Brand Name
Tezruly
Generic Name
Terazosin
View Brand Information FDA approval date: March 30, 1998
Classification: alpha-Adrenergic Blocker
Form: Capsule, Solution
What is Tezruly (Terazosin)?
Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia . 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 capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.
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Brand Information
TEZRULY (Terazosin)
1DOSAGE FORMS & STRENGTHS
Oral solution: 1 mg/mL terazosin, clear, cherry flavored solution, free from visible particulate matter.
2CONTRAINDICATIONS
TEZRULY is contraindicated in patients known to be hypersensitive to terazosin or any component of TEZRULY.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Syncope and ‘‘First-dose’’ Effect
- Orthostatic Hypotension
- Priapism
- Intraoperative Floppy Iris Syndrome
3.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Benign Prostatic Hyperplasia
The incidence rates presented below are based on combined data from six placebo-controlled trials involving once-daily administration of terazosin at doses ranging from 1 to 20 mg. Table 1 summarizes those adverse events reported for patients in these trials when the incidence rate in the terazosin group was at least 1% and was greater than that for the placebo group, or where the reaction is of clinical interest.
Asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence were the only events that were significantly (p ≤ 0.05) more common in patients receiving terazosin than in patients receiving placebo. The incidence of urinary tract infection was significantly lower in the patients receiving terazosin than in patients receiving placebo. An analysis of the incidence rate of hypotensive adverse reactions
Additional adverse reactions have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to terazosin. The safety profile of patients treated in the long-term open-label study was similar to that observed in the controlled studies.
Adverse reactions were usually transient and mild or moderate in intensity, but sometimes were serious enough to interrupt treatment. In the placebo-controlled clinical trials, the rates of premature termination due to adverse reactions were not statistically different between the placebo and terazosin groups. Adverse reactions that were bothersome, reported as the reason for discontinuation of therapy by at least 0.5% of the terazosin group and reported more often than in the placebo group are shown in Table 2.
Hypertension
The prevalence rates presented below are based on combined data from fourteen placebo-controlled studies involving once-daily administration of terazosin, as monotherapy or in combination with other antihypertensive agents, at doses ranging from 1 to 40 mg. Table 3 summarizes those adverse reactions reported for patients in these trials where the prevalence rate in the terazosin group was at least 5%, where the prevalence rate for the terazosin group was at least 2% and was greater than the prevalence rate for the placebo group, or where the reaction is of particular interest. Asthenia, blurred vision, dizziness, nasal congestion, nausea, peripheral edema, palpitations and somnolence were the only symptoms that were significantly (p < 0.05) more common in patients receiving terazosin than in patients receiving placebo. Similar adverse reaction rates were observed in placebo-controlled monotherapy trials.
The following adverse reactions associated with the use of terazosin were identified in clinical studies (≥1%) or during post-approval use of terazosin. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Body as a Whole: edema, facial edema;
Cardiovascular System: chest pain, arrhythmia, vasodilation;
Digestive System: abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting;
Metabolic/Nutritional Disorders: gout;
Musculoskeletal System: arthralgia, arthritis, joint disorder, myalgia, neck pain, shoulder pain;
Nervous System: anxiety, insomnia, nervousness, depression;
Respiratory System: bronchitis, cold symptoms, epistaxis, increased cough, pharyngitis;
Skin and Appendages: pruritus, rash, sweating;
Special Senses: abnormal vision, conjunctivitis, tinnitus;
Urogenital System: urinary frequency, urinary incontinence primarily reported in postmenopausal women;
Adverse reactions were usually mild or moderate in intensity but sometimes were serious enough to interrupt treatment. The adverse reactions that were most bothersome, reported as reason for discontinuation therapy by at least 0.5% of the terazosin group and being reported more often than in the placebo group are shown in Table 4.
3.2Post-marketing Experience
The following adverse reactions have been identified during postapproval use of terazosin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System: thrombocytopenia
Cardiovascular System: atrial fibrillation
Skin and Appndages: allergic reactions, including anaphylaxis
Urogenital System: priapism
During cataract surgery, a variant of small pupil syndrome known as intraoperative floppy iris syndrome (IFIS) has been reported in association with alpha-1 antagonist therapy
4DRUG INTERACTIONS
Co-administration of verapamil with terazosin increases the systemic exposure of terazosin
5OVERDOSAGE
There is limited experience regarding overdosage with terazosin. Following a single oral dose of 300 mg (15 times the maximum recommended human dose of 20 mg), signs and symptoms of ovedosage included hypothermia, bradycardia and hypotension.
Management of overdose leading to hypotension should concentrate on support of the cardiovascular system. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Close medical supervision and monitoring should continue until the patient recovers. Dialysis is unlikely to be effective as terazosin is highly protein bound.
Consult the National Capital Poison Center (1-800-222-1222 or www.poison.org) for up-to-date guidance and advice regarding a TEZRULY overdosage.
6DESCRIPTION
TEZRULY (terazosin), an alpha-1-selective adrenoceptor antagonist, is a quinazoline derivative represented by the following chemical name and structural formula:
1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(tetrahydro-2-furoyl)piperazine monohydrochloride dihydrate
Terazosin hydrochloride is racemic and is a white to pale yellow crystalline substance, sparingly soluble in water. The molecular formula is C
TEZRULY (terazosin) oral solution is supplied in one dosage strength containing 1 mg/mL of terazosin (equivalent to 1.1 mg/mL of terazosin hydrochloride) and the following inactive ingredients: anhydrous citric acid, artificial cherry flavor, glycerin, methylparaben, propylparaben, purified water, sodium citrate dihydrate and sucralose.
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
TEZRULY 1 mg/mL oral solution is a clear, cherry flavored solution, free from visible particulate matter available in bottles of 150 mL with child resistant closure, NDC 70954-592-10.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Keep the container tightly closed.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Administration Instructions
Inform patients that a calibrated measuring device, such as an oral syringe or oral dosing cup, should be obtained from the pharmacy to measure and deliver the prescribed dose accurately. A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device.
Syncope and ‘‘First-dose’’ Effect and Orthostatic Hypotension
Inform patients about 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 more than a few days of 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 therapy, including driving, operating machinery and performing hazardous tasks. 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, advise patients to report these symptoms to their healthcare provider, so that dose adjustment can be considered. Inform patients that drowsiness or somnolence can occur with terazosin, requiring caution in people who must drive or operate heavy machinery
Risk of Hypotension when Tezruly is Taken Concomitantly with Other Antihypertensive Agents and/or Phosphodiesterase Type 5 Inhibitors (PDE5-I)
Advise patients that dosage reduction of their other antihypertensive agents and/or PDE5-I may be necessary to avoid the possibility of developing significant hypotension.
Priapism
Advise the patient about the possibility of priapism as a result of treatment with TEZRULY and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence)
Screening for Prostate Cancer
Advise patients that prostate cancer and BPH frequently present with many of the same symptoms and may co-exist; therefore, inform patients that they should have screening for the presence of prostate cancer prior to treatment with TEZRULY and at regular intervals afterwards
Intraoperative Floppy Iris Syndrome
Advise the patient when considering cataract surgery to tell their ophthalmologist that they have taken TEZRULY
Trademarks are the property of their respective owners.
Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
Issued: 07/2024
LB4752-01
TEZRULY
9PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration.
Issued: 07/2024
LB4752-01
10PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
TEZRULY (terazosin) Oral Solution, 1 mg/mL
NDC 70954-592-10 - 150 mL per bottle
