These highlights do not include all the information needed to use LIOTHYRONINE SODIUM TABLETS safely and effectively. See full prescribing information for LIOTHYRONINE SODIUM TABLETS. LIOTHYRONINE SODIUM tablets, for oral use Initial U.S. Approval: 1956

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

BOXED WARNING SECTION

Thyroid hormones, including liothyronine sodium tablets, 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)].

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Tablets (circular, white to off-white) available as follows: • 5 mcg: debossed ‘589’ on one side and plain on other side • 25 mcg: debossed ‘590’ on one side and breakline on other side • 50 mcg: debossed ‘591’ on one side and breakline on other side

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Liothyronine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

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.

11 DESCRIPTION

DESCRIPTION SECTION

Liothyronine sodium tablets, USP contain the active ingredient, liothyronine (L-triiodothyronine or LT 3 ), 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. C 15 H 11 I 3 NNaO 4 M.W.672.96 Liothyronine sodium tablets, USP contain liothyronine sodium, USP equivalent to liothyronine in 5 mcg, 25 mcg, and 50 mcg. Inactive ingredients consist of corn starch, croscarmellose sodium, gelatin type B, magnesium stearate, mannitol, and microcrystalline cellulose.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Product: 50090-7518 NDC: 50090-7518-0 100 TABLET in a BOTTLE NDC: 50090-7518-1 90 TABLET in a BOTTLE

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Dosing and Administration Instruct patients that liothyronine sodium tablets 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. Important Information Inform patients that the liothyronine in liothyronine sodium tablets 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 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. If patents 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 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)]. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. ISS. 09/2023 5245289

liothyronine sodium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL