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Drug details for : CIALIS
| Generic Name : | Tadalafil |
| Drug description : | Film-coated tablet. The 10mg tablets are light yellow and almond shaped, marked 'C 10' on one side. The 20mg tablets are yellow and almond shaped, marked 'C 20' on one side |
| Presentation : | Tablets, 10mg film-coated, 20mg film-coated |
| Indications : | Treatment of erectile dysfunction. In order for Cialis to be effective, sexual stimulation is required. Cialis is not indicated for use by women. |
| Adult Dosage : | The recommended dose is 10mg taken prior to anticipated sexual activity and without regard to food. In those patients in whom tadalafil 10mg does not produce an adequate effect, 20mg might be tried. 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. The maximum recommended dosing frequency is once per day. Daily use of the medication is strongly discouraged because the long-term safety after prolonged daily dosing has not been established. |
| Child Dosage : | Not applicable. |
| Elderly Dosage : | Dosage adjustments are not required in elderly patients. |
| Contra Indications : | In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Cialis to patients who are using any form of organic nitrate is contra-indicated. Agents for the treatment of erectile dysfunction, including Cialis, should not be used in men with cardiac disease for whom sexual activity is inadvisable. 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 contra-indicated: Patients with myocardial infarction within the last 90 days. Patients with unstable angina or angina occurring during sexual intercourse. Patients with New York Heart Association Class 2 or greater heart failure in the last 6 months. Patients with uncontrolled arrhythmias, hypotension (<90/50mmHg), or uncontrolled hypertension. Patients with a stroke within the last 6 months. Cialis should not be used in patients with hypersensitivity to tadalafil or to any of the excipients. |
| Special Precautions : | 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 section 5.1, 'Pharmacodynamic properties') and as such potentiates the hypotensive effect of nitrates (see section 4.3, 'Contra-indications'). Serious cardiovascular events, including myocardial infarction, unstable angina pectoris, ventricular arrhythmia, strokes, and transient ischaemic attacks occurred during clinical studies of Cialis. 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 observed had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors. There is limited clinical data on the safety of Cialis in the following groups; if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician: Patients with severe renal insufficiency (creatinine clearance 30ml/min). Patients with severe hepatic insufficiency (Child-Pugh Class C). Tadalafil 10mg has been the highest dose studied in patients with mild (creatinine clearance = 51 to 80ml/min) and moderate (creatinine clearance = 31 to 50ml/min) renal failure and in patients with end-stage renal failure undergoing haemodialysis. Priapism was not reported in clinical trials with Cialis. However, priapism has been reported with another PDE5 inhibitor. Patients who experience erections lasting 4 hours 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. Cialis should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease). 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 with spinal cord injuries and patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Cialis should not be administered to patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. The safety and efficacy of combinations of Cialis and other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. In dogs given tadalafil daily for 6 to 12 months at doses of 25mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7-18.6] than seen in humans at a 20mg 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. The effects of longer-term daily dosing have not been established. Therefore, daily use of the medication is strongly discouraged. |
| Interactions : | Many of the interaction studies were conducted with 10mg tadalafil, as indicated below. With regard to those interaction studies where only the 10mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out. Effects of other medicinal products on tadalafil Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole, increased tadalafil AUC by 107%, relative to the AUC values for tadalafil alone (10mg dose). Although specific interactions have not been studied, some protease inhibitors, such as ritonavir and saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice, should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil. Consequently the incidence of the undesirable effects listed in section 4.8 might be increased. The role of transporters (for example, p-glycoprotein) in the disposition of tadalafil is not known. There is thus the potential of drug interactions mediated by inhibition of transporters. A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil alone (10mg dose). It can be expected that concomitant administration of other CYP3A4 inducers, such as phenobarbital, phenytoin and carbamazepine, will also decrease plasma concentrations of tadalafil. Effects of tadalafil on other medicinal products In clinical studies, tadalafil (10mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration of Cialis to patients who are using any form of organic nitrate is contra-indicated (see section 4.3, 'Contra-indications'). Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1 and CYP2C9. Tadalafil (10mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin. Tadalafil (10mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid. In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive agents was examined. Major classes of antihypertensive agents were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10mg, except for studies with angiotensin II receptor blockers and amlodipine in which a 20mg dose was applied) had no clinically significant interaction with any of these classes. Tadalafil (10 and 20mg) had no clinically significant effect on blood pressure changes due to tamsulosin, an alpha-adrenergic receptor blocking agent. In patients receiving concomitant antihypertensive medications, tadalafil 20mg may induce a blood pressure decrease, which is, in general, minor and not likely to be clinically relevant. Analysis of Phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medications. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medications. Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration with tadalafil (10mg). The effect of alcohol on cognitive function was not augmented by tadalafil (10mg) nor was the effect of alcohol on blood pressure augmented by tadalafil (20mg). In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol. Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain. When tadalafil 10mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medications. Specific interaction studies with antidiabetic agents were not conducted. |
| Adverse Reactions : | Headache, dyspepsia, dizziness, flushing, nasal congestion, back pain, myalgia |
| Manufacturer : | Eli Lilly |
| Drug Availability : | (POM) |
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