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| __NOTOC__
| | #REDIRECT [[Terazosin#Warnings]] |
| {{Terazosin}}
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| {{CMG}}; {{AE}} {{AK}}
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| ==Precautions==
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| ===General===
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| ====Prostatic Cancer====
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| Carcinoma of the prostate and [[BPH]] cause many of the same symptoms. These two diseases frequently co-exist. Therefore, patients thought to have BPH should be examined prior to starting terazosin capsule therapy to rule out the presence of carcinoma of the prostate.
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| ====Intraoperative Floppy Iris Syndrome (IFIS)====
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| Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on/or previously treated with alpha-1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative [[miosis]] despite preoperative dilation with standard [[mydriatic]] drugs, and potential prolapse of the iris toward the [[phacoemulsification]] incisions. The patient’s ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha-1 blocker therapy prior to cataract surgery.
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| ====Orthostatic Hypotension====
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| While syncope is the most severe orthostatic effect of terazosin capsules (see [[Terazosin warnings |WARNINGS]]), other symptoms of lowered blood pressure, such as [[dizziness]], [[lightheadedness]] and [[palpitations]], were more common and occurred in some 28% of patients in clinical trials of hypertension. In BPH clinical trials, 21% of the patients experienced one or more of the following: [[dizziness]], hypotension, [[postural hypotension]], [[syncope]], and [[vertigo]]. Patients with occupations in which such events represent potential problems should be treated with particular caution.
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| ===Information for Patients===
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| (See [[Terazosin patient counseling information|PATIENT INFORMATION]].)
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| Patients should be made aware of the possibility of syncopal and [[orthostatic]] symptoms, especially at the initiation of therapy, and to avoid driving or hazardous tasks for 12 hours after the first dose, after a dosage increase, and after interruption of therapy when treatment is resumed. They should be cautioned to avoid situations where injury could result should [[syncope]] occur during initiation of terazosin capsule therapy. They should also be advised of the need to sit or lie down when symptoms of lowered blood pressure occur, although these symptoms are not always orthostatic, and to be careful when rising from a sitting or lying position. If [[dizziness]], [[lightheadedness]], or [[palpitations]] are bothersome they should be reported to the physician, so that dose adjustment can be considered.
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| Patients should also be told that drowsiness or somnolence can occur with terazosin capsules, requiring caution in people who must drive or operate heavy machinery.
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| Patients should be advised about the possibility of [[priapism]] as a result of treatment with terazosin capsules and other similar medications. Patients should know that this reaction to terazosin capsules is extremely rare, but that if it is not brought to immediate medical attention, it can lead to permanent erectile dysfunction ([[impotence]]).
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| ===Laboratory Tests===
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| Small but statistically significant decreases in [[hematocrit]], [[hemoglobin]], white blood cells,[[ total protein]] and [[albumin]] were observed in controlled clinical trials. These laboratory findings suggested the possibility of hemodilution. Treatment with terazosin capsules for up to 24 months had no significant effect on prostate specific antigen ([[PSA]]) levels.
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| ===Drug Interactions===
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| In controlled trials, terazosin capsules have been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. Terazosin capsules have also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. Terazosin capsules have been used concomitantly in at least 50 patients on the following drugs or drug classes:
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| '''analgesic/anti-inflammatory''' (e.g., [[acetaminophen]], [[aspirin]], [[codeine]], [[ibuprofen]], [[indomethacin]]);
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| '''antibiotics''' (e.g., [[erythromycin]], [[trimethoprim]] and [[sulfamethoxazole]]);
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| '''anticholinergic/sympathomimetics''' (e.g., [[phenylephrine]] hydrochloride, [[phenylpropanolamine]] hydrochloride, [[pseudoephedrine]] hydrochloride);
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| '''antigout''' (e.g., [[allopurinol]]);
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| '''antihistamines''' (e.g., [[chlorpheniramine]]);
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| '''cardiovascular agents''' (e.g., [[atenolol]], [[hydrochlorothiazide]], [[methyclothiazide]], [[propranolol]]);
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| '''corticosteroids;'''
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| '''gastrointestinal agents''' (e.g., [[antacids]]);
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| '''hypoglycemics'''
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| '''sedatives and tranquilizers''' (e.g., [[diazepam]]).
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| ====Use With Other Drugs====
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| In a study (n=24) where terazosin and [[verapamil]] were administered concomitantly, terazosin’s mean AUC0-24 increased 11% after the first [[verapamil]] dose and after 3 weeks of verapamil treatment it increased by 24% with associated increases in Cmax (25%) and Cmin (32%) means. Terazosin mean Tmax decreased from 1.3 hours to 0.8 hours after 3 weeks of verapamil treatment. Statistically significant differences were not found in the verapamil level with and without terazosin. In a study (n=6) where terazosin and [[captopril]] were administered concomitantly, plasma disposition of captopril was not influenced by concomitant administration of terazosin and terazosin maximum plasma concentrations increased linearly with dose at steady-state after administration of terazosin plus [[captopril]] (see [[Terazosin dosage and administration|DOSAGE AND ADMINISTRATION]]).
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| ===Pregnancy===
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| ====Teratogenic Effects====
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| '''Pregnancy Category C'''
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| Terazosin capsules were not teratogenic in either rats or rabbits when administered at oral doses up to 280 and 60 times, respectively, the maximum recommended human dose. Fetal resorptions occurred in rats dosed with 480 mg/kg/day, approximately 280 times the maximum recommended human dose. Increased fetal resorptions, decreased fetal weight and an increased number of supernumerary ribs were observed in offspring of rabbits dosed with 60 times the maximum recommended human dose. These findings (in both species) were most likely secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women and the safety of terazosin in pregnancy has not been established. Terazosin capsules are not recommended during pregnancy unless the potential benefit justifies the potential risk to the mother and fetus.
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| ====Nonteratogenic Effects====
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| In a peri- and post-natal development study in rats, significantly more pups died in the group dosed with 120 mg/kg/day (> 75 times the maximum recommended human dose) than in the control group during the three-week postpartum period.
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| ===Nursing Mothers===
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| It is not known whether terazosin is excreted in breast milk. Because many drugs are excreted in breast milk, caution should be exercised when terazosin capsules are administered to a nursing woman.
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| ===Pediatric Use===
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| Safety and effectiveness in pediatric patients have not been determined.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TERAZOSIN HYDROCHLORIDE CAPSULE [CARDINAL HEALTH] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=30503dfd-03bd-46d8-8170-d9ed096fd71d | publisher = | date = | accessdate = 7 March 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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