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Levoxyl Generic Name & Formulations
Legal Class
Rx
General Description
Levothyroxine sodium 25mcg, 50mcg (dye-free), 75mcg, 88mcg, 100mcg, 112mcg, 125mcg, 137mcg, 150mcg, 175mcg, 200mcg; scored tabs.
Pharmacological Class
T4 (synthetic).
How Supplied
Tabs—100, 1000
Manufacturer
Generic Availability
YES
Levoxyl Indications
Indications
As adjunct to surgery and radioiodine therapy for 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 indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Levoxyl Dosage and Administration
Adult
Take in AM on empty stomach, ½ to 1hr before breakfast. May crush tabs and mix in 5–10mL water. Target TSH levels within desired therapeutic range for TSH suppression. Individualize. Doses >2mcg/kg/day may be required.
Children
Not established.
Levoxyl Contraindications
Contraindications
Uncorrected adrenal insufficiency.
Levoxyl Boxed Warnings
Boxed Warning
Not for treatment of obesity or for weight loss.
Levoxyl 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. Oral tabs: not for treating myxedema coma. Adults: Monitor TSH 6–8 weeks after dose change then every 6–12 months. 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. Increased sensitivity in severe hypothyroidism. Diabetes; monitor glucose 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.
Levoxyl Pharmacokinetics
See Literature
Levoxyl 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.
Levoxyl 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.
Levoxyl Clinical Trials
See Literature
Levoxyl Note
Not Applicable
Levoxyl Patient Counseling
See Literature
Levoxyl Generic Name & Formulations
Legal Class
Rx
General Description
Levothyroxine sodium 25mcg, 50mcg (dye-free), 75mcg, 88mcg, 100mcg, 112mcg, 125mcg, 137mcg, 150mcg, 175mcg, 200mcg; scored tabs.
Pharmacological Class
T4 (synthetic).
How Supplied
Tabs—100, 1000
Manufacturer
Generic Availability
YES
Levoxyl Indications
Indications
Hypothyroidism.
Limitations of Use
Not for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Levoxyl Dosage and Administration
Adult
Take in AM on empty stomach, ½ to 1hr before breakfast. Individualize. Primary hypothyroidism: 1.6mcg/kg once daily; titrate in increments of 12.5–25mcg every 4–6 weeks until euthyroid and serum TSH normalized. Elderly or underlying cardiovascular disease: initially 12.5–25mcg once daily; titrate every 6–8 weeks until euthyroid and serum TSH normalized. Usual max 200mcg/day. Severe hypothyroidism: initially 12.5–25mcg once daily; titrate in increments of 12.5–25mcg every 2–4 weeks until euthyroid and serum TSH normalized. Secondary or tertiary hypothyroidism: see full labeling.
Children
Take in AM on empty stomach, ½ to 1hr before breakfast. May crush tabs and mix in 5–10mL water. Congenital or acquired hypothyroidism: 0–3months: 10–15mcg/kg per day; 3–6months: 8–10mcg/kg per day; 6–12months: 6–8mcg/kg per day; 1–5yrs: 5–6mcg/kg per day; 6–12yrs: 4–5mcg/kg per day; >12yrs but growth and puberty incomplete: 2–3mcg/kg per day; growth and puberty complete: as adult. Newborns at risk for cardiac failure: initiate at lower dose; increase dose every 4–6 weeks as needed. Risk for hyperactivity: initially ¼ full replacement dose; increase by ¼ dose weekly until full dose reached.
Levoxyl Contraindications
Contraindications
Uncorrected adrenal insufficiency.
Levoxyl Boxed Warnings
Boxed Warning
Not for treatment of obesity or for weight loss.
Levoxyl 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. Oral tabs: not for treating myxedema coma. Adults: Monitor TSH 6–8 weeks after dose change then every 6–12 months. 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. Increased sensitivity in severe hypothyroidism. Diabetes; monitor glucose 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.
Levoxyl Pharmacokinetics
See Literature
Levoxyl 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.
Levoxyl 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.
Levoxyl Clinical Trials
See Literature
Levoxyl Note
Not Applicable
Levoxyl Patient Counseling
See Literature
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