Liothyronine Sodium (Liothyronine Sodium)

Trade Name : Liothyronine Sodium

Proficient Rx LP

TABLET

Strength 5 ug/1

LIOTHYRONINE SODIUM l-Triiodothyronine [EPC],Triiodothyronine [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Liothyronine Sodium (Liothyronine Sodium) which is also known as Liothyronine Sodium and Manufactured by Proficient Rx LP. It is available in strength of 5 ug/1 per ml. Read more

Liothyronine Sodium (Liothyronine Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. 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.

Thyroid hormone drugs are natural or synthetic preparations containing tetraiodothyronine (T , levothyroxine) sodium or triiodothyronine (T , liothyronine) sodium or both. T and T are produced in the human thyroid gland by the iodination and coupling of the amino acid tyrosine. T contains four iodine atoms and is formed by the coupling of two molecules of diiodotyrosine (DIT). T 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.
Thyroid hormone preparations belong to two categories: (1) natural hormonal preparations derived from animal thyroid, and (2) 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.
Liothyronine sodium tablets contain liothyronine (L-triiodothyronine or LT ), a synthetic form of a natural thyroid hormone, and is available as the sodium salt.
The structural and empirical formulas and molecular weight of liothyronine sodium are given below.
Liothyronine Sodium
L-Tyrosine, O-(4-hydroxy-3-iodophenyl)-3,5-diiodo-,monosodium salt
Twenty-five mcg liothyronine is equivalent to approximately 1 grain of desiccated thyroid or thyroglobulin and 0.1 mg of L-thyroxine.
Inactive ingredients consist of calcium sulfate dihydrate, corn starch, gelatin, magnesium stearate and mannitol.

The mechanisms by which thyroid hormones exert their physiologic action are not well understood. These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate and the metabolism of carbohydrates, lipids and proteins. Thus, they exert a profound influence on every organ system in the body and are of particular importance in the development of the central nervous system.
Pharmacokinetics
Since liothyronine sodium (T ) is not firmly bound to serum protein, it is readily available to body tissues. The onset of activity of liothyronine sodium is rapid, occurring within a few hours. Maximum pharmacologic response occurs within 2 or 3 days, providing early clinical response. The biological half-life is about 2-1/2 days.
T 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.
Liothyronine sodium has a rapid cutoff of activity which permits quick dosage adjustment and facilitates control of the effects of overdosage, should they occur.
The higher affinity of levothyroxine (T ) for both thyroid-binding globulin and thyroid-binding prealbumin as compared to triiodothyronine (T ) 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.

Thyroid hormone drugs are indicated:
Liothyronine sodium tablets can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.

Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis and apparent hypersensitivity to any of their active or extraneous constituents. There is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.
Thyroid hormones should be used with great caution in a number of circumstances where the integrity of the cardiovascular system, particularly the coronary arteries, is suspected. These include patients with angina pectoris or the elderly, in whom there is a greater likelihood of occult cardiac disease. In these patients, liothyronine sodium therapy should be initiated with low doses, with due consideration for its relatively rapid onset of action. Starting dosage of liothyronine sodium tablets is 5 mcg daily, and should be increased by no more than 5 mcg increments at 2-week intervals. When, in such patients, a euthyroid state can only be reached at the expense of an aggravation of the cardiovascular disease, thyroid hormone dosage should be reduced.
Morphologic hypogonadism and nephrosis should be ruled out before the drug is administered. If hypopituitarism is present, the adrenal deficiency must be corrected prior to starting the drug.
Myxedematous patients are very sensitive to thyroid; dosage should be started at a very low level and increased gradually.
Severe and prolonged hypothyroidism can lead to a decreased level of adrenocortical activity commensurate with the lowered metabolic state. When thyroid-replacement therapy is administered, the metabolism increases at a greater rate than adrenocortical activity. This can precipitate adrenocortical insufficiency. Therefore, in severe and prolonged hypothyroidism, supplemental adrenocortical steroids may be necessary. In rare instances the administration of thyroid hormone may precipitate a hyperthyroid state or may aggravate existing hyperthyroidism.

General
The therapy of myxedema coma requires simultaneous administration of glucocorticoids.
Hypothyroidism decreases and hyperthyroidism increases the sensitivity to oral anticoagulants. Prothrombin time should be closely monitored in thyroid-treated patients on oral anticoagulants and dosage of the latter agents adjusted on the basis of frequent prothrombin time determinations. In infants, excessive doses of thyroid hormone preparations may produce craniosynostosis.
Information for the Patient
Laboratory Tests
Drug Interactions
Oral Anticoagulants - Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors. If oral anticoagulants are also being given, compensatory increases in clotting factor synthesis are impaired. Patients stabilized on oral anticoagulants who are found to require thyroid replacement therapy should be watched very closely when thyroid is started. If a patient is truly hypothyroid, it is likely that a reduction in anticoagulant dosage will be required. No special precautions appear to be necessary when oral anticoagulant therapy is begun in a patient already stabilized on maintenance thyroid replacement therapy.
Insulin or Oral Hypoglycemics - Initiating thyroid replacement therapy may cause increases in insulin or oral hypoglycemic requirements. The effects seen are poorly understood and depend upon a variety of factors such as dose and type of thyroid preparations and endocrine status of the patient. Patients receiving insulin or oral hypoglycemics should be closely watched during initiation of thyroid replacement therapy.
Cholestyramine - Cholestyramine binds both T and T in the intestine, thus impairing absorption of these thyroid hormones. studies indicate that the binding is not easily removed. Therefore, 4 to 5 hours should elapse between administration of cholestyramine and thyroid hormones.
Estrogen, Oral Contraceptives - Estrogens tend to increase serum thyroxine-binding globulin (TBg). In a patient with a nonfunctioning thyroid gland who is receiving thyroid replacement therapy, free levothyroxine may be decreased when estrogens are started thus increasing thyroid requirements. However, if the patientu2019s thyroid gland has sufficient function, the decreased free thyroxine will result in a compensatory increase in thyroxine output by the thyroid. Therefore, patients without a functioning thyroid gland who are on thyroid replacement therapy may need to increase their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.
Tricyclic Antidepressants - Use of thyroid products with imipramine and other tricyclic antidepressants may increase receptor sensitivity and enhance antidepressant activity; transient cardiac arrhythmias have been observed. Thyroid hormone activity may also be enhanced.
Digitalis - Thyroid preparations may potentiate the toxic effects of digitalis. Thyroid hormonal replacement increases metabolic rate, which requires an increase in digitalis dosage.
Ketamine - When administered to patients on a thyroid preparation, this parenteral anesthetic may cause hypertension and tachycardia. Use with caution and be prepared to treat hypertension, if necessary.
Vasopressors - Thyroxine increases the adrenergic effect of catecholamines such as epinephrine and norepinephrine. Therefore, injection of these agents into patients receiving thyroid preparations increases the risk of precipitating coronary insufficiency, especially in patients with coronary artery disease. Careful observation is required.
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis and Impairment of Fertility
Pregnancy
Nursing Mothers
Geriatric Use
Pediatric Use
Treatment should be initiated immediately upon diagnosis and maintained for life, unless transient hypothyroidism is suspected, in which case, therapy may be interrupted for 2 to 8 weeks after the age of 3 years to reassess the condition. Cessation of therapy is justified in patients who have maintained a normal TSH during those 2 to 8 weeks.

Adverse reactions, other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period are rare (see ).
In rare instances, allergic skin reactions have been reported with liothyronine sodium tablets.
To report , contact Sigmapharm Laboratories, LLC, Pharmacovigilance at 1-855-332-0731 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Signs and Symptoms
Treatment Of Overdosage
Treatment of acute massive thyroid hormone overdosage is aimed at reducing gastrointestinal absorption of the drugs and counteracting central and peripheral effects, mainly those of increased sympathetic activity. Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex. Treatment is symptomatic and supportive. Oxygen may be administered and ventilation maintained. Cardiac glycosides may be indicated if congestive heart failure develops. Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed. Antiadrenergic agents, particularly propranolol, have been used advantageously in the treatment of increased sympathetic activity. Propranolol may be administered intravenously at a dosage of 1 to 3 mg over a 10-minute period or orally, 80 to 160 mg/day, especially when no contraindications exist for its use.

The dosage of thyroid hormones is determined by the indication and must in every case be individualized according to patient response and laboratory findings.
Liothyronine sodium tablets are intended for oral administration; once-a-day dosage is recommended. Although liothyronine sodium has a rapid cutoff, its metabolic effects persist for a few days following discontinuance.
Mild Hypothyroidism:
The rapid onset and dissipation of action of liothyronine sodium (T ), as compared with levothyroxine sodium (T ), has led some clinicians to prefer its use in patients who might be more susceptible to the untoward effects of thyroid medication. However, the wide swings in serum T levels that follow its administration and the possibility of more pronounced cardiovascular side effects tend to counterbalance the stated advantages.
Liothyronine sodium tablets may be used in preference to levothyroxine (T ) during radioisotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration. It may also be preferred when impairment of peripheral conversion of T to T is suspected.
Myxedema:
Myxedema Coma:
An intravenous preparation of liothyronine sodium is marketed by JONES PHARMA INCORPORATED, under the trade name Triostatu00ae for use in myxedema coma/precoma.
Congenital Hypothyroidism:n- Array
Simple (non-toxic) Goiter:
In the elderly or in pediatric patients,
When switching a patient to Liothyronine Sodium tabletsn- liothyronine sodium
Thyroid Suppression Therapy:
Each 5 mcg tablet contains liothyronine sodium equivalent to 5 mcg of liothyronine. Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. Each 50 mcg tablet contains liothyronine sodium equivalent to 50 mcg of liothyronine.
Liothyronine sodium tablets are given in doses of 75 to 100 mcg/day for 7 days, and radioactive iodine uptake is determined before and after administration of the hormone. If thyroid function is under normal control, the radioiodine uptake will drop significantly after treatment. Liothyronine sodium tablets should be administered cautiously to patients in whom there is a strong suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone effects will be additive to the endogenous source.

Each 5 mcg tablet contains liothyronine sodium equivalent to 5 mcg of liothyronine.
5 mcg - Round, white to off-white color tablets debossed u201cu03a3u201d on one side and u201c18u201don the other side. They are available in bottles of 30s (NDC 71205-150-30), 60s (NDC 71205-150-60) and 90s (NDC 71205-150-90).
Store between 15u00b0 and 30u00b0C (59u00b0 and 86u00b0F).
Manufactured by:
Sigmapharm Laboratories, LLC
Bensalem, PA 19020
Repackaged by:
Proficient Rx, Lp.
Thousand Oaks, CA 91320
OS020-05 REV.0118

Liothyronine Sodium Tablets, USP 5 mcg Container Label
NDC 71205-150-30
Liothyronine Sodium Tablets, USP
5 mcg
30 Tablets
Rx Only

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Liothyronine Sodium (Liothyronine Sodium)

Trade Name : Liothyronine Sodium

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Liothyronine Sodium (Liothyronine Sodium)

Trade Name : Liothyronine Sodium

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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