FLOMAX capsules are not indicated for the treatment of hypertension.There is currently no drug history available for this drug.The empirical formula of tamsulosin hydrochloride is CEach FLOMAX capsule for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: methacrylic acid copolymer dispersion NF, microcrystalline cellulose, triacetin, calcium stearate, talc, FD&C blue No. The 0.8 mg dose should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) (see WARNINGS).If FLOMAX 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. Flomax FDA Alerts The FDA Alert (s) below may be specifically about Flomax or relate to a group or class of drugs which include Flomax (tamsulosin). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition (see There is currently no legal information available for this drug.There are currently no FDA safety alerts available for this drug.There is currently no manufacturer warning information available for this drug.There are currently no FDA labeling changes available for this drug.Flomax® (tamsulosin hydrochloride) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)].If FLOMAX 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.FLOMAX capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of FLOMAX capsules can be increased to 0.8 mg once daily. For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of FLOMAX capsules can be increased to 0.8 mg once daily. As with other alpha-adrenergic blocking agents there is a potential risk of syncope (see Patients beginning treatment with FLOMAX capsules should be cautioned to avoid situations where injury could result should syncope occur.Doses of FLOMAX higher than 0.4 mg (e.g., 0.8 mg) should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole).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). 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. Results from limited in vitro and in vivo studies are inconclusive. FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)].If FLOMAX 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.FLOMAX capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. We comply with the HONcode standard for trustworthy health information - The 0.8 mg dose should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) (see WARNINGS).If FLOMAX 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.FLOMAX capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. If FLOMAX 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. Get email alerts and dashboard notifications when your medications are recalled by the FDA.The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were detected more frequently in FLOMAX capsule-treated patients than in placebo recipients. FLOMAX capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. FLOMAX capsules should not be crushed, chewed or opened.
FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)].
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