A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
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 Pharmacology: Pharmacodynamics under Actions) and as such potentiate the hypotensive effect of nitrates. Prior to prescribing tadalafil, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects (see Contraindications).
Prior to initiating treatment with Tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate.
In patients receiving concomitant antihypertensive medicines, tadalafil may induce a blood pressure decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy.
Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia have been reported either post-marketing and/or in clinical trials. In addition, hypertension and hypotension (including postural hypotension) were also seen infrequently in clinical trials. Most of the patients in whom these events have been reported had preexisting cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a combination of these or other factors.
Cialis 5 mg: Visual defects and cases of non-arteritic ischemic optic neuropathy have been reported in connection with the intake of tadalafil and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, the patient should stop taking tadalafil and consult a physician immediately (see Contraindications).
Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment.
There is limited or no clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh class C). Once-a-day administration has not been extensively evaluated in patients with hepatic insufficiency. If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Cialis 20 mg: Nonarteritic anterior ischemic optic neuropathy (NAION) is a cause of decreased vision including permanent loss of vision. There are rare postmarketing reports of NAION in temporal association with the use of all PDE5 inhibitors. Currently it is not possible to determine whether NAION is related directly to the use of PDE5 inhibitors or other factors. Physicians should advise patients to stop use of tadalafil and seek immediate medical attention in the event of a sudden loss of vision. Physicians should also discuss with patients that individuals who have already experienced NAION are at increased risk of NAION.
The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors have not been studied. Therefore, the use of such combinations is not recommended.
There is no clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C); it prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Patients who experience erections lasting 4 hrs or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Agents for the treatment of erectile dysfunction, including tadalafil should be used with caution in patients with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or in patients who have conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia).
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 tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.
In patients who are taking α1-blockers eg, doxazosin, concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see Interactions). Therefore, the combination of tadalafil and α-blockers is not recommended.
The combination of tadalafil and guanylate cyclase stimulation is not recommended because it may lead to symptomatic hypotension.
Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicine are combined (see Interactions).
The safety and efficacy of combinations of tadalafil and other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
Tadalafil contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Cialis 20 mg: In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7-18.6] than seen in humans at a 20 mg single dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs. Results from two 6 month studies in volunteers suggest that this effect is unlikely in humans (see Pharmacology: Pharmacodynamic under Actions). The effects of longer term daily dosing have not been established. Therefore, daily use of the medication is strongly discouraged.
Effects on the Ability to Drive or Operate Machinery: No studies or no or negligible influence on the effect on the ability to drive and or use machines have been performed. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to tadalafil before driving or operating machinery.
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