Terazosin Hydrochloride Anhydrous
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Questions & Answers
Side Effects & Adverse Reactions
Terazosin hydrochloride capsules, like other alpha-adrenergic blocking agents, can cause marked lowering of blood pressure, especially postural hypotension, and syncope in association with the first dose or first few days of therapy. A similar effect can be anticipated if therapy is interrupted for several days and then restarted. Syncope has also been reported with other alpha-adrenergic blocking agents in association with rapid dosage increases or the introduction of another antihypertensive drug. Syncope is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe supraventricular tachycardia with heart rates of 120 to 160 beats per minute. Additionally, the possibility of the contribution of hemodilution to the symptoms of postural hypotension should be considered.
To decrease the likelihood of syncope or excessive hypotension, treatment should always be initiated with a 1 mg dose of terazosin, given at bedtime. The 2 mg, 5 mg and 10 mg capsules are not indicated as initial therapy. Dosage should then be increased slowly, according to recommendations in the Dosage and Administration section and additional antihypertensive agents should be added with caution. The patient should be cautioned to avoid situations, such as driving or hazardous tasks, where injury could result should syncope occur during initiation of therapy.
In early investigational studies, where increasing single doses up to 7.5 mg were given at 3 day intervals, tolerance to the first dose phenomenon did not necessarily develop and the "first-dose" effect could be observed at all doses. Syncopal episodes occurred in 3 of the 14 subjects given terazosin at doses of 2.5 mg, 5 mg and 7.5 mg, which are higher than the recommended initial dose; in addition, severe orthostatic hypotension (blood pressure falling to 50/0 mmHg) was seen in two others and dizziness, tachycardia, and lightheadedness occurred in most subjects. These adverse effects all occurred within 90 minutes of dosing.
In three placebo-controlled BPH studies 1, 2, and 3 (see CLINICAL PHARMACOLOGY), the incidence of postural hypotension in the terazosin treated patients was 5.1%, 5.2%, and 3.7% respectively.
In multiple dose clinical trials involving nearly 2,000 hypertensive patients treated with terazosin, syncope was reported in about 1% of patients. Syncope was not necessarily associated only with the first dose.
If syncope occurs, the patient should be placed in a recumbent position and treated supportively as necessary. There is evidence that the orthostatic effect of terazosin is greater, even in chronic use, shortly after dosing. The risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals.
Rarely, (probably less than once in every several thousand patients) terazosin and other α1-antagonists have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation). Two or three dozen cases have been reported. Because this condition can lead to permanent impotence if not promptly treated, patients must be advised about the seriousness of the condition (see PRECAUTIONS: Information for Patients).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Terazosin hydrochloride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin hydrochloride. The long-term effects of terazosin hydrochloride on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.
Terazosin hydrochloride is also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.
History
There is currently no drug history available for this drug.
Other Information
Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following structural formula, molecular formula and chemical name:
Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, anhydrous.
Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.9. Each terazosin hydrochloride capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride anhydrous. Each capsule contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D&C Red No. 28, D&C Red No. 33, FD&C Blue No. 1, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, silicon dioxide and titanium dioxide. In addition, the 1 mg capsule contains yellow iron oxide; the 2 mg and 5 mg capsules contain black iron oxide. The black imprinting ink for the 1 mg, 5 mg and 10 mg capsules contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. The white imprinting ink for the 2 mg capsules contain the following ammonium hydroxide, propylene glycol, simethicone and titanium dioxide.
Sources
Terazosin Hydrochloride Anhydrous Manufacturers
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Udl Laboratories, Inc.
![Terazosin Hydrochloride Anhydrous Capsule [Udl Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Terazosin Hydrochloride Anhydrous | Udl Laboratories, Inc.
If terazosin hydrochloride administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen.
Benign Prostatic Hyperplasia Initial Dose1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response.
Subsequent DosesThe dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4 to 6 weeks may be required to assess whether a beneficial response has been achieved. Some patients may not achieve a clinical response despite appropriate titration. Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose. There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20 mg daily. If terazosin hydrochloride administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.
Use With Other DrugsCaution should be observed when terazosin hydrochloride is administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension. When using terazosin hydrochloride and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary (see PRECAUTIONS). Hypotension has been reported when terazosin has been used with phosphodiesterase-5 (PDE-5) inhibitors.
HypertensionThe dose of terazosin hydrochloride and the dose interval (12 or 24 hours) should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration:
Initial Dose1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects.
Subsequent DosesThe dose may be slowly increased to achieve the desired blood pressure response. The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day. Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied. 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 helpful to measure blood pressure 2 to 3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response. If response is substantially diminished at 24 hours an increased dose or use of a twice daily regimen can be considered. If terazosin hydrochloride administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. In clinical trials, except for the initial dose, the dose was given in the morning.
Use With Other Drugs(see above)
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Pd-rx Pharmaceuticals, Inc.
Terazosin Hydrochloride Anhydrous | Pd-rx Pharmaceuticals, Inc.
If terazosin capsule administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen.
Benign Prostatic Hyperplasia Initial Dose1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response.
Subsequent DosesThe dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4 to 6 weeks may be required to assess whether a beneficial response has been achieved. Some patients may not achieve a clinical response despite appropriate titration. Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose. There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20 mg daily. If terazosin capsule administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.
Use With Other DrugsCaution should be observed when terazosin capsules are administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension. 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.
HypertensionThe dose of terazosin capsules and the dose interval (12 or 24 hours) should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration:
Initial Dose1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects.
Subsequent DosesThe dose may be slowly increased to achieve the desired blood pressure response. The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day. Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied. 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 helpful to measure blood pressure 2 to 3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response. If response is substantially diminished at 24 hours an increased dose or use of a twice daily regimen can be considered. If terazosin capsule administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. In clinical trials, except for the initial dose, the dose was given in the morning.
Use With Other Drugs(see above)
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Cardinal Health
Terazosin Hydrochloride Anhydrous | Cardinal Health
If terazosin hydrochloride administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen.
Benign Prostatic Hyperplasia Initial Dose1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response.
Subsequent DosesThe dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4 to 6 weeks may be required to assess whether a beneficial response has been achieved. Some patients may not achieve a clinical response despite appropriate titration. Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose. There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20 mg daily. If terazosin hydrochloride administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.
Use With Other DrugsCaution should be observed when terazosin hydrochloride is administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension. When using terazosin hydrochloride and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary (see PRECAUTIONS). Hypotension has been reported when terazosin has been used with phosphodiesterase-5 (PDE-5) inhibitors.
HypertensionThe dose of terazosin hydrochloride and the dose interval (12 or 24 hours) should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration:
Initial Dose1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects.
Subsequent DosesThe dose may be slowly increased to achieve the desired blood pressure response. The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day. Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied. 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 helpful to measure blood pressure 2 to 3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response. If response is substantially diminished at 24 hours an increased dose or use of a twice daily regimen can be considered. If terazosin hydrochloride administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. In clinical trials, except for the initial dose, the dose was given in the morning.
Use With Other Drugs(see above)
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Mylan Pharmaceuticals Inc.
Terazosin Hydrochloride Anhydrous | Glaxosmithkline Llc
2.1 Patient SelectionConfirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR as a single agent [see Warnings and Precautions (5.2)]. Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR in combination with trametinib. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.
2.2 Recommended DosingThe recommended dosage regimens of TAFINLAR are:
• 150 mg orally taken twice daily, approximately 12 hours apart, as a single agent • 150 mg orally taken twice daily, approximately 12 hours apart, in combination with trametinib 2 mg orally taken once dailyContinue treatment until disease progression or unacceptable toxicity occurs. Take TAFINLAR as a single agent, or TAFINLAR in combination with trametinib, at least 1 hour before or 2 hours after a meal[see Clinical Pharmacology (12.3)]. Do not take a missed dose of TAFINLAR within 6 hours of the next dose of TAFINLAR. Do not open, crush, or break TAFINLAR capsule.
When administered in combination with trametinib, take the once-daily dose of trametinib at the same time each day with either the morning dose or the evening dose of TAFINLAR.
2.3 Dose ModificationsFor New Primary Cutaneous Malignancies: No dose modifications are required.
For New Primary Non-Cutaneous Malignancies: Permanently discontinue TAFINLAR in patients who develop RAS mutation-positive non-cutaneous malignancies. If used in combination with trametinib, no dose modifications are required for trametinib in patients who develop non-cutaneous malignancies.
Table 1. Recommended Dose Reductions Dose Reductions for TAFINLAR When Administered as a Single Agent or in Combination With Trametinib First Dose Reduction 100 mg orally twice daily Second Dose Reduction 75 mg orally twice daily Third Dose Reduction 50 mg orally twice daily Subsequent Modification Permanently discontinue TAFINLAR if unable to tolerate 50 mg orally twice daily Dose Reductions for Trametinib When Administered in Combination With TAFINLAR First Dose Reduction 1.5 mg orally once daily Second Dose Reduction 1 mg orally once daily Subsequent Modification Permanently discontinue if unable to tolerate trametinib 1 mg orally once daily Table 2. Recommended Dose Modifications for TAFINLAR as a Single Agent and for TAFINLAR and Trametinib Administered in CombinationSeverity of Adverse
Reactiona
TAFINLARb
Trametinib
(When Used in Combination)b,c
Febrile drug reaction
• Fever of 101.3°F to 104°FWithhold TAFINLAR until fever resolves. Then resume at same or lower dose level.
Do not modify the dose of trametinib.
• Fever higher than 104°F • Fever complicated by rigors, hypotension, dehydration, or renal failure • Withhold TAFINLAR until fever resolves. Then resume at a lower dose level.Or
• Permanently discontinue TAFINLAR.Withhold trametinib until fever resolves. Then resume trametinib at same or lower dose level.
Cutaneous
• Intolerable Grade 2 skin toxicity • Grade 3 or 4 skin toxicityWithhold TAFINLAR for up to 3 weeks.
• If improved, resume at a lower dose level. • If not improved, permanently discontinue.Withhold trametinib for up to 3 weeks.
• If improved, resume at a lower dose level. • If not improved, permanently discontinue.Cardiac
• Asymptomatic, absolute decrease in LVEF of 10% or greater from baseline and is below institutional lower limits of normal (LLN) from pretreatment valueDo not modify the dose of TAFINLAR.
Withhold trametinib for up to 4 weeks.
• If improved to normal LVEF value, resume at a lower dose level. • If not improved to normal LVEF value, permanently discontinue. • Symptomatic congestive heart failure • Absolute decrease in LVEF of greater than 20% from baseline that is below LLNWithhold TAFINLAR, if improved, then resume at the same dose.
Permanently discontinue trametinib.
Venous Thromboembolism
• Uncomplicated DVT or PEDo not modify the dose of TAFINLAR.
Withhold trametinib for up to 3 weeks.
• If improved to Grade 0-1, resume at a lower dose level. • If not improved, permanently discontinue. • Life Threatening PEPermanently discontinue TAFINLAR.
Permanently discontinue trametinib.
Ocular Toxicities
• Grade 2-3 retinal pigment epithelial detachments (RPED)Do not modify the dose of TAFINLAR.
Withhold trametinib for up to 3 weeks.
• If improved to Grade 0-1, resume at a lower dose level. • If not improved, permanently discontinue. • Retinal vein occlusionDo not modify the dose of TAFINLAR.
Permanently discontinue trametinib.
• Uveitis and IritisWithhold TAFINLAR for up to 6 weeks.
• If improved to Grade 0-1, then resume at the same dose. • If not improved, permanently discontinue.Do not modify the dose of trametinib.
Pulmonary
• Interstitial lung disease/pneumonitisDo not modify the dose of TAFINLAR.
Permanently discontinue trametinib.
Other
• Intolerable Grade 2 adverse reactions • Any Grade 3 adverse reactionWithhold TAFINLAR.
• If improved to Grade 0-1, resume at a lower dose level. • If not improved, permanently discontinue.Withhold trametinib for up to 3 weeks.
• If improved to Grade 0-1, resume at a lower dose level. • If not improved, permanently discontinue. • First occurrence of any Grade 4 adverse reaction • Withhold TAFINLAR until adverse reaction improves to Grade 0-1. Then resume at a lower dose level.Or
• Permanently discontinue TAFINLAR. • Withhold trametinib until adverse reaction improves to Grade 0-1. Then resume at a lower dose level.Or
• Permanently discontinue trametinib. • Recurrent Grade 4 adverse reactionPermanently discontinue TAFINLAR.
Permanently discontinue trametinib.
aNational Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
bSee Table 1 for recommended dose reductions of TAFINLAR and trametinib.
cRefer to Full Prescribing Information for trametinib.
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