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 varioustypes of euthyroid goiters,subacute or chronic lymphocytic thyroiditis
(Hashimoto’s thyroiditis), multinodular goiter and, as an adjunct to surgery and radioiodine therapy in the
management ofthyrotropin-dependent well-differentiated thyroid cancer.
DOSAGE AND ADMINISTRATION
In order to avoid irregular absorption, Thyrin® tablets should be taken preferably at a fixed time on an
empty stomach. Concomitant intake of food may decrease the absorption of Levothyroxine. Dosing must
be individualized and adjustments to be made based on periodic assessment of the patient’s clinical
response and laboratory parameters.
Pediatric Dosage
Newborns: The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be
considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed
based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or
undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of
Levothyroxine Sodium.
Infants and Children: In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with
increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended
full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth
the full-recommended replacement dose until the full recommended replacement dose is reached.
Daily dose per kg body weight:
0-3 months: 10-15 mcg/kg/day
3-6 months: 8-10 mcg/kg/day
6-12 months: 6-8 mcg/kg/day
1-5 years: 5-6 mcg/kg/day
6-12 years: 4-5 mcg/kg/day
12 years but growth and puberty incomplete: 2-3 mcg/kg/day
Growth and puberty complete: 1.7 mcg/kg/day
The dose should be adjusted based on clinical response and laboratory parameters.
CONTRAINDICATIONS
Untreated subclinical or overt thyrotoxicosis of any etiology and acute myocardial infarction.
PRECAUTIONS
Levothyroxine has a narrow therapeutic index. So, careful dosage titration is necessary to avoid the
consequences of over- or under-treatment. Caution is needed when administering Levothyroxine to
patients with cardiovascular disorders, to the elderly in whom there is an increased risk of occult cardiac
disease & for patients with nontoxic diffuse goiter or nodular thyroid disease in order to prevent
precipitation of thyrotoxicosis
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