CARDURA SUMMARY
CARDURA® (doxazosin mesylate) is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha adrenergic receptors.
CARDURA® (doxazosin mesylate) is indicated for the following:
A. Benign Prostatic Hyperplasia (BPH)
CARDURA 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). CARDURA may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with CARDURA monotherapy. CARDURA provides rapid improvement in symptoms and urinary flow rate in 66–71% of patients. Sustained improvements with CARDURA were seen in patients treated for up to 14 weeks in double blind studies and up to 2 years in open-label studies.
B. Hypertension
CARDURA (doxazosin mesylate) is also indicated for the treatment of hypertension. CARDURA may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors.
|
NEWS HIGHLIGHTS
Published Studies Related to Cardura (Doxazosin)
Long-term effects of doxazosin, finasteride, and combination therapy on quality
of life in men with benign prostatic hyperplasia. [2013]
International Prostate Symptom Score [IPSS]-QoL) over 4 years... CONCLUSIONS: QoL of men treated with doxazosin, finasteride, and
Effect of doxazosin gastrointestinal therapeutic system 4 mg vs tamsulosin 0.2 mg on nocturia in Chinese men with lower urinary tract symptoms: a prospective, multicenter, randomized, open, parallel study. [2011.09]
OBJECTIVE: To compare the efficacy of the doxazosin gastrointestinal therapeutic system (doxazosin-GITS) 4 mg and tamsulosin 0.2 mg on nocturia in Chinese men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH)... CONCLUSION: In Chinese patients with LUTS/BPH, doxazosin-GITS is slightly better than tamsulosin in reducing the frequency of nocturia. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Tamsulosin and doxazosin as adjunctive therapy following shock-wave lithotripsy of renal calculi: randomized controlled trial. [2011.08.12]
Alpha-blockers have been established as medical expulsive therapy for urolithiasis. We aimed to assess the effect of tamsulosin and doxazosin as adjunctive therapy following SWL for renal calculi... The side-effects of these agents are common and should be weighted against the benefits of their usage.
An open, comparative, multicentre clinical study of combined oral therapy with sildenafil and doxazosin GITS for treating Chinese patients with erectile dysfunction and lower urinary tract symptoms secondary to benign prostatic hyperplasia. [2011.07]
This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction (ED) and lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH/LUTS)...
[Kidney-tonifying and dampness-expelling Chinese herbal medicine combined with doxazosin for the treatment of chronic epididymitis]. [2010.12]
OBJECTIVE: To study the clinical effects of kidney-tonifying and dampness-expelling Chinese herbal medicine combined with doxazosin in the treatment of chronic epididymitis... CONCLUSION: Either doxazosin alone or kidney-tonifying and dampness-expelling Chinese herbal decoction combined with doxazosin is obviously effective on chronic epididymitis, but the combined medication produces an even better efficacy.
Clinical Trials Related to Cardura (Doxazosin)
The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine [Recruiting]
Human Laboratory Trial of Doxazosin for Cocaine Dependence: Accumulating evidence implicates
noradrenergic (NE) systems in mediating the effects of stimulants (1-8). Mice lacking NE £\
- 1 receptor mice show reduced sensitivity to cocaine and amphetamine (8, 9). Local depletion
of prefrontal cortex (PFC) NE reduced rewarding effects of amphetamine and reduced
amphetamine-induced dopamine (DA) release in the PFC and accumbens (7), suggesting that PFC
NE contributes to the rewarding effects of stimulants. Treatment with the NE Æ’Ă‘-1 antagonist
prazosin has been shown to antagonize a variety of effects produced by cocaine and
amphetamine. In rats, prazosin (1-2 mg/kg) significantly attenuated the locomotor activating
effects produced by cocaine (10-12) and for amphetamine (4, 13, 14). Similar findings have
been observed for the discriminative stimulus effects produced by cocaine and amphetamine in
mice (15) and for food-maintained responding in pigeons (16). More recently, prazosin (0. 3
mg/kg) reduced reinstatement of extinguished cocaine-seeking behavior in rats without
affecting responding for food, suggesting that prazosin my blunt the motivational effects of
drug cues (5). Clinical Experience with Alpha-1 Adrenergic Antagonists: Prazosin is a
prototypical antagonist at NE Ă‚Â£\-1 receptors. When first released the medication was thought
to produce relaxation of smooth muscles in the vasculature. Since then however it has been
determined that prazosin antagonizes norepinephrine and this mediates the antihypertensive
effect (17). The medication has been assessed extensively for the treatment of hypertension
(18). The initial dose is 1mg two or three times per day. The usual dose range is 6mg/day to
15mg/day, with some patients requiring up to 40mg/day in divided doses. The most common side
effects are: dizziness 10. 3%, headache 7. 8%, drowsiness 7. 6%, lack of energy 6. 9%, weakness
6. 5%, palpitations 5. 3%, and nausea 4. 9%. In most instances side effects have disappeared
with continued therapy or have been tolerated with no decrease in dose of drug. More
recently, prazosin has been successfully used to treat post traumatic stress disorder (19,
20). For this indication, prazosin was initiated at 1mg at bedtime and increased as needed
to control symptoms to up to 15mg at bedtime by day 28. This approach resulted in no change
in systolic and diastolic blood pressure compared to pretreatment measurements. Several
subjects reported transient dizziness upon standing (9/14 in the prazosin group and 6/15 in
the placebo group), but none reported syncope. Prazosin has a relatively short elimination
half-life of 3. 5 h (21). Longer-lasting cogeners (e. g. terazosin and doxazosin) are
available, but there is no experience using these medications as treatments for cocaine
dependence. The purpose of this study is to evaluate the effects of doxazosin on the
cardiovascular and subjective effects of cocaine in a human laboratory study. Doxazosin was
selected because it has a longer elimination half-life (22h) compared to terazosin (12h).
The side-effect profile of doxazosin closely resembles that of prazosin.
Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA) [Recruiting]
The purpose of this study is to determinate the effect of a pre-treatment with doxazosin, a
alpha1-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of
3,4-methylenedioxymethamphetamine (MDMA, "ecstasy"). The investigators hypothesize that
doxazosin will attenuate the cardiovascular and subjective response to MDMA.
The Efficacy of Doxazosin for Cocaine Users [Recruiting]
Doxazosin, an alpha 1-adrenergic receptor may play an important role in cocaine addiction in
human. This study will evaluate the effectiveness of doxazosin in preventing drug relapse
among cocaine addicts.
Phenoxybenzamine Versus Doxazosin in PCC Patients [Recruiting]
- Rationale: The optimal preoperative medical management for patients with a
pheochromocytoma is currently unknown. In particular, there is no agreement with
respect to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor
antagonist to be administered before surgical resection of a pheochromocytoma. We
hypothesized that the competitive alfa1-antagonist doxazosin is superior to the
non-competitive alfa1- and alfa2-antagonist phenoxybenzamine.
- Objective: comparing effects of preoperative treatment with either phenoxybenzamine or
doxazosin on intraoperative hemodynamic control in patients undergoing surgical
resection of a pheochromocytoma.
- Study design: Randomised controlled open-label trial.
- Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign
pheochromocytoma.
- Intervention: Patients are randomised to receive oral treatment with either
phenoxybenzamine or doxazosin preoperatively.
- Main study parameters/endpoints: The main study parameter is defined as the frequency
of intraoperative blood pressure episodes outside the predefined target range after
pretreatment with either phenoxybenzamine or doxazosin.
In this multicenter trial, we compare the effects of two commonly used drugs in patients
being medically prepared for resection of a benign pheochromocytoma. Participants are not
subjected to an experimental treatment of any kind, as we merely aim to describe in detail
the perioperative course in general and, in particular, the intraoperative hemodynamic
control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A
routine diagnostic work-up for pheochromocytoma will be performed in all participants. One
extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and
participants need to record their symptoms in a diary. In addition, patients who are
pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with
an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least
2 - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment
with an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by
the nursing staff. The final site visit is planned at 30 days after surgery, in line with
current practice.
Pharmacogenetics of Doxazosin for Cocaine Dependence [Recruiting]
Doxazosin, an alpha 1-adrenergic receptor antagonist, may play an important role in cocaine
addiction in humans. This study will evaluate to what extent the prospective screening for
catecholamine related polymorphisms for alpha 1 NE receptor/transporter, COMT and DBH as
main targets predict the treatment efficacy of doxazosin for cocaine-using behavior.
Reports of Suspected Cardura (Doxazosin) Side Effects
Syncope (14),
Blood Pressure Increased (11),
Hypotension (10),
Dyspnoea (9),
Drug Ineffective (8),
Headache (8),
Cerebrovascular Accident (7),
Prostatic Disorder (7),
Anxiety (7),
Hypertension (7), more >>
|
