CIATON 5 TAB

Erectile Dysfunction (ED) & the signs & symptoms of Benign Prostatic Hyperplasia (BPH).

Anti-erectile dysfunction agent

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

Erectile Dysfunction For Use as Needed 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 & tolerability. The maximum recommended dosing frequency is once per day in most patients. For Once Daily Use The recommended starting dose of Tadalafil for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The Tadalafil dose for once daily use may be increased to 5 mg, based on individual efficacy & tolerability. Use with Food Tadalafil may be taken without regard to food. ild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. Moderate (creatinine clearance 31 to 50 mL/ min): A starting dose of 5 mg not more than once per day is recommended, & the, maximum dose should be limited to 10 mg not more than once in every 48 hours. Severe (creatinine clearance <30 mL/min & on hemodialysis): The maximum recommended dose is 5 mg not more than once in every 72 hours Tadalafil for Once Daily Use Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. Moderate (creatinine clearance 31 to 50 mL/ min): No dose adjustment is required. Severe (creatinine clearance <30 mL/min & on hemodialysis): Tadalafil for once daily use is not recommended. Hepatic Impairment: Tadalafil for Use as Needed: Mild or moderate : The dose of Tadalafil should not exceed 10 mg once per day. The use of Tadalafil once per day has not been extensively evaluated in patients with hepatic insufficiency & therefore, caution is advised. Severe : The use of Tadalafil is not recommended Tadalafil for Once Daily Use ?Mild or moderate : Tadalafil for once daily use has not been extensively evaluated in patients with hepatic insufficiency. Therefore, caution is advised if Tadalafil for once daily use is prescribed to these patients. ?Severe : The use of Tadalafil is not recommended. Geriatrics: No dose adjustment is required in patients >65 years of age.

May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.

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 is contraindicated in patients with a known serious hypersensitivity to tadalafil. Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome & exfoliative dermatitis.

Body as a whole: Hypersensitivity reactions including rash, urticaria, facial edema, Stevens- Johnson syndrome, & exfoliative dermatitis. Cardiovascular & cerebrovascular: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations, & tachycardia, may occur. Most of the patients in whom these events have been reported had pre-existing 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. Hypotension (more commonly reported when tadalafil is given to patients who are already taking antihypertensive agents), hypertension, & syncope.

It is not indicated for use in newborn, children or women.

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.

Keep in a dry place, away from light and heat. Keep out of the reach of children.