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Losartan Potassium and Hydrochlorothiazide 100 mg; 12.5 mg Tablet, Film Coated, 90-count — NDC 43547-0425-09 package photo

Losartan Potassium and Hydrochlorothiazide 100 mg; 12.5 mg Tablet, Film Coated, 90-count

by Solco Healthcare US, LLC · 90 TABLET, FILM COATED in 1 BOTTLE (43547-425-09)
NDC 43547-0425-09
🏷️ FDA NDC (as labeled) 43547-425-09 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$0.0750 NADAC Per package$6.75 / 90 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2716/unit · Part D plans $0.1658/unit — full pricing hub ↓
Also comes in: 30 tablets 43547-0425-03 1000 tablets 43547-0425-11
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 3, 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

⚠️
Other active recalls for Losartan Potassium And Hydrochlorothiazide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 7, 2024 — Presence of foreign substance: plastic-like substance. (MACLEODS PHARMA USA, INC) · FDA recall D-0498-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 43547-425-09
Product NDC 43547-425
11-digit billing NDC 43547042509
NCPDP billing unit EA — each (per item)
RxCUI 979464, 979468, 979471
UNII 3ST302B24A, 0J48LPH2TH
UPC 0343547424091, 0343547425098, 0343547423094
Application # ANDA204901
SPL Set ID 6d677f9e-c0e4-4d6e-bea2-a58e986e4635
Established class (EPC) Thiazide Diuretic
Physiologic effect Increased Diuresis
Chemical class Thiazides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-02-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
GPI-14 36994002450325
GPI class Losartan Potassium-HCTZ
GCN Seq No 059919
GCN 25851
HICL code 009863
Ingredient (HICL) Losartan/Hydrochlorothiazide
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4I
Therapeutic class — specific (HIC3) Angiotensin Receptor Antag.-Thiazide Diuretic Comb
AHFS code 24:32.08.00
AHFS class Angiotensin Ii Receptor Antagonists
FDB label name LOSARTAN-HCTZ 100-12.5 MG TAB
FDB brand name Losartan-Hydrochlorothiazide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 43547-425-09 — 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 → 43547-0425-09. 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 Angiotensin 2 Receptor Blocker class.

Pharmacologic class Angiotensin 2 Receptor Blocker
Drug family (ATC) Angiotensin II receptor blockers (ARBs), plain
How it works Angiotensin 2 Receptor 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

LabelerSolco Healthcare US, LLC
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA204901 (ANDA)
Labeler code43547
First marketedFeb 2018
Product typeHuman Prescription Drug
Portfolio134 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 LOSARTAN-HCTZ 100-12.5 MG TAB Ingredient Losartan/Hydrochlorothiazide
📗 Our plain-language guide HelloPharmacist
  • It's working in two ways at once to lower your blood pressure. Losartan relaxes your blood vessels by blocking a hormone called angiotensin II that would otherwise tighten them. Hy...
  • What exactly is this medication doing for me?
  • You can take it with or without food — a meal won't significantly change how well it works. Picking a consistent time each day (morning is common) helps you remember it and keeps y...
  • Can I take this with food, and does it matter what time of day I take it?
📖 Read our full Hydrochlorothiazide / Losartan 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 Yellow / White
ShapeCapsule
ImprintHH;212
Size15 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 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 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 $0.075 $6.75 / 90 tablets
Medicaid paysCMS SDUD · 12 mo $0.2716 $24.44 / 90 tablets
Medicare drug plans payPart D · Q2 2026 $0.1658 $14.92 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.209 $0.074
▼ Down 58% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 00093-7369-10 Teva 1000 tablets $0.075 AB Availability likely —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 16714-0224-01 NorthStar 30 tablets $0.075 AB Availability likely —
Losartan potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 33342-0051-07 Macleods 30 tablets $0.075 AB Availability likely —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mgthis 43547-0425-09 Solco 90 tablets $0.075 AB Availability likely —
Hyzaar 100 mg/1; 12.5 mg 78206-0140-01 Organon 30 tablets $6.820 AB Availability likely +8999%
losartan potassium and hydrochlorothiazide 12.5 mg/1; 100 mg 29300-0191-01 Unichem 100 tablets — AB FDA listed —
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 12.5 mg 31722-0756-10 Camber 1000 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 42291-0503-90 AvKARE 90 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 46708-0449-10 Alembic 10 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 50090-1745-00 A-S 30 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 50090-5960-00 A-S 30 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 59746-0338-01 Jubilant 100 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 62332-0049-10 Alembic 10 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 63187-0727-30 Proficient 30 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 63187-0918-30 Proficient 30 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 63629-2431-01 Bryant 1000 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 65862-0469-10 Aurobindo 10 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 68071-4159-03 NuCare 30 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 12.5 mg/1; 100 mg 68180-0216-01 Lupin 100 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 12.5 mg/1; 100 mg 68788-8632-01 Preferred 100 tablets — AB FDA listed —
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 12.5 mg 70010-0188-03 Granules 30 tablets — — FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 70518-3398-00 REMEDYREPACK 90 tablets — AB Discontinued —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 71335-2572-01 Bryant 30 tablets — AB FDA listed —
losartan potassium and hydrochlorothiazide 12.5 mg/1; 100 mg 71335-2662-01 Bryant 30 tablets — AB FDA listed —
losartan potassium and hydrochlorothiazide 12.5 mg/1; 100 mg 71335-2827-01 Bryant 90 tablets — AB FDA listed —
Losartan potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 71335-3048-01 Bryant 1000 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 72162-1700-00 Bryant 1000 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 72162-2315-00 Bryant 1000 tablets — AB FDA listed —
losartan potassium and hydrochlorothiazide 12.5 mg/1; 100 mg 72162-2461-00 Bryant 1000 tablets — AB FDA listed —
Losartan potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 72162-2492-00 Bryant 1000 tablets — AB FDA listed —
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 12.5 mg 72189-0098-90 Direct_Rx 90 tablets — AB FDA listed —
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 12.5 mg 72189-0167-30 Direct_Rx 30 tablets — AB FDA listed —
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 12.5 mg 72189-0290-90 DirectRx 90 tablets — AB FDA listed —
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 12.5 mg 72189-0327-90 Direct 90 tablets — AB FDA listed —
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 12.5 mg 82804-0103-90 Proficient 90 tablets — 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

🏛️
2018
On the market since
Feb 2018
📍
2026
Currently FDA-listed
8 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 43547-0425-09, 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
52.9K
Units reimbursed last 4 qtrs
2.4M
Gross reimbursed last 4 qtrs
$657K
Avg / prescription
$12.42
Avg / unit
$0.2716
Latest quarter Q4 2025
13.6KRx
Medicaid pays / ea
$0.2716
gross reimbursed
vs
NADAC / ea
$0.0750
acquisition cost
=
Spread
+$0.1966
+262% 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 ⓘ
43% FFS 57% MCO
Fee-for-service · 22,743 Rx Managed care · 30,160 Rx
State Medicaid map
Alaska: no data reported AK Maine: 4,220 units · 303 per 100k residents ME Washington: 15,504 units · 198 per 100k residents WA Idaho: 9,434 units · 480 per 100k residents ID Montana: 4,023 units · 355 per 100k residents MT North Dakota: 406 units · 51.9 per 100k residents ND Minnesota: 22,846 units · 398 per 100k residents MN Wisconsin: 17,419 units · 295 per 100k residents WI Michigan: 67,018 units · 668 per 100k residents MI New York: 554,989 units · 2,836 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,284 units · 91.6 per 100k residents NH Oregon: 21,206 units · 501 per 100k residents OR Nevada: 11,247 units · 352 per 100k residents NV Wyoming: no data reported WY South Dakota: 4,032 units · 439 per 100k residents SD Iowa: 28,028 units · 874 per 100k residents IA Illinois: 40,145 units · 320 per 100k residents IL Indiana: 18,509 units · 270 per 100k residents IN Ohio: 61,291 units · 520 per 100k residents OH Pennsylvania: 54,369 units · 419 per 100k residents PA New Jersey: 79,395 units · 855 per 100k residents NJ Massachusetts: 79,931 units · 1,142 per 100k residents MA California: 253,300 units · 650 per 100k residents CA Utah: 10,530 units · 308 per 100k residents UT Colorado: 10,905 units · 186 per 100k residents CO Nebraska: 7,267 units · 367 per 100k residents NE Missouri: 24,518 units · 396 per 100k residents MO Kentucky: 38,683 units · 855 per 100k residents KY West Virginia: 13,452 units · 760 per 100k residents WV Virginia: 133,896 units · 1,536 per 100k residents VA Maryland: 105,925 units · 1,714 per 100k residents MD Connecticut: 78,305 units · 2,165 per 100k residents CT Rhode Island: 21,458 units · 1,960 per 100k residents RI Arizona: 9,430 units · 127 per 100k residents AZ New Mexico: 6,619 units · 313 per 100k residents NM Kansas: 2,190 units · 74.5 per 100k residents KS Arkansas: 3,390 units · 111 per 100k residents AR Tennessee: 25,200 units · 354 per 100k residents TN North Carolina: 123,990 units · 1,144 per 100k residents NC South Carolina: 53,392 units · 994 per 100k residents SC Delaware: 2,640 units · 256 per 100k residents DE Oklahoma: 11,750 units · 290 per 100k residents OK Louisiana: 60,982 units · 1,333 per 100k residents LA Mississippi: 10,622 units · 361 per 100k residents MS Alabama: 15,454 units · 303 per 100k residents AL Georgia: 42,160 units · 382 per 100k residents GA D.C.: 40,786 units · 6,007 per 100k residents DC Hawaii: 6,078 units · 424 per 100k residents HI Texas: 24,758 units · 81.2 per 100k residents TX Florida: 21,591 units · 95.5 per 100k residents FL
Units reimbursed · per 100k residents
51.96,007
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 D.C. 6,007 /100k
2 New York 2,836 /100k
3 Connecticut 2,165 /100k
4 Rhode Island 1,960 /100k
5 Maryland 1,714 /100k
6 Virginia 1,536 /100k
7 Louisiana 1,333 /100k
8 North Carolina 1,144 /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.
90 tablets this page43547-0425-09 52,903 Rx · $657,036
1000 tablets43547-0425-11 41,269 Rx · $414,405
30 tablets43547-0425-03 5,226 Rx · $63,316
Drug total (last 4 qtrs): 99,398 Rx · 4,277,162 units · $1,134,756 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 Losartan potassium and hydrochlorothiazide — the ingredient across all brands.

Top reported reactions

Nausea774
Fatigue688
Dizziness590
Headache563
Diarrhoea534
Dyspnoea512
Pain511

Reporter sex

0 reports

Serious outcomes

Death698
Disabling469
Life-threatening425
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 568 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
43547-0425-03 30 TABLET, FILM COATED in 1 BOTTLE (43547-425-03) $0.0750 / ea $2.25 2018-02-15 Active
43547-0425-09 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE (43547-425-09) $0.0750 / ea $6.75 2018-02-15 Active
43547-0425-11 1000 TABLET, FILM COATED in 1 BOTTLE (43547-425-11) $0.0750 / ea $74.95 2018-02-15 Active

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

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0750 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 53% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 43547-0425-09?
NDC 43547-0425-09 is a 90-count package — 90 tablet, film coated in 1 bottle.
What is the difference between NDC 43547-0425-09 and NDC 43547-0425-03?
Both are Losartan Potassium and Hydrochlorothiazide 100 mg; 12.5 mg Tablet, Film Coated — the drug itself is identical. NDC 43547-0425-09 is the 90-count package, while NDC 43547-0425-03 is the 30 tablets package.
What NDC number is used to bill for this package of Losartan Potassium and Hydrochlorothiazide 100 mg; 12.5 mg Tablet, Film Coated?
Bill NDC 43547-0425-09 — the 11-digit billing format is 43547042509. 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 86 words ▾

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 )]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Losartan potassium and hydrochlorothiazide tablets are a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.

There is evidence that this benefit does not apply to Black patients. ( 1.2 )

1.1Hypertension Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide.

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 1 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. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients [see Clinical Studies ( 14 ) and Dosage and Administration ( 2.1 )].

Losartan potassium and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

1.2Hypertensive Patients with Left Ventricular Hypertrophy Losartan potassium and hydrochlorothiazide tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. [See Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 ), and Dosage and Administration ( 2.2 ).]

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Hypertension • Usual starting dose: 50 mg/12.5 mg once daily. ( 2.1 ) • Titrate as needed to a maximum dose of 100 mg/25 mg. ( 2.1 ) Hypertensive Patients with Left Ventricular Hypertrophy • Not controlled on monotherapy: Initiate with 50 mg/12.5 mg. Titrate as needed to a maximum of 100 mg/25 mg. ( 2.2 )

2.1Hypertension The usual starting dose of losartan potassium and hydrochlorothiazide tablets is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily as needed to control blood pressure [see Clinical Studies ( 14.2 )]. Initiate a patient whose blood pressure is not adequately controlled with losartan 50 mg monotherapy with losartan potassium and hydrochlorothiazide tablets 50/12.5 once daily.

If blood pressure remains uncontrolled after about 3 weeks of therapy, the dosage may be increased to two tablets of losartan potassium and hydrochlorothiazide tablets 50/12.5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablets 100/25 once daily. Initiate a patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy with losartan potassium and hydrochlorothiazide tablets 100/12.5 (losartan 100 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of losartan potassium and hydrochlorothiazide tablets 50/12.5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablets 100/25 once daily.

Initiate a patient whose blood pressure is inadequately controlled with hydrochlorothiazide 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen, on losartan potassium and hydrochlorothiazide tablets 50/12.5 once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. Evaluate the clinical response to losartan potassium and hydrochlorothiazide tablets 50/12.5 and, if blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of losartan potassium and hydrochlorothiazide tablets 50/12.5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablets 100/25 once daily.

2.2Hypertensive Patients with Left Ventricular Hypertrophy In patients whose blood pressure is not adequately controlled on 50 mg losartan potassium, initiate treatment with losartan potassium and hydrochlorothiazide tablets 50/12.5. If additional blood pressure reduction is needed, increase the dose to losartan potassium and hydrochlorothiazide tablets 100/12.5, followed by losartan potassium and hydrochlorothiazide tablets 100/25. For further blood pressure reduction add other antihypertensives [see Clinical Studies ( 14 )] .

💊 Dosage Forms and Strengths 105 words ▾

3 DOSAGE FORMS AND STRENGTHS • Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg are yellow, capsule-shaped, film-coated tablets, debossed with “HH” on one side and “211” on the other side. • Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg are white to off-white, capsule-shaped, film-coated tablets, debossed with “HH” on one side and “213” on the other side. • Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg are yellow, capsule-shaped, film-coated tablets, debossed with “HH” on one side and “212” on the other side.

Tablets (losartan potassium/hydrochlorothiazide content): 50 mg/12.5 mg; 100 mg/12.5 mg; and 100 mg/25 mg. ( 3 )

⛔ Contraindications 65 words ▾

4 CONTRAINDICATIONS Losartan potassium and hydrochlorothiazide tablets are contraindicated: • In patients who are hypersensitive to any component of this product. • In patients with anuria • For coadministration with aliskiren in patients with diabetes • Hypersensitivity to any component of losartan potassium and hydrochlorothiazide tablets. ( 4 ) • Anuria. ( 4 ) • Coadministration with aliskiren in patients with diabetes. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration of losartan potassium and hydrochlorothiazide tablets. ( 5.2 ) • Monitor renal function and potassium in susceptible patients. ( 5.3 ) • Observe for clinical signs of fluid or electrolyte imbalance. ( 5.5 ) • Acute angle-closure glaucoma. ( 5.6 ) • Exacerbation of systemic lupus erythematosus. ( 5.7 )

5.1Fetal Toxicity Losartan potassium and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible. Thiazides cross the placental barrier and appear in cord blood.

Adverse reactions include fetal or neonatal jaundice, thrombocytopenia [see Use in Specific Populations ( 8.1 )].

5.2Hypotension in Volume-or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume-or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan potassium and hydrochlorothiazide tablets. Correct volume or salt depletion prior to administration of losartan potassium and hydrochlorothiazide tablets. Do not use losartan potassium and hydrochlorothiazide tablets as initial therapy in patients with intravascular volume depletion.

5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on losartan potassium and hydrochlorothiazide tablets. Monitor renal function periodically in these patients.

Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on losartan potassium and hydrochlorothiazide tablets [see Drug Interactions ( 7.3 ) and Use in Specific Populations ( 8.8 )] .

5.4Hypersensitivity Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma but are more likely in patients with such a history [see Adverse Reactions ( 6.2 )] .

5.5Electrolyte and Metabolic Effects In double-blind clinical trials of various doses of losartan potassium and hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 6.7% versus 3.5% for placebo; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was 0.4% versus 0% for placebo. Losartan potassium and hydrochlorothiazide tablets contain hydrochlorothiazide which can cause hypokalemia, hyponatremia and hypomagnesemia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion.

Losartan potassium and hydrochlorothiazide tablets also contain losartan which can cause hyperkalemia. Monitor serum electrolytes periodically [see Drug Interactions ( 7.1 )] . Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia [see Drug Interactions ( 7.1 )] .

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy. Because losartan decreases uric acid, losartan in combination with hydr…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and greater than placebo) are dizziness, upper respiratory infection, cough, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Losartan potassium-hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3,889 patients treated for hypertension and left ventricular hypertrophy. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy.

In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively. In these double-blind controlled clinical trials, adverse reactions occurring in greater than 2% of subjects treated with losartan-hydrochlorothiazide and at a greater rate than placebo were: back pain (2.1% vs 0.6%), dizziness (5.7% vs 2.9%), and upper respiratory infection (6.1% vs 4.6%). The following additional adverse reactions have been reported in clinical trials with losartan potassium and hydrochlorothiazide tablets and/or the individual components: Blood and the lymphatic system disorders: Anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis.

Metabolism and nutrition disorders: Anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia and hypokalemia. Psychiatric disorders: Insomnia, restlessness. Nervous system disorders: Dysgeusia, headache, migraine, paraesthesias.

Eye disorders: Xanthopsia, transient blurred vision. Cardiac disorders: Palpitation, tachycardia. Vascular disorders: Dose-related orthostatic effects, necrotizing angiitis (vasculitis, cutaneous vasculitis).

Respiratory, thoracic and mediastinal disorders: Nasal congestion. Gastrointestinal disorders: Dyspepsia, abdominal pain, gastric irritation, cramping, nausea, vomiting, pancreatitis, sialoadenitis. Hepato-biliary disorders: Jaundice (intrahepatic cholestatic jaundice).

Skin and subcutaneous tissue disorders: Rash, pruritus, purpura, toxic epidermal necrolysis, urticaria, photosensitivity, cutaneous lupus erythematosus. Musculoskeletal and connective tissue disorders: Muscle cramps, muscle spasm. Renal and urinary disorders: Glycosuria, renal dysfunction, interstitial nephritis, renal failure.

Reproductive system and breast disorders: Erectile dysfunction/impotence. General disorders and administration site conditions: Chest pain, malaise, weakness. Investigations: Liver function abnormalities.

Cough Persistent dry cough has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to losartan 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide (n=135).

The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below. Table 1: Study 1 * HCTZ Losartan Lisinopril Cough 25% 17% 69% Study 2 † Placebo Losartan Lisinopril Cough 35% 29% 62% * Demographics = (89% Caucasian, 64% female) † Demographics = (90% Caucasian, 51% female) These studies demonstrate that the incidence of cough associated with losartan therapy, in a population th…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Agents increasing serum potassium: Risk of hyperkalemia. ( 7.1 ) • Lithium: Risk of lithium toxicity. ( 7.2 ) • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects.

( 7.3 ) • Dual inhibition of the renin-angiotensin system: increased risk of renal impairment, hypotension, syncope, and hyperkalemia. ( 7.4 ) • Antidiabetic drugs: dosage adjustment of antidiabetic may be required. ( 7.5 ) • Cholestyramine and colestipol: Reduced absorption of thiazides.

( 7.5 )

7.1Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

7.2Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics. Monitor lithium levels in patients receiving losartan potassium and hydrochlorothiazide tablets and lithium.

7.3Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors Losartan Potassium In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving losartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. Hydrochlorothiazide The administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when losartan potassium and hydrochlorothiazide tablets and non-steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.

In patients receiving diuretic therapy, coadministration of NSAIDs with angiotensin receptor blockers, including losartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving hydrochlorothiazide, losartan, and NSAID therapy.

7.4Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1,448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years.

Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end-stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. Closely monitor blood pressure, renal function, and electrolytes in patients on losartan potassium and hydrochlorothiazide tablets and other agents that affect the RAS. Do not coadminister aliskiren with losartan potassium and hydrochlorothiazide tablets in patients with diabetes.

Avoid use of aliskiren with losartan potassium and hydrochlorothiazide tablets in patients with renal impairment…

🔄 Drug / Laboratory Test Interactions 114 words ▾

7.5The Use of Hydrochlorothiazide with Other Drugs When administered concurrently, the following drugs may interact with thiazide diuretics [see Clinical Pharmacology ( 12.3 )]: Antidiabetic drugs (oral agents and insulin) — dosage adjustment of the antidiabetic drug may be required. Cholestyramine and colestipol resins — Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.

Stagger the dosage of hydrochlorothiazide and the resin such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Hepatic Impairment: Losartan potassium and hydrochlorothiazide tablets are not recommended for initial therapy, because the recommended starting dose is not available. ( 8.7 )

8.1Pregnancy Risk Summary Losartan potassium and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible (see Clinical Considerations). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.

Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Losartan: Use of drugs that act on the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.

Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue losartan potassium and hydrochlorothiazide tablets, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of gestation.

Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates with histories of in utero exposure to losartan potassium and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to losartan potassium and hydrochlorothiazide tablets, if oliguria or hypotension occurs, support blood pressure and renal perfusion.

Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Hydrochlorothiazide: Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion.

It accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not alter the course of pre-eclampsia, these drugs should not be used to treat hypertension in pregnant women.

The use of hydrochlorothiazide for other indications in pregnancy should be avoided. Data Animal Data There was no evidence of teratogenicity in rats or rabbits treated with a maximum losartan potassium dose of 10 mg/kg/day in…

🤰 Pregnancy 30 words ▾

8.7Hepatic Impairment Initiation of losartan potassium and hydrochlorothiazide tablets is not recommended for patients with hepatic impairment because the appropriate starting dose of losartan, 25 mg, is not available.

🆘 Overdosage 149 words ▾

10 OVERDOSAGE Losartan Potassium Significant lethality was observed in mice and rats after oral administration of 1,000 mg/kg and 2,000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m 2 basis. Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.

If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis. Hydrochlorothiazide The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Losartan Potassium Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland).

There is also an AT 2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. Neither losartan nor its principal active metabolite exhibits any partial agonist activity at the AT 1 receptor, and both have much greater affinity (about 1,000-fold) for the AT 1 receptor than for the AT 2 receptor. In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT 1 receptor.

The active metabolite is 10 to 40 times more potent by weight than losartan and appears to be a reversible, non-competitive inhibitor of the AT 1 receptor. Neither losartan nor its active metabolite inhibits ACE (kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin), nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Hydrochlorothiazide Hydrochlorothiazide is a thiazide diuretic.

Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

The mechanism of the antihypertensive effect of thiazides is unknown.

12.2Pharmacodynamics Losartan Potassium Losartan inhibits the pressor effect of angiotensin II (as well as angiotensin I) infusions. A dose of 100 mg inhibits the pressor effect by about 85% at peak with 25-40% inhibition persisting for 24 hours. Removal of the negative feedback of angiotensin II causes a doubling to tripling in plasma renin activity and consequent rise in angiotensin II plasma concentration in hypertensive patients.

Losartan does not affect the response to bradykinin, whereas ACE inhibitors increase the response to bradykinin. Aldosterone plasma concentrations fall following losartan administration. In spite of the effect of losartan on aldosterone secretion, very little effect on serum potassium was observed.

The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3-6 weeks. In long-term follow-up studies (without placebo control) the effect of losartan appeared to be maintained for up to a year. There is no apparent rebound effect after abrupt withdrawal of losartan.

There was essentially no change in average heart rate in losartan-treated patients in controlled trials. Hydrochlorothiazide After oral administration of hydrochlorothiazide, diuresis begins within 2 hours, peaks in about 4 hours, and lasts about 6 to 12 hours. Drug Interactions Hydrochlorothiazide Alcohol, barbiturates, or narcotics — potentiation of orthostatic hypotension may occur.

Other antihypertensive drugs — additive effect or potentiation. Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) — possible increased responsiveness to the muscle relaxant. Corticosteroids, ACTH, or glycyrrhizin (found in liquorice) — intensified elec…

📦 How Supplied / Storage and Handling 88 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Losartan potassium and hydrochlorothiazide tablets, USP are supplied as a film-coated tablet. Losartan/ Hydrochlorothiazide Color Shape Engraving NDC 43547-xxx-xx Bottle/ 30 Bottle/ 90 Bottle/ 1,000 50 mg/12.5 mg yellow capsule-shaped HH/211 423-03 423-09 423-11 100 mg/12.5 mg white to off-white capsule-shaped HH/213 425-03 425-09 425-11 100 mg/25 mg yellow capsule-shaped HH/212 424-03 424-09 424-11 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep container tightly closed. Protect from light.

📋 Description ~2 min read ▾

11 DESCRIPTION Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p- ( o -1 H -tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22 H 22 ClKN 6 O, and its structural formula is: Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01.

It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP.

Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are colloidal silicon dioxide, lactose monohydrate, macrogol/polyethylene glycol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, pregelatinized starch, talc and titanium dioxide.

Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg and 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake and FD&C blue No. 1/brilliant blue FCF aluminum lake.

Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg also contain lecithin. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium. figure-01 figure-02

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy: Advise female patients of childbearing age about the consequences of exposure to losartan potassium and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant.

Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider. Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure.

If syncope occurs, advise patients to contact their healthcare provider [see Warnings and Precautions ( 5.2 )] . Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions ( 7.1 )] . Acute Myopia and Secondary Angle-closure Glaucoma: Advise patients to discontinue losartan potassium and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions ( 5.6 )].

Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening. Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Manufactured by : Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Zhejiang Huahai Pharmaceutical Technology Co., Ltd.

Jiangnan, Linhai, Zhejiang 317000, China Revised: 11/2025 200499-05 (ZHP Xunqiao) 205050-03 (ZHT Jiangnan)

💬 Medication Guide ~3 min read ▾

FDA-approved patient labeling Patient Information Losartan Potassium and Hydrochlorothiazide Tablets, USP (loe-SAR-tanpoe-TAS-see-um and hye-droe-klor-oh-THYE-ah-zide) 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg Rx only Read the Patient Information that comes with losartan potassium and hydrochlorothiazide tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment.

What is the most important information I should know about losartan potassium and hydrochlorothiazide tablets? • Losartan potassium and hydrochlorothiazide tablets can cause harm or death to an unborn baby. • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. • If you get pregnant while taking losartan potassium and hydrochlorothiazide tablets tell your doctor right away. What are losartan potassium and hydrochlorothiazide tablets? Losartan potassium and hydrochlorothiazide tablets contain 2 prescription medicines, an angiotensin receptor blocker (ARB) and a diuretic (water pill).

It is used to: • lower high blood pressure (hypertension). Losartan potassium and hydrochlorothiazide tablets are not usually the first medicine used to treat high blood pressure. • lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy (LVH). Losartan potassium and hydrochlorothiazide tablets may not help Black patients with this problem.

Losartan potassium and hydrochlorothiazide tablets have not been studied in children less than 18 years old. High Blood Pressure (hypertension). Blood pressure is the force in your blood vessels when your heart beats and when your heart rests.

You have high blood pressure when the force is too much. The losartan ingredient in losartan potassium and hydrochlorothiazide tablets can help your blood vessels relax so your blood pressure is lower. The hydrochlorothiazide ingredient in losartan potassium and hydrochlorothiazide tablets works by making your kidneys pass more water and salt.

Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart’s main pumping chamber). LVH can happen from several things. High blood pressure is the most common cause of LVH.

Who should not take losartan potassium and hydrochlorothiazide tablets? Do not take losartan potassium and hydrochlorothiazide tablets if you: • are allergic to any ingredients in losartan potassium and hydrochlorothiazide tablets. See a complete list of ingredients in losartan potassium and hydrochlorothiazide tablets at the end of this leaflet. • are not passing urine. • have diabetes and are taking a medicine called aliskiren to reduce blood pressure.

What should I tell my doctor before taking losartan potassium and hydrochlorothiazide tablets? Tell your doctor about all your medical conditions including if you: • are pregnant or planning to become pregnant. See "What is the most important information I should know about losartan potassium and hydrochlorothiazide tablets?" • are breastfeeding or plan to breastfeed.

Losartan potassium and Hydrochlorothiazide can pass into your milk and may harm your baby. You and your doctor should decide if you will take losartan potassium and hydrochlorothiazide tablets or breastfeed. You should not do both. • have been vomiting (throwing up), having diarrhea, sweating a lot, or not drinking enough fluids.

These could cause you to have low blood pressure. • have liver problems • have kidney problems • have systemic lupus erythematosus (Lupus; SLE) • have diabetes • have gout • have any allergies • have had skin cancer or if you develop a new skin lesion during the treatment. Treatment with hydrochlorothiazide may increase the risk of some types of skin cancer (non-melanoma skin cancer). Discuss with your doctor how to protect your skin from sun exposure and how often you sh…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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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.