Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of- Erectile
dysfunction (ED), The signs and symptoms of benign prostatic hyperplasia (BPH), ED and the signs and symptoms of BPH (ED/BPH) & Pulmonary Hypertension
Tiagra for Use as Needed for Erectile Dysfunction:
The recommended starting dose of Tadalafil for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. Tadalafil for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of Tadalafil, this should be taken into consideration.
Tadalafil should not be used together with nitrate medication, such as nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil,Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Tadalafil with a nitrate medicine for chest pain or heart problems can
cause a sudden and serious decrease in blood pressure. severe impairment of pulmonary or renal function; moderate impairment of hepatic function; and toxic psychosis. Use not recommended in patients with a recent MI (within 90 days) or stroke (within 6 months); uncontrolled arrhythmias, hypotension (<90/50 mm Hg systolic/diastolic BP) or uncontrolled hypertension (170/110 mm Hg systolic/diastolic BP); heart failure (>NYHA class II) in the previous 6 months; or those with unstable angina or angina occurring during sexual intercourse. Possible hypotension, particularly in patients with left-ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and in patients with severely impaired autonomic control of blood pressure.
Pediatric Use: Safety and efficacy not established in patients <18 years of age.
Geriatric Use: Safety and efficacy in those > 65 years of age is similar to that in younger men. Possibility exists of greater sensitivity to the drug in some geriatric individuals.
Use in Patients with Hepatic Impairment: Use not recommended in patients with severe hepatic impairment.
Use in Patients with Renal Impairment: Clearance decreased in patients with mild (Clcr 51-80 ml/minute) to severe renal insufficiency (end-stage renal disease on hemodialysis), and may result in increased adverse effects (e.g., back pain). No dosage adjustments are necessary in those with mild renal impairment. Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil for once daily use is not recommended
Administration of Tadalafil to patients who are using any form of organic nitrate,
either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, Tadalafil was shown to potentiate the hypotensive effect of nitrates
Tadalafil can potentiate the hypotensive effects of nitrates, alpha blockers, antihypertensives or alcohol. CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase Tadalafil exposure. For concomitant use with potent CYP3A4 inhibitors, dose adjustment may be needed. CYP3A4 inducers (e.g. rifampin) decrease Tadalafil exposure
Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. 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