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Liothyronine Sodium Cytomel Triostat Weight Loss Steroids CAS 55-06-1

55-06-1

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Liothyronine Sodium Cytomel Triostat Weight Loss Steroids CAS 55-06-1

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Thyroid hormone drugs are natural or synthetic preparations containing tetraiodothyronine (T4, levothyroxine) sodium or triiodothyronine (T3, liothyronine) sodium or both. T4 and T3 are produced in the human thyroid gland by the iodination and coupling of the amino acid tyrosine. T4 contains four iodine atoms and is formed by the coupling of two molecules of diiodotyrosine (DIT). T3 contains three atoms of iodine and is formed by the coupling of one molecule of DIT with one molecule of monoiodotyrosine (MIT). Both hormones are stored in the thyroid colloid as thyroglobulin.

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Thyroid hormone preparations belong to two categories:?natural hormonal preparations derived from animal thyroid, and synthetic preparations. Natural preparations include desiccated thyroid and thyroglobulin. Desiccated thyroid is derived from domesticated animals that are used for food by man (either beef or hog thyroid), and thyroglobulin is derived from thyroid glands of the hog. The United States Pharmacopeia (USP) has standardized the total iodine content of natural preparations. Thyroid USP contains not less than (NLT) 0.17 percent and not more than (NMT) 0.23 percent iodine, and thyroglobulin contains not less than (NLT) 0.7 percent of organically bound iodine. Iodine content is only an indirect indicator of true hormonal biologic activity.

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Cytomel (liothyronine sodium) Tablets contain liothyronine (L-triiodothyronine or LT3), a synthetic form of a natural thyroid hormone, and is available as the sodium salt.

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The structural and empirical formulas and molecular weight of liothyronine sodium are given below.

L-Tyrosine, O-(4-hydroxy-3-iodophenyl)-3,5-diiodo-, monosodium salt

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Twenty-five mcg of liothyronine is equivalent to approximately 1 grain of desiccated thyroid or thyroglobulin and 0.1 mg of L-thyroxine.

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Each round, white to off-white Cytomel (liothyronine sodium) tablet contains liothyronine sodium equivalent to liothyronine as follows: 5 mcg debossed KPI and 115; 25 mcg scored and debossed KPI and 116; 50 mcg scored and debossed KPI and 117. Inactive ingredients consist of calcium sulfate, gelatin, starch, stearic acid, sucrose and talc.


GENERIC NAME: liothyronine sodium

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BRAND NAME: Cytomel, Triostat


DRUG CLASS AND MECHANISM: Liothyronine sodium is a synthetic (man-made) version of one of the two hormones made by the thyroid gland, triiodothyronine. It is used for treating individuals who are hypothyroid (do not produce enough thyroid hormones). Thyroid hormones increase the metabolism (activity) of all cells in the body. In the fetus, newborn infant and child, thyroid hormones promote growth and development of tissues. In adults, thyroid hormones help to maintain the function of the brain, the use of food by the body, and body temperature. The FDA approved liothyronine in May 1956.

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PRESCRIBED FOR: Liothyronine is used to treat hypothyroidism (low production of thyroid hormone) in adults and children. Prolonged hypothyroidism can result in a condition called myxedema in which patients develop swollen lips, thickened nose, and unusual deposits of material in the skin that are dry and waxy. These deposits also may appear in body tissues other than the skin. Liothyronine also is used for suppressing production of thyroid stimulating hormone in patients with goiters and for testing how well the thyroid gland is functioning.

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SIDE EFFECTS: Liothyronine therapy generally is well-tolerated. If symptoms occur, they usually occur because there are toxic (too high) levels of thyroid hormone (hyperthyroidism).

Symptoms of hyperthyroidism include:

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chest pain |
increased heart rate |
excessive sweating |
heat intolerance |
nervousness |
headache |
tremor |
insomnia |
diarrhea |
vomiting |
weight loss |
- - - -

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For Healthcare Professionals
Applies to liothyronine: compounding powder, intravenous solution, oral tablet

General
Liothyronine is generally well tolerated. Side effects associated with liothyronine therapy typically result from therapeutic overdosage and include manifestations of hyperthyroidism such as weight loss, increased appetite, diarrhea or increased bowel frequency, insomnia, nervousness, irritability, tremor, excessive sweating, heat intolerance, palpitations, hypertension, tachycardia, chest pain, and menstrual irregularities.


Class: Thyroid Agents
ATC Class: H03AA02
VA Class: HS851
CAS Number: 55-06-1
Brands: Cytomel, Triostat

Introduction

Synthetic thyroid agent; sodium salt of the l-isomer of 3,3′,5-triiodothyronine (l-T3).a b c e

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Uses for Liothyronine Sodium
Used orally as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.a c Specific indications include primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism.a c

Generally considered unsatisfactory for long-term use because of potential problems (i.e., wide swings in serum T3 concentrations, possibility of more pronounced adverse cardiovascular effects);a g o however, may be useful when absorption of levothyroxine is questionable, when impairment of peripheral conversion of thyroxine to triiodothyronine is suspected, or in patients allergic to natural thyroid hormone.a b c Levothyroxine is considered drug of choice for replacement therapy.e


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For treatment of congenital hypothyroidism (cretinism), levothyroxine is considered drug of choice.a

Used IV for treatment of myxedema coma or precoma.a b c Preferred by some clinicians over levothyroxine when a rapid effect or rapidly reversible effect is desired; however, levothyroxine generally is considered drug of choice for this use.a

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Pituitary TSH Suppression
Treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), and multinodular goiter.a c

Adjunct to radioiodine therapy in the management of thyroid cancer?.o

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Diagnosis of Thyroid Disorders
Used diagnostically in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.a c d Use with caution in patients in whom there is a strong suspicion of thyroid gland autonomy because exogenous hormone effects will be additive to endogenous source.c

Liothyronine Sodium Dosage and Administration

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General
Initially, monitor response to therapy about every 6-8 weeks.g o Once normalization of thyroid function and serum TSH concentrations have been achieved, patients may be evaluated less frequently (i.e., every 6-12 months).g o However, if dosage is changed, measure serum TSH concentrations after 8-12 weeks.o
Natural and synthetic thyroid agent preparations are not necessarily directly comparable; however, the following equivalencies have been suggested based on clinical response:d

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Equivalencies of Thyroid Preparations Based on Clinical Responsed
Thyroid Agent

Approximate Equivalent Dosage

Levothyroxine sodium

100 mcg or less

Liothyronine sodium

25 mcg

Liotrix (levothyroxine sodium/liothyronine sodium)

50 mcg/12.5 mcg (Thyrolar)

Thyroglobulin

65 mg

Thyroid

60-65 mg (1 grain)

When switching from another thyroid preparation to liothyronine, discontinue the other preparation, then initiate liothyronine therapy at a low dosage and titrate as needed in small increments after the residual effects of the previous thyroid preparation have subsided.


When switching from liothyronine to another thyroid preparation, consider the rapid onset and dissipation of effects of liothyronine and, to avoid relapse, start therapy with the replacement thyroid preparation several days before complete withdrawal of liothyronine.
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Administration
Administer orally or by IV injection. Do not administer IM or sub-Q.?

Oral Administration
Administer orally once daily.

NG Tube
Has been administered orally via NG tube for treatment of myxedema coma; however, IV administration is preferred.

IV Administration
IV administration may be necessary when oral administration is not feasible or desirable (e.g., in the treatment of myxedema coma, in some neonates, during total parenteral nutrition). Replace with oral therapy as soon as possible.

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Dosage
Available as liothyronine sodium; dosage expressed in terms of liothyronine.a

Each 25 mcg of liothyronine is approximately clinically equivalent to 60-65 mg of thyroid or thyroglobulin or 100 mcg or less of levothyroxine.a b c (See General under Dosage and Administration.)

Adjust dosage carefully according to clinical and laboratory response to treatment.a c d Avoid undertreatment or overtreatment.d (See Therapy Monitoring under Cautions.)

Initiate at a lower dosage level in geriatric patients, in patients with functional or ECG evidence of cardiovascular disease, and in patients with severe, long-standing hypothyroidism or other endocrinopathies.a

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Pediatric Patients
Hypothyroidism
Oral
Initiate therapy as soon as possible after diagnosis of hypothyroidism to prevent deleterious effects on intellectual and physical growth and development.a c d

Recommended initial dosage is 5 mcg once daily.a c Increase by increments of 5 mcg daily at intervals of 3-4 days until desired response is obtained.a c

Maintenance dosage: Infants a few months old may require only 20 mcg daily.c At 1 year of age, 50 mcg daily may be required.c At >3 years of age, full adult daily dosage may be required.c

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Adults
Hypothyroidism
Oral
For management of mild hypothyroidism, recommended initial dosage is 25 mcg once daily.a c Increase by increments of 12.5 or 25 mcg daily at intervals of 1-2 weeks until desired response is obtained.a c Usual maintenance dosage is 25-75 mcg daily;a c some patients may require higher or lower dosages.a

For management of severe hypothyroidism (e.g., myxedema), recommended initial dosage is 5 mcg once daily.a c Increase by increments of 5-10 mcg daily at intervals of 1-2 weeks.a c When a dosage of 25 mcg daily is reached, may increase by 5-25 mcg daily at intervals of 1 or 2 weeks until desired response is obtained.c Usual maintenance dosage is 50-100 mcg once daily.

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Myxedema Coma or Precoma
IV, then Oral
In patients who do not have severe cardiovascular disease, recommended initial dose is 25-50 mcg IV.a b A dosage of ≥65 mcg IV daily in the initial days of therapy reportedly associated with lower mortality; however, clinical experience with dosages >100 mcg daily is limited.a b

Because of potentially wide swings in serum T3 concentrations (possibly precipitating adverse cardiovascular effects), adjust dosage with caution.a b Administer additional doses ≥4 hours apart to allow for adequate assessment of therapeutic response, but no more than 12 hours should elapse between doses to avoid fluctuations in hormone levels.a b

Replace with oral therapy as soon as patient’s condition stabilizes and drug can be given orally.a b

When switching from IV to oral liothyronine therapy, discontinue IV liothyronine, then initiate oral liothyronine at low dosage and increase gradually according to patient’s response.a b

When switching from IV liothyronine to oral levothyroxine therapy, consider delay (several days) in onset of activity of levothyroxine and discontinue IV liothyronine gradually.a b

Pituitary TSH Suppression


Simple (Nontoxic) Goiter
Oral
Recommended initial dosage is 5 mcg daily.a c Increase by increments of 5-10 mcg daily at intervals of 1-2 weeks.a c When a dosage of 25 mcg daily is reached, may increase by 12.5 or 25 mcg daily at intervals of 1-2 weeks until desired response is obtained.a c

Usual maintenance dosage is 75 mcg daily.a c

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Diagnosis of Thyroid Disorders
Oral
75-100 mcg daily for 7 days.a c Perform radioactive I 131 uptake test before and after administration of the 7-day course of liothyronine.a c A ≥50% reduction of I 131 uptake after treatment indicates a normal thyroid-pituitary axis and thus rules out thyroid gland autonomy.c

Prescribing Limits
Adults
Myxedema Coma
IV
Limited clinical experience with dosages >100 mcg daily.a b

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Special Populations
Patients with Cardiovascular Disease
Hypothyroidism
Initiate therapy at lower dosages than those recommended for patients without cardiovascular disease.c d

Usual initial dosage is 5 mcg daily.c Increase by increments of 5 mcg at intervals of 2 weeks until desired response is obtained.c If cardiovascular disease is aggravated, reduce dosage or temporarily withhold therapy and then cautiously restart therapy at a lower dosage.

Myxedema Coma
If liothyronine therapy is clinically indicated, smaller initial IV doses (i.e., 10-20 mcg) may be necessary.

Titrate dosage gradually.

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Geriatric Patients
Hypothyroidism
Initiate therapy at lower dosages than those recommended for younger patients.

Usual initial dosage is 5 mcg once daily.a Increase by increments of 5 mcg at intervals of 1-2 weeks until desired response is obtained.a If cardiovascular disease is aggravated, reduce dosage or temporarily withhold therapy and then cautiously restart therapy at a lower dosage.

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Myxedema Coma
Reduced initial IV dose may be appropriate in geriatric patients because of increased risk of cardiovascular disease.
Cautions for Liothyronine Sodium
Contraindications
Untreated thyrotoxicosis.
AMI uncomplicated by hypothyroidism.
Uncorrected adrenal insufficiency.
Concomitant use of IV liothyronine with artificial rewarming of patients.
Known hypersensitivity to any ingredient in the formulation.b c d (See Sensitivity Reactions under Cautions.)
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Warnings/Precautions
Warnings
Unlabeled Uses
Should not be used for the treatment of obesity or for weight loss either alone or with other therapeutic agents.?In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.?Larger doses may produce serious or life-threatening toxicity, particularly when given in conjunction with sympathomimetic amines (e.g., anorectic agents).

Should not be used in the treatment of male or female infertility unless this condition is associated with hypothyroidism.

Sensitivity Reactions
Hypersensitivity to thyroid hormone is not known to occur.b c However, hypersensitivity reactions to inactive ingredients of thyroid hormone products have been reported and include urticaria, pruritus, rash, flushing, angioedema, abdominal pain, nausea, vomiting, diarrhea, fever, arthralgia, serum sickness, and wheezing.d Allergic skin reactions to liothyronine tablets have been reported rarely.

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General Precautions
Therapy Monitoring
Thyroid agents have a narrow therapeutic index.d Avoid undertreatment or overtreatment, which may result in adverse effects on growth and development in pediatric patients, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, GI function, and glucose and lipid metabolism.

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Periodically perform appropriate laboratory tests (e.g., serum TSH, total T3) and clinical evaluations to monitor adequacy of therapy.?

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Preexisting Cardiovascular Disease
Use with extreme caution.b d (See Patients with Cardiovascular Disease under Dosage and Administration.) Potential for cardiotoxicity may be greater than with preparations that do not contain T3.e Patients with CHD should be monitored closely during surgical procedures due to increased risk of arrhythmias.

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Associated Endocrine Disorders
Hypopituitarism, adrenal insufficiency, and other endocrine disorders such as diabetes mellitus and diabetes insipidus are characterized by signs and symptoms which may be diminished in severity or obscured by hypothyroidism.d Thyroid agents may aggravate the intensity of previously obscured symptoms in patients with endocrine disorders, and appropriate adjustment of therapy for these concomitant disorders may be required.

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In patients with secondary or tertiary hypothyroidism, consider possibility of additional hypothalamic/pituitary hormone deficiencies and treat if diagnosed.

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Chronic autoimmune thyroiditis may occur in association with other autoimmune disorders (e.g., adrenal insufficiency, pernicious anemia, type 1 diabetes mellitus).

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Patients with concomitant adrenal insufficiency should be treated with replacement corticosteroids prior to initiation of thyroid agents.b c d Failure to do so may precipitate an acute adrenal crisis due to increased metabolic clearance of corticosteroids when the thyroid agent is initiated.

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Patients with diabetes mellitus may require increased dosages of antidiabetic agents when treated with liothyronine.

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Specific Populations
Pregnancy
Category A.

During pregnancy, serum free tetraiodothyronine (thyroxine, T4) levels may decrease and serum TSH levels increase to values outside the normal range.h i Elevations in serum TSH may occur at 4 weeks’ gestation;i monitor TSH levels during each trimester (or every 6 weeks) and adjust liothyronine dosage accordingly.f g o Reduce dosage to pre-pregnancy level immediately after delivery, since postpartum TSH concentrations are similar to preconception levels;i o measure serum TSH concentrations 6-8 weeks postpartum.o

Lactation
Although thyroid hormones are distributed minimally into human milk, exercise caution when administering to a nursing woman.b c However, adequate replacement dosages generally are needed to maintain normal lactation.

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Pediatric Use
Safety and efficacy of IV liothyronine not established in pediatric patients.

The goal of treatment in pediatric patients with hypothyroidism is to achieve and maintain normal intellectual and physical growth and development.d Initiate therapy immediately upon diagnosis.c d Maintain therapy for life, unless transient hypothyroidism is suspected.

Neonates with suspected hypothyroidism should receive thyroid agent therapy pending results of confirmative tests.d If a positive diagnosis cannot be made on the basis of laboratory findings but there is a strong clinical suspicion of congenital hypothyroidism, initiate replacement therapy to achieve euthyroidism until the child is 1-2 years of age.d During the first 2 weeks of therapy, closely monitor infants for cardiac overload, arrhythmias, and aspiration resulting from avid suckling.d Evaluate infant’s clinical response to therapy about 6 weeks after initiation of thyroid agent therapy and at least at 6 and 12 months of age and yearly thereafter.

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When transient hypothyroidism is suspected, temporarily discontinue therapy for 2-8 weeks to reassess the condition when the child is >3 years of age.c q If the diagnosis of permanent hypothyroidism is confirmed, reinstitute full replacement therapy.d However, if serum concentrations of T4 and TSH are normal, discontinue thyroid agent therapy and monitor carefully;c d repeat thyroid function tests if manifestations of hypothyroidism develop.

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In pediatric patients with transient severe hypothyroidism, reduce replacement dose by half for 30 days to reasses condition.q If, after 30 days, serum TSH is >20 mU/L, consider the hypothyroidism permanent and reinstitute full replacement therapy.q However, if serum TSH has not increased, temporarily discontinue thyroid agent therapy for another 30 days, then repeat serum T4 and TSH measurements.q Reinstitute or discontinue replacement therapy based on laboratory findings.

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Monitor patients closely to avoid undertreatment or overtreatment.d Undertreatment may result in impaired intellectual development, poor school performance (due to impaired concentration and slowed mentation), and reduced adult height.d Overtreatment may result in craniosynostosis in infants and accelerate aging of bones, resulting in premature epiphyseal closure and compromised adult stature.

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Treated children may manifest a period of catch-up growth, which may be adequate in some cases to achieve normal adult height.d In children with severe or long-standing hypothyroidism, catch-up growth may not be adequate to achieve normal adult height.

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Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving thyroid agents.

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Geriatric Use
Because of the increased risk of cardiovascular disease among geriatric patients, liothyronine therapy should not be initiated at the full replacement dose.b c d o (See Geriatric Patients under Dosage and Administration.)

Because of age-related decreases in renal function, may be useful to monitor renal function.

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Common Adverse Effects
Adverse reactions result from overdosage and resemble manifestations of hyperthyroidism,a c d including fatigue, weight loss, increased appetite, heat intolerance, fever, excessive sweating, headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia, tremor, muscle weakness, palpitations, tachycardia, arrhythmias, increased heart rate and BP, heart failure, angina, AMI, cardiac arrest, diarrhea, vomiting, abdominal cramps, elevations in liver function test results, hair loss, flushing, decreased bone mineral density, menstrual irregularities, and impaired fertility.

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Interactions for Liothyronine Sodium
Drugs Affecting Hepatic Microsomal Enzymes
Potential increased metabolism of thyroid agent with drugs that induce hepatic microsomal enzymes resulting in increased thyroid agent dosage requirements.

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Drugs That May Decrease T4 5’-Deiodinase Activity
Inhibitors of T4 5’-deiodinase decrease peripheral conversion of T4 to T3, resulting in decreased T3 concentrations.d i u However, serum T4 concentrations usually remain within normal range but may occasionally be slightly increased.


Uses
Liothyronine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally made by the thyroid gland. Liothyronine is a man-made form of thyroid hormone. Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation/medications or removed by surgery. Having enough thyroid hormone helps you stay healthy. For children, having enough thyroid hormone helps them grow and learn normally.

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This medication is also used to treat other types of thyroid problems (such as certain types of goiters, thyroid cancer). It can also be used to test for certain types of thyroid disease.

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This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels...

Liothyronine is a replacement thyroid hormone. It is used to treat the more severe conditions in which the thyroid doesn& acute;t produce enough thyroxine.

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You will need regular blood tests to check your thyroid levels, particularly at the beginning of this treatment.

If you experience any side-effects, speak with your doctor, as your dose may need adjusting.

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If you have an underactive thyroid gland, it means that your thyroid does not produce enough thyroid hormone. This is a condition known as hypothyroidism. Liothyronine restores the balance of thyroid hormone in your body. It is similar to thyroxine, the hormone which your body produces naturally. Although a medicine called levothyroxine is usually prescribed in preference to liothyronine for people with this condition, liothyronine is given when a fast action is needed, as it works more quickly.

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