Data from FDA - Curated by EPG Health - Last updated 19 December 2016
PRECAUTIONS General Prostatic
These two diseases frequently coexist.
Therefore, patients thought to have BPH should be examined prior to starting terazosin hydrochloride 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
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
Orthostatic Hypotension While
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
Information for Patients (see Patient Package Insert) Patients should be made
They should also be advised of the
If dizziness, light-headedness, or
Patients should also be told that drowsiness or somnolence can occur with terazosin, requiring
Patients should be advised about the possibility of priapism as a result of treatment with terazosin and other similar medications.
Patients should know that
These laboratory findings suggested the possibility of hemodilution.
Treatment with terazosin for up to
Drug Interactions In
Terazosin has also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies,
Terazosin has been used concomitantly in at least 50 patients on the following drugs or drug classes: 1) analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); 2) antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); 3) anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); 4) antigout (e.g., allopurinol); 5) antihistamines (e.g., chlorpheniramine); 6) cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); 7) corticosteroids; 8) gastrointestinal agents (e.g., antacids); 9) hypoglycemics; 10) sedatives and tranquilizers (e.g., diazepam).
Use with Other Drugs In a study (n=24) where terazosin and verapamil were administered concomitantly,
In a study (n=6) where terazosin and captopril were administered concomitantly, plasma disposition of captopril was not influenced by
Terazosin, administered in the feed to
This dose is 175 times the maximum
Terazosin was not oncogenic in mice when administered in feed for 2 years at a maximum tolerated dose of 32 mg/kg/day (110 mg/M2; 9 times the maximum
The effect of terazosin on fertility was assessed in a standard fertility/reproductive performance study in which male and female
Four of 20 male
Testicular weights and morphology were unaffected by treatment.
Oral administration of terazosin for one or two years elicited a statistically significant
This lesion has also been seen with prazosin, another selective alpha-1
Pregnancy Teratogenic Effects Pregnancy Category C Terazosin was not teratogenic in either
Fetal resorptions occurred in
These findings (in both species) were most likely secondary to maternal toxicity.
Nonteratogenic Effects In a peri - and post-natal development study in
Nursing Mothers It is not known whether terazosin is excreted in breast milk.
Because many drugs are excreted in breast milk,
The incidence rates presented below are based on combined data from six placebo-controlled trials involving once a day administration of terazosin at doses ranging from 1 mg to 20 mg.
Table 1 summarizes
Asthenia, postural hypotension, dizziness, somnolence, nasal
The incidence of urinary tract
An analysis of the incidence rate of hypotensive
Asthenia 7.4 % p?
0.05 comparison between groups.
3.3 % Flu Syndrome 2.4 % 1.7 %
In the placebo-controlled clinical trials, the rates of
TABLE 2 DISCONTINUATION DURING
The prevalence rates presented below are based on combined data from fourteen placebo-controlled trials involving once a day administration of terazosin, as monotherapy or in combination with other antihypertensive agents, at doses ranging from 1 mg to 40 mg.
Table 3 summarizes
4.3 % Back
METABOLIC AND NUTRITIONAL
The following additional
Cardiovascular System: arrhythmia, vasodilation;
Digestive System: constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting; Metabolic/Nutritional
DISCONTINUATIONS DURING PLACEBO-CONTROLLED
TRIALS HYPERTENSION Body System Terazosin (N=859) Placebo (N=506) BODY AS A WHOLE Asthenia 1.6 % 0 %
There have been reports of priapism and thrombocytopenia during post-marketing surveillance.
Atrial fibrillation has been reported.
During cataract surgery, a variant of
DOSAGE AND ADMINISTRATION If
Doses of 10 mg once
Therefore, treatment with 10 mg for a minimum of 4 to
Although some additional patients responded at a 20 mg daily dose, there was an
When using terazosin capsules and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary (see PRECAUTIONS).
Hypotension has been reported when terazosin capsules have been used with phosphodiesterase-5 (PDE-5) inhibitors.
Hypertension The dose of terazosin capsules and the dose interval (12 or 24 hours) should be
The following is a guide to its administration: Initial Dose 1 mg at bedtime is the starting dose for all patients, and
Doses over 20 mg do not appear to provide further
Blood pressure should be monitored at the end of the dosing interval to be sure control is maintained throughout the interval.
It may also be
In clinical trials, except for the initial dose, the dose was given in the morning.
Use With Other Drugs (see above)
|Date Last Revised||12-10-2012|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Mylan Institutional Inc.|