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Tirosint SOL Levothyroxine Sodium 13 ug/mL Solution — NDC 71858-0105-05 package photo

Tirosint SOL Levothyroxine Sodium 13 ug/mL Solution

by IBSA Pharma Inc. · 6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6)
NDC 71858-0105-05
🏷️ FDA NDC (as labeled) 71858-0105-5 billing pads the package segment with a zero
This package
Contains1 mL in 1 ampule Pack sizes3 compare ↓
Also priced by: Part D plans $5.15/unit — full pricing hub ↓
Also comes in: 2 pouches 71858-0105-01 6 pouches 71858-0105-02
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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 Levothyroxine Sodium (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0781-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0786-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0782-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0775-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0777-2026
Class II · Aug 6, 2026 — Subpotent Drug (ACCORD HEALTHCARE, INC.) · FDA recall D-0776-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (6)
Class II · Jan 30, 2023 · Terminated — Subpotent Drug (IBSA PHARMA INC) · FDA recall D-0342-2023
Class II · Jan 30, 2023 · Terminated — Subpotent Drug (IBSA PHARMA INC) · FDA recall D-0339-2023
Class II · Jan 30, 2023 · Terminated — Subpotent Drug (IBSA PHARMA INC) · FDA recall D-0340-2023
Class II · Jan 30, 2023 · Terminated — Subpotent Drug (IBSA PHARMA INC) · FDA recall D-0341-2023
Class II · Jan 30, 2023 · Terminated — Subpotent Drug (IBSA PHARMA INC) · FDA recall D-0344-2023
Class II · Jan 30, 2023 · Terminated — Subpotent Drug (IBSA PHARMA INC) · FDA recall D-0345-2023

🆔 Identity & classification

FDA NDC (as labeled) 71858-0105-5
Product NDC 71858-0105
11-digit billing NDC 71858010505
NCPDP billing unit ML — per mL (volume)
RxCUI 2056462, 2056466, 2056468, 2056470, 2056472, 2056474, 2056476, 2056478,
UNII 9J765S329G
UPC 0371858011754, 0371858013055, 0371858012553, 0371858011556 +10 more
Application # NDA206977
SPL Set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Established class (EPC) l-Thyroxine
Chemical class Thyroxine
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-03-01
Route ORAL
Dosage form SOLUTION
Substance LEVOTHYROXINE SODIUM
GPI-14 28100010102025
GPI class Tirosint-SOL
GCN Seq No 076957
GCN 42807
HICL code 002849
Ingredient (HICL) Levothyroxine Sodium
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P3
Therapeutic class — intermediate (HIC2) Drugs Affecting Thyroid Function
HIC3 code P3A
Therapeutic class — specific (HIC3) Thyroid Hormones
AHFS code 68:36.04.00
AHFS class Thyroid Agents
FDB label name TIROSINT-SOL 13 MCG/ML SOLN
FDB brand name Tirosint-Sol
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 71858-0105-5 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71858-0105-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the l-Thyroxine class.

Pharmacologic class l-Thyroxine
Drug family (ATC) Thyroid hormones
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

LabelerIBSA Pharma Inc.
Application holderIBSA INSTITUT BIOCHIMIQUE SA
FDA applicationNDA206977 (NDA)
Labeler code71858
First marketedMar 2019
Product typeHuman Prescription Drug
Portfolio36 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 TIROSINT-SOL 13 MCG/ML SOLN Ingredient Levothyroxine Sodium
📖 What it is MedlinePlus · NLM

Levothyroxine is used to treat hypothyroidism (condition where the thyroid gland does not produce enough thyroid hormone). It is also used with surgery and radioactive iodine therapy to treat thyroid cancer. Levothyroxine is in a class of medications called hormones. It works by replacing thyroid hormone that is normally produced by the body. Without thyroid hormone, your body cannot function properly, which may result in poor growth, slow speech, lack of energy, excessive tiredness, constipation, weight gain, hair loss, dry, thick skin, increased sensitivity to cold, joint and muscle pain, he...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Your thyroid gland isn't making enough of a hormone called T4, which your whole body depends on to regulate your energy, metabolism, heart rate, and more. Levothyroxine is a precis...
  • What exactly is levothyroxine doing for me — why do I need to take it every day?
  • Timing really does make a difference with this medication. Food — especially high-fiber foods or anything soy-based — can block your gut from absorbing it properly. Taking it 30 to...
  • Why does it matter so much when I take it — can't I just take it with breakfast?
📖 Read our full Levothyroxine guide →
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.

🧪 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $5.15 $154.35 / 30 ml
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
Tirosint SOL 13 ug/mLthis 71858-0105-05 IBSA 6 pouches — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2016
First FDA approval
Dec 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2044
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 15, 2016 RLD RS ⏳ ~18 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3758)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 11241382 — method of use (U-3757)
US 12564565 — drug product
US 12564565 — drug product
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US 10537538 — drug product
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US 10537538 — drug product
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US 10537538 — drug product
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2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042 2044
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (75)
PatentTypeUse codeExpires
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3758 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 11241382 ↗ Method of use U-3757 Sep 17, 2039
US 12564565 ↗ Drug product — Sep 26, 2044
US 12564565 ↗ Drug product — Sep 26, 2044
US 12564565 ↗ Drug product — Sep 26, 2044
US 11096913 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 12564565 ↗ Drug product — Sep 26, 2044
US 11096913 ↗ Drug product — Feb 28, 2037
US 12564565 ↗ Drug product — Sep 26, 2044
US 12564565 ↗ Drug product — Sep 26, 2044
US 10537538 ↗ Drug product — Feb 28, 2037
US 12564565 ↗ Drug product — Sep 26, 2044
US 10537538 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 12564565 ↗ Drug product — Sep 26, 2044
US 10537538 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 12564565 ↗ Drug product — Sep 26, 2044
US 12564565 ↗ Drug product — Sep 26, 2044
US 10537538 ↗ Drug product — Feb 28, 2037
US 12564565 ↗ Drug product — Sep 26, 2044
US 12564565 ↗ Drug product — Sep 26, 2044
US 12564565 ↗ Drug product — Sep 26, 2044
US 10537538 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 12564565 ↗ Drug product — Sep 26, 2044
US 12564565 ↗ Drug product — Sep 26, 2044
US 11096913 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 10537538 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
US 11096913 ↗ Drug product — Feb 28, 2037
Common questions
Is there a generic version of TIROSINT-SOL 13 MCG/ML SOLN?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TIROSINT-SOL 13 MCG/ML SOLN. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2044 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Tirosint-Sol — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tirosint-Sol. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$987.3K
Claims incl. refills
4.3K
Beneficiaries
2.4K
Spend / beneficiary
$404.45
Spend / claim
$228.27
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Levothyroxine Sodium — the ingredient across all brands.

Top reported reactions

Fatigue26,585
Nausea22,605
Headache19,408
Diarrhoea18,759
Dyspnoea16,717
Pain16,375
Dizziness15,848

Age at onset

Neonate282
Infant75
Child220
Adolescent179
Adult19,320
Elderly21,623

Reporter sex

312,551 reports
Male · 19%
Female · 81%
Unknown · 0%

Serious outcomes

Hospitalization90,712
Death20,300
Life-threatening10,774
Disabling9,272
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 19,277 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 Marketing startStatus
71858-0105-01 2 POUCH in 1 CARTON (71858-0105-1) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) 2019-03-01 Discontinued by firm
71858-0105-05 You're viewing this 6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) 2019-03-01 Active
71858-0105-02 6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) 2025-07-25 Active

Pack size FAQ

What quantity is in NDC 71858-0105-05?
NDC 71858-0105-05 is listed by the FDA — 6 pouch in 1 carton / 5 ampule in 1 pouch / 1 ml in 1 ampule.
What NDC number is used to bill for this package of Tirosint SOL Levothyroxine Sodium 13 ug/mL Solution?
Bill NDC 71858-0105-05 — the 11-digit billing format is 71858010505. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
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📄 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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 149 words ▾

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including TIROSINT-SOL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ].

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning Thyroid hormones, including TIROSINT-SOL, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life threatening manifestations of toxicity ( 6 , 10 ).

🎯 Indications and Usage 216 words ▾

1 INDICATION AND USAGE TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use Tirosint-SOL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with TIROSINT-SOL may induce hyperthyroidism [see Warnings and Precautions (5.1) ] .

Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer once daily, on an empty stomach, 15 minutes before breakfast ( 2.1 ) Administer at least 4 hours before or after drugs that are known to interfere with absorption ( 2.1 ) Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption ( 2.1 ) To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water ( 2.1 ) To administer TIROSINT-SOL directly, either squeeze it into the mouth OR onto a spoon and immediately consume ( 2.1 ) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medications, co-administered food, and the specific nature of the condition being treated.

Peak therapeutic effect may not be attained for 4-6 weeks ( 2.2 ) See full prescribing information for dosing in specific patient populations ( 2.3 ) Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status ( 2.4 )

2.1General Administration Information Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast. Administer TIROSINT-SOL at least 4 hours before or after drugs known to interfere with TIROSINT-SOL absorption [see Drug Interactions (7.1)] . Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption [see Dosage and Administration (2.2 and 2.3) , Drug Interactions (7.9) and Clinical Pharmacology (12.3) ] .

TIROSINT-SOL may be administered in water or directly into the mouth: To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken.

Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule and prepare the solution immediately before intake. To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.

2.2Important Considerations for Dosing The dosage of TIROSINT-SOL for hypothyroidism or pituitary TSH suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated [see Dosage and Administration (2.3), Warnings and Precautions (5), and Drug Interactions (7)] . Dosing must be individualized to account for these factors and dosage adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4)] .

For adult patients with primary hypothyroidism, titrate until the patient is clinically euthyroid and the serum TSH returns to normal [see Dosage and Administration (2.3)]. For secondary or tertiary hypothyroidism, serum TSH is not a reliable measure of TIROSINT-SOL dosage adequacy and should not be used to monitor therapy. Use the serum free-T4 level to titrate TIROSINT-SOL dosing until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range [see Dosage and Administration (2.3)].

The peak therapeutic effect of a given dose of TIROSINT-SOL may not be attained for 4 to 6 weeks.

2.3Recommended Dosage and Titration Primary, Secondary, and Tertiary Hypothyroidism in Adults The recommended starting daily dosage of TIROSINT-SOL in adults with primary, secondary, or tertiary hypothyroidism is based on age and comorbid cardiac conditions, as described in Table 1. For patients at risk of atrial fibrillation or patients with underlying cardiac disease, start with a lower dosage and titrate the dosage more slowly to avoid exacer…

💊 Dosage Forms and Strengths 105 words ▾

3 DOSAGE FORMS AND STRENGTHS TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule. Each ampule bears a colored label with the dosage strength and the product name (TIROSINT-SOL) (Table 4). Table 4. TIROSINT-SOL Solution Strengths and Identifying Features Strength (mcg/mL) Color 13 Green 25 Orange

37.5 Dark Blue 44 Red 50 White 75 Purple

62.5Grey 88 Olive 100 Yellow 112 Rose 125 Brown 137 Turquoise 150 Blue 175 Lilac 200 Pink Oral solution: 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200 mcg/mL ( 3 )

⛔ Contraindications 42 words ▾

4 CONTRAINDICATIONS TIROSINT-SOL is contraindicated in patients with: Hypersensitivity to glycerol, the inactive ingredient in TIROSINT-SOL [see Adverse Events (6) ]. Uncorrected adrenal insufficiency [see Warnings and Precautions (5.4) ] Hypersensitivity to glycerol ( 4 ) Uncorrected adrenal insufficiency ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serious risks related to overtreatment or undertreatment with TIROSINT-SOL: Titrate the dose of TIROSINT-SOL carefully and monitor response to titration. ( 5.1 ) Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease : Initiate TIROSINT-SOL at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation. ( 2.3 , 5.2 , 8.5 ) Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma.

( 5.3 ) Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of TIROSINT‑SOL treatment. ( 5.4 ) Worsening of diabetic control: therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy.

( 5.5 ) Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone resorption and decrease bone mineral density. Give the lowest effective dose. 5.6 )

5.1Serious Risks Related to Overtreatment or Undertreatment with TIROSINT-SOL TIROSINT-SOL has a narrow therapeutic index. Overtreatment or undertreatment with TIROSINT-SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, gastrointestinal function, and glucose and lipid metabolism in adult or pediatric patients. In pediatric patients with congenital and acquired hypothyroidism, undertreatment may adversely affect cognitive development and linear growth, and overtreatment is associated with craniosynostosis and acceleration of bone age [see Use in Specific Populations (8.4)].

Titrate the dose of TIROSINT-SOL carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4)]. Consider the potential for food or drug interactions and adjust the administration or dosage of TIROSINT-SOL as needed [see Dosage and Administration (2.4), Drug Interactions (7.1), and Clinical Pharmacology (12.3)].

5.2Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease Overtreatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility, and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. Initiate TIROSINT-SOL therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease [see Dosage and Administration (2.3) and Use in Specific Populations (8.5) ].

Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive TIROSINT-SOL therapy. Monitor patients receiving concomitant TIROSINT-SOL and sympathomimetic agents for signs and symptoms of coronary insufficiency . If cardiac symptoms develop or worsen, reduce the TIROSINT-SOL dose or withhold it for one week and restart at a lower dose.

5.3Myxedema Coma Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Use of oral thyroid hormone drug products is not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma.

5.4Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating t…

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Adverse reactions associated with TIROSINT-SOL therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) and Overdosage (10) ]. They include the following: General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal: tremors, muscle weakness, muscle spasm Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory : dyspnea Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic: hair loss, flushing, rash Endocrine: decreased bone mineral density Reproductive: menstrual irregularities, impaired fertility Seizures have been reported rarely with the institution of levothyroxine therapy.

Adverse reactions associated with TIROSINT-SOL are primarily those of hyperthyroidism due to therapeutic overdosage including: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Adverse Reactions in Pediatric Patients Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy.

Overtreatment may result in craniosynostosis in infants who have not undergone closure of the fontanelles, and in premature closure of the epiphyses in pediatric patients still experiencing growth with resultant compromised adult height. Hypersensitivity Reactions Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include urticaria, pruritus, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness, and wheezing.

Hypersensitivity to levothyroxine itself is not known to occur.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT-SOL ( 7 )

7.1Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT-SOL (Tables 5 to 8). Table 5. Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of TIROSINT-SOL by binding and delaying or preventing absorption, potentially resulting in hypothyroidism.

Drug or Drug Class Effect Phosphate Binders (e.g., calcium carbonate, ferrous sulfate, sevelamer, lanthanum) Phosphate binders may bind to levothyroxine. Administer TIROSINT-SOL at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and TIROSINT‑SOL for changes in thyroid function.

Bile Acid Sequestrants (e.g., colesevelam, cholestyramine, colestipol Ion Exchange Resins (e.g., Kayexalate) Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption. Administer TIROSINT-SOL at least 4 hours prior to these drugs or monitor TSH levels. Sucralfate Antacids (e.g., aluminum & magnesium hydroxides, simethicone) Gastric acidity is an essential requirement for adequate absorption of levothyroxine.

However, gastric acidity may not be as essential for the absorption of TIROSINT-SOL. Sucralfate and antacids may cause hypochlorhydria, affect gastric pH, and reduce levothyroxine absorption. Monitor patients appropriately.

Table 6. Drugs That May Alter T4 and Triiodothyronine (T3) Serum Transport Without Affecting Free Thyroxine (FT4) Concentration (Euthyroidism) Drug or Drug Class Effect Clofibrate Estrogen-containing oral contraceptives Estrogens (oral) Heroin / Methadone 5-Fluorouracil Mitotane Tamoxifen These drugs may increase serum thyroxine-binding globulin (TBG) concentration. Androgens / Anabolic Steroids Asparaginase Glucocorticoids Slow-Release Nicotinic Acid These drugs may decrease serum TBG concentration.

Potential impact (below): Administration of these agents with TIROSINT-SOL results in an initial transient increase in FT4. Continued administration results in a decrease in serum T4 and normal FT4 and TSH concentrations. Salicylates (> 2 g/day) Salicylates inhibit binding of T4 and T3 to TBG and transthyretin.

An initial increase in serum FT4 is followed by return of FT4 to normal levels with sustained therapeutic serum salicylate concentrations, although total T4 levels may decrease by as much as 30%. Other drugs: Carbamazepine Furosemide (> 80 mg IV) Heparin Hydantoins Non-Steroidal Anti-inflammatory Drugs: Fenamates These drugs may cause protein-binding site displacement. Furosemide has been shown to inhibit the protein binding of T4 to TBG and albumin, causing an increase free‑T4 fraction in serum.

Furosemide competes for T4-binding sites on TBG, prealbumin, and albumin, so that a single high dose can acutely lower the total T4 level. Phenytoin and carbamazepine reduce serum protein binding of levothyroxine, and total and free‑T4 may be reduced by 20% to 40%, but most patients have normal serum TSH levels and are clinically euthyroid. Closely monitor thyroid hormone parameters.

Table 7. Drugs That May Alter Hepatic Metabolism of T4 (Hypothyroidism) Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased TIROSINT-SOL requirements. Drug or Drug Class Effect Phenobarbital Rifampin Phenobarbital has been shown to reduce the response to thyroxine.

Phenobarbital increases L-thyroxine metabolism by inducing uridine 5’ diphospho-glucuron…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy may require the use of higher doses of TIROSINT-SOL ( 2.3 , 8.1 ) See 17 for PATIENT COUNSELING INFORMATION and FDA‑approved patient labeling.

8.1Pregnancy Risk Summary The clinical experience, including data from published postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and TIROSINT‑SOL dosage adjusted during pregnancy [see Clinical Considerations ] .

Animal reproductive studies have not been conducted with levothyroxine sodium. TIROSINT-SOL should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. 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 Maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery.

Untreated maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. Dose Adjustments During Pregnancy and the Postpartum Period Pregnancy may increase TIROSINT-SOL requirements. Serum TSH levels should be monitored and the TIROSINT-SOL dosage adjusted during pregnancy.

Since postpartum TSH levels are similar to preconception values, the TIROSINT-SOL dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration (2.3) ].

8.2Lactation Risk Summary Published studies report that levothyroxine is present in human milk following the administration of oral levothyroxine. No adverse effects on the breastfed infant have been reported and this no information on the effects of levothyroxine on milk production. Adequate levothyroxine treatment during lactation may normalize milk production in hypothyroid lactating mothers with low milk supply.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TIROSINT-SOL and any potential adverse effects on the breastfed infant from TIROSINT-SOL or from the underlying maternal condition.

8.4Pediatric Use TIROSINT-SOL is indicated in patients from birth to less than 17 years of age: As a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on cognitive development as well as on overall physical growth and maturation.

Therefore, initiate TIROSINT-SOL therapy immediately upon diagnosis. Levothyroxine is generally continued for life in these patients [see Warnings and Precautions (5.1) ]. Closely monitor infants during the first two weeks of TIROSINT-SOL therapy for cardiac overload and arrhythmias.

8.5Geriatric Use Because of the increased prevalence of cardiovascular disease among the elderly, initiate TIROSINT-SOL at less than the full replacement dose [ see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtr…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary The clinical experience, including data from published postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and TIROSINT‑SOL dosage adjusted during pregnancy [see Clinical Considerations ] .

Animal reproductive studies have not been conducted with levothyroxine sodium. TIROSINT-SOL should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. 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 Maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery.

Untreated maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. Dose Adjustments During Pregnancy and the Postpartum Period Pregnancy may increase TIROSINT-SOL requirements. Serum TSH levels should be monitored and the TIROSINT-SOL dosage adjusted during pregnancy.

Since postpartum TSH levels are similar to preconception values, the TIROSINT-SOL dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration (2.3) ].

🧒 Pediatric Use 116 words ▾

8.4Pediatric Use TIROSINT-SOL is indicated in patients from birth to less than 17 years of age: As a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on cognitive development as well as on overall physical growth and maturation.

Therefore, initiate TIROSINT-SOL therapy immediately upon diagnosis. Levothyroxine is generally continued for life in these patients [see Warnings and Precautions (5.1) ]. Closely monitor infants during the first two weeks of TIROSINT-SOL therapy for cardiac overload and arrhythmias.

🧓 Geriatric Use 59 words ▾

8.5Geriatric Use Because of the increased prevalence of cardiovascular disease among the elderly, initiate TIROSINT-SOL at less than the full replacement dose [ see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly .

🆘 Overdosage 112 words ▾

10 OVERDOSAGE The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5) and Adverse Reactions (6) ]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported.

Seizures occurred in a 3-year-old child ingesting 3.6 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium. Reduce the TIROSINT-SOL dose or discontinue temporarily if signs or symptoms of overdosage occur.

Initiate appropriate supportive treatment as dictated by the patient's medical status. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.

12.2Pharmacodynamics Oral levothyroxine sodium is a synthetic T4 hormone that exerts the same physiologic effect as endogenous T4, thereby maintaining normal T4 levels when a deficiency is present.

12.3Pharmacokinetics Absorption Absorption of orally administered T4 from the gastrointestinal (GI) tract ranges from 40% to 80%. The majority of the levothyroxine dose is absorbed from the jejunum and upper ileum. The relative bioavailability of TIROSINT-SOL compared to TIROSINT capsules, is approximately 98%.

T4 absorption is increased by fasting, and decreased in malabsorption syndromes and by certain foods such as soybeans. Dietary fiber decreases the bioavailability of T4. Absorption may also decrease with age.

In addition, many drugs and foods affect T4 absorption [see Drug Interactions (7) ]. Effect of Food No clinically significant differences in levothyroxine pharmacokinetics were observed between Tirosint-SOL administered 15 minutes and 30 minutes before a high-fat high-calorie meal (about 800 – 1000 kcal, 50% fat) [see Dosage and Administration (2.1) ]. Distribution Circulating thyroid hormones are greater than 99% bound to plasma proteins, including thyroxine-binding globulin (TBG), thyroxine-binding prealbumin (TBPA), and thyroxine-binding albumin (TBA), whose capacities and affinities vary for each hormone.

The higher affinity of both TBG and TBPA for T4 partially explains the higher serum levels, slower metabolic clearance, and longer half-life of T4 compared to T3. Protein-bound thyroid hormones exist in reverse equilibrium with small amounts of free hormone. Only unbound hormone is metabolically active.

Many drugs and physiologic conditions affect the binding of thyroid hormones to serum proteins [see Drug Interactions (7) ]. Thyroid hormones do not readily cross the placental barrier [see Use in Specific Populations (8.1) ]. Elimination Metabolism T4 is slowly eliminated (Table 9) .

The major pathway of thyroid hormone metabolism is through sequential deiodination. Approximately 80% of circulating T3 is derived from peripheral T4 by monodeiodination. The liver is the major site of degradation for both T4 and T3, with T4 deiodination also occurring at a number of additional sites, including the kidney and other tissues.

Approximately 80% of the daily dose of T4 is deiodinated to yield equal amounts of T3 and reverse T3 (rT3). T3 and rT3 are further deiodinated to diiodothyronine. Thyroid hormones are also metabolized via conjugation with glucuronides and sulfates and excreted directly into the bile and gut where they undergo enterohepatic recirculation.

Excretion Thyroid hormones are primarily eliminated by the kidneys. A portion of the conjugated hormone reaches the colon unchanged and is eliminated in the feces. Approximately 20% of T4 is eliminated in the stool.

Urinary excretion of T4 decreases with age. Table 9. Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients Hormone Ratio in Thyroglobulin Biologic Potency Half-Life (Days) Protein Binding (%)* Levothyroxine (T4) 10 – 20 1 6 – 7**

99.96 Liothyronine (T3) 1 4 ≤ 2

99.5Drug Interaction Study No clinically significant differences in TIROSINT-SOL pharmacokinetics were observed when orally coadministered with omeprazole.

🧬 Mechanism of Action 79 words ▾

12.1Mechanism of Action Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.

📦 How Supplied / Storage and Handling 215 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied TIROSINT-SOL (levothyroxine sodium) oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule. The dosage strength is identified on the box and the pouch, and is associated with a distinct color. Each ampule bears a colored label with the dosage strength and the product name (TIROSINT-SOL) (Table 10).

Table 10. TIROSINT-SOL Solution Strengths and Packaging Description Strength (mcg/mL) Color a Box NDC (30 Unit-Dose Ampules) Pouch NDC (5 Unit-Dose Ampules) 13 Green 71858-0105-5 71858-0105-4 25 Orange 71858-0110-5 71858-0110-4

37.5Dark Blue 71858-0112-5 71858-0112-4 44 Red 71858-0113-5 71858-0113-4 50 White 71858-0115-5 71858-0115-4

62.5Grey 71858-0117-5 71858-0117-4 75 Purple 71858-0120-5 71858-0120-4 88 Olive 71858-0125-5 71858-0125-4 100 Yellow 71858-0130-5 71858-0130-4 112 Rose 71858-0135-5 71858-0135-4 125 Brown 71858-0140-5 71858-0140-4 137 Turquoise 71858-0145-5 71858-0145-4 150 Blue 71858-0150-5 71858-0150-4 175 Lilac 71858-0155-5 71858-0155-4 200 Pink 71858-0160-5 71858-0160-4 Storage and Handling Store TIROSINT-SOL in the original container (closed pouch) at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Use TIROSINT-SOL oral solution within three (3) months after opening the pouch. Keep the ampules in the pouch until ready to use as important information may be lost (i.e., manufacturer/distributor names and distributor contact phone number).

📦 Storage and Handling 142 words ▾

How Supplied TIROSINT-SOL (levothyroxine sodium) oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule. The dosage strength is identified on the box and the pouch, and is associated with a distinct color. Each ampule bears a colored label with the dosage strength and the product name (TIROSINT-SOL) (Table 10).

Table 10. TIROSINT-SOL Solution Strengths and Packaging Description Strength (mcg/mL) Color a Box NDC (30 Unit-Dose Ampules) Pouch NDC (5 Unit-Dose Ampules) 13 Green 71858-0105-5 71858-0105-4 25 Orange 71858-0110-5 71858-0110-4

37.5Dark Blue 71858-0112-5 71858-0112-4 44 Red 71858-0113-5 71858-0113-4 50 White 71858-0115-5 71858-0115-4

62.5Grey 71858-0117-5 71858-0117-4 75 Purple 71858-0120-5 71858-0120-4 88 Olive 71858-0125-5 71858-0125-4 100 Yellow 71858-0130-5 71858-0130-4 112 Rose 71858-0135-5 71858-0135-4 125 Brown 71858-0140-5 71858-0140-4 137 Turquoise 71858-0145-5 71858-0145-4 150 Blue 71858-0150-5 71858-0150-4 175 Lilac 71858-0155-5 71858-0155-4 200 Pink 71858-0160-5 71858-0160-4

📋 Description 118 words ▾

11 DESCRIPTION TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15 H 10 I 4 NNaO 4 ∙ x H 2 O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown: TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200.

The inactive ingredients in TIROSINT-SOL are glycerol and water. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Dosing and Administration Instruct patients to take TIROSINT-SOL only as directed by their healthcare provider. Instruct patients to take TIROSINT-SOL 15 minutes before breakfast.

Instruct patients about the TIROSINT-SOL dosing instructions. Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take TIROSINT-SOL within 4 hours of these agents.

Instruct patients to notify their healthcare provider should they become pregnant or are thinking of becoming pregnant while taking TIROSINT-SOL. Important Information Inform patients that it may take several weeks before they notice an improvement in symptoms. Inform patients that the levothyroxine in TIROSINT-SOL is intended to replace a hormone that is normally produced by the thyroid gland.

Generally, replacement therapy is to be taken for life. Inform patients that TIROSINT-SOL should not be used as a primary or adjunctive therapy in a weight control program. Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations.

Instruct patients to notify their healthcare provider of any other medical conditions, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems, as the dose of medications used to control these other conditions may need to be adjusted while taking TIROSINT-SOL. If they have diabetes, instruct patients to monitor their blood and/or urinary glucose levels as directed by their physician and immediately report any changes to their physician. If patients are taking anticoagulants, their clotting status should be checked frequently.

Instruct patients to notify their physician or dentist that they are taking TIROSINT-SOL prior to any surgery. Adverse Reactions Instruct patients to notify their healthcare provider if they experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event.

Inform patients that partial hair loss may occur rarely during the first few months of TIROSINT-SOL therapy, but this is usually temporary.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71858-0060-01 · IBSA 71858-0110-01 · IBSA →
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.