Liothyronine Sodium


Proficient Rx Lp
Human Prescription Drug
NDC 71205-150
Liothyronine Sodium is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Liothyronine Sodium is 71205-150. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Liothyronine Sodium drug includes Liothyronine Sodium - 5 ug/1 . The currest status of Liothyronine Sodium drug is Active.

Drug Information:

Drug NDC: 71205-150
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Liothyronine Sodium
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Liothyronine Sodium
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Proficient Rx Lp
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:LIOTHYRONINE SODIUM - 5 ug/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 03 Dec, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA200295
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Proficient Rx LP
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:903456
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UNII:GCA9VV7D2N
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Triiodothyronine [CS]
l-Triiodothyronine [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
71205-150-3030 TABLET in 1 BOTTLE (71205-150-30)01 Nov, 2018N/ANo
71205-150-6060 TABLET in 1 BOTTLE (71205-150-60)01 Nov, 2018N/ANo
71205-150-9090 TABLET in 1 BOTTLE (71205-150-90)01 Nov, 2018N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Liothyronine sodium liothyronine sodium calcium sulfate dihydrate starch, corn gelatin, unspecified magnesium stearate mannitol liothyronine sodium liothyronine white to off-white 18

Boxed Warning:

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.

Indications and Usage:

Indications and usage thyroid hormone drugs are indicated: 1. as replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. this category includes cretinism, myxedema and ordinary hypothyroidism in patients of any age (pediatric patients, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary) or tertiary (hypothalamic) hypothyroidism (see warnings ). 2. as pituitary thyroid-stimulating hormone (tsh) suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (hashimoto’s) and multinodular goiter. 3. as diagnostic agents in suppression tests to differe
ntiate suspected mild hyperthyroidism or thyroid gland autonomy. liothyronine sodium tablets can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.

Warnings:

Warnings 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. 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 greate
r 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.

Dosage and Administration:

Dosage and administration 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: recommended starting dosage is 25 mcg daily. daily dosage then may be increased by up to 25 mcg every 1 or 2 weeks. usual maintenance dose is 25 to 75 mcg daily. the rapid onset and dissipation of action of liothyronine sodium (t 3 ), as compared with levothyroxine sodium (t 4 ), 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 3 levels that follow its administration and the possibility of more pronounced cardiovascular side effects tend to counterbala
nce the stated advantages. liothyronine sodium tablets may be used in preference to levothyroxine (t 4 ) 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 4 to t 3 is suspected. myxedema: recommended starting dosage is 5 mcg daily. this may be increased by 5 to 10 mcg daily every 1 or 2 weeks. when 25 mcg daily is reached, dosage may be increased by 5 to 25 mcg every 1 or 2 weeks until a satisfactory therapeutic response is attained. usual maintenance dose is 50 to 100 mcg daily. myxedema coma: myxedema coma is usually precipitated in the hypothyroid patient of long standing by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency. an intravenous preparation of liothyronine sodium is marketed by jones pharma incorporated, under the trade name triostat® for use in myxedema coma/precoma. congenital hypothyroidism: recommended starting dosage is 5 mcg daily, with a 5 mcg increment every 3 to 4 days until the desired response is achieved. infants a few months old may require only 20 mcg daily for maintenance. at 1 year, 50 mcg daily may be required. above 3 years, full adult dosage may be necessary (see precautions, pediatric use ). simple (non-toxic) goiter: recommended starting dosage is 5 mcg daily. this dosage may be increased by 5 to 10 mcg daily every 1 or 2 weeks. when 25 mcg daily is reached, dosage may be increased every week or two by 12.5 or 25 mcg. usual maintenance dosage is 75 mcg daily. in the elderly or in pediatric patients, therapy should be started with 5 mcg daily and increased only by 5 mcg increments at the recommended intervals. when switching a patient to liothyronine sodium tablets from thyroid, l-thyroxine or thyroglobulin, discontinue the other medication, initiate liothyronine sodium at a low dosage, and increase gradually according to the patient's response. when selecting a starting dosage, bear in mind that this drug has a rapid onset of action, and that residual effects of the other thyroid preparation may persist for the first several weeks of therapy. thyroid suppression therapy: administration of thyroid hormone in doses higher than those produced physiologically by the gland results in suppression of the production of endogenous hormone. this is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom baseline laboratory tests appear normal or to demonstrate thyroid gland autonomy in patients with graves’ ophthalmopathy. 131 i uptake is determined before and after the administration of the exogenous hormone. a 50% or greater suppression of uptake indicates a normal thyroid-pituitary axis and thus rules out thyroid gland autonomy. 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.

Contraindications:

Contraindications 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.

Adverse Reactions:

Adverse reactions adverse reactions, other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period are rare (see overdosage ). in rare instances, allergic skin reactions have been reported with liothyronine sodium tablets. 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.

Overdosage:

Overdosage signs and symptoms - headache, irritability, nervousness, sweating, arrhythmia (including tachycardia), increased bowel motility and menstrual irregularities. angina pectoris or congestive heart failure may be induced or aggravated. shock may also develop. massive overdosage may result in symptoms resembling thyroid storm. chronic excessive dosage will produce the signs and symptoms of hyperthyroidism. treatment of overdosage - dosage should be reduced or therapy temporarily discontinued if signs and symptoms of overdosage appear. treatment may be reinstituted at a lower dosage. in normal individuals, normal hypothalamic-pituitary-thyroid axis function is restored in 6 to 8 weeks after thyroid suppression. 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.

Description:

Description thyroid hormone drugs are natural or synthetic preparations containing tetraiodothyronine (t 4 , levothyroxine) sodium or triiodothyronine (t 3 , liothyronine) sodium or both. t 4 and t 3 are produced in the human thyroid gland by the iodination and coupling of the amino acid tyrosine. t 4 contains four iodine atoms and is formed by the coupling of two molecules of diiodotyrosine (dit). t 3 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 3 ), 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. image description

Clinical Pharmacology:

Clinical pharmacology 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 3 ) 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 3 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 ac
tivity which permits quick dosage adjustment and facilitates control of the effects of overdosage, should they occur. the higher affinity of levothyroxine (t 4 ) for both thyroid-binding globulin and thyroid-binding prealbumin as compared to triiodothyronine (t 3 ) 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.

How Supplied:

How supplied each 5 mcg tablet contains liothyronine sodium equivalent to 5 mcg of liothyronine. 5 mcg - round, white to off-white color tablets debossed “Σ” on one side and “18”on 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 15° and 30°c (59° and 86°f). manufactured by: sigmapharm laboratories, llc bensalem, pa 19020 repackaged by: proficient rx, lp. thousand oaks, ca 91320 os020-05 rev.0118

Package Label Principal Display Panel:

Liothyronine sodium tablets, usp 5 mcg- 30 tablets container label liothyronine sodium tablets, usp 5 mcg container label ndc 71205-150-30 liothyronine sodium tablets, usp 5 mcg 30 tablets rx only 71205-150-30


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.