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Levothyroxine

Generic Name
Levothyroxine
Brand Names
Eltroxin, Ermeza, Euthyrox, Levo-T, Levothroid, Levoxyl, Np Thyroid, Synthroid, Thyquidity, Tirosint, Unithroid
Drug Type
Small Molecule
Chemical Formula
C15H11I4NO4
CAS Number
51-48-9
Unique Ingredient Identifier
Q51BO43MG4

Overview

Levothyroxine is a synthetically produced form of thyroxine, a major endogenous hormone secreted by the thyroid gland. Also known as L-thyroxine or the brand name product Synthroid, levothyroxine is used primarily to treat hypothyroidism, a condition where the thyroid gland is no longer able to produce sufficient quantities of the thyroid hormones T (tetraiodothyronine or thyroxine) and T (triiodothyronine or Liothyronine), resulting in diminished down-stream effects of these hormones. Without sufficient quantities of circulating thyroid hormones, symptoms of hypothyroidism begin to develop such as fatigue, increased heart rate, depression, dry skin and hair, muscle cramps, constipation, weight gain, memory impairment, and poor tolerance to cold temperatures. In response to Thyroid Stimulating Hormone (TSH) release by the pituitary gland, a normally functioning thyroid gland will produce and secrete T, which is then converted through deiodination (by type I or type II 5′-deiodinases) into its active metabolite T. While T is the major product secreted by the thyroid gland, T exerts the majority of the physiological effects of the thyroid hormones; T and T have a relative potency of ~1:4 (T4:T3). T and T act on nearly every cell of the body, but have a particularly strong effect on the cardiac system. As a result, many cardiac functions including heart rate, cardiac output, and systemic vascular resistance are closely linked to thyroid status. Prior to the development of levothyroxine, Thyroid, porcine or desiccated thyroid, used to be the mainstay of treatment for hypothyroidism. However, this is no longer recommended for the majority of patients due to several clinical concerns including limited controlled trials supporting its use. Desiccated thyroid products contain a ratio of T4 to T3 of 4.2:1, which is significantly lower than the 14:1 ratio of secretion by the human thyroid gland. This higher proportion of T3 in desiccated thyroid products can lead to supraphysiologic levels of T3 which may put patients at risk of thyrotoxicosis if thyroid extract therapy is not adjusted according to the serum TSH.

Background

Levothyroxine is a synthetically produced form of thyroxine, a major endogenous hormone secreted by the thyroid gland. Also known as L-thyroxine or the brand name product Synthroid, levothyroxine is used primarily to treat hypothyroidism, a condition where the thyroid gland is no longer able to produce sufficient quantities of the thyroid hormones T (tetraiodothyronine or thyroxine) and T (triiodothyronine or Liothyronine), resulting in diminished down-stream effects of these hormones. Without sufficient quantities of circulating thyroid hormones, symptoms of hypothyroidism begin to develop such as fatigue, increased heart rate, depression, dry skin and hair, muscle cramps, constipation, weight gain, memory impairment, and poor tolerance to cold temperatures. In response to Thyroid Stimulating Hormone (TSH) release by the pituitary gland, a normally functioning thyroid gland will produce and secrete T, which is then converted through deiodination (by type I or type II 5′-deiodinases) into its active metabolite T. While T is the major product secreted by the thyroid gland, T exerts the majority of the physiological effects of the thyroid hormones; T and T have a relative potency of ~1:4 (T4:T3). T and T act on nearly every cell of the body, but have a particularly strong effect on the cardiac system. As a result, many cardiac functions including heart rate, cardiac output, and systemic vascular resistance are closely linked to thyroid status. Prior to the development of levothyroxine, Thyroid, porcine or desiccated thyroid, used to be the mainstay of treatment for hypothyroidism. However, this is no longer recommended for the majority of patients due to several clinical concerns including limited controlled trials supporting its use. Desiccated thyroid products contain a ratio of T4 to T3 of 4.2:1, which is significantly lower than the 14:1 ratio of secretion by the human thyroid gland. This higher proportion of T3 in desiccated thyroid products can lead to supraphysiologic levels of T3 which may put patients at risk of thyrotoxicosis if thyroid extract therapy is not adjusted according to the serum TSH.

Indication

Levothyroxine is indicated as replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Associated Conditions

  • Edematous Fibrosclerotic Panniculopathy (Cellulite)
  • Hypothyroidism
  • Localized Adiposity
  • Myxedema coma
  • Euthyroid Goitre
  • Thyrotropin dependent Well-Differentiated Thyroid Cancer

FDA Approved Products

LEVOTHYROXINE SODIUM
Manufacturer:Med-Health Pharma, LLC
Route:ORAL
Strength:0.100 mg in 1 1
Approved: 2011/01/01
NDC:51138-044
Levothyroxine Sodium
Manufacturer:Cardinal Health 107, LLC
Route:ORAL
Strength:100 ug in 1 1
Approved: 2023/07/05
NDC:55154-5381
LEVOTHYROXINE SODIUM
Manufacturer:Med-Health Pharma, LLC
Route:ORAL
Strength:0.075 mg in 1 1
Approved: 2011/01/01
NDC:51138-042
levothyroxine sodium
Manufacturer:NuCar Pharmaceuticals,Inc.
Route:ORAL
Strength:100 ug in 1 1
Approved: 2022/02/07
NDC:68071-5235
LEVOTHYROXINE SODIUM
Manufacturer:DirectRx
Route:ORAL
Strength:100 ug in 1 1
Approved: 2019/05/16
NDC:61919-872

Singapore Approved Products

LEVOTHYROXINE SODIUM FOR INJECTION 500 mcg/vial
Manufacturer:FRESENIUS KABI USA, LLC
Form:INJECTION, POWDER, FOR SOLUTION
Strength:500 mcg/vial
Online:Yes
Approved: 1998/05/19
Approval:SIN09760P
THYROCORD 50 TABLET 50 MCG
Manufacturer:Intas Pharmaceuticals Limited.
Form:TABLET
Strength:0.05 mg
Online:Yes
Approved: 2023/02/15
Approval:SIN16696P
EUTHYROX TABLET 50 mcg
Manufacturer:Merck S.A. de C.V., Merck Healthcare KGaA
Form:TABLET
Strength:50 mcg
Online:Yes
Approved: 1998/05/06
Approval:SIN09740P
ROVEXINE-75 TABLETS 75MCG
Manufacturer:Acme Generics LLP.
Form:TABLET
Strength:75 mcg
Online:Yes
Approved: 2022/10/10
Approval:SIN16627P
EUTHYROX TABLET 25 mcg
Manufacturer:Merck S.A. de C.V., Merck Healthcare KGaA
Form:TABLET
Strength:25 mcg
Online:Yes
Approved: 1998/05/06
Approval:SIN09739P

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