HomeNDC LookupIngredientsTerazosin › 23155-0738-01
terazosin 10 mg Capsule, 100-count — NDC 23155-0738-01 package photo

terazosin 10 mg Capsule, 100-count

by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · 100 CAPSULE in 1 BOTTLE (23155-738-01)
NDC 23155-0738-01
🏷️ FDA NDC (as labeled) 23155-738-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1346 NADAC Per package$13.46 / 100 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3932/unit · Part D plans $0.2378/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 23155-738-01
Product NDC 23155-738
11-digit billing NDC 23155073801
NCPDP billing unit EA — each (per item)
UNII D32S14F082
UPC 0323155737011, 0323155735017, 0323155738018, 0323155736014
Application # ANDA075614
SPL Set ID 1dabd4d6-3023-460a-8577-08b3690e7c93
Established class (EPC) alpha-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-30
Route ORAL
Dosage form CAPSULE
Substance TERAZOSIN HYDROCHLORIDE
GPI-14 36202040100120
GPI class Terazosin HCl
GCN Seq No 022652
GCN 47127
HICL code 000094
Ingredient (HICL) Terazosin Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7B
Therapeutic class — specific (HIC3) Alpha-Adrenergic Blocking Agents
AHFS code 24:16.00.00
AHFS class Alpha-Adrenergic Blocking Agents (24:16)
FDB label name TERAZOSIN 10 MG CAPSULE
FDB brand name Terazosin Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 23155-738-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 23155-0738-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker
Drug family (ATC) Alpha-adrenoreceptor antagonists
How it works Adrenergic alpha-Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application holderHERITAGE PHARMA LABS INC DBA AVET PHARMACEUTICALS LABS INC
FDA applicationANDA075614 (ANDA)
Labeler code23155
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio253 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TERAZOSIN 10 MG CAPSULE Ingredient Terazosin Hcl
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • It can actually be used for both. Terazosin relaxes smooth muscle in the prostate and bladder neck, which helps urine flow more easily if you have an enlarged prostate (BPH). That...
  • What exactly does terazosin do — is it for my prostate or my blood pressure?
  • The first dose — and doses after any break or increase — can cause a significant drop in blood pressure, especially when you stand up. That can make you dizzy or even faint. Taking...
  • Why do I have to take the first dose at bedtime? Can't I just take it in the morning?
📖 Read our full Terazosin guide →
1
Nutrient depletion considerations

Terazosin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White / Yellow / Orange / Blue
ShapeCapsule
Imprint738;10mg
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

15 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.135 $13.46 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.3932 $39.32 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.2378 $23.78 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.172 $0.128
▼ Down 14% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
terazosin 10 mgthis 23155-0738-01 Heritage 100 capsules $0.135 AB Availability likely
Terazosin 10 mg 27241-0291-01 Ajanta 100 capsules $0.135 AB Availability likely
Terazosin 10 mg 50268-0767-15 AvPAK 50 capsules $0.135 AB Availability likely
Terazosin 10 mg 59746-0386-06 Jubilant 100 capsules $0.135 AB Availability likely
Terazosin 10 mg 62135-0461-90 Chartwell 90 capsules $0.135 AB Availability likely
Terazosin 10 mg 69452-0333-20 Bionpharma 100 capsules $0.135 AB Availability likely
Terazosin 10 mg 42291-0823-10 AvKARE 1000 capsules AB FDA listed
Terazosin 10 mg 50090-2371-00 A-S 30 capsules AB Discontinued
Terazosin 10 mg 63187-0620-30 Proficient 30 capsules AB FDA listed
Terazosin 10 mg 63629-2439-01 Bryant 100 capsules AB FDA listed
Terazosin 10 mg 63629-5237-01 Bryant 30 capsules AB FDA listed
Terazosin Hydrochloride 10 mg 69292-0204-01 Amici 100 capsules AB FDA listed
Terazosin 10 mg 71335-3123-01 Bryant 30 capsules AB FDA listed
terazosin 10 mg 71335-9607-01 Bryant 30 capsules AB FDA listed
Terazosin Hydrochloride 10 mg 71610-0594-60 Aphena 90 capsules AB FDA listed
Terazosin 10 mg 71610-0780-60 Aphena 90 capsules AB FDA listed
Terazosin 10 mg 72162-1702-00 Bryant 1000 capsules AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 23155-0738-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
712
Units reimbursed last 4 qtrs
30.7K
Gross reimbursed last 4 qtrs
$12.1K
Avg / prescription
$16.97
Avg / unit
$0.3932
Latest quarter Q4 2025
66Rx
Medicaid pays / ea
$0.3932
gross reimbursed
vs
NADAC / ea
$0.1346
acquisition cost
=
Spread
+$0.2586
+192% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
46% FFS 54% MCO
Fee-for-service · 327 Rx Managed care · 385 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 1,865 units · 18.6 per 100k residents MI New York: 4,642 units · 23.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 450 units · 14.0 per 100k residents IA Illinois: 868 units · 6.9 per 100k residents IL Indiana: no data reported IN Ohio: 561 units · 4.8 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 1,350 units · 19.3 per 100k residents MA California: 7,411 units · 19.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 965 units · 15.6 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 870 units · 10.0 per 100k residents VA Maryland: no data reported MD Connecticut: 1,200 units · 33.2 per 100k residents CT Rhode Island: 526 units · 48.0 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,170 units · 25.6 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 401 units · 3.6 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 309 units · 1.0 per 100k residents TX Florida: 684 units · 3.0 per 100k residents FL
Units reimbursed · per 100k residents
1.048.0
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Rhode Island 48.0 /100k
2 Connecticut 33.2 /100k
3 Louisiana 25.6 /100k
4 New York 23.7 /100k
5 Massachusetts 19.3 /100k
6 California 19.0 /100k
7 Michigan 18.6 /100k
8 Missouri 15.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 712 Rx · 30,722 units · $12,080 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Terazosin — the ingredient across all brands.

Top reported reactions

Fatigue543
Dyspnoea502
Diarrhoea458
Dizziness457
Asthenia418
Death387
Acute Kidney Injury375

Age at onset

Neonate5
Infant1
Child1
Adolescent1
Adult341
Elderly959

Reporter sex

8,843 reports
Male · 85%
Female · 15%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 719 158
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
23155-0738-01 You're viewing this 100 CAPSULE in 1 BOTTLE (23155-738-01) $0.1346 / ea $13.46 2021-04-30 Active
23155-0738-10 1000 CAPSULE in 1 BOTTLE (23155-738-10) $0.1346 / ea $134.58 2021-04-30 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1346 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 23155-0738-01?
NDC 23155-0738-01 is a 100-count package — 100 capsule in 1 bottle.
What is the difference between NDC 23155-0738-01 and NDC 23155-0738-10?
Both are terazosin 10 mg Capsule — the drug itself is identical. NDC 23155-0738-01 is the 100-count package, while NDC 23155-0738-10 is the 1000 capsules package.
What NDC number is used to bill for this package of terazosin 10 mg Capsule?
Bill NDC 23155-0738-01 — the 11-digit billing format is 23155073801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 95 words

INDICATIONS AND USAGE Terazosin capsules are 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. The long term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.

Terazosin capsules are also indicated for the treatment of hypertension. They can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION If terazosin capsules administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen. Benign Prostatic Hyperplasia Initial Dose 1 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 Doses The 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 administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. Use With Other Drugs Caution 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 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 adjusted according to the patient's individual blood pressure response. The following is a guide to its administration: Initial Dose 1 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 Doses The 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 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).

Contraindications 14 words

CONTRAINDICATIONS Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.

⚠️ Warnings ~2 min read

WARNINGS Syncope and "First-dose" Effect Terazosin 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, 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 ), 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, 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. Priapism Rarely, (probably less than once in every several thousand patients), terazosin and other α 1 – 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 ).

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS Benign Prostatic Hyperplasia The incidence of treatment-emergent adverse events has been ascertained from clinical trials conducted worldwide. All adverse events reported during these trials were recorded as adverse reactions. 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 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 events (see PRECAUTIONS ) adjusted for the length of drug treatment has shown that the risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals. Additional adverse events 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.

The adverse events 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 events were not statistically different between the placebo and terazosin groups. The adverse events that were bothersome, as judged by their being reported as reasons for discontinuation of therapy by at least 0.5% of the terazosin group and being reported more often than in the placebo group, are shown in Table 2.

Hypertension The prevalence of adverse reactions has been ascertained from clinical trials conducted primarily in the United States. All adverse experiences (events) reported during these trials were recorded as adverse reactions. 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 to 40 mg.

Table 3 summarizes those adverse experiences 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. 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 following additional adverse reactions were reported by at least 1% of 1987 patients who received terazosin in controlled or open, short- or long-term clinical trials or have been reported during marketing experience: Body as a Whole Chest pain, facial edema, fever, abdominal pain, neck pain, shoulder pain Cardiovascular System Arrhythmia, vasodilation Digestive System Constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting Metabolic/Nutritional Disorders Gout Musculoskeletal System Arthralgia, arthritis, joint disord…

🔄 Drug Interactions 116 words

Drug Interactions In controlled trials, terazosin has been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. Terazosin has also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. 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).

🤰 Pregnancy 129 words

Pregnancy Teratogenic Effects: Pregnancy category C Terazosin was not teratogenic in either rats or rabbits when administered at oral doses up to 280 and 60 times, respectively, the maximum recommended human dose. Fetal resorptions occurred in rats dosed with 480 mg/kg/day, approximately 280 times the maximum recommended human dose. Increased fetal resorptions, decreased fetal weight and an increased number of supernumerary ribs were observed in offspring of rabbits dosed with 60 times the maximum recommended human dose.

These findings (in both species) were most likely secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women and the safety of terazosin in pregnancy has not been established. Terazosin is not recommended during pregnancy unless the potential benefit justifies the potential risk to the mother and fetus.

🧒 Pediatric Use 11 words

Pediatric Use Safety and effectiveness in children have not been determined.

🆘 Overdosage 85 words

OVERDOSAGE Should overdosage of terazosin lead to hypotension, support of the cardiovascular system is of first importance. 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. Laboratory data indicate that terazosin is 90 to 94% protein bound; therefore, dialysis may not be of benefit.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Pharmacodynamics A. Benign Prostatic Hyperplasia (BPH) The symptoms associated with BPH are related to bladder outlet obstruction, which is comprised of two underlying components: a static component and a dynamic component. The static component is a consequence of an increase in prostate size.

Over time, the prostate will continue to enlarge. However, clinical studies have demonstrated that the size of the prostate does not correlate with the severity of BPH symptoms or the degree of urinary obstruction. The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck, leading to constriction of the bladder outlet.

Smooth muscle tone is mediated by sympathetic nervous stimulation of alpha-1 adrenoceptors, which are abundant in the prostate, prostatic capsule and bladder neck. The reduction in symptoms and improvement in urine flow rates following administration of terazosin is related to relaxation of smooth muscle produced by blockade of alpha-1 adrenoceptors in the bladder neck and prostate. Because there are relatively few alpha-1 adrenoceptors in the bladder body, terazosin is able to reduce the bladder outlet obstruction without affecting bladder contractility.

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.

The questionnaire 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 to 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 as follows: 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 compared to placebo, 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. 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). 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): In this long-term trial, both symptom scores and peak urinary flow rates showed statistically significant improvement suggesting a relaxation of smooth muscle cells. Although blockade 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: B.

Hypertension 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 m…

📦 How Supplied / Storage and Handling ~1 min read

HOW SUPPLIED Terazosin Capsules, USP 1 mg, are available as size 3 white opaque cap and body hard gelatin capsules, imprinted with "735" on the cap and "1 mg" on the body in black ink, packaged in bottles of 100 and 1000 capsules, NDC # 23155-735-01 and NDC # 23155-735-10. Terazosin Capsules, USP 2 mg, are available as size 3 yellow opaque cap and white opaque body hard gelatin capsules, imprinted with "736" on the cap and "2 mg" on the body in black ink, packaged in bottles of 100 and 1000 capsules, NDC # 23155-736-01 and NDC # 23155-736-10.

Terazosin Capsules, USP 5 mg, are available as size 3 swedish orange opaque cap and white opaque body hard gelatin capsules, imprinted with "737" on the cap and "5 mg" on the body in black ink, packaged in bottles of 100 and 1000 capsules, NDC # 23155-737-01 and NDC # 23155-737-10. Terazosin Capsules, USP 10 mg, are available as size 3 aqua blue opaque cap and white opaque body hard gelatin capsules, imprinted with "738" on the cap and "10 mg" on the body in black, packaged in bottles of 100 and 1000 capsules, NDC # 23155-738-01 and NDC # 23155-738-10.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT AND MOISTURE Distributed by: Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 08/2021 Image

📋 Description 142 words

DESCRIPTION Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative. The chemical name for terazosin hydrochloride, USP is (RS)-Piperazine, 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. It has the following structural formula: Terazosin hydrochloride, USP is a white, crystalline substance, freely soluble in water and isotonic saline.

Each capsule for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg or 10 mg terazosin. In addition, each capsule contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, talc and corn starch. The capsule shells and imprinting inks contain: titanium dioxide, gelatin, shellac glaze, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, D&C Yellow #10 aluminum lake and FD&C Blue #1.

The 2 mg capsule shell also contains D&C Red #33. FDA approved dissolution test specifications differ from USP. Image

💬 Medication Guide ~3 min read

PATIENT INFORMATION ABOUT TERAZOSIN CAPSULES, USP (ter ay'zoe sin) Rx only When used to treat HYPERTENSION or BENIGN PROSTATIC HYPERPLASIA (BPH) Please read this leaflet before you start taking terazosin capsules. Also, read it each time you get a new prescription. This is a summary and should NOT take the place of a full discussion with your doctor who has additional information about terazosin capsules.

You and your doctor should discuss terazosin capsules and your condition before you start taking it and at your regular check-ups. Terazosin capsules are used to treat high blood pressure (hypertension). Terazosin capsules are also used to treat benign prostatic hyperplasia (BPH) in men.

This leaflet describes terazosin capsules as a treatment for hypertension or BPH. What is hypertension (high blood pressure)? Blood pressure is the tension of the blood within the blood vessels.

If blood is pumped too forcefully, or if the blood vessels are too narrow, the pressure of the blood against the walls of the vessels rises. If high blood pressure is not treated, over time, the increased pressure can damage blood vessels or it can cause the heart to work too hard and may decrease the flow of blood to the heart, brain, and kidneys. As a result, these organs may become damaged and not function correctly.

If high blood pressure is controlled, this damage is less likely to happen. Treatment options for hypertension Non-drug treatments are sometimes effective in controlling mild hypertension. The most important lifestyle changes to lower blood pressure are to lose weight, reduce salt, fat, and alcohol in the diet, quit smoking, and exercise regularly.

However, many hypertensive patients require one or more ongoing medications to control their blood pressure. There are different kinds of medications used to treat hypertension. Your doctor has prescribed terazosin capsules for you.

What Terazosin Capsules do to treat hypertension Terazosin capsules work by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure. What is BPH?

The prostate is a gland located below the bladder of men. It surrounds the urethra (you-REETH-rah), which is a tube that drains urine from the bladder. BPH is an enlargement of the prostate gland.

The symptoms of BPH, however, can be caused by an increase in the tightness of muscles in the prostate. If the muscles inside the prostate tighten, they can squeeze the urethra and slow the flow of urine. This can lead to symptoms such as: a weak or interrupted stream when urinating a feeling that you can not empty your bladder completely a feeling of delay when you start to urinate a need to urinate often, especially at night, or a feeling that you must urinate right away Treatment options for BPH There are three main treatment options for BPH: Program of monitoring or "Watchful Waiting".

Some men have an enlarged prostate gland, but no symptoms, or symptoms that are not bothersome. If this applies, you and your doctor may decide on a program of monitoring including regular checkups, instead of medication or surgery. Medication.

There are different kinds of medication used to treat BPH. Your doctor has prescribed terazosin capsules for you. See "What Terazosin Capsules do to treat BPH" below.

Surgery. Some patients may need surgery. Your doctor can describe several different surgical procedures to treat BPH.

Which procedure is best depends on your symptoms and medical condition. What Terazosin Capsules do to treat BPH Terazosin capsules relax the tightness of a certain type of muscle in the prostate and at the opening of the bladder. This may increase the rate of urine flow and/or decrease the symptoms you are having.

Terazosin capsules help to relieve the symptoms of BPH. It does NOT change the size of the prostate, which may continue to grow. However, a larger prostate does not necessarily cause more or worse symptoms.

If terazosin capsules are helping you, you should notice…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.