TEZRULY Terazosin 1 mg/mL Solution, 150 mL — NDC 70954-592-10 (Billing 70954-0592-10)
This is a package of 150 mL of TEZRULY Terazosin 1 mg/mL Solution from ANI Pharmaceuticals, Inc., marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 70954-592-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 70954 labeler · 592 product · 10 package
- Package marketed since
- Apr 18, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 150 mL per package
- Barcode (UPC)
- 0370954592105
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 086374
- GCN: 56081
- GPI-14 (Medi-Span): 36202040102020
- HICL (First Databank): 000094
- AHFS class code: 24:16.00.00
- RxCUI (RxNorm): 2689133
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the alpha-Adrenergic Blocker class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Terazosin is used to: treat benign prostatic hyperplasia (BPH; enlarged prostate that can cause difficulty urinating, painful urination or increased urinary frequency or urgency). treat high blood pressure. Terazosin is in a class of medications called alpha-blockers. It relieves the symptoms of BPH by relaxing the muscles of the bladder and prostate. It lowers blood pressure by relaxing the blood vessels so that blood can flow more easily through the body. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys and oth...
Read the full MedlinePlus article ↗- It treats symptoms of an enlarged prostate (BPH) and high blood pressure. Your prescriber will tell you which one you are taking it for.
- The first dose can drop your blood pressure and cause dizziness or fainting. Taking it at bedtime lowers the chance of an injury. Avoid driving or hazardous tasks for 12 hours afte...
- Why do I take the first dose at bedtime?
- Do not just jump back to your usual dose. After more than a few days off, the label says to restart with the starting regimen. Call your prescriber or me for guidance.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Terazosin — tap one for details:
Terazosin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70954-0592-10 You're viewing this Main listing | 150 mL in 1 BOTTLE | 2025-04-18 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tezruly 1 mg/mLthis 70954-0592-10 | ANI | 150 ml | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 12427108 ↗ | Method of use | U-3990 | Feb 1, 2041 |
| US 12427108 ↗ | Method of use | U-3991 | Feb 1, 2041 |
| US 11224572 ↗ | Method of use | U-3990 | Feb 1, 2041 |
| US 11224572 ↗ | Method of use | U-3991 | Feb 1, 2041 |
Is there a generic version of TEZRULY 1 MG/ML SOLUTION?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from ANI Pharmaceuticals, Inc. labeler code 70954
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- Estradiol 2 mg Tablet NDC 70954-566-10
- Prucalopride 1 mg Tablet NDC 70954-596-10
- Prucalopride 2 mg Tablet NDC 70954-597-10
- Fluoxetine Hydrochloride 20 mg/5mL Solution NDC 70954-600-10
- Indomethacin 25 mg/5mL Suspension NDC 70954-637-10
- Estradiol .75 mg/1.25g Gel, Metered NDC 70954-646-10
- Ketoconazole 20 mg/mL Shampoo NDC 70954-662-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE TEZRULY TM (terazosin) is an alpha-1 adrenoceptor antagonist indicated for: The treatment of signs and symptoms of benign prostatic hyperplasia (BPH) (1.1) The treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. (1.2)
1.1Benign Prostatic Hyperplasia TEZRULY is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult males [see Clinical Studies (14.1)] .
1.2Hypertension TEZRULY is indicated for the treatment of hypertension, to lower blood pressure in adults [see Clinical Studies (14.2)] . Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. TEZRULY may be used alone or in combination with other antihypertensive agents.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION For the treatment of BPH: Initiate therapy at 1 mg orally once daily at bedtime. Titrate the dose upwards step-wise from 2 mg to 10 mg once daily. Doses of 10 mg once daily are generally required for a clinical response.
Data is insufficient to support doses greater than 20 mg once daily. (2.1) For the treatment hypertension: Initiate therapy at 1 mg orally once daily at bedtime. Usual recommended dose range is 1 mg to 5 mg once daily.
If response is substantially diminished at 24 hours, increase the dose or use twice daily. Dose may be titrated as needed up to 20 mg once daily. (2.2) If terazosin is discontinued for more than a few days, restart using the initial dosing regimen.
(2.1)
2.1Recommended Dosage for Benign Prostatic Hyperplasia Initial Dose: 1 mg orally once daily at bedtime. This dose should not be exceeded as an initial dose. Closely follow patients during initial administration in order to minimize the risk of severe hypotensive response, including syncope.
For administration instructions, see Dosage and Administration (2.3). Subsequent Doses: The dose should be increased in a stepwise fashion from 2 mg to 10 mg orally once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for a clinical response.
Therefore, treatment with 10 mg for a minimum of 4 weeks to 6 weeks may be required to assess whether a beneficial response has been achieved. Although some patients responded to 20 mg per daily, data are insufficient to draw definitive conclusions about this dose. There are insufficient data to support the use of doses higher than 20 mg daily.
If TEZRULY is discontinued for more than a few days, therapy should be restarted using the initial dosing regimen. For administration instructions, see Dosage and Administration (2.3).
2.2Recommended Dosage for Hypertension Initial Dose: 1 mg orally once daily at bedtime. Do not exceed the initial dosing regimen to minimize the potential for severe hypotensive effects, including syncope. For administration instructions, see Dosage and Administration (2.3).
Subsequent Doses: Slowly increase the dose to achieve the desired blood pressure response. The usual recommended dose range is 1 mg to 5 mg orally once daily; 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 ensure control throughout the dosing interval. It may also be helpful to measure blood pressure 2 hours 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, consider increasing the dose or use a twice daily dosing regimen.
In clinical trials, except for the initial dose, the dose was given in the morning. If TEZRULY is discontinued for more than a few days, therapy should be restarted using the initial dosing regimen. For administration instructions, see Dosage and Administration (2.3).
TEZRULY may be used alone or in combination with other antihypertensive agents. Adjust the dose of TEZRULY and the dose frequency (every 12 hours or 24 hours) based on the patient’s individual blood pressure response.
2.3Administration Information Take TEZRULY orally with or without food. A calibrated measuring device, such as an oral syringe or oral dosing cup, is recommended to measure and deliver the prescribed dose accurately. A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Oral solution: 1 mg/mL terazosin, clear, cherry flavored solution, free from visible particulate matter. Oral solution: 1 mg/mL of terazosin (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS TEZRULY is contraindicated in patients known to be hypersensitive to terazosin or any component of TEZRULY. Hypersensitivity to terazosin hydrochloride or any other ingredient in TEZRULY. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Syncope and “First-dose” Effect: Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur, especially when starting TEZRULY. (5.1) Orthostatic Hypotension: Dizziness, lightheadedness, and palpitations can occur with use of TEZRULY. Advise patients to take their first dose of TEZRULY at bedtime 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.
(5.2) Risk of Hypotension with Concomitant Use of Other Antihypertensive Agents and Phospodiesterase Type 5 Inhibitors (PDE5-I): Concomitant administration of TEZRULY with antihypertensives or phosphodiesterase-5 (PDE-5) inhibitors can result in additive blood pressure lowering effects and symptomatic hypotension (5.3). Priapism: Advise patients about the possibility and seriousness of priapism. (5.4) Intraoperative Floppy Iris Syndrome: Advise patients considering cataract surgery to tell their ophthalmologist that they have taken terazosin as Intraoperative Floppy Iris Syndrome as been observed during cataract surgery in some patients.
(5.5) Prostatic Cancer: Screen for the presence of prostatic cancer prior to treatment for BPH and at regular intervals afterwards. (5.6)
5.1Syncope and ‘‘First-dose’’ Effect TEZRULY, like other alpha-1-adrenoceptors antagonists, can cause marked lowering of blood pressure, especially postural hypotension, and syncope in association with the first dose or first few days of therapy [see Warnings and Precautions (5.2)] . A similar effect can be anticipated if therapy is interrupted for several days and then restarted. Syncope has also been reported with other alpha-1-adrenoceptors antagonists 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 120-160 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, initiate treatment with a 1 mg dose of terazosin, given at bedtime.
Higher doses (e.g., 2 to 10 mg) are not indicated as initial therapy. Then slowly increase the dose [see Dosage and Administration (2.1 and 2.2)] , and add additional antihypertensive agents with caution. Advise patients 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, 5 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 (1 2 )] , 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 2000 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, place the patient in a recumbent position and treat supportively as necessary. There is evidence that the orthostatic effect of terazosin is greater, even in chronic use, s… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Syncope and ‘‘First-dose’’ Effect [see Warnings and Precautions (5.1)] Orthostatic Hypotension [see Warnings and Precautions (5.2)] Priapism [see Warnings and Precautions (5.3)] Intraoperative Floppy Iris Syndrome [see Warnings and Precautions (5.5)] In treatment of BPH, the most common adverse reactions (≥1% of patients and at a higher incidence than placebo) were asthenia, flu syndrome, postural hypotension, nausea, somnolence, vertigo, dyspnea, nasal congestion/rhinitis, blurred vision/amblyopia and erectile dysfunction.
(6.1) In treatment of hypertension, the most common adverse reactions where the incidence on terazosin was ≥ 5%, where the incidence on terazosin was at least 2% and greater than placebo or where the reaction was of particular interest were asthenia, back pain, pain in the extremities, headache, palpitations, postural hypotension, tachycardia, nausea, edema, peripheral edema, weight gain, depression, dizziness, libido, decreased, nervousness, paresthesia, somnolence, dyspnea, nasal congestion, sinusitis, blurred vision, and erectile dysfunction.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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 [see Warnings and Precautions (5.1, 5.2)] adjusted for the length of drug treatment has shown that the risk of the reactions is greatest during the initial seven days of treatment but continues at all time intervals.
Table 1. Adverse Reactions Reported During Placebo-Controlled Studies of Terazosin in Patients with Benign Prostatic Hyperplasia Body System Terazosin (N=636) % Placebo (N=360) % BODY AS A WHOLE †Asthenia 7* 3 Flu Syndrome 2 2 Headache 5 6 CARDIOVASCULAR SYSTEM Hypotension 1 1 Palpitations 1 1 Postural Hypotension 4* 1 Syncope 1 0 DIGESTIVE SYSTEM Nausea 2 1 METABOLIC AND NUTRITIONAL DISORDERS Peripheral Edema 1 0 Weight Gain 1 0 NERVOUS SYSTEM Dizziness 9* 4 Somnolence 4 2 Vertigo 1 0 RESPIRATORY SYSTEM Dyspnea 2 1 Nasal Congestion/Rhinitis 2* 0 UROGENITAL SYSTEM Erectile Dysfunction 2* 1 Urinary Tract Infection 1 4* † Includes weakness, tiredness, lassitude and fatigue. * p ≤ 0.05, comparison between groups.
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 rea… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Co-administration of verapamil with terazosin increases the systemic exposure of terazosin [see Clinical Pharmacology (12.3)] , which may increase the risk of hypotenstion. To reduce the risk of hypotension, dosage reduction and re-titration of either agent may be necessary [see Warnings and Precautions (5.3)] . Co-administration of verapamil with terazosin increases the systemic exposure of terazosin and may lead to hypotension.
Dosage reduction and re-titration of either agent may be necessary. (7)
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary The limited available data on terazosin use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed when terazosin was orally administered to pregnant rats and rabbits during the period of organogenesis at doses of up to 230 and 60 times, respectively, the maximum recommended human dose on a body surface area (mg/m 2 ) basis.
In the rat and rabbit oral doses at 230 and 60 times, respectively, the maximum recommended human dose on a body surface area basis, reduced fetal survival was observed [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Studies in rats and rabbits at oral doses up to 230 and 60 times, respectively, the maximum recommended human dose on a body surface area (mg/m 2 ) basis, have revealed no evidence of adverse developmental effects. In rats, fetal resorptions were observed at 480 mg/kg/day, approximately 230 times the maximum recommended human dose on a body surface area basis. In rabbits,. increased fetal resorptions, decreased fetal weight and an increased number of supernumerary ribs were observed at 60 mg/kg/day, 60 times the maximum recommended human dose on a body surface area basis.
These findings (in both species) were most likely secondary to maternal toxicity. In a peri- and post-natal development study in rats, significantly more pups died at 120 mg/kg/day (60 times the maximum recommended human dose on a body surface area basis) than in the control group during the three-week postpartum period.
8.2Lactation Risk Summary There are no available data on the presence of terazosin in human milk, effects on the breastfed infant, or the effects on milk production.
8.3Females and Males of Reproductive Potential Infertility Males Possible effects on male fertility could be observed based on findings in rats at exposures that were at least 15 times higher than at the maximum recommended human dose on a body surface area basis. The clinical relevance of this finding is unknown [see Nonclincal Toxicology (13.1)] .
8.4Pediatric Use The safety and effectiveness of terazosin have not been established in pediatric patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited available data on terazosin use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed when terazosin was orally administered to pregnant rats and rabbits during the period of organogenesis at doses of up to 230 and 60 times, respectively, the maximum recommended human dose on a body surface area (mg/m 2 ) basis.
In the rat and rabbit oral doses at 230 and 60 times, respectively, the maximum recommended human dose on a body surface area basis, reduced fetal survival was observed [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Studies in rats and rabbits at oral doses up to 230 and 60 times, respectively, the maximum recommended human dose on a body surface area (mg/m 2 ) basis, have revealed no evidence of adverse developmental effects. In rats, fetal resorptions were observed at 480 mg/kg/day, approximately 230 times the maximum recommended human dose on a body surface area basis. In rabbits,. increased fetal resorptions, decreased fetal weight and an increased number of supernumerary ribs were observed at 60 mg/kg/day, 60 times the maximum recommended human dose on a body surface area basis.
These findings (in both species) were most likely secondary to maternal toxicity. In a peri- and post-natal development study in rats, significantly more pups died at 120 mg/kg/day (60 times the maximum recommended human dose on a body surface area basis) than in the control group during the three-week postpartum period.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of terazosin have not been established in pediatric patients.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Benign Prostatic Hyperplasia The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate.
The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck. The degree of tone in this area is mediated by the alpha-1-adrenoceptors, which is reent in high density in the prostate stroma, prostatic capsule, prostatic urethra, and bladder neck. Blockade of the alpha-1 receptor decreases urethral resistance and may relieve the obstruction of BPH symptoms and improve urine flow Hypertension The mechanism of action of terazosin is selective blockade of the alpha-1 subtype of adrenergic receptors.
The antihypertensive effect of terazosin results from a decrease in systemic vascular resistance. In animals, terazosin causes a decrease in blood pressure by decreasing total peripheral vascular resistance. The vasodilatory hypotensive action of terazosin appears to be produced mainly by antagonism of alpha-1 adrenoceptors.
Terazosin decreases blood pressure within 15 minutes following oral administration.
12.2Pharmacodynamics Benign Prostatic Hyperplasia (BPH) Administration of terazosin 10 mg to patients with BPH resulted in significant improvement in both symptoms and peak urinary flow rate compared to placebo [see Clinical Studies (14.1)] . Terazosin administration to normotensive men with BPH did not result in a clinically significant blood pressure lowering effect [see Clinical Studies (14.1)] . Hypertension Terazosin’s antihypertensive effects usually persist throughout the dosing interval (usually 24 hours), with the supine systolic and diastolic responses 5 to 10 mmHg and 3.5 to 8 mmHg greater, respectively than placebo.
Limited data show that the peak blood pressure response measured 2 to 3 hours post-dose is greater than about twice the trough (24 hour) response during chronic administration [see Clinical Studies (14.2)] .
12.3Pharmacokinetics Absorption Following a single oral dose administration of TEZRULY in healthy subjects under fasted conditions, the median (range) time to reach peak plasma terazosin levels was 0.67 (0.50 - 1.75) hours. Mean (standard deviation) terazosin C max and AUC 0-∞ were 27.09 (7.85) ng/mL and 285.62 (74.77) h*ng/mL, respectively. Effect of Food No clinically significant differences in TERZULY pharmacokinetics were observed following administration of a high-fat, high calorie meal [995.5 Kcalories; 38.31 g protein, 80.75 g carbohydrate, and 57.7 g fat].
Distribution Terazosin is 90 to 94% bound to plasma proteins and binding is constant over the clinically observed concentration range. Elimination Terazosin has a half-life of approximately 13 hours. Metabolism Terazosin has been shown to undergo minimal hepatic first-pass metabolism and nearly all of the circulating dose is in the form of parent drug.
Elimination Approximately 10% of an orally administered dose is excreted as parent drug in the urine and approximately 20% is excreted in the feces. The remainder is eliminated as metabolites. Overall, approximately 40% of the administered dose is excreted in the urine and approximately 60% in the feces.
Specific Populations Geriatric Patients In a study that evaluated the effect of age on terazosin pharmacokinetics, the mean plasma half-lives were 14.0 and 11.4 hours for the age group ≥ 70 years and the age group of 20-39 years, respectively. After oral administration, the plasma clearance decreased by 31.7% in patients ≥ 70 years of age compared to patients 20-39 years of age. Patients with Renal Impairment Impaired renal funct… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Benign Prostatic Hyperplasia The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate.
The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck. The degree of tone in this area is mediated by the alpha-1-adrenoceptors, which is reent in high density in the prostate stroma, prostatic capsule, prostatic urethra, and bladder neck. Blockade of the alpha-1 receptor decreases urethral resistance and may relieve the obstruction of BPH symptoms and improve urine flow Hypertension The mechanism of action of terazosin is selective blockade of the alpha-1 subtype of adrenergic receptors.
The antihypertensive effect of terazosin results from a decrease in systemic vascular resistance. In animals, terazosin causes a decrease in blood pressure by decreasing total peripheral vascular resistance. The vasodilatory hypotensive action of terazosin appears to be produced mainly by antagonism of alpha-1 adrenoceptors.
Terazosin decreases blood pressure within 15 minutes following oral administration.
📦 How Supplied / Storage and Handling ▾
16 HOW 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.
📋 Description ▾
11 DESCRIPTION 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 19 H 25 N 5 O 4 . HCl.
2H 2 O and the molecular weight is 459.92. 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. structure
💬 Information for Patients ▾
17 PATIENT 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 [see Warnings and Precautions (5.1, 5.2)].
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) [ see Warnings and Precautions (5.3) ] .
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 [ see Warnings and Precautions (5.4) ] . Intraoperative Floppy Iris Syndrome Advise the patient when considering cataract surgery to tell their ophthalmologist that they have taken TEZRULY [ see Warnings and Precautions (5.5) ] .
Trademarks are the property of their respective owners. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 07/2024 LB4752-01 TEZRULY TM is a pending trademark of ANI Pharmaceuticals, Inc.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Following a single oral dose administration of TEZRULY in healthy subjects under fasted conditions, the median (range) time to reach peak plasma terazosin levels was 0.67 (0.50 - 1.75) hours. Mean (standard deviation) terazosin C max and AUC 0-∞ were 27.09 (7.85) ng/mL and 285.62 (74.77) h*ng/mL, respectively. Effect of Food No clinically significant differences in TERZULY pharmacokinetics were observed following administration of a high-fat, high calorie meal [995.5 Kcalories; 38.31 g protein, 80.75 g carbohydrate, and 57.7 g fat].
Distribution Terazosin is 90 to 94% bound to plasma proteins and binding is constant over the clinically observed concentration range. Elimination Terazosin has a half-life of approximately 13 hours. Metabolism Terazosin has been shown to undergo minimal hepatic first-pass metabolism and nearly all of the circulating dose is in the form of parent drug.
Elimination Approximately 10% of an orally administered dose is excreted as parent drug in the urine and approximately 20% is excreted in the feces. The remainder is eliminated as metabolites. Overall, approximately 40% of the administered dose is excreted in the urine and approximately 60% in the feces.
Specific Populations Geriatric Patients In a study that evaluated the effect of age on terazosin pharmacokinetics, the mean plasma half-lives were 14.0 and 11.4 hours for the age group ≥ 70 years and the age group of 20-39 years, respectively. After oral administration, the plasma clearance decreased by 31.7% in patients ≥ 70 years of age compared to patients 20-39 years of age. Patients with Renal Impairment Impaired renal function had no significant effect on the elimination of terazosin.
Dosage adjustment to compensate for the drug removal during hemodialysis (approximately 10%) does not appear to be necessary. Drug Interactions In a study (n=24) where terazosin and verapamil were co-administered, terazosin’s mean AUC 0-24 increased 11% after the first verapamil dose. After 3 weeks of verapamil treatment, terazosin’s mean AUC 0-24 increased by 24% with associated increases in C max (25%) and C min (32%) means and decrease in mean T max from 1.3 hours to 0.8 hours.
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.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Benign Prostatic Hyperplasia (BPH) Administration of terazosin 10 mg to patients with BPH resulted in significant improvement in both symptoms and peak urinary flow rate compared to placebo [see Clinical Studies (14.1)] . Terazosin administration to normotensive men with BPH did not result in a clinically significant blood pressure lowering effect [see Clinical Studies (14.1)] . Hypertension Terazosin’s antihypertensive effects usually persist throughout the dosing interval (usually 24 hours), with the supine systolic and diastolic responses 5 to 10 mmHg and 3.5 to 8 mmHg greater, respectively than placebo.
Limited data show that the peak blood pressure response measured 2 to 3 hours post-dose is greater than about twice the trough (24 hour) response during chronic administration [see Clinical Studies (14.2)] .
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Benign Prostatic Hyperplasia Terazosin has been studied in 1222 men with symptomatic BPH. In three placebo-controlled studies, symptom evaluation and uroflowmetric measurements were performed approximately 24 hours following dosing. Symptoms were quantified using the Boyarsky Index which evaluated both obstructive (hesitancy, intermittency, terminal dribbling, impairment of size and force of stream, sensation of incomplete bladder emptying) and irritative (nocturia, daytime frequency, urgency, dysuria) symptoms by rating each of the 9 symptoms from 0-3, for a total score of 27 points.
Results from these studies indicated that terazosin statistically significantly improved symptoms and peak urine flow rates over placebo (Table 6). Table 5. Symptom and Uroflowmetry Scores 24 Hours Following Terazosin Dosing in Three Placebo-Controlled Studies in BPH Symptom Score (Range 0-27) Peak Flow Rate (mL/sec) Mean Mean Mean Mean N Baseline Change (%) N Baseline Change (%) Study 1 (10 mg) a Titration to fixed dose (12 wk) Placebo 55 9.7 -2.3 (24) 54 10.1 +1.0 (10) Terazosin 54 10.1 -4.5 (45)* 52 8.8 +3.0 (34)* Study 2 (2, 5, 10, 20 mg) b Titration to response (24 wk) Placebo 89 12.5 -3.8 (30) 88 8.8 +1.4 (16) Terazosin 85 12.2 -5.3 (43)* 84 8.4 +2.9 (35)* Study 3 (1, 2, 5, 10 mg) c Titration to response (24 wk) Placebo 74 10.4 -1.1 (11) 74 8.8 +1.2 (14) Terazosin 73 10.9 -4.6 (42)* 73 8.6 +2.6 (30)* a Highest dose 10 mg shown. b 23% of patients on 10 mg, 41% of patients on 20 mg. c 67% of patients on 10 mg. * Significantly (p ≤ 0.05) more improvement than placebo.
In all three studies, both symptom scores and peak urine flow rates showed statistically significant improvement from baseline in patients treated with terazosin from week 2 (or the first clinic visit) and throughout the study duration. Analysis of the effect of terazosin on individual urinary symptoms demonstrated that terazosin significantly improved the symptoms of hesitancy, intermittency, impairment in size and force of urinary stream, sensation of incomplete emptying, terminal dribbling, daytime frequency and nocturia, compared to placebo.
Global assessments of overall urinary function and symptoms were also performed by investigators who were blinded to patient treatment assignment. In Studies 1 and 3, patients treated with terazosin had a significantly (p ≤ 0.001) greater overall improvement compared to placebo treated patients. In a short-term study (Study 1), patients were randomized to either 2, 5 or 10 mg of terazosin or placebo.
Patients randomized to the 10 mg group achieved a statistically significant response in both symptoms and peak flow rate compared to placebo (Figure 1). Figure 1 Study 1 Mean Change in Total Symptom Score from Baseline + Mean Increase in Peak Flow Rate (mL/sec) from Baseline + + for baseline values see above table; * p ≤ 0.05, compared to placebo group In a long-term, open-label, non-placebo controlled clinical trial, 181 men were followed for 2 years and 58 of these men were followed for 30 months. The effect of terazosin on urinary symptom scores and peak flow rates was maintained throughout the study duration (Figures 2 and 3): Figure 2 Mean Change in Total Symptom Score from Baseline Long-Term, Open-Label, Non-Placebo Controlled Study (N=494) *p ≤ 0.05 vs. baseline; mean baseline =
10.7Figure 3 Mean Change in Peak Flow Rate from Baseline Long-Term, Open-Label, Non-Placebo Controlled Study (N=494) * p ≤ 0.05 vs. baseline; mean baseline =
9.9In this long-term trial, both symptom scores and peak urinary flow rates showed statistically significant improvement suggesting a relaxation of smooth muscle cells. Although antagonism of alpha-1-adrenoceptors also lowers blood pressure in hypertensive patients with increased peripheral vascular resistance, terazosin treatment of normotensive men with BPH did not result in a clinically significant blood pressure lowering effect (Table 6). Table 6.
Mean Changes in Blood Pressu… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Terazosin, administered in the feed to rats at doses of 8, 40, and 250 mg/kg/day (48, 240, and 1500 mg/m 2 /day), for two years, was associated with a statistically significant increase in benign adrenal medullary tumors of male rats exposed to the 250 mg/kg dose. This dose is 120 times the maximum recommended human dose of 20 mg (12 mg/m 2 ) on a body surface area basis. Female rats were unaffected.
Terazosin was not oncogenic in mice when administered in feed for 2 years at a maximum tolerated dose of 32 mg/kg/day (96 mg/m 2 /day; 8 times the maximum recommended human dose on a body surface area basis). The absence of mutagenicity in a battery of tests, of tumorigenicity of any cell type in the mouse carcinogenicity assay, of increased total tumor incidence in either species, and of proliferative adrenal lesions in female rats, suggests a male rat species-specific event. Numerous other diverse pharmaceutical and chemical compounds have also been associated with benign adrenal medullary tumors in male rats without supporting evidence for carcinogenicity in man.
Mutagenesis Terazosin was devoid of mutagenic potential when evaluated in vivo and in vitro (the Ames test, in vivo cytogenetics, the dominant lethal test in mice, in vivo Chinese hamster chromosome aberration test and V79 forward mutation assay). Impairment of Fertility The effect of terazosin on fertility was assessed in a standard fertility/reproductive performance study in which male and female rats were administered oral doses of 8, 30 and 120 mg/kg/day. Four of 20 male rats given 30 mg/kg (180 mg/m 2 ; 15 times the maximum recommended human dose on a body surface area basis) and five of 19 male rats given 120 mg/kg (720 mg/m 2 ; 60 times the maximum recommended human dose on a body surface area basis) failed to sire a litter.
Testicular weights and morphology were unaffected by treatment. However, vaginal smears at 30 and 120 mg/kg/day appeared to contain less sperm than smears from control matings and good correlation was reported between sperm count and subsequent pregnancy.
13.2Animal Pharmacology & OR Toxicology Oral administration of terazosin for one or two years elicited a statistically significant increase in the incidence of testicular atrophy in rats exposed to 40 and 250 mg/kg/day (20 and 120 times the maximum recommended human dose on a body surface area basis), but not in rats exposed to 8 mg/kg/day (4 times the maximum recommended human dose on a body surface area basis). Testicular atrophy was also observed in dogs dosed with 300 mg/kg/day (> 490 times the maximum recommended human dose on a body surface area basis) for three months but not after one year when dosed with 20 mg/kg/day (30 times the maximum recommended human dose on a body surface area basis).
This finding has also been seen with prazosin, another alpha-1 adrenergic antagonist. The disposition of terazosin in animals is qualitatively similar to that in man. In animals, terazosin causes a decrease in blood pressure by decreasing total peripheral vascular resistance.
The vasodilatory hypotensive action of terazosin appears to be produced mainly by antagonism of alpha-1-adrenoceptors.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Terazosin, administered in the feed to rats at doses of 8, 40, and 250 mg/kg/day (48, 240, and 1500 mg/m 2 /day), for two years, was associated with a statistically significant increase in benign adrenal medullary tumors of male rats exposed to the 250 mg/kg dose. This dose is 120 times the maximum recommended human dose of 20 mg (12 mg/m 2 ) on a body surface area basis. Female rats were unaffected.
Terazosin was not oncogenic in mice when administered in feed for 2 years at a maximum tolerated dose of 32 mg/kg/day (96 mg/m 2 /day; 8 times the maximum recommended human dose on a body surface area basis). The absence of mutagenicity in a battery of tests, of tumorigenicity of any cell type in the mouse carcinogenicity assay, of increased total tumor incidence in either species, and of proliferative adrenal lesions in female rats, suggests a male rat species-specific event. Numerous other diverse pharmaceutical and chemical compounds have also been associated with benign adrenal medullary tumors in male rats without supporting evidence for carcinogenicity in man.
Mutagenesis Terazosin was devoid of mutagenic potential when evaluated in vivo and in vitro (the Ames test, in vivo cytogenetics, the dominant lethal test in mice, in vivo Chinese hamster chromosome aberration test and V79 forward mutation assay). Impairment of Fertility The effect of terazosin on fertility was assessed in a standard fertility/reproductive performance study in which male and female rats were administered oral doses of 8, 30 and 120 mg/kg/day. Four of 20 male rats given 30 mg/kg (180 mg/m 2 ; 15 times the maximum recommended human dose on a body surface area basis) and five of 19 male rats given 120 mg/kg (720 mg/m 2 ; 60 times the maximum recommended human dose on a body surface area basis) failed to sire a litter.
Testicular weights and morphology were unaffected by treatment. However, vaginal smears at 30 and 120 mg/kg/day appeared to contain less sperm than smears from control matings and good correlation was reported between sperm count and subsequent pregnancy.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL TEZRULY (terazosin) Oral Solution, 1 mg/mL NDC 70954-592-10 - 150 mL per bottle label
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