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dangers hytrin use |
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dangers hytrin use Manufacturer: Abbott
Terazosin hydrochloride is a white, crystalline substance, freely soluble inwater and isotonic saline and has a molecular weight of 459.93 dangers hytrin use. HYTRIN capsules(terazosin hydrochloride capsules) for oral ingestion are supplied in four dosagestrengths containing terazosin hydrochloride equivalent to 1 mg, 2 mg, 5 mg,or 10 mg of terazosin dangers hytrin use. Inactive Ingredients: 2 mg capsules: D&C yellow No dangers hytrin use. 10, gelatin, glycerin, methylparaben, mineraloil, polyethylene glycol, povidone, propylparaben, titanium dioxide, and vanillin dangers hytrin use. 5 mg capsules: D&C red No dangers hytrin use. 28, FD&C red No dangers hytrin use. 40, gelatin, glycerin,methylparaben, mineral oil, polyethylene glycol, povidone, propylparaben, titaniumdioxide, and vanillin dangers hytrin use. 10 mg capsules: FD&C blue No dangers hytrin use. 1, gelatin, glycerin, methylparaben, mineraloil, polyethylene glycol, povidone, propylparaben, titanium dioxide, and vanillin dangers hytrin use.
Terazosin has been studied in 1222 men with symptomatic BPH dangers hytrin use. In three placebo-controlledstudies, symptom evaluation and uroflowmetric measurements were performed approximately24 hours following dosing dangers hytrin use. Symptoms were quantified using the Boyarsky Index dangers hytrin use. The questionnaire evaluated both obstructive (hesitancy, intermittency, terminaldribbling, impairment of size and force of stream, sensation of incomplete bladderemptying) and irritative (nocturia, daytime frequency, urgency, dysuria) symptomsby rating each of the 9 symptoms from 0-3, for a total score of 27 points dangers hytrin use. Resultsfrom these studies indicated that terazosin statistically significantly improvedsymptoms and peak urine flow rates over placebo as follows: N Symptom Score
Analysis of the effect of terazosin on individual urinary symptoms demonstratedthat compared to placebo, terazosin significantly improved the symptoms of hesitancy,intermittency, impairment in size and force of urinary stream, sensation ofincomplete emptying, terminal dribbling, daytime frequency and nocturia dangers hytrin use. Global assessments of overall urinary function and symptoms were also performedby investigators who were blinded to patient treatment assignment dangers hytrin use. In studies1 and 3, patients treated with terazosin had a significantly (p </= 0.001)greater overall improvement compared to placebo treated patients dangers hytrin use. In a short term study (Study 1), patients were randomized to either 2, 5 or10 mg of terazosin or placebo dangers hytrin use. Patients randomized to the 10 mg group achieveda statistically significant response in both symptoms and peak flow rate comparedto placebo (Figure 1) dangers hytrin use. + for baseline values see above table * p </= 0.05, compared to placebo group In a long-term, open-label, non-placebo controlled clinical trial, 181 menwere followed for 2 years and 58 of these men were followed for 30 months dangers hytrin use. Theeffect of terazosin on urinary symptom scores and peak flow rates was maintainedthroughout the study duration (Figures 2 and 3): In this long-term trial, both symptom scores and peak urinary flow rates showedstatistically significant improvement suggesting a relaxation of smooth musclecells dangers hytrin use. Although blockade of alpha-1 adrenoceptors also lowers blood pressure in hypertensivepatients with increased peripheral vascular resistance, terazosin treatmentof normotensive men with BPH did not result in a clinically significant bloodpressure lowering effect: Mean Changes in Blood Pressure from
Patients in clinical trials of terazosin were administered once daily (thegreat majority) and twice daily regimens with total doses usually in the rangeof 5-20 mg/day, and had mild (about 77%, diastolic pressure 95-105 mmHg) ormoderate (23%, diastolic pressure 105-115 mmHg) hypertension dangers hytrin use. Because terazosin,like all alpha antagonists, can cause unusually large falls in blood pressureafter the first dose or first few doses, the initial dose was 1 mg in virtuallyall trials, with subsequent titration to a specified fixed dose or titrationto some specified blood pressure end point (usually a supine diastolic pressureof 90 mmHg) dangers hytrin use. Blood pressure responses were measured at the end of the dosing interval (usually24 hours) and effects were shown to persist throughout the interval, with theusual supine responses 5-10 mmHg systolic and 3.5-8 mmHg diastolic greater thanplacebo dangers hytrin use. The responses in the standing position tended to be somewhat larger,by 1-3 mmHg, although this was not true in all studies dangers hytrin use. The magnitude of theblood pressure responses was similar to prazosin and less than hydrochlorothiazide(in a single study of hypertensive patients) dangers hytrin use. In measurements 24 hours afterdosing, heart rate was unchanged dangers hytrin use. Limited measurements of peak response (2-3 hours after dosing) during chronicterazosin administration indicate that it is greater than about twice the trough(24 hour) response, suggesting some attenuation of response at 24 hours, presumablydue to a fall in blood terazosin concentrations at the end of the dose interval dangers hytrin use. This explanation is not established with certainty, however, and is not consistentwith the similarity of blood pressure response to once daily and twice dailydosing and with the absence of an observed dose-response relationship over arange of 5-20 mg, i.e., if blood concentrations had fallen to the point of providingless than full effect at 24 hours, a shorter dosing interval or larger doseshould have led to increased response dangers hytrin use. Further dose response and dose duration studies are being carried out dangers hytrin use. Bloodpressure should be measured at the end of the dose interval; if response isnot satisfactory, patients may be tried on a larger dose or twice daily dosingregimen dangers hytrin use. The latter should also be considered if possibly blood pressure-relatedside effects, such as dizziness, palpitations, or orthostatic complaints, areseen within a few hours after dosing dangers hytrin use. The greater blood pressure effect associated with peak plasma concentrations(first few hours after dosing) appears somewhat more position-dependent (greaterin the erect position) than the effect of terazosin at 24 hours and in the erectposition there is also a 6-10 beat per minute increase in heart rate in thefirst few hours after dosing dangers hytrin use. During the first 3 hours after dosing 12.5% ofpatients had a systolic pressure fall of 30 mmHg or more from supine to standing,or standing systolic pressure below 90 mmHg with a fall of at least 20 mmHg,compared to 4% of a placebo group dangers hytrin use. There was a tendency for patients to gain weight during terazosin therapy dangers hytrin use. In placebo-controlled monotherapy trials, male and female patients receivingterazosin gained a mean of 1.7 and 2.2 pounds respectively, compared to lossesof 0.2 and 1.2 pounds respectively in the placebo group dangers hytrin use. Both differences werestatistically significant dangers hytrin use. During controlled clinical trials, patients receiving terazosin monotherapyhad a small but statistically significant decrease (a 3% fall) compared to placeboin total cholesterol and the combined low-density and very-low-density lipoproteinfractions dangers hytrin use. No significant changes were observed in high-density lipoproteinfraction and triglycerides compared to placebo dangers hytrin use. Analysis of clinical laboratory data following administration of terazosinsuggested the possibility of hemodilution based on decreases in hematocrit,hemoglobin, white blood cells, total protein and albumin dangers hytrin use. Decreases in hematocritand total protein have been observed with alpha-blockade and are attributedto hemodilution dangers hytrin use. |
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