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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
Generic Availability
NO
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
Adult
Take on empty stomach ½–1hr 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. Doses >2mcg/kg/day may be required.
Children
Not established.
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
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
See Literature
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, proton pump inhibitors, 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
Generic Availability
NO
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 ½–1hr 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. Elderly or underlying cardiac disease: initially 12.5–25mcg once daily; increase every 6–8 weeks, as needed. Severe hypothyroidism: initially 12.5–25mcg once daily; adjust in increments of 12.5–25mcg every 2–4 weeks. Secondary or tertiary hypothyroidism, pregnancy: see full labeling.
Children
Take on empty stomach ½–1hr before breakfast. May mix ampule contents in water or give directly. Congenital or acquired 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
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
See Literature
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, proton pump inhibitors, 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
