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PRZ-TADALAFIL is a brand name for Tadalafil, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................. 3 CONTRAINDICATIONS....................................................................................... 3 WARNINGS AND PRECAUTIONS ..................................................................... 4 ADVERSE REACTIONS…
Verbatim from this product's HC label. Tap a section to expand.
, Use in the Elderly). Children – Tadalafil has not been evaluated in individuals less than 18 years old. Hepatic Insufficiency – In a clinical pharmacology study using tadalafil 10 mg, tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) was comparable to exposure in healthy subjects.
Daily use of PRZ-TADALAFIL 10 or 20 mg should be avoided in patients with hepatic impairment. A starting dose of 10 mg prior to anticipated sexual activity should be considered for these patients, but no more frequently than on alternate days, and not exceeding 3 times a week.
If the 10 mg dose is tolerated but insufficiently effective, the dose may be increased to 20 mg. If the 10 mg dose is not tolerated, PRZ-TADALAFIL On-Demand dosing should be discontinued (see PRECAUTIONS: Use in Patients with Hepatic Impairment, and DOSAGE AND ADMINISTRATION).
PRZ-TADALAFIL 5 mg Once-a-Day for treatment of ED, BPH and ED/BPH may be considered for patients with hepatic impairment. 5 mg Once-a-Day, based on individual tolerability. Use of PRZ-TADALAFIL Once-a-Day is not recommended in patients with severe hepatic impairment.
Renal Insufficiency – In clinical pharmacology studies using single-dose tadalafil 5 to 20 mg, tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min) renal insufficiency, and in subjects with end-stage renal disease on dialysis.
In dialysis patients, Cmax was 41% higher than that observed in healthy subjects. Hemodialysis contributed negligibly to tadalafil elimination. Daily use of PRZ-TADALAFIL 10 or 20 mg should be avoided in patients with renal impairment.
A starting dose of 10 mg prior to anticipated sexual activity should be considered for these patients, but no more frequently than on alternate days, and not exceeding 3 times a week. If the 10 mg dose is tolerated but insufficiently effective, the dose may be increased to 20 mg.
If the 10 mg dose is not tolerated, PRZ-TADALAFIL On-Demand dosing for treatment of ED should be discontinued (see WARNINGS AND PRECAUTIONS: Use in Patients with Renal Impairment, and DOSAGE AND ADMINISTRATION). PRZ-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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tadalafil in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
5 mg Once-a-Day, based on individual tolerability. PRZ-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. Page 22 of 51 STORAGE AND STABILITY Store at controlled room temperature, 15-30C.
5 mg (for Once-a-Day use): yellow tablets, debossed on one side with “TAD”. 5 mg (for Once-a-Day use): yellow tablets, debossed on one side with “T5”. 10 mg (for On-Demand dosing): yellow tablets, debossed on one side with “T10”.
20 mg (for On-Demand dosing): yellow tablets, debossed on one side with “T20”. 5, 5, 10 or 20 mg of tadalafil and the following inactive ingredients: hydroxy propylcellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide and triacetin.
5 mg tablets (for Once-a-Day use): Blisters of 4 and bottles of 30 or 90 tablets. 5 mg tablets: (for Once-a-Day use): Blisters of 4 and bottles of 30 or 90 tablets. 10 mg tablets: (for On-Demand dosing): Blisters of 4 and bottles of 30 or 90 tablets.
20 mg tablets: (for On-Demand dosing): Blisters of 4 and bottles of 30 or 90 tablets. 4 g/mol Description: White or almost white powder. Freely soluble in Dimethylsulphoxide. Slightly soluble in methylene chloride and practically insoluble in water.
) in normal, healthy, adult, human male subjects under fasting conditions (n = 37). ). ) were purchased in Canada. € […]