TAMSULOSIN HYDROCHLORIDE- tamsulosin hydrochloride capsule
Tamsulosin Hydrochloride Capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [ see Clinical Studies (14) ]. Tamsulosin Hydrochloride Capsules are not indicated for the treatment of hypertension.
Tamsulosin Hydrochloride Capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. Tamsulosin Hydrochloride Capsules should not be crushed, chewed or opened.
For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of Tamsulosin Hydrochloride Capsules can be increased to 0.8 mg once daily. Tamsulosin Hydrochloride Capsule 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g.,ketoconazole) [ see Warnings and Precautions (5.2) ]. If Tamsulosin Hydrochloride Capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.
Capsule: 0.4 mg, White to off white pellets filled in hard gelatin capsule size ” 1″ Olive green opaque cap & orange opaque body imprinted with “TAM’ on cap & ” 0.4 mg” on body in black ink.
Tamsulosin Hydrochloride Capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of Tamsulosin Hydrochloride Capsules. Reactions have included skin rash, urticaria, pruritus,angioedema, and respiratory symptoms [ see Adverse Reactions (6.2) ].
The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more frequently in Tamsulosin Hydrochloride Capsules -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 in which injury could result should syncope occur.
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
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 co-administered 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)].
Rarely (probably less than 1 in 50,000 patients), tamsulosin, like other alpha 1 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.
Prostate cancer and BPH frequently co-exist; therefore, patients should be screened for the presence of prostate cancer prior to treatment with Tamsulosin Hydrochloride Capsules and at regular intervals afterwards.
Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract and glaucoma surgery in some patients on or previously treated with alpha
1 blockers, including Tamsulosin Hydrochloride Capsules [
see Adverse Reactions
Most reports were in patients taking the alpha 1 blocker when IFIS occurred, but in some cases, the alpha 1 blocker had been stopped prior to surgery. 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 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. IFIS may increase the risk of eye complications during and after the operation. 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.
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.
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 in ≥2% of 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 1 Adverse Events Occurring in ≥ 2% of Tamsulosin Hydrochloride Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical Studies.
BODY AS A WHOLE
|Headache||97 (19.3%)||104 (21.1%)||99 (20.1%)|
|45 (9.0%)||53 (10.8%)||37 (7.5%)|
|Asthenia||39 (7.8%)||42 (8.5%)||27 (5.5%)|
|Back pain||35 (7.0%)||41 (8.3%)||27 (5.5%)|
|Chest pain||20 (4.0%)||20 (4.1%)||18 (3.7%)|
|Somnolence||15 (3.0%)||21 (4.3%)||8 (1.6%)|
|Insomnia||12 (2.4%)||7 (1.4%)||3 (0.6%)|
|Libido decreased||5 (1.0%)||10 (2.0%)||6 (1.2%)|
|Rhinitis 3||66(13.1%)||88 (17.9%)||41 (8.3%)|
|Pharyngitis||29 (5.8%)||25 (5.1%)||23 (4.7%)|
|Cough increased||17 (3.4%)||22 (4.5%)||12 (2.4%)|
|Sinusitis||11 (2.2%)||18 (3.7%)||8 (1.6%)|
|Diarrhea||31 (6.2%)||21 (4.3%)||22 (4.5%)|
|Nausea||13 (2.6%)||19 (3.9%)||16 (3.2%)|
|Tooth disorder||6 (1.2%)||10 (2.0%)||7 (1.4%)|
|Abnormal ejaculation||42 (8.4%)||89 (18.1%)||1 (0.2%)|
|Blurred vision||1 (0.2%)||10 (2.0%)||2 (0.4%)|
1 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.
2 Coding preferred terms also include cold, common cold, head cold, flu, and flu-like symptoms.
3 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 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 <65 mmHg during the orthostatic test; (3) an increase in pulse rate of ≥ 20 bpm upon standing with a standing pulse rate ≥ 100 bpm during the orthostatic test; and (4) the presence of clinical symptoms (faintness, lightheadedness/lightheaded, dizziness, spinning sensation, vertigo, or postural hypotension) upon standing during the orthostatic test.
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 Capsules -treated patients than in placebo recipients, there is a potential risk of syncope [ see Warnings and Precautions (5.1) ].
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.
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).
To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
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