FDA label 31a18cdf-b07e-18f5-e054-00144ff8d46c

5.0 WARNINGS 5.1 Orthostasis The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were detected more frequently in tamsulosin hydrochloride capsule-treated patients than in placebo recipients. 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 where injury could result should syncope occur [see Patient Counseling Information (17.1) ]. 5.2 Drug Interactions Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Tamsulosin hydrochloride capsules should be used with caution in combination with cimetidine, particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Tamsulosin hydrochloride capsules should not be used in combination with other alpha adrenergic blocking agents [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) ]. Caution is advised when alpha adrenergic blocking agents including tamsulosin hydrochloride capsules are coadministered with PDE5 inhibitors. 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) ]. Caution should be exercised with concomitant administration of warfarin and tamsulosin hydrochloride capsules [See Drug Interactions (7.4) and Clinical Pharmacology (12.3) ]. 5.3 Priapism Rarely (probably less than 1 in 50,000 patients), tamsulosin, like other alpha1 antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition [see Patient Counseling Information (17.2) ]. 5.4 Screening for Prostate Cancer Patient Counseling Information (17.3) ]. 5.5 Intraoperative Floppy Iris Syndrome Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha1 blockers, including tamsulosin hydrochloride capsules [see Adverse Reactions (6.2) ]. Most reports were in patients taking the alpha1 blocker when IFIS occurred, but in some cases, the alpha1 blocker had been stopped prior to surgery. In most of these cases, the alpha1 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 alpha1 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 patient's 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 alpha1 blocker therapy prior to cataract surgery has not been established. 5.6 Sulfa Allergy In patients with sulfa allergy, allergic reaction to tamsulosin hydrochloride capsules has been rarely reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted when administering tamsulosin hydrochloride capsules.

6.0 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg tamsulosin hydrochloride capsules were used. These studies evaluated safety in 1783 patients treated with tamsulosin hydrochloride capsules and 798 patients administered placebo. Table 1 summarizes the treatment-emergent adverse events that occurred inof patients receiving either tamsulosin hydrochloride capsules 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. trials (US92-03A and US93-01) conducted in 1487 men. Table 1 Treatment-Emergent * Adverse Events Occurring inof Tamsulosin Hydrochloride Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical Studies BODY SYSTEM/TAMSULOSIN HYDROCHLORIDEPLACEBO CAPSULES GROUPSADVERSE EVENT0.4 mg n=5020.8 mg n=492n=493BODY AS WHOLE Headache97 (19.3%)104 (21.1%)99 (20.1%)Infection 45 (9.0%)53 (10.8%)37 (7.5%)Asthenia39 (7.8%)42 (8.5%)27 (5.5%)Back pain35 (7.0%)41 (8.3%)27 (5.5%)Chest pain20 (4.0%)20 (4.1%)18 (3.7%) NERVOUS SYSTEM Dizziness75 (14.9%)84 (17.1%)50 (10.1%)Somnolence15 (3.0%)21 (4.3%)8 (1.6%)Insomnia12 (2.4%)7 (1.4%)3 (0.6%)Libido decreased5 (1.0%)10 (2.0%)6 (1.2%) RESPIRATORY SYSTEM Rhinitis 66 (13.1%)88 (17.9%)41 (8.3%)Pharyngitis29 (5.8%)25 (5.1%)23 (4.7%)Cough increased17 (3.4%)22 (4.5%)12 (2.4%)Sinusitis11 (2.2%)18 (3.7%)8 (1.6%) DIGESTIVE SYSTEM Diarrhea31 (6.2%)21 (4.3%)22 (4.5%)Nausea13 (2.6%)19 (3.9%)16 (3.2%)Tooth disorder6(1.2%)10 (2.0%)7 (1.4%) UROGENITAL SYSTEM Abnormal ejaculation42 (8.4%)89 (18.1%)1 (0.2%)SPECIAL SENSESBlurred vision1 (0.2%)10 (2.0%)2 (0.4%) * A treatment-emergent adverse event was defined as any event satisfying one of the following criteria: The adverse event occurred for the first time after initial dosing with double-blind study medication. The adverse event was present prior to or at the time of initial dosing with double-blind study medication and subsequently increased in severity during double-blind treatment; or The adverse event was present prior to or at the time of initial dosing with double-blind study medication, disappeared completely, and then reappeared during double-blind treatment. Coding preferred terms also include cold, common cold, head cold, flu, and flu-likesymptoms. Coding preferred terms also include nasal congestion, stuffy nose, runny nose, sinus congestion, and hay fever. Signs and Symptoms of Orthostasis In the two U.S. studies, symptomatic postural hypotension 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 by no patients in the placebo group. 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. Multiple testing for orthostatic hypotension was conducted in a number of studies. Such a test was considered positive if it met one or more of the following criteria: (1) a decrease in systolic blood pressure ofbpm upon standing with a standing pulse rate Following the first dose of double-blind medication in Study 1, a positive orthostatic test result at 4 hours post-dose was observed in 7% of patients (37 of 498) who received tamsulosin hydrochloride capsules 0.4 mg once daily and in 3% of the patients (8 of 253) who received placebo. 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). In Studies 1 and 2, at least one positive orthostatic test result was observed during the course of these studies for 81 of the 502 patients (16%) in the tamsulosin hydrochloride capsules 0.4 mg once-daily group, 92 of the 491 patients (19%) in the tamsulosin hydrochloride capsules 0.8 mg once-daily group and 54 of the 493 patients (11%) in the placebo group. 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) ]. Abnormal Ejaculation Abnormal ejaculation includes ejaculation failure, ejaculation disorder, retrograde ejaculation and ejaculation decrease. As shown in Table 1, abnormal ejaculation was associated with tamsulosin hydrochloride capsules administration and was dose-related in the U.S. studies. 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. Laboratory Tests No laboratory test interactions with tamsulosin hydrochloride capsules are known. Treatment with tamsulosin hydrochloride capsules for up to 12 months had no significant effect on prostate-specific antigen (PSA). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of tamsulosin hydrochloride capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causalconnection to tamsulosin hydrochloride capsules. Allergic-type reactions such as skin rash, urticaria, pruritus, angioedema and respiratory symptoms have been reported with positive rechallenge in some cases. Priapism has been reported rarely. Infrequent reports of palpitations, hypotension, skin desquamation, constipation and vomiting have been received during the post-marketing period. During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha1 blocker therapy [see Warnings and Precautions (5.5) ].