Generic Name
Liothyronine
Brand Names
Liomny, Cytomel
FDA approval date: May 08, 1956
Classification: l-Triiodothyronine
Form: Injection, Tablet
What is Liomny (Liothyronine)?
Liothyronine sodium injection is indicated in the treatment of myxedema coma/precoma. Liothyronine sodium injection can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.
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Brand Information
Liomny (Liothyronine Sodium)
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
- Thyroid hormones, including LIOMNY, 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
1DOSAGE FORMS AND STRENGTHS
Tablets (white to off-white, round, SC) available as follows:
- 5 mcg: debossed “σ” on one side and “5 μg” on the other side
- 25 mcg: debossed “σ” on one side and BISECTED on the other side with “25” debossed above the bisect and on “μg” debossed below the bisect
- 50 mcg: debossed “σ” on one side and BISECTED on the other side with “50” debossed above the bisect and on “μg” debossed below the bisect
2CONTRAINDICATIONS
LIOMNY is contraindicated in patients with uncorrected adrenal insufficiency
3ADVERSE REACTIONS
Adverse reactions associated with LIOMNY therapy are primarily those of hyperthyroidism due to therapeutic overdosage
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.
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.
4OVERDOSAGE
The signs and symptoms of overdosage are those of hyperthyroidism
Reduce the LIOMNY 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.
5DESCRIPTION
LIOMNY contains 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,
LIOMNY contains 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.
6HOW SUPPLIED/STORAGE AND HANDLING
LIOMNY tablets (white to off-white, round, SC) are supplied as follows:
7LIOMNY TMMCG- 30 TABLETS CONTAINER LABEL
Principal Display Panel – 5 mcg Bottle Label
NDC 42794-
LIOMNY
(liothyronine sodium tablets, USP)
5 mcg*
PHARMACIST: SEE SIDE PANEL FOR
WARNINGS.
WARNINGS.
Sigmapharm Laboratories, LLC
Rx only
30 Tablets
8LIOMNY TMMCG- 30 TABLETS CONTAINER LABEL
Principal Display Panel – 25 mcg Bottle Label
NDC 42794-
LIOMNY
(liothyronine sodium tablets, USP)
25 mcg*
PHARMACIST: SEE SIDE PANEL FOR
WARNINGS.
WARNINGS.
Sigmapharm Laboratories, LLC
Rx only
30 Tablets
9LIOMNY TMMCG- 30 TABLETS CONTAINER LABEL
Principal Display Panel – 50 mcg Bottle Label
NDC 42794-
LIOMNY
(liothyronine sodium tablets, USP)
50 mcg*
PHARMACIST: SEE SIDE PANEL FOR
WARNINGS.
WARNINGS.
Sigmapharm Laboratories, LLC
Rx only
30 Tablets