BOXED WARNING Not for treatment of obesity or weight loss; doses beyond daily hormonal requirements may cause serious or life-threatening toxicity, esp. with sympathomimetic amines.
FDA dosing
Population
Start
Target
Max
Primary/secondary/tertiary hypothyroidism
Adults
1.6 mcg/kg QD (full replacement); some require lower
Titrate to euthyroid / normal TSH
Doses >200 mcg/day seldom required
Hypothyroidism
Adults at risk of AF / with cardiac disease or elderly
<1.6 mcg/kg QD (lower start)
Titrate slowly to euthyroid
Congenital/acquired hypothyroidism
Pediatric (weight/age-based)
10–15 mcg/kg QD (0–3 mo) down to 1.6 mcg/kg QD when growth complete
Titrate to euthyroid
Pre-existing hypothyroidism in pregnancy
Pregnant
Pre-pregnancy dose, often increased 12.5–25 mcg/day
TSH within trimester-specific range
TSH suppression in well-differentiated thyroid cancer
Adults & pediatric
Dose targeted to desired TSH suppression
Per cancer stage/status
Titration Adults: adjust 12.5–25 mcg every 4–6 weeks (every 6–8 weeks if cardiac/elderly); pediatric: every 2 weeks.
Renal Undefined
Hepatic Undefined
Narrow therapeutic index; peak therapeutic effect may take 4–6 weeks.
Instructions
Take once daily on an empty stomach, 30–60 minutes before breakfast.
Administer at least 4 hours before or after drugs that impair absorption.
Pediatric patients unable to swallow tablets: crush and suspend freshly in 5–10 mL water, give immediately by spoon/dropper; do not give in soybean-based formula.
Stop biotin supplements >=2 days before assessing TSH/T4.
Return to pre-pregnancy dose immediately after delivery.
Decreased bone mineral density; menstrual irregularities
Pediatric: pseudotumor cerebri, slipped capital femoral epiphysis, craniosynostosis
Hypersensitivity to inactive ingredients (urticaria, rash, angioedema)
Pregnancy No increased rate of birth defects/miscarriage with euthyroid maintenance; do not discontinue; requirements often increase — monitor TSH and adjust.
Lactation Present in human milk; no adverse effects on breastfed infant reported.