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2CLINICAL PHARMACOLOGYPharmacodynamicsA. Benign Prostatic Hyperplasia (BPH)Benign prostatic hyperplasia (BPH) is a common cause of urinary outflow obstruction in agingmales. Severe BPH may lead to urinary retention and renal damage. A static and a dynamic component contribute to the symptoms and reduced urinary flow rate associated with BPH. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and thedegree of urethral obstruction do not correlate well with the size of the prostate. The dynamiccomponent of BPH is associated with an increase in smooth muscle tone in the prostate and bladder neck. The degree of tone in this area is mediated by the alpha1adrenoceptor, which is present in high density in the prostatic stroma, prostatic capsule and bladder neck. Blockade of the alpha1receptor decreases urethral resistance and may relieve the obstruction and BPH symptoms. In the human prostate, CARDURAÆ antagonizes phenylephrine (alpha1agonist)-induced contractions, in vitro, and binds with high affinity to the alpha1cadrenoceptor. The receptor subtype is thought to be the predominant functional type in the prostate. CARDURAÆacts within 1-2 weeks to decrease the severity of BPH symptoms and improve urinary flow rate. Since alpha1adrenoceptors are of low density in the urinary bladder (apart from the bladder neck), CARDURAÆ should maintain bladder contractility. The efficacy of CARDURAÆ was evaluated extensively in over 900 patients with BPH in double-blind, placebo-controlled trials. CARDURAÆ treatment was superior to placebo in improving patient symptoms and urinary flow rate. Significant relief with CARDURAÆ was seen as early as one week into the treatment regimen, with CARDURAÆ treated patients (N=173) showing a significant (p<0.01) increase in maximum flow rate of 0.8 mL/sec compared to a decrease of 0.5 mL/sec in the placebo group (N=41). In long-term studies improvement was maintained for up to 2 years of treatment. In 66-71% of patients, improvements above baseline were seen in both symptoms and maximum urinary flow rate. In three placebo-controlled studies of 14-16 weeks duration obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritativesymptoms (nocturia, daytime frequency, urgency, burning) of BPH were evaluated at each visitby patient-assessed symptom questionnaires. The bothersomeness of symptoms was measured with a modified Boyarsky questionnaire. Symptom severity/frequency was assessed using a modified Boyarsky questionnaire or an AUA-based questionnaire. Uroflowmetric evaluations were performed at times of peak (2-6 hours post-dose) and/or trough (24 hours post-dose) plasma concentrations of CARDURAÆ. The results from the three placebo-controlled studies (N=609) showing significant efficacy with 4 mg and 8 mg doxazosin are summarized in Table 1. In all three studies, CARDURAÆ resulted in statistically significant relief of obstructive and irritative symptoms compared to placebo. Statistically significant improvements of 2.3-3.3 mL/sec in maximum flow rate were seen with CARDURAÆ in Studies 1 and 2, compared to 0.1-0.7 mL/sec with placebo. cardura effects medication side Keep all appointments with your doctor. Your blood pressure should be checked regularly to determine your response to doxazosin. cardura medicine Why is this drug prescribed? cardura If you suspect an overdose, seek medical attention immediately. cardura generic order ∑ feeling light-headed, fainting; cardura xl
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-------------------------------------------------------------------------------- cardura generic ï Store Cardura at room temperature away from moisture and heat. cardura medication Page 11 cardura effects side Page 18 Click here for more information on Cardura
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7flow rate in 66-71% of patients. Sustained improvements with CARDURAÆ were seen inpatients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies. B. Hypertension. CARDURAÆ (doxazosin mesylate) is also indicated for the treatment of hypertension. CARDURAÆ may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors. CONTRAINDICATIONSCARDURAÆ is contraindicated in patients with a known sensitivity to quinazolines (e.g., prazosin, terazosin), doxazosin, or any of the inert ingredients. WARNINGSSyncope and ìFirst-doseî Effect: Doxazosin, like other alpha-adrenergic blocking agents, can cause marked hypotension, especially in the upright position, with syncope and otherpostural 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 isessential 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 section) 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/daywithout experiencing symptomatic postural hypotension. In another study of 24 healthynormotensive 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 dosingat 1 mg/day resulting in a 4% incidence of postural side effects at 1 mg/day with no cases ofsyncope. 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 theseevents 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 taking2 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 ï Cardura can affect the pupils of your eyes during cataract surgery. If you have cataract surgery during your treatment with Cardura, tell the surgeon ahead of time that you take Cardura. Do not stop using the medication before surgery unless your surgeon tells you to. -------------------------------------------------------------------------------- advertisement The usual starting dose is 1 milligram taken once a day. To minimize the potential for dizziness or fainting associated with Cardura, which may occur between 2 and 6 hours after a dose, your doctor will monitor your blood pressure during this period and afterwards.
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What is Cardura? -------------------------------------------------------------------------------- ï Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by Cardura. What side effects may occur? ADULTS
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