HomeNDC LookupIngredientsPrazosin Hydrochloride › 00093-4069-05
Prazosin Hydrochloride 5 mg Capsule, 500-count — NDC 00093-4069-05 package photo

Prazosin Hydrochloride 5 mg Capsule, 500-count

by Teva Pharmaceuticals USA, Inc. · 500 CAPSULE in 1 BOTTLE (0093-4069-05)
NDC 00093-4069-05
🏷️ FDA NDC (as labeled) 0093-4069-05 billing pads the labeler segment with a zero
This package
Contains500-count Cost per ea$0.1293 NADAC Per package$64.65 / 500 capsules Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.3397/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 →
🚨
Active recall for this product.
Class II · Oct 7, 2025 — CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. (Teva Pharmaceuticals USA, Inc) · FDA recall D-0104-2026
Class II · Oct 7, 2025 — CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. (Teva Pharmaceuticals USA, Inc) · FDA recall D-0105-2026
Class II · Oct 7, 2025 — CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. (Teva Pharmaceuticals USA, Inc) · FDA recall D-0106-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
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) 0093-4069-05
Product NDC 0093-4069
11-digit billing NDC 00093406905
NCPDP billing unit EA — each (per item)
RxCUI 198141, 312593, 312594
UNII X0Z7454B90
UPC 0300934068016, 0300934069013, 0300934067019
Application # ANDA071745
SPL Set ID 7293cef3-ef9e-40dc-9995-875ef047f693
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 2007-01-18
Route ORAL
Dosage form CAPSULE
Substance PRAZOSIN HYDROCHLORIDE
GPI-14 36202030100115
GPI class Prazosin HCl
GCN Seq No 000293
GCN 01252
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 5 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 0093-4069-05 — a 4-4-2 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 labeler segment → 00093-4069-05. 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

LabelerTeva Pharmaceuticals USA, Inc.
Application holderTEVA PHARMACEUTICALS USA
FDA applicationANDA071745 (ANDA)
Labeler code00093
First marketedJan 2007
Product typeHuman Prescription Drug
Portfolio504 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 5 MG CAPSULE Ingredient Prazosin Hcl
📖 What it is MedlinePlus · NLM

Prazosin is used to treat high blood pressure. Prazosin is in a class of medications called alpha-blockers. It works 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, can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure....

Read the full MedlinePlus article ↗
📗 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
ImprintTEVA;4069
Size22 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 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 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 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.

5 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 $0.129 $64.65 / 500 capsules
Medicaid paysCMS SDUD · 12 mo $0.3397 $169.85 / 500 capsules
Medicare drug plans payPart D · Q2 2026 $0.2217 $110.85 / 500 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.539 $0.129
▼ Down 75% 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
Prazosin Hydrochloride 5 mgthis 00093-4069-05 Teva 500 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 00378-3205-01 Mylan 100 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 00904-7022-61 Major 100 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 51079-0632-20 Mylan 100 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 59651-0273-01 Aurobindo 100 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 60687-0572-32 American 20 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 62332-0693-31 Alembic 100 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 66993-0433-85 Prasco 90 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 70010-0086-01 Granules 100 capsules $0.129 AB Availability likely
Prazosin hydrochloride 5 mg 70377-0068-11 Biocon 100 capsules $0.129 AB Availability likely
prazosin hydrochloride 5 mg 70756-0440-11 Lifestar 100 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 70954-0021-10 ANI 100 capsules $0.129 AB Availability likely
prazosin hydrochloride 5 mg 72205-0277-91 Novadoz 100 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 76282-0723-01 Exelan 100 capsules $0.129 AB Availability likely
Prazosin 5 mg 00527-4182-37 Lannett 100 capsules FDA listed
Prazosin Hydrochloride 5 mg 10135-0668-01 Marlex 100 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 43063-0248-30 PD-Rx 30 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 46708-0693-31 Alembic 100 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 48433-0086-20 Safecor 100 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 67046-0781-03 Coupler 30 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 67046-1678-03 Coupler 30 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 68788-7849-01 Preferred 100 capsules AB Discontinued
prazosin hydrochloride 5 mg 68788-8660-01 Preferred 100 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 70518-1443-02 REMEDYREPACK 50 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 70518-3352-00 REMEDYREPACK 100 capsules AB FDA listed
prazosin hydrochloride 5 mg 70518-4288-00 REMEDYREPACK 30 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 71205-0585-30 Proficient 30 capsules AB FDA listed
prazosin hydrochloride 5 mg 71335-2348-01 Bryant 60 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 71610-0829-27 Aphena 1250 capsules AB FDA listed
Prazosin HCL 5 mg 72189-0470-30 Direct_Rx 30 capsules AB FDA listed
prazosin hydrochloride 5 mg 76420-0526-01 ASCLEMED 100 capsules AB FDA listed
prazosin hydrochloride 5 mg 82804-0089-90 Proficient 90 capsules AB FDA listed
prazosin hydrochloride 5 mg 67046-1050-03 Coupler 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

🏛️
2007
On the market since
Jan 2007
📍
2026
Currently FDA-listed
19 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 00093-4069-05, 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
288
Units reimbursed last 4 qtrs
11.7K
Gross reimbursed last 4 qtrs
$4K
Avg / prescription
$13.76
Avg / unit
$0.3397
Latest quarter Q4 2025
81Rx
Medicaid pays / ea
$0.3397
gross reimbursed
vs
NADAC / ea
$0.1293
acquisition cost
=
Spread
+$0.2104
+163% 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
35% FFS 65% MCO
Fee-for-service · 100 Rx Managed care · 188 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: 250 units · 4.4 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 630 units · 3.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,110 units · 26.2 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,100 units · 5.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 3,313 units · 38.0 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 720 units · 9.7 per 100k residents 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: 3,540 units · 87.3 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.287.3
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 Oklahoma 87.3 /100k
2 Virginia 38.0 /100k
3 Oregon 26.2 /100k
4 Arizona 9.7 /100k
5 California 5.4 /100k
6 Minnesota 4.4 /100k
7 New York 3.2 /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 capsules00093-4069-01 48,745 Rx · $846,567
250 capsules00093-4069-52 262 Rx · $6,534
Drug total (last 4 qtrs): 49,295 Rx · 2,176,631 units · $857,063 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
00093-4069-01 100 CAPSULE in 1 BOTTLE (0093-4069-01) $0.1293 / ea $12.93 2007-02-22 Active
00093-4069-05 You're viewing this 500 CAPSULE in 1 BOTTLE (0093-4069-05) $0.1293 / ea $64.65 2007-01-18 Active
00093-4069-52 250 CAPSULE in 1 BOTTLE (0093-4069-52) $0.1293 / ea $32.32 2007-02-22 Active

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

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.1293 NADAC).

This pack accounts for about 0.6% of this product's recent Medicaid fills; most go to the 100 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 00093-4069-05?
NDC 00093-4069-05 is a 500-count package — 500 capsule in 1 bottle.
What is the difference between NDC 00093-4069-05 and NDC 00093-4069-01?
Both are Prazosin Hydrochloride 5 mg Capsule — the drug itself is identical. NDC 00093-4069-05 is the 500-count package, while NDC 00093-4069-01 is the 100 capsules package.
What NDC number is used to bill for this package of Prazosin Hydrochloride 5 mg Capsule?
Bill NDC 00093-4069-05 — the 11-digit billing format is 00093406905. 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 USP 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 USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.

⏱️ Dosage and Administration 203 words

DOSAGE AND ADMINISTRATION The dose of prazosin hydrochloride capsules USP 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 capsules USP should be reduced to 1 mg or 2 mg three times a day and retitration then carried out. Concomitant administration of prazosin hydrochloride capsules USP 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 capsules USP.

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 prazosin hydrochloride capsules, 1 mg.

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 postmarketing 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 ~1 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 preexisting narcolepsy. A causal relationship is uncertain in these cases.

In postmarketing 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 ).

🔄 Drug Interactions 157 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 82 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.

🤰 Pregnancy 200 words

Usage in Pregnancy Teratogenic Effects Pregnancy category C 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.

🧒 Pediatric Use 12 words

Usage in Children Safety and effectiveness in children have not been established.

🆘 Overdosage 107 words

OVERDOSAGE Accidental ingestion of at least 50 mg of prazosin 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 dialyzable 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 175 words

HOW SUPPLIED Prazosin hydrochloride capsules USP are available as follows: 1 mg: An ivory opaque capsule, filled with white powder, imprinted with "TEVA" on the cap and "4067" on the body, containing prazosin hydrochloride, USP equivalent to 1 mg of prazosin, packaged in bottles of 100 (NDC 0093-4067-01) and 1000 (NDC 0093-4067-10) capsules. 2 mg: A pink opaque capsule, filled with white powder, imprinted with "TEVA" on the cap and "4068" on the body, containing prazosin hydrochloride, USP equivalent to 2 mg of prazosin, packaged in bottles of 100 (NDC 0093-4068-01) and 1000 (NDC 0093-4068-10) capsules.

5 mg: A light blue opaque capsule, filled with white powder, imprinted with "TEVA" on the cap and "4069" on the body, containing prazosin hydrochloride, USP equivalent to 5 mg of prazosin, packaged in bottles of 100 (NDC 0093-4069-01), 250 (NDC 0093-4069-52), and 500 (NDC 0093-4069-05) capsules. Dispense in a well-closed, light-resistant container as defined in the USP. Use child-resistant closure.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

📋 Description 136 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: C 19 H 21 N 5 O 4 •HCl M.W. 419.87 It is a white, crystalline substance, slightly soluble in water and isotonic saline.

Each capsule for oral administration, contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inactive ingredients include: anhydrous lactose, magnesium stearate, and pregelatinized starch. Additional inactive ingredients for the gelatin capsule include: 1 mg (Ivory): D&C Yellow No.

10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C Red No. 40, D&C Red No.

28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 and titanium dioxide. prazosin hydrochloride capsules structural formula

💬 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.