3/31/2021 0 Comments 1 Blocker 1 4 6 0
Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.It should be administered approximately one-half hour following the same meal each day.Tamsulosin hydrochloride capsules should not be crushed, chewed or opened.Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms see Adverse Reactions (6.2).
![]() As with other alpha adrenergic blocking agents there is a potential risk of syncope see Adverse Reactions (6.1). Patients beginning treatment with Tamsulosin hydrochloride capsules should be cautioned to avoid situations in which injury could result should syncope occur. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension see Drug Interactions (7.3) and Clinical Pharmacology (12.3). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition. In most of these cases, the alpha 1 blocker had been stopped recently prior to surgery (2 to 14 days), but in a few cases, IFIS was reported after the patient had been off the alpha 1 blocker for a longer period (5 weeks to 9 months). IFIS is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs and potential prolapse of the iris toward the phacoemulsification incisions. The patients ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. The benefit of stopping alpha 1 blocker therapy prior to cataract or glaucoma surgery has not been established. The initiation of therapy with Tamsulosin in patients for whom cataract or glaucoma surgery is scheduled is not recommended. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted when administering Tamsulosin hydrochloride capsules. These studies evaluated safety in 1783 patients treated with Tamsulosin hydrochloride capsules, USP and 798 patients administered placebo. Table 1 summarizes the treatment-emergent adverse events that occurred in 2 of patients receiving either Tamsulosin hydrochloride capsules, USP 0.4 mg or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. US92-03A and US93-01) conducted in 1487 men. Syncope was reported by 0.2 of patients (1 of 502) in the 0.4 mg group, 0.4 of patients (2 of 492) in the 0.8 mg group, and 0.6 of patients (3 of 493) in the placebo group. Dizziness was reported by 15 of patients (75 of 502) in the 0.4 mg group, 17 of patients (84 of 492) in the 0.8 mg group, and 10 of patients (50 of 493) in the placebo group. Vertigo was reported by 0.6 of patients (3 of 502) in the 0.4 mg group, 1 of patients (5 of 492) in the 0.8 mg group, and by 0.6 of patients (3 of 493) in the placebo group. Such a test was considered positive if it met one or more of the following criteria: (1) a decrease in systolic blood pressure of 20 mmHg upon standing from the supine position during the orthostatic tests; (2) a decrease in diastolic blood pressure 10 mmHg upon standing, with the standing diastolic blood pressure. At 8 hours post-dose, a positive orthostatic test result was observed for 6 of the patients (31 of 498) who received Tamsulosin hydrochloride capsules 0.4 mg once daily and 4 (9 of 250) who received placebo (Note: patients in the 0.8 mg group received 0.4 mg once daily for the first week of Study 1). Because orthostasis was detected more frequently in Tamsulosin hydrochloride capsule-treated patients than in placebo recipients, there is a potential risk of syncope see Warnings and Precautions (5.1). As shown in Table 1, abnormal ejaculation was associated with Tamsulosin hydrochloride capsules administration and was dose-related in the U.S. Withdrawal from these clinical studies of Tamsulosin hydrochloride capsules because of abnormal ejaculation was also dose-dependent, with 8 of 492 patients (1.6) in the 0.8 mg group and no patients in the 0.4 mg or placebo groups discontinuing treatment due to abnormal ejaculation. Treatment with Tamsulosin hydrochloride capsules for up to 12 months had no significant effect on prostate-specific antigen (PSA).
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