Doxazosin

Doxazosin

Doxazosin Recall

Doxazosin Mesylate 1mg, 2mg, 4mg, and 8mg tablets were voluntarily recalled by Sandoz Inc. as a result of some tablets being too large in size and dose. (fda.gov)

    Questions & Answers

  • Question

    RAYSMITHA1@AOL.COM

    WHAT IS THE REASON FOR RECALL

    posted on July 3, 2016
    • Answer

      Risa Blair, M.S. Ed., MHC

      This medication was voluntarily recalled nationwide in 2009 along with a long list of other medications by ETHEX Corporation because it was discovered that some pills were too large and contained too high a dose of medication.

      posted on July 20, 2016
  • Side Effects & Adverse Reactions

    Syncope and “First-dose” Effect

    Doxazosin, like other alpha-adrenergic blocking agents, can cause marked hypotension, especially in the upright position, with syncope and other postural symptoms such as dizziness. Marked orthostatic effects are most common with the first dose but can also occur when there is a dosage increase, or if therapy is interrupted for more than a few days. To decrease the likelihood of excessive hypotension and syncope, it is essential that treatment be initiated with the 1 mg dose. The 2, 4, and 8 mg tablets are not for initial therapy. Dosage should then be adjusted slowly (see DOSAGE AND ADMINISTRATION), with evaluations and increases in dose every two weeks to the recommended dose. Additional antihypertensive agents should be added with caution.

    Patients being titrated with doxazosin should be cautioned to avoid situations where injury could result should syncope occur, during both the day and night.

    In an early investigational study of the safety and tolerance of increasing daily doses of doxazosin in normotensives beginning at 1 mg/day, only 2 of 6 subjects could tolerate more than 2 mg/day without experiencing symptomatic postural hypotension. In another study of 24 healthy normotensive male subjects receiving initial doses of 2 mg/day of doxazosin, seven (29%) of the subjects experienced symptomatic postural hypotension between 0.5 and 6 hours after the first dose, necessitating termination of the study. In this study, 2 of the normotensive subjects experienced syncope. Subsequent trials in hypertensive patients always began doxazosin dosing at 1 mg/day, resulting in a 4% incidence of postural side effects at 1 mg/day with no cases of syncope.

    In multiple-dose clinical trials in hypertension involving over 1500 hypertensive patients with dose titration every one to two weeks, syncope was reported in 0.7% of patients. None of these events occurred at the starting dose of 1 mg, and 1.2% (8/664) occurred at 16 mg/day.

    In placebo-controlled clinical trials in BPH, 3 out of 665 patients (0.5%) taking doxazosin reported syncope. Two of the patients were taking 1 mg doxazosin, while one patient was taking 2 mg doxazosin when syncope occurred. In the open-label, long-term extension follow-up of approximately 450 BPH patients, there were 3 reports of syncope (0.7%). One patient was taking 2 mg, one patient was taking 8 mg, and one patient was taking 12 mg when syncope occurred. In a clinical pharmacology study, one subject receiving 2 mg experienced syncope.

    If syncope occurs, the patient should be placed in a recumbent position and treated supportively as necessary.

    Priapism

    Rarely (probably less frequently than once in every several thousand patients), alpha1 antagonists, including doxazosin, have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation). Because this condition can lead to permanent impotence if not promptly treated, patients must be advised about the seriousness of the condition (see PRECAUTIONS, Information for Patients).

      Legal Issues

      There is currently no legal information available for this drug.

        FDA Safety Alerts

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

          Manufacturer Warnings

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

            FDA Labeling Changes

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

              Uses

              Benign Prostatic Hyperplasia (BPH)

              Doxazosin mesylate is indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin mesylate may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin mesylate monotherapy. Doxazosin mesylate provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin mesylate were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies.

              Hypertension

              Doxazosin mesylate is also indicated for the treatment of hypertension. Doxazosin mesylate may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers, or angiotensin-converting enzyme inhibitors.

                History

                There is currently no drug history available for this drug.

                  Other Information

                  Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. It has the following structure:

                  doxazosin mesylate structural formula

                  C23H25N5O5•CH4O3S M.W. 547.6

                  Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Each doxazosin tablet USP, for oral administration, contains 1 mg, 2 mg, 4 mg, or 8 mg of doxazosin as the free base.

                  The inactive ingredients for all tablets are: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate.

                    Doxazosin Manufacturers


                    • Lake Erie Medical Dba Quality Care Products Llc
                      Doxazosin (Doxazosin Mesylate) Tablet [Lake Erie Medical Dba Quality Care Products Llc]
                    • Remedyrepack Inc.
                      Doxazosin Tablet [Remedyrepack Inc. ]
                    • Remedyrepack Inc.
                      Doxazosin Tablet [Remedyrepack Inc. ]
                    • Avkare, Inc.
                      Doxazosin (Doxazosin) Tablet [Avkare, Inc.]
                    • St Marys Medical Park Pharmacy
                      Doxazosin (Doxazosin Mesylate) Tablet [St Marys Medical Park Pharmacy]
                    • American Health Packaging
                      Doxazosin Tablet [American Health Packaging]
                    • Stat Rx Usa
                      Doxazosin Tablet [Stat Rx Usa]
                    • State Of Florida Doh Central Pharmacy
                      Doxazosin (Doxazosin Mesylate) Tablet [State Of Florida Doh Central Pharmacy]
                    • Physicians Total Care, Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Physicians Total Care, Inc.]
                    • Pd-rx Pharmaceuticals, Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Pd-rx Pharmaceuticals, Inc.]
                    • Rebel Distributors Corp
                      Doxazosin (Doxazosin Mesylate) Tablet [Rebel Distributors Corp]
                    • Pd-rx Pharmaceuticals, Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Pd-rx Pharmaceuticals, Inc.]
                    • Teva Pharmaceuticals Usa Inc
                      Doxazosin (Doxazosin Mesylate) Tablet [Teva Pharmaceuticals Usa Inc]
                    • Bryant Ranch Prepack
                      Doxazosin (Doxazosin Mesylate) Tablet [Bryant Ranch Prepack]
                    • Bryant Ranch Prepack
                      Doxazosin (Doxazosin Mesylate) Tablet [Bryant Ranch Prepack]
                    • Bryant Ranch Prepack
                      Doxazosin (Doxazosin Mesylate) Tablet [Bryant Ranch Prepack]
                    • Remedyrepack Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Remedyrepack Inc. ]
                    • Remedyrepack Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Remedyrepack Inc. ]
                    • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
                      Doxazosin (Doxazosin Mesylate) Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
                    • Major Pharmaceuticals
                      Doxazosin Tablet [Major Pharmaceuticals]
                    • Remedyrepack Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Remedyrepack Inc. ]
                    • Unit Dose Services
                      Doxazosin (Doxazosin Mesylate) Tablet [Unit Dose Services]
                    • Unit Dose Services
                      Doxazosin (Doxazosin Mesylate) Tablet [Unit Dose Services]
                    • Remedyrepack Inc.
                      Doxazosin Tablet [Remedyrepack Inc. ]
                    • Unit Dose Services
                      Doxazosin (Doxazosin Mesylate) Tablet [Unit Dose Services]
                    • Preferred Pharmaceuticals, Inc.
                      Doxazosin Tablet [Preferred Pharmaceuticals, Inc.]
                    • Legacy Pharmaceutical Packaging
                      Doxazosin Tablet [Legacy Pharmaceutical Packaging]
                    • Lake Erie Medical Dba Quality Care Products Llc
                      Doxazosin (Doxazosin Mesylate) Tablet [Lake Erie Medical Dba Quality Care Products Llc]
                    • Lake Erie Medical Dba Quality Care Products Llc
                      Doxazosin (Doxazosin Mesylate) Tablet [Lake Erie Medical Dba Quality Care Products Llc]
                    • Remedyrepack Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Remedyrepack Inc. ]
                    • Remedyrepack Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Remedyrepack Inc. ]
                    • Cardinal Health
                      Doxazosin (Doxazosin Mesylate) Tablet [Cardinal Health]
                    • Preferred Pharmaceuticals, Inc
                      Doxazosin (Doxazosin Mesylate) Tablet [Preferred Pharmaceuticals, Inc]
                    • Aidarex Pharmaceuticals Llc
                      Doxazosin (Doxazosin Mesylate) Tablet [Aidarex Pharmaceuticals Llc]
                    • Apotex Corp.
                      Doxazosin Tablet [Apotex Corp.]
                    • Teva Pharmaceuticals Usa Inc
                      Doxazosin (Doxazosin Mesylate) Tablet [Teva Pharmaceuticals Usa Inc]
                    • Remedyrepack Inc.
                      Doxazosin Tablet [Remedyrepack Inc. ]
                    • St Marys Medical Park Pharmacy
                      Doxazosin Tablet [St Marys Medical Park Pharmacy]
                    • Mylan Pharmaceuticals Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Mylan Pharmaceuticals Inc.]
                    • Aphena Pharma Solutions – Tennessee, Llc
                      Doxazosin (Doxazosin Mesylate) Tablet [Aphena Pharma Solutions – Tennessee, Llc]
                    • Aphena Pharma Solutions – Tennessee, Llc
                      Doxazosin (Doxazosin Mesylate) Tablet [Aphena Pharma Solutions – Tennessee, Llc]
                    • Mylan Institutional Inc.
                      Doxazosin (Doxazosin Mesylate) Tablet [Mylan Institutional Inc.]
                    • Cardinal Health
                      Doxazosin Tablet [Cardinal Health]
                    • Accord Healthcare Inc.
                      Doxazosin Tablet [Accord Healthcare Inc. ]

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