Terazosin precautions: Difference between revisions
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===PRECAUTIONS== | |||
===General=== | |||
====Prostatic Cancer==== | |||
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. | |||
====Intraoperative Floppy Iris Syndrome (IFIS)==== | |||
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. | |||
====Orthostatic Hypotension==== | |||
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. | |||
===Information for Patients=== | |||
(See [[Terazosin patient counseling information|PATIENT INFORMATION]].) | |||
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. | |||
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. | |||
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]]). | |||
===Laboratory Tests=== | |||
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. | |||
===Drug Interactions=== | |||
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: | |||
'''analgesic/anti-inflammatory''' (e.g., [[acetaminophen]], [[aspirin]], [[codeine]], [[ibuprofen]], [[indomethacin]]); | |||
'''antibiotics''' (e.g., [[erythromycin]], [[trimethoprim]] and [[sulfamethoxazole]]); | |||
'''anticholinergic/sympathomimetics''' (e.g., [[phenylephrine]] hydrochloride, [[phenylpropanolamine]] hydrochloride, [[pseudoephedrine]] hydrochloride); | |||
'''antigout''' (e.g., [[allopurinol]]); | |||
'''antihistamines''' (e.g., [[chlorpheniramine]]); | |||
'''cardiovascular agents''' (e.g., [[atenolol]], [[hydrochlorothiazide]], [[methyclothiazide]], [[propranolol]]); | |||
'''corticosteroids;''' | |||
'''gastrointestinal agents''' (e.g., [[antacids]]); | |||
'''hypoglycemics''' | |||
'''sedatives and tranquilizers''' (e.g., [[diazepam]]). | |||
====Use With Other Drugs==== | |||
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]]).<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> | |||
Revision as of 03:02, 7 March 2014
Terazosin |
---|
Terazosin®, Hytrin® FDA Package Insert |
Indications and Usage |
Dosage and Administration |
Contraindications |
Warnings |
Precautions |
Adverse Reactions |
Drug Interactions |
Use in Specific Populations |
Overdosage |
Description |
Clinical Pharmacology |
Nonclinical Toxicology |
How Supplied/Storage and Handling |
Patient Counseling Information |
Labels and Packages |
Clinical Trials on Terazosin |
ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
=PRECAUTIONS
General
Prostatic Cancer
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.
Intraoperative Floppy Iris Syndrome (IFIS)
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.
Orthostatic Hypotension
While syncope is the most severe orthostatic effect of terazosin capsules (see 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.
Information for Patients
(See PATIENT INFORMATION.) 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.
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.
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).
Laboratory Tests
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.
Drug Interactions
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:
analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); antigout (e.g., allopurinol); antihistamines (e.g., chlorpheniramine); cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); corticosteroids; gastrointestinal agents (e.g., antacids); hypoglycemics sedatives and tranquilizers (e.g., diazepam).
Use With Other Drugs
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 DOSAGE AND ADMINISTRATION).[1]
References
- ↑ "TERAZOSIN HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]". Retrieved 7 March 2014.