Tamplus Adverse Reactions

Finasteride: In controlled clinical studies where patients received 5 mg of Finasteride over periods of up to four years, the following adverse reactions were considered possibly, probably or definitely drug-related and occurred with a frequency greater than placebo and greater than or equal to 1%: impotence, decreased libido, ejaculation disorder, decreased volume of ejaculate; breast enlargement, breast tenderness and rash. There was no evidence of increased adverse experiences with increased duration of treatment with Finasteride and the incidence of new drug-related sexual adverse experiences decreased with duration of treatment. The MTOPS study compared Finasteride 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), combination therapy of Finasteride 5 mg/day and doxazosin 4 or 8 mg/day (n=786), and placebo (n=737). In this study, the safety and tolerability profile of the combination therapy was generally consistent with the profiles of the individual components. The incidence of ejaculation disorder events without regard to drug relationship were: Finasteride 8.3%, doxazosin 5.3%, combination 15.0%, placebo 3.9%. The following additional adverse experiences have been reported in post-marketing experience: hypersensitivity reactions, including pruritus, urticaria and swelling of the lips and face; testicular pain.
Tamsulosin: The following adverse reactions have been reported with the use of Tamsulosin: dizziness, abnormal ejaculation and, less frequently (1-2%) headache, asthenia, postural hypotension, palpitations and rhinitis. Gastrointestinal reactions such as nausea, vomiting, diarrhea, and constipation can occasionally occur. Hypersensitivity reactions such as rash, pruritus, and urticaria can occur occasionally. As with other alpha-blockers, drowsiness, blurred vision, dry mouth or edema can occur. Syncope has been reported rarely, and there have been very rare reports of angioedema and priapism. During cataract surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of Tamsulosin during post-marketing surveillance.