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Liothyronine Sodium 5 ug Tablet, 30-count — NDC 87063-0080-30 package photo

Liothyronine Sodium 5 ug Tablet, 30-count

by ASCLEMED USA INC. · 30 TABLET in 1 BOTTLE (87063-080-30)
NDC 87063-0080-30
🏷️ FDA NDC (as labeled) 87063-080-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.3824/unit — full pricing hub ↓
Also comes in: 60 tablets 87063-0080-60 90 tablets 87063-0080-90 100 tablets 87063-0080-01 1000 tablets 87063-0080-00
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 87063-080-30
Product NDC 87063-080
11-digit billing NDC 87063008030
RxCUI 903456, 903697, 903703
UNII GCA9VV7D2N
Application # ANDA200295
SPL Set ID 26cf6872-f4d4-41dd-8957-a000f13efbb3
Established class (EPC) l-Triiodothyronine
Chemical class Triiodothyronine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-12-03
Route ORAL
Dosage form TABLET
Substance LIOTHYRONINE SODIUM
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 87063-080-30 — 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 → 87063-0080-30. 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-Triiodothyronine class.

Pharmacologic class l-Triiodothyronine
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

LabelerASCLEMED USA INC.
Application holderSIGMAPHARM LABORATORIES LLC
FDA applicationANDA200295 (ANDA)
Labeler code87063
First marketedDec 2012
Product typeHuman Prescription Drug
Portfolio123 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

📗 Our plain-language guide HelloPharmacist
  • Both are thyroid hormone replacements, but they're not the same thing. Levothyroxine is T4, a hormone your body has to convert into the active form (T3) before it can be used. Liot...
  • What exactly is liothyronine, and how is it different from levothyroxine?
  • No — and this is actually a boxed warning on the label. If your thyroid levels are already normal, liothyronine won't meaningfully help you lose weight. Taking doses high enough to...
  • I've heard people use thyroid hormone to lose weight. Is that safe?
📖 Read our full Liothyronine 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 white
ShapeRound
Imprint20
Size8 mm
ScoringScored — splits in 2
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 4846Q921YM
    Calcium sulfate dihydrate is a white, crystalline mineral salt. It works as a filler and binder in tablets and capsules, helping give them structure and hold ingredients together.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3824 $11.47 / 30 tablets
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
Liothyronine Sodium 5 ug 00093-2179-01 Teva 100 tablets $0.220 AB Availability likely —
Liothyronine sodium 5 ug 16714-0166-01 Northstar 100 tablets $0.220 AB Availability likely —
Liothyronine Sodium 5 ug 42794-0018-02 SIGMAPHARM 100 tablets $0.220 AB Availability likely —
Liothyronine Sodium 5 ug 59762-1206-01 Mylan 100 tablets $0.220 AB Availability likely —
Liothyronine sodium 5 ug 68382-0582-01 Zydus 100 tablets $0.220 AB Availability likely —
Liothyronine Sodium 5 ug 75907-0039-01 Dr. 100 tablets $0.220 AB Availability likely —
Cytomel 5 ug 60793-0115-01 Pfizer 100 tablets $0.386 AB Availability likely —
Liomny 5 ug 42794-0131-02 SIGMAPHARM 100 tablets — AB FDA listed —
Liothyronine Sodium 5 ug 50090-3131-00 A-S 100 tablets — AB FDA listed —
Liothyronine sodium 5 ug 50090-5586-00 A-S 100 tablets — AB FDA listed —
liothyronine sodium 5 ug 50090-7518-00 A-S 100 tablets — AB FDA listed —
Liothyronine Sodium 5 ug 51407-0384-01 Golden 100 tablets — AB FDA listed —
liothyronine sodium 5 ug 62756-0589-08 Sun 100 tablets — AB FDA listed —
Liothyronine Sodium 5 ug 68071-3571-09 NuCare 90 tablets — AB FDA listed —
Liothyronine Sodium 5 ug 68788-7269-03 Preferred 30 tablets — AB FDA listed —
Liothyronine sodium 5 ug 70377-0114-11 Biocon 90 tablets — AB FDA listed —
Liothyronine sodium 5 ug 70771-1606-00 Zydus 1000 tablets — AB FDA listed —
Liothyronine Sodium 5 ug 71205-0150-30 Proficient 30 tablets — AB FDA listed —
Liothyronine Sodium 5 ug 71335-0341-01 Bryant 30 tablets — AB FDA listed —
Liothyronine sodium 5 ug 71335-2001-01 Bryant 30 tablets — AB FDA listed —
Liothyronine Sodium 5 ugthis 87063-0080-30 ASCLEMED 30 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

🏛️
2012
On the market since
Dec 2012
📍
2026
Currently FDA-listed
14 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.

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

Medicare Part D (outpatient prescription) spending for Liothyronine Sodium — the program that covers self-administered drugs. 9 manufacturers.
⚠️ 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 Liothyronine Sodium. 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
$6.84M
Claims incl. refills
214.4K
Beneficiaries
167.9K
Spend / beneficiary
$40.76
Spend / claim
$31.93
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87063-0080-00 1000 TABLET in 1 BOTTLE (87063-080-00) 2026-02-09 Active
87063-0080-01 100 TABLET in 1 BOTTLE (87063-080-01) 2026-02-09 Active
87063-0080-30 You're viewing this 30 TABLET in 1 BOTTLE (87063-080-30) 2026-02-09 Active
87063-0080-60 60 TABLET in 1 BOTTLE (87063-080-60) 2026-02-09 Active
87063-0080-90 90 TABLET in 1 BOTTLE (87063-080-90) 2026-02-09 Active

You're viewing the smallest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 87063-0080-30?
NDC 87063-0080-30 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 87063-0080-30 and NDC 87063-0080-60?
Both are Liothyronine Sodium 5 ug Tablet — the drug itself is identical. NDC 87063-0080-30 is the 30-count package, while NDC 87063-0080-60 is the 60 tablets package.
What NDC number is used to bill for this package of Liothyronine Sodium 5 ug Tablet?
Bill NDC 87063-0080-30 — the 11-digit billing format is 87063008030. 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
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 87063-080-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 87063-0080-30, written without dashes as 87063008030. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 87063-0080-30, the first segment (87063) is the labeler code FDA assigned to ASCLEMED USA INC.; the middle segment (0080) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ASCLEMED USA INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 60 tablets (87063-0080-60), 90 tablets (87063-0080-90), 100 tablets (87063-0080-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ASCLEMED USA INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 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 151 words ▾

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including liothyronine sodium, 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 liothyronine sodium 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 , 7.7 , 10 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Liothyronine sodium is an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy ( 1.3 ) 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 hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 )

1.1Hypothyroidism Liothyronine Sodium Tablets, USP are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

1.2Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Liothyronine Sodium Tablets, USP are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.

1.3Thyroid Suppression Test Liothyronine Sodium Tablets, USP are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use Liothyronine Sodium Tablets, USP are 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 Liothyronine Sodium Tablets, USP may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. Liothyronine Sodium Tablets, USP are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer Liothyronine Sodium Tablets, USP orally once daily and individual dosage according to patient response and laboratory findings ( 2.1 ) See full prescribing information for recommended dosage for hypothyroidism ( 2.2 ) TSH suppression in well-differentiated thyroid cancer ( 2.3 ) and for thyroid suppression test ( 2.4 ) When switching a patient to Liothyronine Sodium Tablets, USP discontinue levothyroxine therapy and initiate Liothyronine Sodium Tablets, USP at a low dosage. Gradually increase the dose according to the patient's response ( 2.5 ) Adequacy of therapy determined with periodic monitoring of TSH and T3 levels as well as clinical status ( 2.6 )

2.1General Principles of Dosing The dose of Liothyronine Sodium Tablets, USP for hypothyroidism or pituitary Thyroid-Stimulating Hormone (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 (2.2 , 2.3 , 2.4 ), Warnings and Precautions (5) , and Drug Interactions (7) ] . Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4) ].

Administer Liothyronine Sodium Tablets, USP orally once daily.

2.2Recommended Dosage for Hypothyroidism Adults The recommended starting dosage is 25 mcg orally once daily. Increase the dose by 25 mcg daily every 1 or 2 weeks, if needed. The usual maintenance dose is 25 mcg to 75 mcg once daily.

For elderly patients or patients with underlying cardiac disease, start with Liothyronine Sodium Tablets, USP 5 mcg once daily and increase by 5 mcg increments at the recommended intervals. Serum TSH is not a reliable measure of liothyronine sodium dose adequacy in patients with secondary or tertiary hypothyroidism and should not be used to monitor therapy. Use the serum T3 level to monitor adequacy of therapy in this patient population.

Pediatric Patients The recommended starting dosage is 5 mcg once daily, with a 5 mcg increase every 3 to 4 days until the desired response is achieved. Infants a few months old may require 20 mcg once daily for maintenance. At 1 year of age, 50 mcg once daily may be required.

Above 3 years of age, the full adult dosage may be necessary [see Use in Specific Populations (8.4) ]. Newborns (0 to 3 months) at Risk for Cardiac Failure: Consider a lower starting dose in infants at risk for cardiac failure. Increase the dose as needed based on clinical and laboratory response.

Pediatric Patients at Risk for Hyperactivity: To minimize the risk of hyperactivity in pediatric patients, start at one-fourth the recommended full replacement dose, and increase on a weekly basis by one-fourth the full recommended replacement dose until the full recommended replacement dose is reached. Pregnancy Pre-existing Hypothyroidism: Thyroid hormone dose requirements may increase during pregnancy. Measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at minimum, during each trimester of pregnancy.

In patients with primary hypothyroidism, maintain serum TSH in the trimester-specific reference range. For patients with serum TSH above the normal trimester-specific range, increase the dose of thyroid hormone and measure TSH every 4 weeks until a stable dose is reached and serum TSH is within the normal trimester-specific range. Reduce thyroid hormone dosage to pre-pregnancy levels immediately after delivery and measure serum TSH levels 4 to 8 weeks postpartum to ensure thyroid hormone dose is appropriate.

2.3Recommended Dosage for TSH Suppression in Well-Differentiated Thyroid Cancer The dose of Liothyronine Sodium Tablets, USP should target TSH levels within the desired therapeutic range. This may require h…

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets (white to off-white, round, SC) available as follows: 5 mcg: debossed “∑” on one side and “18” on the other side 25 mcg: debossed “∑19” on one side and “BISECTED” on the other side 50 mcg: debossed “∑20” on one side and “BISECTED” on the other side Tablets: 5 mcg, 25 mcg, 50 mcg

⛔ Contraindications 24 words ▾

4 CONTRAINDICATIONS Liothyronine Sodium Tablets, USP are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ]. Uncorrected adrenal cortical insufficiency

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate Liothyronine Sodium Tablets, USP at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation ( 2.3 , 5.1 , 8.5 ) Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. ( 5.2 ) Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of liothyronine sodium treatment ( 5.3 ) Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism.

( 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 )

5.1Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease Overtreatment with thyroid hormone 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 liothyronine sodium 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 liothyronine sodium therapy. Monitor patients receiving concomitant Liothyronine Sodium Tablets, USP and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiovascular symptoms develop or worsen, reduce or withhold the liothyronine sodium dose for one week and restart at a lower dose.

5.2Myxedema Coma Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of thyroid hormone 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.

5.3Acute 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 treatment with Liothyronine Sodium Tablets, USP [see Contraindications (4) ].

5.4Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism Liothyronine sodium has a narrow therapeutic index. Over- or undertreatment with liothyronine sodium may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and on glucose and lipid metabolism. Titrate the dose of Liothyronine Sodium Tablets, USP carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4) ] .

Monitor for the presence of drug or food interactions when using Liothyronine Sodium Tablets, USP and adjust the dose as necessary [see Drug Interactions (7) and Clinical Pharmacology (12.3) ].

5.5 Worsening of Diabetic Control Addition of thyroid hormone therapy in pat…

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Adverse reactions associated with liothyronine sodium therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5.4) 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 and cramps Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory: dyspnea Gastrointestinal: diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic: hair loss, flushing Endocrine: decreased bone mineral density Reproductive: menstrual irregularities, impaired fertility Adverse Reactions in Pediatric Patients Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving thyroid replacement therapy.

Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in pediatric patients 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 gastrointestinal symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing.

To report SUSPECTED ADVERSE REACTIONS , contact Sigmapharm Laboratories, LLC, Pharmacovigilance at 1-855-332-0731 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Most common adverse reactions for Liothyronine Sodium Tablets, USP are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash To report SUSPECTED ADVERSE REACTIONS, contact Sigmapharm Laboratories, LLC, Pharmacovigilance at 1-855-332-0731 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~3 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 liothyronine sodium

7.1Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g. absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to liothyronine sodium (see Tables 1 - 4). Table 1: Drugs That May Decrease T3 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of liothyronine sodium by binding and delaying or preventing absorption, potentially resulting in hypothyroidism.

Drug or Drug Class Effect Bile Acid Sequestrants -Colesevelam -Cholestyramine -Colestipol Ion Exchange Resins -Kayexalate -Sevelamer Bile acid sequestrants and ion exchange resins are known to decrease thyroid hormones absorption. Administer Liothyronine Sodium Tablets, USP at least 4 hours prior to these drugs or monitor TSH levels. Table 2: Drugs That May Alter 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. 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 increased 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 thyroid hormones, and total and FT4 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 3: Drugs That May Alter Hepatic Metabolism of Thyroid hormones Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of thyroid hormones, resulting in increased liothyronine sodium 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-glucuronosyltransferase (UGT) and leads to a lower T4 serum levels. Changes in thyroid status may occur if barbiturates are added or withdrawn from patients being treated for hypothyroidism.

Rifampin has been shown to accelerate the metabolism of thyroid hormones. Table 4: Drugs That May Decrease Conversion of T4 to T3 Potential impact: Administration of these enzyme inhibitors decreases the peripheral conversion of T4 to T3, leading to decreased T3 levels. However, serum T4 levels are usually normal but may occasionally be slightly increased.

Drug or Drug Class Effect Beta-adrenergic antagonists (e.g., Propranolol >160 mg/day) In patients treated with large doses of propranolol (>160 mg/day), T3 and T4 levels change, TSH levels remain normal, and patients are clinically euthyroid. Actions of particular beta-adrenergic antagonists may be impaired when a hypothyroid patient is converte…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy may require the use of higher doses of thyroid hormone ( 2.2 , 8.1 )

8.1Pregnancy Risk Summary Experience with liothyronine use in pregnant women, including data from post-marketing studies, have not reported increased rates of major birth defects or miscarriages (see Data ). 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 liothyronine sodium dosage adjusted during pregnancy (see Clinical Considerations ).

There are no animal studies conducted with liothyronine during pregnancy. Liothyronine Sodium Tablets, USP 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.

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 liothyronine sodium requirements. Serum TSH levels should be monitored and the liothyronine sodium dosage adjusted during pregnancy. Since postpartum TSH levels are similar to preconception values, the liothyronine sodium dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration (2.3) ] .

Data Human Data Liothyronine is approved for use as a replacement therapy for hypothyroidism. Data from post-marketing studies have not reported increased rates of fetal malformations, miscarriages, or other adverse maternal or fetal outcomes associated with liothyronine use in pregnant women.

8.2Lactation Risk Summary Limited published studies report that liothyronine is present in human milk. However, there is insufficient information to determine the effects of liothyronine on the breastfed infant and no available information on the effects of liothyronine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for liothyronine sodium and any potential adverse effects on the breastfed infant from liothyronine sodium or from the underlying maternal condition.

8.4Pediatric Use The initial dose of Liothyronine Sodium Tablets, USP varies with age and body weight. Dosing adjustments are based on an assessment of the individual patient's clinical and laboratory parameters [see Dosage and Administration (2.3 , 2.4 )]. In pediatric patients in whom a diagnosis of permanent hypothyroidism has not been established, discontinue thyroid hormone for a trial period, but only after the child is at least 3 years of age.

Obtain serum TSH, T4, and T3 levels at the end of the trial period, and use laboratory test results and clinical assessments to guide diagnosis and treatment, if warranted [see Dosage and Administration (2.6) ]. Congenital Hypothyroidism [see Dosage and Administration (2.2 , 2.6 )] Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on intellectual development as well as on overall physical growth and maturation. Therefore, initiate thyroid hormone immediately upon diagnosis.

Thyroid hormone is generally continued for life in these patients. Closely monitor infants during the first 2 weeks of thyroid hormone therapy for cardiac overload, arrhythmias, and aspiration from avid suckling. Closely monitor patients to avoid under…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Experience with liothyronine use in pregnant women, including data from post-marketing studies, have not reported increased rates of major birth defects or miscarriages (see Data ). 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 liothyronine sodium dosage adjusted during pregnancy (see Clinical Considerations ).

There are no animal studies conducted with liothyronine during pregnancy. Liothyronine Sodium Tablets, USP 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.

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 liothyronine sodium requirements. Serum TSH levels should be monitored and the liothyronine sodium dosage adjusted during pregnancy. Since postpartum TSH levels are similar to preconception values, the liothyronine sodium dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration (2.3) ] .

Data Human Data Liothyronine is approved for use as a replacement therapy for hypothyroidism. Data from post-marketing studies have not reported increased rates of fetal malformations, miscarriages, or other adverse maternal or fetal outcomes associated with liothyronine use in pregnant women.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The initial dose of Liothyronine Sodium Tablets, USP varies with age and body weight. Dosing adjustments are based on an assessment of the individual patient's clinical and laboratory parameters [see Dosage and Administration (2.3 , 2.4 )]. In pediatric patients in whom a diagnosis of permanent hypothyroidism has not been established, discontinue thyroid hormone for a trial period, but only after the child is at least 3 years of age.

Obtain serum TSH, T4, and T3 levels at the end of the trial period, and use laboratory test results and clinical assessments to guide diagnosis and treatment, if warranted [see Dosage and Administration (2.6) ]. Congenital Hypothyroidism [see Dosage and Administration (2.2 , 2.6 )] Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on intellectual development as well as on overall physical growth and maturation. Therefore, initiate thyroid hormone immediately upon diagnosis.

Thyroid hormone is generally continued for life in these patients. Closely monitor infants during the first 2 weeks of thyroid hormone therapy for cardiac overload, arrhythmias, and aspiration from avid suckling. Closely monitor patients to avoid undertreatment or overtreatment.

Undertreatment may have deleterious effects on intellectual development and linear growth. Overtreatment is associated with craniosynostosis in infants, may adversely affect the tempo of brain maturation, and may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature [see Dosage and Administration (2.6) and Adverse Reactions (6) ]. Acquired Hypothyroidism in Pediatric Patients Closely monitor patients to avoid undertreatment and overtreatment.

Undertreatment may result in poor school performance due to impaired concentration and slowed mentation and in reduced adult height. Overtreatment may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature. Treated children may manifest a period of catch-up growth, which may be adequate in some cases to normalize adult height.

In children with severe or prolonged hypothyroidism, catch-up growth may not be adequate to normalize adult height [see Adverse Reactions (6) ].

🧓 Geriatric Use 62 words ▾

8.5Geriatric Use Because of the increased prevalence of cardiovascular disease among the elderly, initiate Liothyronine Sodium Tablets, USP 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 thyroid hormone overtreatment in the elderly.

🆘 Overdosage 101 words ▾

10 OVERDOSAGE The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5.4) and Adverse Reactions (6) ] . In addition, confusion and disorientation may occur. Cerebral embolism, seizure, shock, coma, and death have been reported.

Symptoms may not necessarily be evident or may not appear until several days after ingestion. Reduce the liothyronine sodium dose or temporarily discontinued 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 ~1 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 The onset of activity of liothyronine sodium occurs within a few hours. Maximum pharmacologic response occurs within 2 or 3 days.

12.3Pharmacokinetics Absorption T3 is almost totally absorbed, 95 percent in 4 hours. The hormones contained in the natural preparations are absorbed in a manner similar to the synthetic hormones. Distribution Liothyronine sodium (T3) is not firmly bound to serum protein.

The higher affinity of levothyroxine (T4) for both thyroid-binding globulin and thyroid-binding prealbumin as compared to triiodothyronine (T3) partially explains the higher serum levels and longer half-life of the former hormone. Both protein-bound hormones exist in reverse equilibrium with minute amounts of free hormone, the latter accounting for the metabolic activity. Elimination Metabolism 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. T3 is 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.

The biological half-life is about 2-1/2 days.

🧬 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 181 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Liothyronine Sodium Tablets, USP (white to off-white, round, SC) are supplied as follows: Strength Tablet Markings NDC 5 mcg debossed “Σ” on one side and “18” on the other side 30 count - 87063-080-30 (repackaged from NDC 42794-018-XX) 60 count - 87063-080-60 (repackaged from NDC 42794-018-XX) 90 count - 87063-080-90 (relabeled from NDC 42794-018-12) 100 count - 87063-080-01 (relabeled from NDC 42794-018-02) 1000 count - 87063-080-00 (relabeled from NDC 42794-018-06) 25 mcg debossed “Σ19” on one side and “BISECTED” on the other side 30 count - 87063-081-30 (repackaged from NDC 42794-019-XX) 60 count - 87063-081-60 (repackaged from NDC 42794-019-XX) 90 count - 87063-081-90 (relabeled from NDC 42794-019-12) 100 count - 87063-081-01 (relabeled from NDC 42794-019-02) 1000 count - 87063-081-00 (relabeled from NDC 42794-019-06) 50 mcg debossed “Σ20” on one side and “BISECTED” on the other side 30 count - 87063-082-30 (repackaged from NDC 42794-020-XX) 60 count - 87063-082-60 (repackaged from NDC 42794-020-XX) 90 count - 87063-082-90 (relabeled from NDC 42794-020-12) 100 count - 87063-082-01 (relabeled from NDC 42794-020-02) Store between 15°C and 30°C (59°F and 86°F).

📦 Storage and Handling 8 words ▾

Store between 15°C and 30°C (59°F and 86°F).

📋 Description 84 words ▾

11 DESCRIPTION Liothyronine Sodium Tablets, USP contain the active ingredient, liothyronine (L-triiodothyronine or LT3), a synthetic form of a thyroid hormone liothyronine in sodium salt form. It is chemically designated as L-Tyrosine, O -(4-hydroxy-3-iodophenyl)-3,5-diiodo-, monosodium salt. The molecular formula, molecular weight and structural formula of liothyronine sodium are given below.

Liothyronine Sodium Tablets, USP contain liothyronine sodium equivalent to liothyronine in 5 mcg, 25 mcg, and 50 mcg. Inactive ingredients consist of calcium sulfate dihydrate, corn starch, gelatin, magnesium stearate and mannitol. image description

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Dosing and Administration Instruct patients that Liothyronine Sodium Tablets, USP should only be taken as directed by their healthcare provider. Instruct patients to notify their healthcare provider should they become pregnant or breastfeeding or are thinking of becoming pregnant, while taking Liothyronine Sodium Tablets, USP. Important Information Inform patients that the liothyronine in Liothyronine Sodium Tablets, USP are 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 Liothyronine Sodium Tablets, USP 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 Liothyronine Sodium Tablets, USP. If patients are taking anticoagulants (blood thinners), their clotting status should be checked frequently. Instruct patients to notify their physician or dentist if they are taking Liothyronine Sodium Tablets, USP 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 gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event [see Adverse Reactions (6) ] . Inform patients that partial hair loss may occur rarely during the first few months of liothyronine sodium therapy; this is usually temporary [see Adverse Reactions (6) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87063-0079-01 · Asclemed 87063-0081-00 · ASCLEMED →
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.