Home › NDC Lookup › Ingredients › Tamsulosin Hydrochloride › 62756-0160-13
Tamsulosin Hydrochloride .4 mg Capsule, 500-count — NDC 62756-0160-13 package photo

Tamsulosin Hydrochloride .4 mg Capsule, 500-count

by Sun Pharmaceutical Industries, Inc. · 500 CAPSULE in 1 BOTTLE (62756-160-13)
NDC 62756-0160-13
🏷️ FDA NDC (as labeled) 62756-160-13 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0522 NADAC Per package$26.10 / 500 capsules Pack sizes6 compare ↓
Also priced by: Medicaid pays $0.2215/unit · Part D plans $0.1304/unit — full pricing hub ↓
Also comes in: 30 capsules 62756-0160-83 90 capsules 62756-0160-81 100 capsules 62756-0160-08 100 capsules 62756-0160-88 1000 capsules 62756-0160-18
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 62756-160-13
Product NDC 62756-160
11-digit billing NDC 62756016013
NCPDP billing unit EA — each (per item)
RxCUI 863669
UNII 11SV1951MR
UPC 0362756160811
Application # ANDA090931
SPL Set ID d742707b-4c17-4b08-a9d0-491ba2bf6415
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 2010-07-15
Route ORAL
Dosage form CAPSULE
Substance TAMSULOSIN HYDROCHLORIDE
GPI-14 56852070100110
GPI class Tamsulosin HCl
GCN Seq No 027546
GCN 48191
HICL code 013864
Ingredient (HICL) Tamsulosin Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q9
Therapeutic class — intermediate (HIC2) Urological Preparations
HIC3 code Q9B
Therapeutic class — specific (HIC3) Benign Prostatic Hypertrophy/Micturition Agents
AHFS code 12:16.04.12
AHFS class Selective Alpha-1-Adrenergic Block.agent
FDB label name TAMSULOSIN HCL 0.4 MG CAPSULE
FDB brand name Tamsulosin Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 62756-160-13 — 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 → 62756-0160-13. 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA090931 (ANDA)
Labeler code62756
First marketedJul 2010
Product typeHuman Prescription Drug
Portfolio889 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 TAMSULOSIN HCL 0.4 MG CAPSULE Ingredient Tamsulosin Hcl
📖 What it is MedlinePlus · NLM

Tamsulosin is used to treat benign prostatic hyperplasia (BPH; enlarged prostate that can cause difficulty urinating, painful urination or increased urinary frequency or urgency). Tamsulosin is in a class of medications called alpha blockers. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Your prostate contains tiny muscle fibers that can squeeze too tight when the prostate is enlarged, making it hard to urinate. Tamsulosin blocks the signals that keep those muscles...
  • What exactly does tamsulosin do for my prostate?
  • Yes — timing really does matter with this one. Take your capsule about 30 minutes after the same meal every day. Taking it on an empty stomach pushes blood levels much higher, whic...
  • Does it matter when I take it or whether I eat first?
📖 Read our full Tamsulosin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 Green / Yellow
ShapeCapsule
Imprint160
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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 24P2YXD2PW
    A cellulose derivative used as a film-coating agent and binder in tablets and capsules. It helps protect the medicine from moisture, controls how quickly the drug dissolves, and holds ingredients together.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

11 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 DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 $0.052 $26.10 / 500 capsules
Medicaid paysCMS SDUD · 12 mo $0.2215 $110.75 / 500 capsules
Medicare drug plans payPart D · Q2 2026 $0.1304 $65.20 / 500 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 May 2022 Nov 2022 Feb 2026 $0.065 $0.052
▼ Down 14% over the last 18 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
Tamsulosin Hydrochloride .4 mg 00904-7383-61 Major 100 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 50268-0740-15 AvPAK 50 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 57237-0014-01 Rising 100 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 62135-0775-30 Chartwell 30 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 65862-0598-01 Aurobindo 100 capsules $0.051 — Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 67877-0450-01 Ascend 100 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 68084-0299-01 American 100 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 68382-0132-01 Zydus 100 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 72603-0115-01 NorthStar 100 capsules $0.051 AB Availability likely save 2%
Tamsulosin hydrochloride .4 mg 76282-0744-05 EXELAN 500 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mg 82009-0025-10 Quallent 1000 capsules $0.051 AB Availability likely save 2%
Tamsulosin Hydrochloride .4 mgthis 62756-0160-13 Sun 500 capsules $0.052 — FDA listed —
tamsulosin hydrochloride .4 mg 00781-2076-01 Sandoz 100 capsules $0.054 — FDA listed +3%
Tamsulosin Hydrochloride .4 mg 00115-8211-01 Amneal 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 00615-8055-05 NCS 15 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 33342-0159-07 Macleods 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 42291-0989-10 AvKARE 1000 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 43063-0725-30 PD-Rx 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 43063-0947-30 PD-Rx 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-1846-00 A-S 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-3646-00 A-S 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-4906-00 A-S 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-5553-00 A-S 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-6699-00 A-S 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 50090-6700-00 A-S 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 51407-0879-90 Golden 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 51655-0832-52 Northwind 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 55154-2142-00 Cardinal 10 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 55154-2636-00 Cardinal 10 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 60760-0598-90 St. 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 61919-0703-90 DIRECT 5904900000 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 63187-0358-07 Proficient 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 63187-0371-07 Proficient 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 63187-0469-30 Proficient 30 capsules — — FDA listed —
Tamsulosin Hydrochloride .4 mg 63629-4346-01 Bryant 30 capsules — AB FDA listed —
Tamsulosin hydrochloride .4 mg 63672-0021-09 Synthon 20000 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 65841-0695-01 Zydus 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 67046-1015-03 Coupler 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 67296-2220-01 Redpharm 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-1840-01 NuCare 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-2561-01 NuCare 10 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-4443-01 NuCare 10 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-4872-09 NuCare 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68071-5118-01 NuCare 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68788-7050-01 Preferred 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 70518-0179-00 REMEDYREPACK 30 capsules — AB Discontinued —
Tamsulosin Hydrochloride .4 mg 70518-2052-00 REMEDYREPACK 90 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71205-0217-07 Proficient 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71205-0688-07 Proficient 7 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71335-0398-01 Bryant 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71335-1538-01 Bryant 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71335-1784-01 Bryant 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71610-0724-30 Aphena 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71610-0738-30 Aphena 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 71610-0835-30 Aphena 30 capsules — AB FDA listed —
Tamsulosin hydrochloride .4 mg 71610-0910-30 Aphena 30 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 72162-2217-05 Bryant 500 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 72162-2502-00 Bryant 1000 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 72162-2509-01 Bryant 100 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 72865-0282-01 XLCare 100 capsules — AB FDA listed —
tamsulosin hydrochloride .4 mg 72865-0350-05 XLCare 500 capsules — AB FDA listed —
Tamsulosin Hydrochloride .4 mg 68788-4145-01 Preferred 100 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

🏛️
2010
On the market since
Jul 2010
📍
2026
Currently FDA-listed
16 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 62756-0160-13, 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
2.4K
Units reimbursed last 4 qtrs
94.6K
Gross reimbursed last 4 qtrs
$20.9K
Avg / prescription
$8.87
Avg / unit
$0.2215
Latest quarter Q4 2025
383Rx
Medicaid pays / ea
$0.2215
gross reimbursed
vs
NADAC / ea
$0.0522
acquisition cost
=
Spread
+$0.1693
+324% 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 ⓘ
48% FFS 52% MCO
Fee-for-service · 1,124 Rx Managed care · 1,238 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: 795 units · 13.9 per 100k residents MN Wisconsin: no data reported WI Michigan: 4,132 units · 41.2 per 100k residents MI New York: 47,740 units · 244 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: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 1,321 units · 10.2 per 100k residents PA New Jersey: 7,043 units · 75.8 per 100k residents NJ Massachusetts: no data reported MA California: 3,606 units · 9.3 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: 2,878 units · 163 per 100k residents WV Virginia: 3,284 units · 37.7 per 100k residents VA Maryland: 4,737 units · 76.7 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 398 units · 3.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 4,539 units · 99.2 per 100k residents LA Mississippi: 640 units · 21.8 per 100k residents MS Alabama: no data reported AL Georgia: 1,154 units · 10.5 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 930 units · 4.1 per 100k residents FL
Units reimbursed · per 100k residents
3.7244
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 New York 244 /100k
2 West Virginia 163 /100k
3 Louisiana 99.2 /100k
4 Maryland 76.7 /100k
5 New Jersey 75.8 /100k
6 Michigan 41.2 /100k
7 Virginia 37.7 /100k
8 Mississippi 21.8 /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.
500 capsules this page62756-0160-13 2,362 Rx · $20,950
100 capsules62756-0160-88 608 Rx · $6,473
100 capsules62756-0160-08 No Medicaid data
1000 capsules62756-0160-18 No Medicaid data
90 capsules62756-0160-81 No Medicaid data
30 capsules62756-0160-83 No Medicaid data
Drug total (last 4 qtrs): 2,970 Rx · 121,940 units · $27,423 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 Tamsulosin Hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue1,552
Dyspnoea1,477
Dizziness1,307
Diarrhoea1,268
Headache991
Fall938
Asthenia923

Reporter sex

21,328 reports
Male · 95%
Female · 5%
Unknown · 0%

Serious outcomes

Death2,262
Disabling709
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,272 0
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
62756-0160-08 100 CAPSULE in 1 BOTTLE (62756-160-08) — — 2010-07-15 Active
62756-0160-13 You're viewing this 500 CAPSULE in 1 BOTTLE (62756-160-13) $0.0522 / ea $26.08 2010-07-15 Active
62756-0160-18 1000 CAPSULE in 1 BOTTLE (62756-160-18) — — 2010-07-15 Active
62756-0160-81 90 CAPSULE in 1 BOTTLE (62756-160-81) $0.0522 / ea $4.69 2010-07-15 Active
62756-0160-83 30 CAPSULE in 1 BOTTLE (62756-160-83) — — 2010-07-15 Active
62756-0160-88 100 CAPSULE in 1 BOTTLE (62756-160-88) $0.0522 / ea $5.22 2010-07-15 Active

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0522 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 80% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 62756-0160-13?
NDC 62756-0160-13 is a 500-count package — 500 capsule in 1 bottle.
What is the difference between NDC 62756-0160-13 and NDC 62756-0160-83?
Both are Tamsulosin Hydrochloride .4 mg Capsule — the drug itself is identical. NDC 62756-0160-13 is the 500-count package, while NDC 62756-0160-83 is the 30 capsules package.
What NDC number is used to bill for this package of Tamsulosin Hydrochloride .4 mg Capsule?
Bill NDC 62756-0160-13 — the 11-digit billing format is 62756016013. 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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 79 words ▾

1 INDICATIONS AND USAGE Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [ see Clinical Studies ( 14 ) ]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride is an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia ( 1 ) Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension ( 1 )

⏱️ Dosage and Administration 217 words ▾

2 DOSAGE AND ADMINISTRATION Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules should not be crushed, chewed or opened.

For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules can be increased to 0.8 mg once daily. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [ see Warnings and Precautions ( 5.2 ) ]. If tamsulosin hydrochloride capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.

0.4mg once daily taken approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules should not be crushed, chewed or opened. ( 2 ) Can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing ( 2 ) If discontinued or interrupted for several days, therapy should start again with the 0.4 mg once-daily dose ( 2 )

💊 Dosage Forms and Strengths 31 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsule: 0.4 mg, olive green and light yellow hard gelatin, imprinted with “160” in black ink on cap and body. Capsules: 0.4 mg ( 3 )

⛔ Contraindications 65 words ▾

4 CONTRAINDICATIONS Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [ see Adverse Reactions ( 6.2 ) ] . Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules ( 4 , 6.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur ( 5.1 ) Should not be used in combination with strong inhibitors of CYP3A4. Use with caution in combination with moderate inhibitors of CYP3A4, with strong or moderate inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers, or in combination with other cytochrome P450 inhibitors. ( 5.2 , 7.1 , 12.3 ) Should not be used in combination with other alpha adrenergic blocking agents ( 5.2 , 7.2 , 12.3 ) Exercise caution with concomitant administration of warfarin ( 5.2 , 7.4 , 12.3 ) Advise patients about the possibility and seriousness of priapism ( 5.3 ) Intraoperative Floppy Iris Syndrome has been observed during cataract and glaucoma surgery in some patients.

Advise patients considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken tamsulosin hydrochloridecapsules. ( 5.5 ) Advise patients to be screened for the presence of prostate cancer prior to treatment and at regular intervals afterwards ( 5.4 )

5.1Orthostasis The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more frequently in tamsulosin hydrochloridecapsule-treated patients than in placebo recipients. As with other alpha adrenergic blocking agents there is a potential risk of syncope [ see Adverse Reactions ( 6.1 ) ]. Patients beginning treatment with tamsulosin hydrochloridecapsules should be cautioned to avoid situations in which injury could result should syncope occur .

5.2Drug Interactions Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ]. Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ].

Tamsulosin hydrochloride capsules should be used with caution in combination with cimetidine, particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ]. Tamsulosin hydrochloride capsules should not be used in combination with other alpha adrenergic blocking agents [ see Drug Interactions ( 7.2 ) and Clinical Pharmacology ( 12.3 ) ]. Caution is advised when alpha adrenergic blocking agents including tamsulosin hydrochloride are coadministered with PDE5 inhibitors.

Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [ see Drug Interactions ( 7.3 ) and Clinical Pharmacology ( 12.3 ) ]. Caution should be exercised with concomitant administration of warfarin and tamsulosin hydrochloride capsules [ see Drug Interactions ( 7.4 ) and Clinical Pharmacology ( 12.3 ) ] .

5.3Priapism Rarely (probably less than 1 in 50,000 patients), tamsulosin, like other alpha 1 antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition.

5.4Screening for Prostate Cancer Prostate cancer and BPH frequently coexist; therefore, patients should be screened for the presence of prostate cancer prior to treatment with tamsulosin hydrochloride capsules and at regular intervals afterwards.

5.5Intraoperative Floppy Iris Syndrome Intraoperative Floppy Iris Syndrome (IFIS) has been obs…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse events (≥2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg tamsulosin hydrochloride capsules were used.

These studies evaluated safety in 1783 patients treated with tamsulosin hydrochloride capsules and 798 patients administered placebo. Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either tamsulosin hydrochloride capsules 0.4 mg or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials (US92-03A and US93-01) conducted in 1487 men. Table 1 Treatment-Emergent A treatment-emergent adverse event was defined as any event satisfying one of the following criteria:•The adverse event occurred for the first time after initial dosing with double-blind study medication.•The adverse event was present prior to or at the time of initial dosing with double-blind study medication and subsequently increased in severity during double-blind treatment; or•The adverse event was present prior to or at the time of initial dosing with double-blind study medication, disappeared completely, and then reappeared during double-blind treatment.

Adverse Events Occurring in ≥2% of Tamsulosin Hydrochloride Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical Studies BODY SYSTEM/ADVERSE EVENT TAMSULOSIN HYDROCHLORIDE CAPSULES GROUPS PLACEBO n=493 0.4 mg n=502 0.8 mg n=492 BODY AS WHOLE Headache 97 (19.3%) 104 (21.1%) 99 (20.1%) Infection Coding preferred terms also include cold, common cold, head cold, flu, and flu-like symptoms. 45 (9%) 53 (10.8%) 37 (7.5%) Asthenia 39 (7.8%) 42 (8.5%) 27 (5.5%) Back pain 35 (7%) 41 (8.3%) 27 (5.5%) Chest pain 20 (4%) 20 (4.1%) 18 (3.7%) NERVOUS SYSTEM Dizziness 75 (14.9%) 84 (17.1%) 50 (10.1%) Somnolence 15 (3%) 21 (4.3%) 8 (1.6%) Insomnia 12 (2.4%) 7 (1.4%) 3 (0.6%) Libido decreased 5 (1%) 10 (2%) 6 (1.2%) RESPIRATORY SYSTEM Rhinitis Coding preferred terms also include nasal congestion, stuffy nose, runny nose, sinus congestion, and hay fever.

66 (13.1%) 88 (17.9%) 41 (8.3%) Pharyngitis 29 (5.8%) 25 (5.1%) 23 (4.7%) Cough increased 17 (3.4%) 22 (4.5%) 12 (2.4%) Sinusitis 11 (2.2%) 18 (3.7%) 8 (1.6%) DIGESTIVE SYSTEM Diarrhea 31 (6.2%) 21 (4.3%) 22 (4.5%) Nausea 13 (2.6%) 19 (3.9%) 16 (3.2%) Tooth disorder 6 (1.2%) 10 (2%) 7 (1.4%) UROGENITAL SYSTEM Abnormal ejaculation 42 (8.4%) 89 (18.1%) 1 (0.2%) SPECIAL SENSES Blurred vision 1 (0.2%) 10 (2%) 2 (0.4%) Signs and Symptoms of Orthostasis In the two U.S. studies, symptomatic postural hypotension was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group, and by no patients in the placebo group.

Syncope was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group, and 0.6% of patients (3 of 493) in the placebo group. Dizziness was reported by 15% of patients (75 of 502) in the 0.4 mg group, 17% of patients (84 of 492) in the 0.8 mg group, and 10% of patients (50 of 493) in the placebo group. Vert…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Tamsulosin hydrochloride capsules 0.4 mg should not be used with strong inhibitors of CYP3A4 (e.g., ketoconazole). Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be CYP2D6 poor metabolizers, particularly at a dose higher than 0.4 mg (e.g., 0.8 mg). ( 5.2 , 7.1 , 12.3 ) Concomitant use of PDE5 inhibitors with tamsulosin can potentially cause symptomatic hypotension ( 5.2 , 7.3 , 12.3 )

7.1Cytochrome P450 Inhibition Strong and Moderate Inhibitors of CYP3A4 or CYP2D6 Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6. Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) resulted in an increase in the C max and AUC of tamsulosin by a factor of 2.2 and 2.8, respectively [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ]. The effects of concomitant administration of a moderate CYP3A4 inhibitor (e.g., erythromycin) on the pharmacokinetics of tamsulosin hydrochloride have not been evaluated [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ].

Concomitant treatment with paroxetine (a strong inhibitor of CYP2D6) resulted in an increase in the C max and AUC of tamsulosin by a factor of 1.3 and 1.6, respectively [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ]. A similar increase in exposure is expected in CYP2D6 poor metabolizers (PM) as compared to extensive metabolizers (EM). Since CYP2D6 PMs cannot be readily identified and the potential for significant increase in tamsulosin exposure exists when tamsulosin hydrochloride 0.4 mg is coadministered with strong CYP3A4 inhibitors in CYP2D6 PMs, tamsulosin hydrochloride 0.4 mg capsules should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ].

The effects of concomitant administration of a moderate CYP2D6 inhibitor (e.g., terbinafine) on the pharmacokinetics of tamsulosin hydrochloride have not been evaluated [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ]. The effects of coadministration of both a CYP3A4 and a CYP2D6 inhibitor with tamsulosin hydrochloride capsules have not been evaluated. However, there is a potential for significant increase in tamsulosin exposure when tamsulosin hydrochloride 0.4 mg is coadministered with a combination of both CYP3A4 and CYP2D6 inhibitors [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ].

Cimetidine Treatment with cimetidine resulted in a significant decrease (26%) in the clearance of tamsulosin hydrochloride, which resulted in a moderate increase in tamsulosin hydrochloride AUC (44%) [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ].

7.2Other Alpha Adrenergic Blocking Agents The pharmacokinetic and pharmacodynamic interactions between tamsulosin hydrochloride capsules and other alpha adrenergic blocking agents have not been determined; however, interactions between tamsulosin hydrochloride capsules and other alpha adrenergic blocking agents may be expected [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ].

7.3PDE5 Inhibitors Caution is advised when alpha adrenergic blocking agents including tamsulosin hydrochloride are coadministered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [ see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ].

7.4Warfarin A definitive drug-drug interaction study between tamsulosin hydrochloride and warfarin was not conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution s…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Not indicated for use in pediatric populations ( 8.4 , 12.3 ) Geriatric Use: No overall differences in efficacy or safety vs younger patients, but greater sensitivity of some older adults cannot be ruled out ( 8.5 , 12.3 ) Renal Impairment: Has not been studied in patients with end-stage renal disease ( 8.6 , 12.3 ) Hepatic Impairment: Has not been studied in patients with severe hepatic impairment ( 8.7 , 12.3 )

8.1Pregnancy Risk Summary Tamsulosin hydrochloride capsule is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride capsules in pregnant women. No adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [ see Data ] .

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Administration of tamsulosin hydrochloride to pregnant female rats during the period of organogenesis at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. Administration of tamsulosin hydrochloride to pregnant rabbits during the period of organogenesis at dose levels up to 50 mg/kg/day produced no evidence of fetal harm.

8.2Lactation Tamsulosin hydrochloride capsule is not indicated for use in women. There are no data on the presence of tamsulosin hydrochloride in human milk, the effects of tamsulosin hydrochloride on the breastfed infant, or the effects of tamsulosin hydrochloride on milk production. Tamsulosin hydrochloride is present in the milk of lactating rats [ see Data ] .

Data Oral administration of radiolabeled tamsulosin hydrochloride to rats demonstrated that tamsulosin hydrochloride and/or its metabolites are excreted into the milk of rats.

8.3Females and Males of Reproductive Potential Infertility Males Abnormal ejaculation including ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease has been associated with tamsulosin hydrochloride capsule [ see Clinical Trials Experience (6.1) ] . Studies in rats revealed significantly reduced fertility in males considered to be due to impairment of ejaculation, which was reversible [ see Nonclinical Toxicology (13.1) ] . Females Tamsulosin hydrochloride capsule is not indicated for use in women.

Female fertility in rats was significantly reduced, considered to be due to impairment of fertilization [ see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use Tamsulosin hydrochloride capsules are not indicated for use in pediatric populations. Efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 years of age with elevated detrusor leak point pressure (>40 cm H 2 O) associated with known neurological disorder (e.g., spina bifida). Patients in both studies were treated on a weight-based mg/kg schema (0.025 mg, 0.05 mg, 0.1 mg, 0.2 mg, or 0.4 mg tamsulosin hydrochloride) for the reduction in detrusor leak point pressure below 40 cm H 2 O.

In a randomized, double-blind, placebo-controlled, 14-week, pharmacokinetic, safety and efficacy study in 161 patients, no statistically significant difference in the proportion of responders was observed between groups receiving tamsulosin hydrochloride and placebo. In an open-label, 12-month safety study, 87 patients were treated with tamsulosin hydrochloride. The most frequently reported adverse events (≥5%) from the pooled data of both studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation.

8.5 Geriatric Use Of the total number of subjects (1783) in cli…

🤰 Pregnancy 165 words ▾

8.1Pregnancy Risk Summary Tamsulosin hydrochloride capsule is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride capsules in pregnant women. No adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [ see Data ] .

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Administration of tamsulosin hydrochloride to pregnant female rats during the period of organogenesis at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. Administration of tamsulosin hydrochloride to pregnant rabbits during the period of organogenesis at dose levels up to 50 mg/kg/day produced no evidence of fetal harm.

🧒 Pediatric Use 169 words ▾

8.4Pediatric Use Tamsulosin hydrochloride capsules are not indicated for use in pediatric populations. Efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 years of age with elevated detrusor leak point pressure (>40 cm H 2 O) associated with known neurological disorder (e.g., spina bifida). Patients in both studies were treated on a weight-based mg/kg schema (0.025 mg, 0.05 mg, 0.1 mg, 0.2 mg, or 0.4 mg tamsulosin hydrochloride) for the reduction in detrusor leak point pressure below 40 cm H 2 O.

In a randomized, double-blind, placebo-controlled, 14-week, pharmacokinetic, safety and efficacy study in 161 patients, no statistically significant difference in the proportion of responders was observed between groups receiving tamsulosin hydrochloride and placebo. In an open-label, 12-month safety study, 87 patients were treated with tamsulosin hydrochloride. The most frequently reported adverse events (≥5%) from the pooled data of both studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation.

🧓 Geriatric Use 75 words ▾

8.5Geriatric Use Of the total number of subjects (1783) in clinical studies of tamsulosin, 36% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [ see Clinical Pharmacology ( 12.3 ) ].

🆘 Overdosage 106 words ▾

10 OVERDOSAGE Should overdosage of tamsulosin hydrochloride capsules lead to hypotension [ see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ] , 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, then administration of intravenous fluids should be considered.

If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that tamsulosin hydrochloride is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate.

The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck leading to constriction of the bladder outlet. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha 1 adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH.

Tamsulosin, an alpha 1 adrenoceptor blocking agent, exhibits selectivity for alpha 1 receptors in the human prostate. At least three discrete alpha 1 adrenoceptor subtypes have been identified: alpha 1A , alpha 1B , and alpha 1D ; their distribution differs between human organs and tissue. Approximately 70% of the alpha 1 receptors in the human prostate are of the alpha 1A subtype.

Tamsulosin hydrochloride capsules are not intended for use as an antihypertensive drug.

12.2Pharmacodynamics Urologic pharmacodynamic effects have been evaluated in neurologically impaired pediatric patients and in adults with BPH [ see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14 ) ].

12.3Pharmacokinetics The pharmacokinetics of tamsulosin hydrochloride have been evaluated in adult healthy volunteers and patients with BPH after single and/or multiple administration with doses ranging from 0.1 mg to 1 mg. Absorption Absorption of tamsulosin hydrochloride from tamsulosin hydrochloride capsules 0.4 mg is essentially complete (>90%) following oral administration under fasting conditions. Tamsulosin hydrochloride exhibits linear kinetics following single and multiple dosing, with achievement of steady-state concentrations by the fifth day of once-a-day dosing.

Effect of Food The time to maximum concentration (T max ) is reached by 4 to 5 hours under fasting conditions and by 6 to 7 hours when tamsulosin hydrochloride capsules are administered with food. Taking tamsulosin hydrochloride capsules under fasted conditions results in a 30% increase in bioavailability (AUC) and 40% to 70% increase in peak concentrations (C max ) compared to fed conditions (Figure 1). Figure 1 Mean Plasma Tamsulosin Hydrochloride Concentrations Following Single-Dose Administration of Tamsulosin Hydrochloride Capsules 0.4 mg Under Fasted and Fed Conditions (n=8) The effects of food on the pharmacokinetics of tamsulosin hydrochloride are consistent regardless of whether a tamsulosin hydrochloride capsule is taken with a light breakfast or a high-fat breakfast (Table 2).

Table 2 Mean (± S.D.) Pharmacokinetic Parameters Following Tamsulosin Hydrochloride Capsules 0.4 mg Once Daily or 0.8 mg Once Daily with a Light Breakfast, High-Fat Breakfast or Fasted Pharmacokinetic Parameter 0.4 mg QD to healthy volunteers; n=23 (age range 18 to 32 years) 0.8 mg QD to healthy volunteers; n=22 (age range 55 to 75 years) Light Breakfast Fasted Light Breakfast High-Fat Breakfast Fasted C min (ng/mL) 4 ± 2.6 3.8 ± 2.5 12.3 ± 6.7 13.5 ± 7.6 13.3 ±

13.3C max (ng/mL) 10.1 ± 4.8 17.1 ± 17.1 29.8 ± 10.3 29.1 ± 11 41.6 ±

15.6C max /C min Ratio 3.1 ± 1 5.3 ± 2.2 2.7 ± 0.7 2.5 ± 0.8 3.6 ±

1.1T max (hours) 6 4 7 6.6 5 T 1/2 (hours) - - - - 14.9 ±

3.9AUC t (ng•hr/mL) 151 ± 81.5 199 ± 94.1 440 ± 195 449 ± 217 557 ± 257 C min = observed minimum concentration C max = observed maximum tamsulosin hydrochloride plasma concentration T max = median time-to-maximum concentration T 1/2 =…

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate.

The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck leading to constriction of the bladder outlet. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha 1 adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH.

Tamsulosin, an alpha 1 adrenoceptor blocking agent, exhibits selectivity for alpha 1 receptors in the human prostate. At least three discrete alpha 1 adrenoceptor subtypes have been identified: alpha 1A , alpha 1B , and alpha 1D ; their distribution differs between human organs and tissue. Approximately 70% of the alpha 1 receptors in the human prostate are of the alpha 1A subtype.

Tamsulosin hydrochloride capsules are not intended for use as an antihypertensive drug.

📦 How Supplied / Storage and Handling 135 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tamsulosin hydrochloride capsules USP, 0.4 mg are supplied in high density polyethylene bottles as follows: Hard gelatin capsules, size ‘2’ Olive Green colored cap and Light Yellow colored body with “160” imprinted in black ink on cap and body, containing white to off white pellets. Bottles of 30’s with Child Resistant Cap……………NDC 62756-160-83 Bottles of 90’s with Child Resistant Cap……………NDC 62756-160-81 Bottles of 100’s with Child Resistant Cap…………..NDC 62756-160-88 Bottles of 100’s with Non Child Resistant Cap……..NDC 62756-160-08 Bottles of 500’s with Non Child Resistant Cap……..NDC 62756-160-13 Bottles of 1000’s with Non Child Resistant Cap…....NDC 62756-160-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.

📋 Description 185 words ▾

11 DESCRIPTION Tamsulosin hydrochloride is an antagonist of alpha 1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R )-5-[2-[[2-( o -Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 230°C.

It is slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol, sparingly soluble in methanol, slightly soluble in glacial acetic acid, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C 20 H 28 N 2 O 5 S • HCl. The molecular weight of tamsulosin hydrochloride is 444.98.

Its structural formula is: Each tamsulosin hydrochloride capsule USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, methacrylic acid copolymer dispersion, hypromellose acetate succinate, triethyl citrate, talc, and sodium lauryl sulfate. The capsule shell contains gelatin, sodium lauryl sulfate, FD&C blue No. 2, ferric oxide red, ferric oxide yellow, and titanium dioxide.

Imprinting black ink contains shellac, dehydrated alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. It meets USP Dissolution Test 9. chemical-structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypotension Advise the patient about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when taking tamsulosin hydrochloride capsules, and they should be cautioned about driving, operating machinery, or performing hazardous tasks [ see Warnings and Precautions ( 5.1 ) ]. Drug Interactions Advise the patient that tamsulosin hydrochloride capsules should not be used in combination with strong inhibitors of CYP3A4 [ see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.1 ) ].

Priapism Advise the patient about the possibility of priapism as a result of treatment with tamsulosin hydrochloride capsules and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [ see Warnings and Precautions ( 5.3 ) ]. Screening for Prostate Cancer Prostate cancer and BPH frequently coexist; therefore, screen patients for the presence of prostate cancer prior to treatment with tamsulosin hydrochloride capsules and at regular intervals afterwards [ see Warnings and Precautions ( 5.4 ) ].

Intraoperative Floppy Iris Syndrome Advise the patient when considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken tamsulosin hydrochloride capsules [ see Warnings and Precautions ( 5.5 ) ]. Administration Advise the patient that tamsulosin hydrochloride capsules should not be crushed, chewed or opened [ see Dosage and Administration ( 2 ) ]. FDA-approved Patient Labeling Patient labeling provided as a separate leaflet is reprinted at the end of this prescribing information.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62756-0159-11 · SUN 62756-0170-14 · SUN →
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.