NRA-TADALAFIL

Use in Patients with Renal Impairment, and DOSAGE AND ADMINISTRATION). NRA-TADALAFIL 5 mg Once-a-Day for treatment of ED, BPH or ED/ BPH may be considered for patients with mild to moderate renal impairment. 5 mg Once-a-Day, based on individual tolerability.

NRA-TADALAFIL for Once-a-Day use is not recommended for patients with severe renal impairment. Patients with Diabetes Mellitus – In male patients with diabetes mellitus after a 10 mg tadalafil dose, exposure (AUC) was reduced approximately 19% and Cmax was 5% lower than that observed in healthy subjects.

No dose adjustment is warranted. Patients with BPH — In patients with BPH following single and multiple-doses of 20 mg tadalafil, no statistically significant differences in exposure (AUC and Cmax) were observed between elderly (≥ 70 to 85 years) and younger (≤ 60 years) subjects.

No clinically relevant differences in tadalafil exposure were observed between patients with BPH and healthy subjects. No dose adjustment is warranted. STORAGE AND STABILITY Store at controlled room temperature, 15-30C. 5 mg (for Once-a-Day use): Off white to pale yellow coloured, almond shaped, biconvex, film coated tablets, debossed with "FJl" on one side and plain on other side.

 5 mg (for Once-a-Day use): Light yellow coloured, almond shaped, biconvex, film coated tablets debossed with "FJ2" on one side and plain on other side.  10 mg (for On-Demand dosing): Yellow coloured, almond shaped, biconvex, film coated tablets, debossed with "FJ3"on one side and plain on other side.

 20 mg (for On-Demand dosing): Yellow coloured, almond shaped, biconvex, film coated tablets, debossed with "FJ4" on one side and plain on other side. 5 mg tablets only), iron oxide yellow, talc, titanium dioxide, and triacetin. 5 mg tablets (for Once-a-Day use): Bottles of 30 and Blisters of 14 or 28 tablets.

 5 mg tablets: (for Once-a-Day use): Bottles of 30 and Blisters of 14 or 28 tablets.  10 mg tablets: (for On-Demand dosing): Blisters of 2, 4, or 8 tablets.  20 mg tablets: (for On-Demand dosing): Bottles of 30 and Blisters of 2, 4, or 8 tablets.

41 g/mol Description: It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. ) was conducted in 40 healthy, adult, human male subjects under fasting conditions. ) 3 Expressed as the median (range) only 4 Expressed as the arithmetic mean (CV%) only Tadalafil On-Demand for Treatment of ED – Pivotal Clinical Trials Study Design – Tadalafil has been studied in the ED population in 5 randomized, double-blind, placebo-controlled, primary efficacy studies of 12 to 24 weeks duration (N=1112).

Tadalafil was taken as needed, up to once daily. These studies included patients 21 to 82 years of age with ED of various severities (mild, moderate, severe), etiologies (organic, psychogenic, mixed) and with co- morbid conditions such as diabetes mellitus and cardiovascular disease, including hypertension.

An additional primary efficacy study was performed in ED patients with diabetes mellitus. Patients were required to have a history of erectile dysfunction (defined as a consistent change in the quality of erection that adversely affected the patient’s satisfaction with sexual intercourse) of at least 3 months.

Most (90%) patients reported ED of more than 1 year in duration. Patients had a clinical diagnosis of ED, as assessed by the investigator. 2%. See WARNINGS, for patients with specific cardiovascular disease who were not included in the clinical trials.

In addition, patients with significant renal insufficiency were excluded from these pivotal studies. Several assessment tools were used to evaluate the effect of tadalafil on erectile function, including the International Index of Erectile Function (IIEF, including MAPI© version), Sexual Encounter Profile (SEP), and Global Assessment […]