HomeNDC LookupIngredientsPrazosin Hydrochloride › 67046-1050-03
prazosin hydrochloride 5 mg Capsule, 30-count — NDC 67046-1050-03 package photo

prazosin hydrochloride 5 mg Capsule, 30-count

by Coupler LLC · 30 CAPSULE in 1 BLISTER PACK (67046-1050-3)
NDC 67046-1050-03
🏷️ FDA NDC (as labeled) 67046-1050-3 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 20, 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) 67046-1050-3
Product NDC 67046-1050
11-digit billing NDC 67046105003
RxCUI 198141
UNII X0Z7454B90
Application # ANDA215697
SPL Set ID 583b4b06-71e4-4696-e063-6294a90a15bf
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 2026-08-04
Route ORAL
Dosage form CAPSULE
Substance PRAZOSIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 67046-1050-3 — a 5-4-1 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 package segment → 67046-1050-03. 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

LabelerCoupler LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA215697 (ANDA)
Labeler code67046
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio463 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

📖 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 blue
ShapeCapsule
ImprintLifestar;440
Size18 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

12 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 mg 59651-0273-01 Aurobindo 100 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 70756-0440-11 Lifestar 100 capsules $0.129 AB Availability likely
Prazosin Hydrochloride 5 mg 76282-0723-01 Exelan 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 70954-0021-10 ANI 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 70377-0068-11 Biocon 100 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 00093-4069-01 Teva 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 51079-0632-20 Mylan 100 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 46708-0693-31 Alembic 100 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 71205-0585-30 Proficient 30 capsules AB FDA listed
prazosin hydrochloride 5 mg 68788-8660-01 Preferred 100 capsules AB FDA listed
prazosin hydrochloride 5 mg 76420-0526-01 ASCLEMED 100 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 67046-1678-03 Coupler 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 Hydrochloride 5 mg 70518-1443-02 REMEDYREPACK 50 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 68788-7849-01 Preferred 100 capsules AB Discontinued
Prazosin Hydrochloride 5 mg 10135-0668-01 Marlex 100 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 67046-0781-03 Coupler 30 capsules AB FDA listed
prazosin hydrochloride 5 mg 70518-4288-00 REMEDYREPACK 30 capsules AB FDA listed
prazosin hydrochloride 5 mg 82804-0089-90 Proficient 90 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 43063-0248-30 PD-Rx 30 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 48433-0086-20 Safecor 100 capsules AB FDA listed
Prazosin Hydrochloride 5 mg 70518-3352-00 REMEDYREPACK 100 capsules AB FDA listed
prazosin hydrochloride 5 mgthis 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🔬 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 Marketing startStatus
67046-1050-03 You're viewing this 30 CAPSULE in 1 BLISTER PACK (67046-1050-3) 2026-08-04 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 67046-1050-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 67046-1050-03, written without dashes as 67046105003. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 67046-1050-03, the first segment (67046) is the labeler code FDA assigned to Coupler LLC; the middle segment (1050) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Coupler LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Coupler LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 199 words

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

Concomitant administration of prazosin hydrochloride capsules 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.

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 capsules 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 120–160 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 capsules.

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 capsules 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 capsules.

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 capsules 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 capsules 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 1–4% 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 capsules 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 Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 153 words

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

🆘 Overdosage 112 words

OVERDOSAGE Accidental ingestion of at least 50 mg of prazosin hydrochloride capsules 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 capsules are 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 White opaque cap/ white opaque body, hard gelatin capsule imprinted with on cap and "429" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-429-11 bottles of 100 capsules.

This package is child resistant NDC 70756-429-12 bottles of 1000 capsules. This package is not child resistant The 2 mg capsule is Pink opaque cap/ Pink opaque body, hard gelatin capsule imprinted with on cap and "430" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-430-11 bottles of 100 capsules.

This package is child resistant NDC 70756-430-12 bottles of 1000 capsules. This package is not child resistant The 5 mg capsule is Blue opaque cap/ Blue opaque body, hard gelatin capsule imprinted with on cap and "440" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-440-11 bottles of 100 capsules.

This package is child resistant NDC 70756-440-12 bottles of 1000 capsules. This package is not child resistant Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP Keep this and all medication out of the reach of children.

📋 Description 190 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 white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86.

Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide.

In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No.

1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac.

FDA approved dissolution test specifications differ from USP.

💬 Information for Patients 119 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 capsules, 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.