Because of insufficient information in patients with se

20 Jul 2018 18:02

Back to list of posts

In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended dose. Therefore, PDE5 inhibitors, including TADALISTA, should be used with caution in these patients and only when the anticipated benefits outweigh the risks.

TADALISTA should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia , multiple myeloma , or leukemia ), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for TADALISTA, and therefore until further information is available, TADALISTA is not recommended for the following groups of patients:

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of TADALISTA. Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Coadministration of Tadalista (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects.

Tadalista had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did Tadalista affect changes in prothrombin time induced by warfarin. Tadalista had no significant effect on the pharmacokinetics of theophylline When Tadalista was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed. Tadalista did not potentiate the increase in bleeding time caused by aspirin.

When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Administration of TADALISTA to patients who are using any form of organic nitrate, is contraindicated. It is not possible to determine whether these events are related directly to TADALISTA, to sexual activity, to the patient's underlying cardiovascular disease , to a combination of these factors, or to other factors see WARNINGS AND PRECAUTIONS.

Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of TADALISTA without sexual activity. The following section identifies additional, less frequent events (<2%) reported in controlled clinical trials of TADALISTA for once daily use or use as needed. Across placebo-controlled studies with TADALISTA for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with TADALISTA (2.5% of patients) see Use In Specific Populations.

Comments: 0

Add a New Comment

Unless otherwise stated, the content of this page is licensed under Creative Commons Attribution-ShareAlike 3.0 License