil 5 mg only The recommended dose is 5 mg, taken at approximately the same time every day with or without food. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day.

Patients who are unable to tolerate tadalafil 5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil 2. Special Populations Dose adjustments are not required in elderly patients. Men with Renal Impairment Dose adjustments are not required in patients with mild to moderate renal impairment.

For patients with severe renal impairment, 10 mg is the maximum recommended dose. Once-a-day dosing of 2. There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment. Men with Diabetes Dose adjustments are not required in diabetic patients. Paediatric population There is no relevant use of CIALIS in the paediatric population with regard to the treatment of erectile dysfunction.

In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated see section 4.

Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.

The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAION , regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4.

The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension see section 4. Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see section 5.

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if CIALIS is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.

Tadalafil 5 mg - Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions see section 4.

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