Tirosint-sol

— THERAPEUTIC CATEGORIES —
  • Pancreatic, thyroid, and other endocrine cancers
  • Thyroid disease
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Tirosint-sol Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Levothyroxine sodium 13mcg/mL, 25mcg/mL, 37.5mcg/mL, 44mcg/mL, 50mcg/mL, 62.5mcg/mL, 75mcg/mL, 88mcg/mL, 100mcg/mL, 112mcg/mL, 125mcg/mL, 137mcg/mL, 150mcg/mL, 175mcg/mL, 200mcg/mL; oral soln; contains glycerol.

    Pharmacological Class

    T4 (synthetic).

    How Supplied

    Unit-dose ampules (1mL)—5, 30

    Manufacturer

    IBSA Pharma Inc

    Generic Availability

    NO

    Mechanism of Action

    Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

    Tirosint-sol Indications

    Indications

    As an adjunct to surgery and radioiodine therapy, in the management of thyrotropin-dependent well-differentiated thyroid cancer.

    Limitations of Use

    Not for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. Not for transient hypothyroidism during recovery phase of subacute thyroiditis.

    Tirosint-sol Dosage and Administration

    Adults and Children

    Take on empty stomach 15mins before breakfast. May mix ampule contents in water or give directly as single dose. Target TSH levels within desired therapeutic range for TSH suppression. Individualize. 

    Tirosint-sol Contraindications

    Contraindications

    Glycerol hypersensitivity. Uncorrected adrenal insufficiency.

    Tirosint-sol Boxed Warnings

    Boxed Warning

    Not for treatment of obesity or for weight loss.

    Tirosint-sol Warnings/Precautions

    Warnings/Precautions

    Serious risks related to over- or under-treatment; titrate dose carefully and monitor. Underlying cardiovascular disease. Monitor for cardiac arrhythmias during surgery in those with coronary artery disease. Reduce or withhold dose for 1 week if cardiac symptoms develop or worsen; restart at lower dose. Myxedema coma: use IV levothyroxine. Adults: Monitor TSH 6–8 weeks after dose change then every 6–12 months when stable. Peds: Monitor TSH and total or free-T4 at 2 and 4 weeks after initiation, 2 weeks after dose change then every 3–12 months thereafter. Correct adrenal insufficiency before initiation. Diabetes; monitor glycemic control. Increased bone resorption and decreased BMD (esp. in post-menopausal women). Use lowest effective dose. Elderly. Pregnancy: monitor TSH/free-T4 at least every trimester; adjust dose and do not discontinue (see full labeling). Nursing mothers.

    Tirosint-sol Pharmacokinetics

    Distribution

    Plasma protein bound: >99%.

    Metabolism

    Hepatic (primarily by sequential deiodination). 

    Elimination

    Renal (~80%), fecal (~20%). Half-life (T4): 3–4 days in hyperthyroidism, 9–10 days in hypothyroidism; (T3): ≤2 days.

    Tirosint-sol Interactions

    Interactions

    See full labeling. Absorption reduced by some foods (eg, soy flour, cottonseed meal, walnuts, fiber, grapefruit juice), aluminum and magnesium hydroxide, simethicone, iron, sucralfate; monitor. Give at least 4hrs apart from calcium carbonate, ferrous sulfate, bile acid sequestrants (eg, colesevelam, cholestyramine, colestipol), ion exchange resins (eg, kayexalate, sevelamer). Thyroid levels may be affected by clofibrate, estrogens, heroin, methadone, 5-fluorouracil, mitotane, tamoxifen, androgens, anabolic steroids, asparaginase, glucocorticoids, nicotinic acid (slow-release), salicylates (>2g/day), β-blockers (eg, propranolol), glucocorticoids, amiodarone. Monitor thyroid parameters with concomitant carbamazepine, furosemide (>80mg IV), heparin, hydantoins, NSAIDs. Potentiates, and is potentiated by, tri- and tetracyclic antidepressants. Concomitant sympathomimetics; monitor for coronary insufficiency. Antagonized by phenobarbital, rifampin, sertraline. Antagonizes digitalis glycosides. Marked hypertension and tachycardia with ketamine. Hypothyroidism risk with concomitant tyrosine kinase inhibitors (eg, imatinib). Monitor with oral anticoagulants, antidiabetic agents, orlistat.

    Tirosint-sol Adverse Reactions

    Adverse Reactions

    Arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, skin rash; seizures (rare); Children: pseudotumor cerebri, slipped capital femoral epiphysis.

    Tirosint-sol Clinical Trials

    See Literature

    Tirosint-sol Note

    Not Applicable

    Tirosint-sol Patient Counseling

    See Literature

    Tirosint-sol Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Levothyroxine sodium 13mcg/mL, 25mcg/mL, 37.5mcg/mL, 44mcg/mL, 50mcg/mL, 62.5mcg/mL, 75mcg/mL, 88mcg/mL, 100mcg/mL, 112mcg/mL, 125mcg/mL, 137mcg/mL, 150mcg/mL, 175mcg/mL, 200mcg/mL; oral soln; contains glycerol.

    Pharmacological Class

    T4 (synthetic).

    How Supplied

    Unit-dose ampules (1mL)—5, 30

    Manufacturer

    IBSA Pharma Inc

    Generic Availability

    NO

    Mechanism of Action

    Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

    Tirosint-sol Indications

    Indications

    Hypothyroidism.

    Limitations of Use

    Not for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. Not for transient hypothyroidism during recovery phase of subacute thyroiditis.

    Tirosint-sol Dosage and Administration

    Adult

    Take on empty stomach 15mins before breakfast. May mix ampule contents in water or give directly as single dose. Individualize. Adjust dose as needed until patient is euthyroid and serum TSH normalized. Primary hypothyroidism: 1.6mcg/kg/day; adjust in increments of 12.5–25mcg every 4–6 weeks. Usual max 200mcg/day. Risk for atrial fibrillation, underlying cardiac disease, or elderly: lower starting dose (<1.6mcg/kg/day); adjust every 6–8 weeks, as needed. Secondary or tertiary hypothyroidism, pregnancy: see full labeling.

    Children

    Take on empty stomach 15mins before breakfast. May mix ampule contents in water or give directly. Primary, secondary, or tertiary hypothyroidism: 0–3mos: 10–15mcg/kg/day; 3–6mos: 8–10mcg/kg/day; 6–12mos: 6–8mcg/kg/day; 1–5yrs: 5–6mcg/kg/day; 6–12yrs: 4–5mcg/kg/day; >12yrs (but growth and puberty incomplete): 2–3mcg/kg/day; (growth and puberty complete): 1.6mcg/kg/day. Newborns at risk for cardiac failure: consider lower initial dose; increase every 4–6 weeks as needed. Risk for hyperactivity: initially ¼ full replacement dose; increase by ¼ dose weekly until full dose reached.

    Tirosint-sol Contraindications

    Contraindications

    Glycerol hypersensitivity. Uncorrected adrenal insufficiency.

    Tirosint-sol Boxed Warnings

    Boxed Warning

    Not for treatment of obesity or for weight loss.

    Tirosint-sol Warnings/Precautions

    Warnings/Precautions

    Serious risks related to over- or under-treatment; titrate dose carefully and monitor. Underlying cardiovascular disease. Monitor for cardiac arrhythmias during surgery in those with coronary artery disease. Reduce or withhold dose for 1 week if cardiac symptoms develop or worsen; restart at lower dose. Myxedema coma: use IV levothyroxine. Adults: Monitor TSH 6–8 weeks after dose change then every 6–12 months when stable. Peds: Monitor TSH and total or free-T4 at 2 and 4 weeks after initiation, 2 weeks after dose change then every 3–12 months thereafter. Correct adrenal insufficiency before initiation. Diabetes; monitor glycemic control. Increased bone resorption and decreased BMD (esp. in post-menopausal women). Use lowest effective dose. Elderly. Pregnancy: monitor TSH/free-T4 at least every trimester; adjust dose and do not discontinue (see full labeling). Nursing mothers.

    Tirosint-sol Pharmacokinetics

    Distribution

    Plasma protein bound: >99%.

    Metabolism

    Hepatic (primarily by sequential deiodination). 

    Elimination

    Renal (~80%), fecal (~20%). Half-life (T4): 3–4 days in hyperthyroidism, 9–10 days in hypothyroidism; (T3): ≤2 days.

    Tirosint-sol Interactions

    Interactions

    See full labeling. Absorption reduced by some foods (eg, soy flour, cottonseed meal, walnuts, fiber, grapefruit juice), aluminum and magnesium hydroxide, simethicone, iron, sucralfate; monitor. Give at least 4hrs apart from calcium carbonate, ferrous sulfate, bile acid sequestrants (eg, colesevelam, cholestyramine, colestipol), ion exchange resins (eg, kayexalate, sevelamer). Thyroid levels may be affected by clofibrate, estrogens, heroin, methadone, 5-fluorouracil, mitotane, tamoxifen, androgens, anabolic steroids, asparaginase, glucocorticoids, nicotinic acid (slow-release), salicylates (>2g/day), β-blockers (eg, propranolol), glucocorticoids, amiodarone. Monitor thyroid parameters with concomitant carbamazepine, furosemide (>80mg IV), heparin, hydantoins, NSAIDs. Potentiates, and is potentiated by, tri- and tetracyclic antidepressants. Concomitant sympathomimetics; monitor for coronary insufficiency. Antagonized by phenobarbital, rifampin, sertraline. Antagonizes digitalis glycosides. Marked hypertension and tachycardia with ketamine. Hypothyroidism risk with concomitant tyrosine kinase inhibitors (eg, imatinib). Monitor with oral anticoagulants, antidiabetic agents, orlistat.

    Tirosint-sol Adverse Reactions

    Adverse Reactions

    Arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, skin rash; seizures (rare); Children: pseudotumor cerebri, slipped capital femoral epiphysis.

    Tirosint-sol Clinical Trials

    See Literature

    Tirosint-sol Note

    Not Applicable

    Tirosint-sol Patient Counseling

    See Literature

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