Tirosint Sol

Product manufactured by Ibsa Pharma Inc.

Application Nr Approved Date Route Status External Links
NDA206977 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indication And Usage Tirosint-Sol Is L-Thyroxine (T4) Indicated For: Hypothyroidism - As Replacement Therapy In Primary (Thyroidal), Secondary (Pituitary), And Tertiary (Hypothalamic) Congenital Or Acquired Hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Timulating Hormone, Tsh) Suppression - As An Adjunct To Surgery And Radioiodine Therapy In The Management Of Thyrotropin-Dependent Well-Differentiated Thyroid Cancer ( 1 ) Limitations Of Use: Not Indicated For Suppression Of Benign Thyroid Nodules And Nontoxic Diffuse Goiter In Iodine-Sufficient Patients ( 1 ) Not Indicated For Treatment Of Transient Hypothyroidism During The Recovery Phase Of Subacute Thyroiditis ( 1 ) Hypothyroidism Tirosint-Sol Is Indicated As A Replacement Therapy In Primary (Thyroidal), Secondary (Pituitary), And Tertiary (Hypothalamic) Congenital Or Acquired Hypothyroidism. Pituitary Thyrotropin (Thyroidstimulating Hormone, Tsh) Suppression Tirosint-Sol Is Indicated As An Adjunct To Surgery And Radioiodine Therapy In The Management Of Thyrotropin-Dependent-Well-Differentiated Thyroid Cancer. Limitations Of Use: Tirosint-Sol Is Not Indicated For Suppression Of Benign Thyroid Nodules And Nontoxic Diffuse Goiter In Iodine-Sufficient Patients As There Are No Clinical Benefits And Overtreatment With Tirosint-Sol May Induce Hyperthyroidism [See Warnings And Precautions (5.4) ] . Tirosint-Sol Is Not Indicated For Treatment Of Transient Hypothyroidism During The Recovery Phase Of Subacute Thyroiditis.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levothyroxine Sodium LEVOTHYROXINE SODIUM ZINC3830993

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