Flomax label

Flomax

Flomax Recall

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Side Effects & Adverse Reactions

The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were detected more frequently in FLOMAX capsule-treated patients than in placebo recipients. As with other alpha-adrenergic blocking agents there is a potential risk of syncope (see ADVERSE REACTIONS).

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). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition (see PRECAUTIONS, Information for Patients).

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Flomax® (tamsulosin hydrochloride) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX capsules are not indicated for the treatment of hypertension.

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History

There is currently no drug history available for this drug.

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Other Information

Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.

Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether.

The empirical formula of tamsulosin hydrochloride is C20H28N2O5S • HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:

Tamsulosin's structural formula

Each 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. 2, titanium dioxide, ferric oxide, gelatin, and trace amounts of black edible ink.

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Flomax Manufacturers

  • A-s Medication Solutions Llc
    Flomax | A-s Medication Solutions Llc
    No Recall

    Flomax | A-s Medication Solutions Llc

    Flomax | A-s Medication Solutions Llc

    FLOMAX 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.

    For those patients who fail to respond to the 0.4 mg dose after two to four weeks of dosing, the dose of FLOMAX capsules can be increased to 0.8 mg once daily. 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.

  • Stat Rx Usa Llc
    Flomax | Stat Rx Usa Llc
    No Recall

    Flomax | Stat Rx Usa Llc

    Flomax | Stat Rx Usa Llc

    FLOMAX 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.

    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. 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.

  • Lake Erie Medical Dba Quality Care Products
    Flomax | Lake Erie Medical Dba Quality Care Products
    No Recall

    Flomax | Lake Erie Medical Dba Quality Care Products

    Flomax | Lake Erie Medical Dba Quality Care Products
    2  DOSAGE AND ADMINISTRATION

    FLOMAX 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.

     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. 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.

  • Physicians Total Care, Inc.
    Flomax | Physicians Total Care, Inc.
    No Recall

    Flomax | Physicians Total Care, Inc.

    Flomax | Physicians Total Care, Inc.

    FLOMAX 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.

    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. 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.

  • Remedyrepack Inc.
    Flomax | Remedyrepack Inc.
    No Recall

    Flomax | Remedyrepack Inc.

    Flomax | Remedyrepack Inc.
    DOSAGE AND ADMINISTRATION
    FLOMAX 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.
    For those patients who fail to respond to the 0.4 mg dose after two to four weeks of dosing, the dose of FLOMAX capsules can be increased to 0.8 mg once daily. 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.

  • Cardinal Health
    Flomax | Cardinal Health
    No Recall

    Flomax | Cardinal Health

    Flomax | Cardinal Health

    FLOMAX 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.

    For those patients who fail to respond to the 0.4 mg dose after two to four weeks of dosing, the dose of FLOMAX capsules can be increased to 0.8 mg once daily. 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.

  • Bryant Ranch Prepack
    Flomax | Bryant Ranch Prepack
    No Recall

    Flomax | Bryant Ranch Prepack

    Flomax | Bryant Ranch Prepack

    FLOMAX 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.

    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. 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.

  • Boehringer Ingelheim Pharmaceuticals, Inc.
    Flomax | Boehringer Ingelheim Pharmaceuticals, Inc.
    No Recall

    Flomax | Boehringer Ingelheim Pharmaceuticals, Inc.

    Flomax | Boehringer Ingelheim Pharmaceuticals, Inc.

    FLOMAX 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. FLOMAX 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 FLOMAX capsules can be increased to 0.8 mg once daily. 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.

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