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| {{DrugProjectFormSinglePage
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| |authorTag={{JS}}
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| |genericName=Doxazosin mesylate
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| |aOrAn=a
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| |drugClass=alpha-adrenergic blocker
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| |indication=[[benign prostatic hyperplasia]] ([[BPH]]) and [[hypertension]]
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| |adverseReactions=[[edema]], [[hypotension]], [[nausea]], [[dizziness]], [[headache]], [[somnolence]], [[vertigo]] and [[fatigue]]
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| |blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
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| |blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
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| |fdaLIADAdult======BENIGN PROSTATIC HYPERPLASIA =====
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| * Initial dose:
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| :* ''1 mg once a day''
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| * Depending on the patient's [[urodynamics]] and [[BPH]] symptomatology, dosage may be increased, with a recommended titration interval of 1-2 weeks, to:
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| :*''2 mg once a day'', followed by ''4 mg once a day'' until the maximum dosage of ''8 mg once a day''.
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| =====HYPERTENSION=====
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| * Initial dose:
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| :* ''1 mg once a day''
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| * Depending on the patient's standing [[blood pressure]] response (based on measurements taken at 2–6 hours post-dose and 24 hours post-dose), dosage may then be increased to:
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| :* ''2 mg once a day'', followed by ''4 mg once a day'', than ''8 mg once a day'' until the maximum dosage of ''16 mg once a day'' to achieve the desired reduction in [[blood pressure]].
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| |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Doxazonin sandbox in adult patients.
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| |offLabelAdultNoGuideSupport======Cardiac syndrome X=====
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| =====Disorder of the urinary system=====
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| * Dosing Information
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| :* 2 mg at bedtime, twice daily
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| =====Erectile dysfunction; Diagnosis=====
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| * Dosing Information
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| :* 4 mg daily
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| =====Pheochromocytoma=====
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| * Dosing Information
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| :* 2—16 mg daily
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| =====Ureteric stone=====
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| * Dosing Information
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| :* 4 mg daily
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| |fdaLIADPed======Hypertension=====
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| * Dosing Information
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| :* Initial: 1 mg/day PO until the maximum dosage of 4 mg/day
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| |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of [[Doxazosin]] in pediatric patients.
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| |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of [[Doxazosin]] in pediatric patients.
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| |contraindications=* Doxazosin tablets are contraindicated in patients with a known [[sensitivity]] to quinazolines (e.g., [[prazosin]], [[terazosin]]), doxazosin, or any of the inert ingredients.
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| |warnings======Syncope and "First-dose" Effect=====
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| * Doxazosin, like other [[alpha-adrenergic blocking agent]]s, 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 mg, 4 mg, and 8 mg tablets are not for initial therapy. Dosage should then be adjusted slowly with evaluations and increases in dose every two weeks to the recommended dose. Additional antihypertensive agents should be added with caution.
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| * Patients being titrated with doxazosin should be cautioned to avoid situations where injury could result should syncope occur, during both the day and night.
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| * If syncope occurs, the patient should be placed in a recumbent position and treated supportively as necessary.
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| =====Priapism=====
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| * 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.
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| |clinicalTrials======Benign Prostatic Hyperplasia (BPH)=====
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| The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 3) are based on combined data from seven placebo-controlled trials involving once daily administration of doxazosin in doses of 1 mg to 16 mg in hypertensives and 0.5 mg to 8 mg in normotensives. The adverse events when the incidence in the doxazosin group was at least 1% are summarized in Table 3. No significant difference in the incidence of adverse events compared to placebo was seen except for dizziness, fatigue, hypotension, edema and dyspnea. Dizziness and dyspnea appeared to be dose-related.
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| [[File:DOXAZOSIN- Adverse Reactions 1.jpg|thumb|none|500px|This image is provided by the National Library of Medicine - Adverse reactions during placebo-controlled studies]]
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| In these placebo-controlled studies of 665 doxazosin patients, treated for a mean of 85 days, additional adverse reactions have been reported. These are less than 1% and not distinguishable from those that occurred in the placebo group. Adverse reactions with an incidence of less than 1% but of clinical interest are (doxazosin vs. placebo): Cardiovascular System: angina pectoris (0.6% vs. 0.7%), postural hypotension (0.3% vs. 0.3%), syncope (0.5% vs. 0%), tachycardia (0.9% vs. 0%); Urogenital System: dysuria (0.5% vs. 1.3%), and Psychiatric Disorders: libido decreased (0.8% vs. 0.3%). The safety profile in patients treated for up to three years was similar to that in the placebo-controlled studies.
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| The majority of adverse experiences with doxazosin were mild.
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| =====Hypertension=====
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| Doxazosin mesylate has been administered to approximately 4,000 hypertensive patients, of whom 1,679 were included in the hypertension clinical development program. In that program, minor adverse effects were frequent, but led to discontinuation of treatment in only 7% of patients. In placebo-controlled studies adverse effects occurred in 49% and 40% of patients in the doxazosin and placebo groups, respectively, and led to discontinuation in 2% of patients in each group. The major reasons for discontinuation were postural effects (2%), edema, malaise/fatigue, and some heart rate disturbance, each about 0.7%.
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| In controlled hypertension clinical trials directly comparing doxazosin to placebo there was no significant difference in the incidence of side effects, except for dizziness (including postural), weight gain, somnolence and fatigue/malaise. Postural effects and edema appeared to be dose related. The prevalence rates presented below are based on combined data from placebo-controlled studies involving once daily administration of doxazosin at doses ranging from 1 mg to 16 mg. Table 4 summarizes those adverse experiences (possibly/probably related) reported for patients in these hypertension studies where the prevalence rate in the doxazosin group was at least 0.5% or where the reaction is of particular interest.
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| [[File:DOXAZOSIN (DOXAZOSIN MESYLATE) - Adverse Reactions 2.jpg|thumb|none|500px|This image is provided by the National Library of Medicine - Adverse reactions during placebo-controlled studies]]
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| Additional adverse reactions have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to doxazosin. The following adverse reactions occurred with a frequency of between 0.5% and 1%: syncope, hypoesthesia, increased sweating, agitation, increased weight. The following additional adverse reactions were reported by < 0.5% of 3,960 patients who received doxazosin in controlled or open, short- or long-term clinical studies, including international studies. Cardiovascular System: angina pectoris, myocardial infarction, cerebrovascular accident; Autonomic Nervous System: pallor; Metabolic: thirst, gout, hypokalemia; Hematopoietic: lymphadenopathy, purpura; Reproductive System: breast pain; Skin Disorders: alopecia, dry skin, eczema; Central Nervous System: paresis, tremor, twitching, confusion, migraine, impaired concentration; Psychiatric: paroniria, amnesia, emotional lability, abnormal thinking, depersonalization; Special Senses: parosmia, earache, taste perversion, photophobia, abnormal lacrimation; Gastrointestinal System: increased appetite, anorexia, fecal incontinence, gastroenteritis; Respiratory System: bronchospasm, sinusitis, coughing, pharyngitis; Urinary System: renal calculus; General Body System: hot flushes, back pain, infection, fever/rigors, decreased weight, influenza-like symptoms.
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| Doxazosin has not been associated with any clinically significant changes in routine biochemical tests. No clinically relevant adverse effects were noted on serum potassium, serum glucose, uric acid, blood urea nitrogen, creatinine or liver function tests. Doxazosin has been associated with decreases in white blood cell counts.
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| In post-marketing experience the following additional adverse reactions have been reported: Autonomic Nervous System: priapism; Central Nervous System: hypoesthesia; Endocrine System: gynecomastia; Gastrointestinal System: vomiting; General Body System: allergic reaction; Heart Rate/Rhythm: bradycardia; Hematopoietic: leukopenia, thrombocytopenia; Liver/Biliary System: hepatitis, hepatitis cholestatic; Respiratory System: bronchospasm aggravated; Skin Disorders: urticaria; Special Senses: Intraoperative Floppy Iris Syndrome (see PRECAUTIONS: General: Cataract Surgery); Urinary System: hematuria, micturition disorder, micturition frequency, nocturia.
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| |postmarketing=(Description)
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| |drugInteractions=* Drug 1
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| * Drug 2
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| * Drug 3
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| * Drug 4
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| * Drug 5
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| =====Drug 1=====
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| (Description)
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| =====Drug 2=====
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| (Description)
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| =====Drug 3=====
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| (Description)
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| =====Drug 4=====
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| (Description)
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| =====Drug 5=====
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| (Description)
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| |useInPregnancyFDA=(Description)
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| |useInPregnancyAUS=(Description)
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| |useInLaborDelivery=(Description)
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| |useInNursing=(Description)
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| |useInPed=(Description)
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| |useInGeri=(Description)
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| |useInGender=(Description)
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| |useInRace=(Description)
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| |useInRenalImpair=(Description)
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| |useInHepaticImpair=(Description)
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| |useInReproPotential=(Description)
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| |useInImmunocomp=(Description)
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| |othersTitle=Others
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| |useInOthers=(Description)
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| |administration=(Oral/Intravenous/etc)
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| |monitoring======Condition 1=====
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| (Description regarding monitoring, from ''Warnings'' section)
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| =====Condition 2=====
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| (Description regarding monitoring, from ''Warnings'' section)
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| =====Condition 3=====
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| (Description regarding monitoring, from ''Warnings'' section)
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| |IVCompat====Solution===
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| ====Compatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Not Tested====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Variable====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Incompatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ===Y-Site===
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| ====Compatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Not Tested====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Variable====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Incompatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ===Admixture===
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| ====Compatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Not Tested====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Variable====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Incompatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ===Syringe===
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| ====Compatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Not Tested====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Variable====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Incompatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ===TPN/TNA===
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| ====Compatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Not Tested====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Variable====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| ====Incompatible====
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| * Solution 1
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| * Solution 2
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| * Solution 3
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| |overdose=* Experience with doxazosin overdosage is limited.
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| |drugBox={{Drugbox2
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| | verifiedrevid =
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| | IUPAC_name =
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| | image =
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| | drug_name =
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| <!--Clinical data-->
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| | tradename =
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| | MedlinePlus =
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| | licence_US =
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| | pregnancy_AU =
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| | pregnancy_US =
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| | legal_status =
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| | routes_of_administration =
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| <!--Pharmacokinetic data-->
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| | bioavailability =
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| | metabolism =
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| | elimination_half-life =
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| | excretion =
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| <!--Identifiers-->
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| | CAS_number_Ref =
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| | UNII_Ref =
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| | KEGG_Ref =
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| | KEGG =
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| | ChEBI_Ref =
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| | ChEBI =
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| | ChEMBL_Ref =
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| | ChEMBL =
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|
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| <!--Chemical data-->
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| | C= | H= | N= | O=
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| | molecular_weight =
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| | smiles =
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| | InChI =
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| | InChIKey =
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| | StdInChI_Ref =
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| | StdInChI =
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| | StdInChIKey_Ref =
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| | StdInChIKey =
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| | melting_point =
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| }}
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| |mechAction=(Description)
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| |structure=(Description with picture)
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| |PD=(Description)
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| |PK=(Description)
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| |nonClinToxic=(Description)
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| |clinicalStudies======Condition 1=====
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| (Description)
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| =====Condition 2=====
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| (Description)
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| =====Condition 3=====
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| (Description)
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| |howSupplied=(Description)
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| |fdaPatientInfo=(Patient Counseling Information)
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| |alcohol=Alcohol-Doxazonin sandbox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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| |lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
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| * (Paired Confused Name 2a) — (Paired Confused Name 2b)
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| * (Paired Confused Name 3a) — (Paired Confused Name 3b)
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| }}
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