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Doxazosin is used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH), which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency. It is also used alone or in combination with other medications to treat high blood pressure. Doxazosin is in a class of medications called alpha-blockers. It relieves the symptoms of BPH by relaxing the muscles of the bladder and prostate. It lowers blood pressure by relaxing the blood vessels so that blood can flow more easily through the body. cardura medicine Doxazosin controls high blood pressure and the symptoms of BPH but does not cure them. Continue to take doxazosin even if you feel well. Do not stop taking doxazosin without talking to your doctor. cardura generic This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. cardura generic order Before taking doxazosin, cardura tell your doctor if you have or have ever had liver disease. cardura medication
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shortness of breath cardura xl painful erection of the penis that lasts for hours cardura effects side To link to or bookmark this page, use the following url: http://www.google.com/search?q=cache:CaX2gopehscJ:www.pfizer.com/pfizer/download/uspi_cardura.pdf+cardura&hl=en&ct=clnk&cd=4 cardura effects medication side -------------------------------------------------------------------------------- 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.
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Page 5 11Mutagenicity studies revealed no drug- or metabolite-related effects at either chromosomal orsubchromosomal levels. Studies in rats showed reduced fertility in males treated with doxazosin at oral doses of 20 (but not 5 or 10) mg/kg/day, about 4 times the AUC exposures obtained with a 12 mg/day human dose. This effect was reversible within two weeks of drug withdrawal. There have been no reports of any effects of doxazosin on male fertility in humans. Pregnancy: Teratogenic Effects, Pregnancy Category C. Studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations 10 and 4 times human Cmaxand AUC exposures with a 12 mg/day therapeutic dose), have revealed no evidence of harm to the fetus. A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, CARDURAÆ should be used during pregnancy only if clearly needed. Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats. Nonteratogenic Effects: In peri-postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (8 times human AUC exposure with a 12 mg/daytherapeutic dose) was delayed as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes. Nursing Mothers: Studies in lactating rats given a single oral dose of 1 mg/kg of [2-14C]-CARDURAÆ indicate that doxazosin accumulates in rat breast milk with a maximumconcentration about 20 times greater than the maternal plasma concentration. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CARDURAÆ is administered to a nursing mother. Pediatric Use: The safety and effectiveness of CARDURAÆ as an antihypertensive agent have not been established in children. Geriatric Use: The safety and effectiveness profile of CARDURA in BPH was similar in theelderly (age > 65 years) and younger (age < 65 years) patients. For hypertension: Clinical studies of CARDURA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usuallystarting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 14Disorders: libido decreased (0.8% vs. 0.3%). The safety profile in patients treated for up to threeyears was similar to that in the placebo-controlled studies. The majority of adverse experiences with CARDURAÆ were mild. B. HypertensionCARDURAÆ has been administered to approximately 4000 hypertensive patients, of whom 1679 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. Inplacebo-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 someheart rate disturbance, each about 0.7%. In controlled hypertension clinical trials directly comparing CARDURAÆ 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 fromplacebo-controlled studies involving once daily administration of doxazosin at doses rangingfrom 1-16 mg. Table 4 summarizes those adverse experiences (possibly/probably related) reported for patients in these hypertension studies where the prevalence rate in the doxazosingroup was at least 0.5% or where the reaction is of particular interest. 16TABLE 4ADVERSE REACTIONS DURING PLACEBO-CONTROLLED STUDIES HYPERTENSIONDOXAZOSIN (N=339) PLACEBO(N=336) RESPIRATORYRhinitis Dyspnea Epistaxis 3%1%1%1%1%0%URINARYPolyuria Urinary Incontinence Micturition Frequency2%1%0%0%0%2%GENERALFatigue/Malaise Chest Pain Asthenia Face Edema Pain12%2%1%1%2%6%2%1%0%2%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 followingadverse 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 3960 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. ï Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.
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ï Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. ï Symptoms of a Cardura overdose may include drowsiness, fainting, or seizure (convulsions). ï Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. ∑ fast or pounding heartbeats; ï Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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Pronounced: car-DUHR-uh cardura generic cardura Cardura is also used in the treatment of high blood pressure. It is effective when used alone or in combination with other blood pressure medications, such as diuretics, beta-blocking medications, calcium channel blockers or ACE inhibitors. cardura xl If you have high blood pressure, you must take Cardura regularly for it to be effective. Since blood pressure declines gradually, it may be several weeks before you get the full benefit of Cardura; and you must continue taking it even if you are feeling well. Cardura does not cure high blood pressure; it merely keeps it under control. --If you miss a dose... cardura generic order --------------------------------------------------------------------------------
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