Composition : Levothyroxine Sodium USP 50 mcg.
Indication : Hypothyroidism : As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.
Specific indications : Primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism.
Pituitary TSH Suppression : In the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), multinodular goiter and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Dosage & Administration : Dosing must be individualized and adjustments made based on periodic assessment of the patient’s clinical response and laboratory parameters. Thyrolar is administrated as a single daily dose at a fixed time preferably one-half to one hour before Breakfast.Thyrolar may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5 – 10 ml or 1 – 2 teaspoons) of water. Do not store the suspension.
Adult Dosage : In hypothyroidism the initial adult dose is 50 – 100 mcg once daily, with gradual increments of 25 – 50 mcg at about 4 weeks intervals until the thyroid deficiency is corrected and a maintenance dose (Usually100 – 200 mcg/day) is established.
Pediatric Dosage : Levothyroxine therapy of children should be instituted at full replacement doses as soon as possible, with the recommended dose per body weight decreasing with age.
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AGE
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Daily Dose Per Kg Body Weight
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0 – 3 months
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10 – 15 mcg/kg/day
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3 – 6 months
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8 – 10 mcg/kg/day
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6 – 12 months
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6 – 8 mcg/kg/day
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1 – 5 years
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5 – 6 mcg/kg/day
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6 – 12 years
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4 – 5 mcg/kg/day
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> 12 years but growth and puberty incomplete
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2 – 3 mcg/kg/day
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Growth and puberty complete
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1.7 mcg/kg/day
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In children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2 – 4 weeks until the desired effect is achieved. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day.
