HomeNDC LookupIngredientsPrazosin Hydrochloride › 62332-0691-31
PRAZOSIN HYDROCHLORIDE 1 mg Capsule, 100-count — NDC 62332-0691-31 package photo

PRAZOSIN HYDROCHLORIDE 1 mg Capsule, 100-count

by Alembic Pharmaceuticals Inc. · 100 CAPSULE in 1 BOTTLE (62332-691-31)
NDC 62332-0691-31
🏷️ FDA NDC (as labeled) 62332-691-31 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0858 NADAC Per package$8.58 / 100 capsules Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2355/unit · Part D plans $0.2217/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 →
⚠️
Other active recalls for Prazosin Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 27, 2026 — cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. (Appco Pharma LLC) · FDA recall D-0419-2026
Class II · Mar 27, 2026 — cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. (Appco Pharma LLC) · FDA recall D-0420-2026
Class II · Mar 27, 2026 — cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. (Appco Pharma LLC) · FDA recall D-0421-2026
Class II · Oct 16, 2025 — Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit (Amerisource Health Services LLC) · FDA recall D-0103-2026
Class II · Oct 16, 2025 — Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit (Amerisource Health Services LLC) · FDA recall D-0102-2026
Class II · Oct 16, 2025 — Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit (Amerisource Health Services LLC) · FDA recall D-0101-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 62332-691-31
Product NDC 62332-691
11-digit billing NDC 62332069131
NCPDP billing unit EA — each (per item)
RxCUI 198141, 312593, 312594
UNII X0Z7454B90
UPC 0362332693313
Application # ANDA217268
SPL Set ID d4af73d1-c97e-4418-9e24-007b10af0bd9
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 2023-03-09
Route ORAL
Dosage form CAPSULE
Substance PRAZOSIN HYDROCHLORIDE
GPI-14 36202030100105
GCN Seq No 000291
GCN 01250
HICL code 000091
Ingredient (HICL) Prazosin 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 PRAZOSIN 1 MG CAPSULE
FDB brand name Prazosin 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 62332-691-31 — 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 → 62332-0691-31. 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

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA217268 (ANDA)
Labeler code62332
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio491 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 PRAZOSIN 1 MG CAPSULE Ingredient Prazosin Hcl
📗 Our plain-language guide HelloPharmacist
  • Prazosin is used to treat high blood pressure (hypertension). By lowering your blood pressure, it helps reduce your risk of serious problems like stroke and heart attack. It can be...
  • Unfortunately, that's a known risk, especially with the first dose. Prazosin can cause a sudden drop in blood pressure — most likely in the 30 to 90 minutes after taking it — which...
  • I felt really dizzy and almost fainted after my first dose. Is that normal?
  • The biggest ones to know about are erectile dysfunction drugs — like sildenafil (Viagra) — and other blood pressure medications or water pills. These can make prazosin's blood pres...
📖 Read our full Prazosin guide →
1
Nutrient depletion considerations

Prazosin 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 / Pink / Blue
ShapeCapsule
ImprintA;322
Size21 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $0.086 $8.58 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.2355 $23.55 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.2217 $22.17 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.147 $0.083
▼ Down 42% over the last 12 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
Prazosin Hydrochloride 1 mg 00093-4067-01 Teva 100 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 00378-1101-01 Mylan 100 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 00904-7020-61 Major 100 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 51079-0630-20 Mylan 100 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 59651-0271-01 Aurobindo 100 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mgthis 62332-0691-31 Alembic 100 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 66993-0431-85 Prasco 90 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 68084-0996-01 American 100 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 70010-0084-01 Granules 100 capsules $0.086 AB Availability likely
Prazosin hydrochloride 1 mg 70377-0066-11 Biocon 100 capsules $0.086 AB Availability likely
prazosin hydrochloride 1 mg 70756-0429-11 Lifestar 100 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 70954-0019-10 ANI 100 capsules $0.086 AB Availability likely
prazosin hydrochloride 1 mg 72205-0275-90 Novadoz 90 capsules $0.086 AB Availability likely
Prazosin Hydrochloride 1 mg 76282-0721-01 Exelan 100 capsules $0.086 AB Availability likely
Prazosin 1 mg 00527-4180-37 Lannett 100 capsules FDA listed
Prazosin Hydrochloride 1 mg 00615-8519-39 NCS 30 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 10135-0666-01 Marlex 100 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 46708-0691-31 Alembic 100 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 48433-0084-20 Safecor 100 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 50090-5695-00 A-S 100 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 55154-4156-00 Cardinal 10 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 55154-8181-00 Cardinal 10 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 55289-0536-60 PD-Rx 60 capsules AB FDA listed
prazosin hydrochloride 1 mg 60760-0820-30 ST. 30 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 63629-8750-01 Bryant 1000 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 63629-8756-01 Bryant 100 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 67046-0680-03 Coupler 30 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 68788-7335-01 Preferred 100 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 70518-3271-00 REMEDYREPACK 30 capsules AB FDA listed
prazosin hydrochloride 1 mg 70518-3669-00 REMEDYREPACK 60 capsules AB Discontinued
Prazosin hydrochloride 1 mg 70518-3928-00 REMEDYREPACK 30 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 70518-4457-00 REMEDYREPACK 30 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 70518-4489-00 REMEDYREPACK 30 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 71335-1401-01 Bryant 30 capsules AB Discontinued
Prazosin Hydrochloride 1 mg 71335-1724-01 Bryant 30 capsules AB FDA listed
prazosin hydrochloride 1 mg 71335-9648-01 Bryant 30 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 71610-0693-30 Aphena 30 capsules AB FDA listed
Prazosin HCL 1 mg 72189-0436-30 Direct_Rx 30 capsules AB FDA listed
prazosin hydrochloride 1 mg 76420-0523-01 ASCLEMED 100 capsules AB FDA listed
Prazosin Hydrochloride 1 mg 87441-0067-01 Unit 30 capsules AB FDA listed
prazosin hydrochloride 1 mg 70518-4712-00 REMEDYREPACK 30 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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 62332-0691-31, 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
68.1K
Units reimbursed last 4 qtrs
3.3M
Gross reimbursed last 4 qtrs
$775.9K
Avg / prescription
$11.39
Avg / unit
$0.2355
Latest quarter Q4 2025
15.5KRx
Medicaid pays / ea
$0.2355
gross reimbursed
vs
NADAC / ea
$0.0858
acquisition cost
=
Spread
+$0.1497
+174% 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
24% FFS 76% MCO
Fee-for-service · 16,564 Rx Managed care · 51,549 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: 12,478 units · 1,594 per 100k residents ND Minnesota: 66,992 units · 1,168 per 100k residents MN Wisconsin: 70,503 units · 1,193 per 100k residents WI Michigan: 112,597 units · 1,122 per 100k residents MI New York: 366,751 units · 1,874 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: 31,867 units · 994 per 100k residents IA Illinois: 216,312 units · 1,724 per 100k residents IL Indiana: 533,198 units · 7,770 per 100k residents IN Ohio: 519,705 units · 4,410 per 100k residents OH Pennsylvania: 620,386 units · 4,787 per 100k residents PA New Jersey: 190,089 units · 2,046 per 100k residents NJ Massachusetts: 15,283 units · 218 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: 50,344 units · 856 per 100k residents CO Nebraska: 23,938 units · 1,210 per 100k residents NE Missouri: 102,266 units · 1,651 per 100k residents MO Kentucky: 31,290 units · 691 per 100k residents KY West Virginia: 103,605 units · 5,853 per 100k residents WV Virginia: 38,954 units · 447 per 100k residents VA Maryland: 99,960 units · 1,617 per 100k residents MD Connecticut: 3,644 units · 101 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 14,164 units · 482 per 100k residents KS Arkansas: 7,665 units · 250 per 100k residents AR Tennessee: 1,798 units · 25.2 per 100k residents TN North Carolina: 5,702 units · 52.6 per 100k residents NC South Carolina: no data reported SC Delaware: 16,967 units · 1,646 per 100k residents DE Oklahoma: 21,012 units · 518 per 100k residents OK Louisiana: 3,097 units · 67.7 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 1,813 units · 267 per 100k residents DC Hawaii: no data reported HI Texas: 12,487 units · 40.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
25.27,770
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 Indiana 7,770 /100k
2 West Virginia 5,853 /100k
3 Pennsylvania 4,787 /100k
4 Ohio 4,410 /100k
5 New Jersey 2,046 /100k
6 New York 1,874 /100k
7 Illinois 1,724 /100k
8 Missouri 1,651 /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.
100 capsules this page62332-0691-31 68,113 Rx · $775,866
250 capsules62332-0691-61 No Medicaid data
1000 capsules62332-0691-91 No Medicaid data
Drug total (last 4 qtrs): 68,113 Rx · 3,294,867 units · $775,866 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 Prazosin Hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue110
Abdominal Pain95
Nausea85
Diarrhoea72
Pain71
Headache64
Dyspnoea63

Age at onset

Neonate1
Infant1
Child1
Adolescent2
Adult279
Elderly74

Reporter sex

1,308 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization400
Life-threatening50
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 297 105
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
62332-0691-31 You're viewing this 100 CAPSULE in 1 BOTTLE (62332-691-31) $0.0858 / ea $8.58 2023-03-09 Active
62332-0691-61 250 CAPSULE in 1 BOTTLE (62332-691-61) 2023-03-09 Active
62332-0691-91 1000 CAPSULE in 1 BOTTLE (62332-691-91) 2023-03-09 Active

You're viewing the smallest of 3 pack sizes for this product.

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 62332-0691-31?
NDC 62332-0691-31 is a 100-count package — 100 capsule in 1 bottle.
What is the difference between NDC 62332-0691-31 and NDC 62332-0691-61?
Both are PRAZOSIN HYDROCHLORIDE 1 mg Capsule — the drug itself is identical. NDC 62332-0691-31 is the 100-count package, while NDC 62332-0691-61 is the 250 capsules package.
What NDC number is used to bill for this package of PRAZOSIN HYDROCHLORIDE 1 mg Capsule?
Bill NDC 62332-0691-31 — the 11-digit billing format is 62332069131. 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 ~2 min read

INDICATIONS AND USAGE Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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, including this drug.

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. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.

⏱️ Dosage and Administration 194 words

DOSAGE AND ADMINISTRATION The dose of prazosin hydrochloride should be adjusted according to the patient’s individual blood pressure response. The following is a guide to its administration: Initial Dose 1 mg two or three times a day (see WARNINGS.) Maintenance Dose Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses.

Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a daily dose of 40 mg given in divided doses. After initial titration some patients can be maintained adequately on a twice daily dosage regimen. Use With Other Drugs When adding a diuretic or other antihypertensive agent, the dose of prazosin hydrochloride should be reduced to 1 mg or 2 mg three times a day and retitration then carried out.

Concomitant administration of prazosin hydrochloride with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension; therefore, PDE-5 inhibitor therapy should be initiated at the lowest dose in patients taking prazosin hydrochloride.

Contraindications 20 words

CONTRAINDICATIONS Prazosin hydrochloride capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.

⚠️ Warnings ~2 min read

WARNINGS As with all alpha-blockers, prazosin hydrochloride may cause syncope with sudden loss of consciousness. In most cases, this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe tachycardia with heart rates of 120 to 160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally, they have been reported in association with rapid dosage increases or the introduction of another antihypertensive drug into the regimen of a patient taking high doses of prazosin hydrochloride.

The incidence of syncopal episodes is approximately 1% in patients given an initial dose of 2 mg or greater. Clinical trials conducted during the investigational phase of this drug suggest that syncopal episodes can be minimized by limiting the initial dose of the drug to 1 mg, by subsequently increasing the dosage slowly, and by introducing any additional antihypertensive drugs into the patient’s regimen with caution (see DOSAGE AND ADMINISTRATION). Hypotension may develop in patients given prazosin hydrochloride who are also receiving a beta-blocker such as propranolol.

If syncope occurs, the patient should be placed in the recumbent position and treated supportively as necessary. This adverse effect is self-limiting and in most cases does not recur after the initial period of therapy or during subsequent dose titration. Patients should always be started on the 1 mg capsules of prazosin hydrochloride.

The 2 and 5 mg capsules are not indicated for initial therapy. More common than loss of consciousness are the symptoms often associated with lowering of the blood pressure, namely, dizziness and lightheadedness. The patient should be cautioned about these possible adverse effects and advised what measures to take should they develop.

The patient should also be cautioned to avoid situations where injury could result should syncope occur during the initiation of prazosin hydrochloride therapy. Priapism Prolonged erections and priapism have been reported with alpha-1 blockers including prazosin in post marketing experience. In the event of an erection that persists longer than 4 hours, seek immediate medical assistance.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Clinical trials were conducted on more than 900 patients. During these trials and subsequent marketing experience, the most frequent reactions associated with prazosin hydrochloride therapy are: dizziness 10.3%, headache 7.8%, drowsiness 7.6%, lack of energy 6.9%, weakness 6.5%, palpitations 5.3%, and nausea 4.9%. In most instances, side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug.

Less frequent adverse reactions which are reported to occur in 1 to 4% of patients are: Gastrointestinal: vomiting, diarrhea, constipation. Cardiovascular: edema, orthostatic hypotension, dyspnea, syncope. Central Nervous System: vertigo, depression, nervousness.

Dermatologic: rash. Genitourinary: urinary frequency. EENT: blurred vision, reddened sclera, epistaxis, dry mouth, nasal congestion.

In addition, fewer than 1% of patients have reported the following (in some instances, exact causal relationships have not been established): Gastrointestinal: abdominal discomfort and/or pain, liver function abnormalities, pancreatitis. Cardiovascular: tachycardia. Central Nervous System: paresthesia, hallucinations.

Dermatologic: pruritus, alopecia, lichen planus. Genitourinary: incontinence, impotence, priapism. EENT: tinnitus.

Other: diaphoresis, fever, positive ANA titer, arthralgia. Single reports of pigmentary mottling and serous retinopathy, and a few reports of cataract development or disappearance have been reported. In these instances, the exact causal relationship has not been established because the baseline observations were frequently inadequate.

In more specific slit-lamp and funduscopic studies, which included adequate baseline examinations, no drug-related abnormal ophthalmological findings have been reported. Literature reports exist associating prazosin hydrochloride therapy with a worsening of pre-existing narcolepsy. A causal relationship is uncertain in these cases.

In post-marketing experience, the following adverse events have been reported: Autonomic Nervous System: flushing. Body As A Whole: allergic reaction, asthenia, malaise, pain. Cardiovascular, General: angina pectoris, hypotension.

Endocrine: gynecomastia. Heart Rate/Rhythm: bradycardia. Psychiatric: insomnia.

Skin/Appendages: urticaria. Vascular (Extracardiac): vasculitis. Vision: eye pain.

Special Senses: During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha-1 blocker therapy (see PRECAUTIONS). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 148 words

Drug Interactions Prazosin hydrochloride has been administered without any adverse drug interaction in limited clinical experience to date with the following: (1) cardiac glycosides– digitalis and digoxin; (2) hypoglycemics–insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide; (3) tranquilizers and sedatives–chlordiazepoxide, diazepam, and phenobarbital; (4) antigout– allopurinol, colchicine, and probenecid; (5) antiarrhythmics–procainamide, propranolol (see WARNINGS however), and quinidine; and (6) analgesics, antipyretics and anti-inflammatories – propoxyphene, aspirin, indomethacin, and phenylbutazone.

Addition of a diuretic or other antihypertensive agent to prazosin hydrochloride has been shown to cause an additive hypotensive effect. This effect can be minimized by reducing the prazosin hydrochloride dose to 1 to 2 mg three times a day, by introducing additional antihypertensive drugs cautiously, and then by retitrating prazosin hydrochloride based on clinical response. Concomitant administration of prazosin hydrochloride with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension (see DOSAGE AND ADMINISTRATION).

🔄 Drug / Laboratory Test Interactions 106 words

Drug/Laboratory Test Interactions In a study on five patients given from 12 to 24 mg of prazosin per day for 10 to 14 days, there was an average increase of 42% in the urinary metabolite of norepinephrine and an average increase in urinary VMA of 17%. Therefore, false positive results may occur in screening tests for pheochromocytoma in patients who are being treated with prazosin. If an elevated VMA is found, prazosin should be discontinued and the patient retested after a month.

Laboratory Tests In clinical studies in which lipid profiles were followed, there were generally no adverse changes noted between pre- and post-treatment lipid levels.

🤰 Pregnancy 195 words

Usage in Pregnancy: Prazosin hydrochloride has been shown to be associated with decreased litter size at birth, 1, 4, and 21 days of age in rats when given doses more than 225 times the usual maximum recommended human dose. No evidence of drug-related external, visceral, or skeletal fetal abnormalities were observed. No drug-related external, visceral, or skeletal abnormalities were observed in fetuses of pregnant rabbits and pregnant monkeys at doses more than 225 times and 12 times the usual maximum recommended human dose, respectively.

The use of prazosin and a beta-blocker for the control of severe hypertension in 44 pregnant women revealed no drug-related fetal abnormalities or adverse effects. Therapy with prazosin was continued for as long as 14 weeks. 1 Prazosin has also been used alone or in combination with other hypotensive agents in severe hypertension of pregnancy by other investigators.

No fetal or neonatal abnormalities have been reported with the use of prazosin. 2 There are no adequate and well controlled studies which establish the safety of prazosin hydrochloride in pregnant women. Prazosin hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

🆘 Overdosage 110 words

OVERDOSAGE Accidental ingestion of at least 50 mg of prazosin hydrochloride in a two year old child resulted in profound drowsiness and depressed reflexes. No decrease in blood pressure was noted. Recovery was uneventful.

Should overdosage 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. Renal function should be monitored and supported as needed. Laboratory data indicate prazosin hydrochloride is not dialysable because it is protein bound.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY The exact mechanism of the hypotensive action of prazosin is unknown. Prazosin causes a decrease in total peripheral resistance and was originally thought to have a direct relaxant action on vascular smooth muscle. Recent animal studies, however, have suggested that the vasodilator effect of prazosin is also related to blockade of postsynaptic alpha-adrenoceptors.

The results of dog forelimb experiments demonstrate that the peripheral vasodilator effect of prazosin is confined mainly to the level of the resistance vessels (arterioles). Unlike conventional alpha-blockers, the antihypertensive action of prazosin is usually not accompanied by a reflex tachycardia. Tolerance has not been observed to develop in long term therapy.

Hemodynamic studies have been carried out in man following acute single dose administration and during the course of long term maintenance therapy. The results confirm that the therapeutic effect is a fall in blood pressure unaccompanied by a clinically significant change in cardiac output, heart rate, renal blood flow and glomerular filtration rate. There is no measurable negative chronotropic effect.

In clinical studies to date, prazosin hydrochloride has not increased plasma renin activity. In man, blood pressure is lowered in both the supine and standing positions. This effect is most pronounced on the diastolic blood pressure.

Following oral administration, human plasma concentrations reach a peak at about three hours with a plasma half-life of two to three hours. The drug is highly bound to plasma protein. Bioavailability studies have demonstrated that the total absorption relative to the drug in a 20% alcoholic solution is 90%, resulting in peak levels approximately 65% of that of the drug in solution.

Animal studies indicate that prazosin hydrochloride is extensively metabolized, primarily by demethylation and conjugation, and excreted mainly via bile and feces. Less extensive human studies suggest similar metabolism and excretion in man. In clinical studies in which lipid profiles were followed, there were generally no adverse changes noted between pre- and post-treatment lipid levels.

📦 How Supplied / Storage and Handling ~1 min read

HOW SUPPLIED Prazosin hydrochloride capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin. The 1 mg capsule is opaque white cap/opaque white body hard gelatin capsules size “4” having imprinting “A” on cap with black ink and “320” on body with black ink filled with white to off white granular powder. They are available as follows: Bottle of 100 capsules with child-resistant closure, NDC 62332-691-31 Bottle of 250 capsules, NDC 62332-691-61 Bottle of 1000 capsules, NDC 62332-691-91 The 2 mg capsule is opaque pink cap/opaque white body hard gelatin capsules size “2” having imprinting “A” on cap with black ink and “321” on body with black ink filled with white to off white granular powder.

They are available as follows: Bottle of 100 capsules with child-resistant closure, NDC 62332-692-31 Bottle of 250 capsules, NDC 62332-692-61 Bottle of 1000 capsules, NDC 62332-692-91 The 5 mg capsule is opaque blue cap/opaque white body hard gelatin capsules size “0” having imprinting “A” on cap with black ink and “322” on body with black ink filled with white to off white granular powder. They are available as follows: Bottle of 100 capsules with child-resistant closure, NDC 62332-693-31 Bottle of 250 capsules, NDC 62332-693-61 Bottle of 1000 capsules, NDC 62332-693-91 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant containers (USP). References 1. Lubbe, WF, and Hodge, JV: New Zealand Med J, 94 (691) 169–172, 1981.

2. Davey, DA, and Dommisse, J: S.A. Med J , Oct.

4, 1980 (551–556). Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals Limited Bedminster, NJ 07921, USA Revised: 05/2023

📋 Description 182 words

DESCRIPTION Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is: Molecular formula C 19 H 21 N 5 O 4• HCl It is a white to tan powder, slightly soluble in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in chloroform and in acetone. It has a molecular weight of 419.87.

Each capsule for oral administration contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: sucrose, corn starch, sodium lauryl sulfate, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide.

In addition, the 2 mg and 5 mg empty hard gelatin capsule shell also contain FD&C Blue 1 and FD&C Red 3. The empty hard gelatin capsule shells are imprinted with edible black ink containing shellac, potassium hydroxide and black iron oxide. Prazosin hydrochloride capsules, USP meets USP Dissolution Test 3 . structure

💬 Information for Patients 118 words

Information for Patients: Dizziness or drowsiness may occur after the first dose of this medicine. Avoid driving or performing hazardous tasks for the first 24 hours after taking this medicine or when the dose is increased. Dizziness, lightheadedness, or fainting may occur, especially when rising from a lying or sitting position.

Getting up slowly may help lessen the problem. These effects may also occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While taking prazosin hydrochloride, be careful in the amount of alcohol you drink.

Also, use extra care during exercise or hot weather, or if standing for long periods. Check with your physician if you have any questions.

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.