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Author: Admin | 2025-04-28
Adverse effect on fetal neurocognitive development. Dose Adjustments During Pregnancy and the Postpartum PeriodPregnancy may increase LEVOXYL requirements. Serum TSH level should be monitored and the LEVOXYL dosage adjusted during pregnancy. Since postpartum TSH levels are similar to preconception values, the LEVOXYL dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration (2.3)].DataHuman DataLevothyroxine is approved for use as a replacement therapy for hypothyroidism. There is a long experience of levothyroxine use in pregnant women, including data from post-marketing studies that have not reported increased rates of fetal malformations, miscarriages or other adverse maternal or fetal outcomes associated with levothyroxine use in pregnant women.8.2 LactationRisk SummaryLimited published studies report that levothyroxine is present in human milk. However, there is insufficient information to determine the effects of levothyroxine on the breastfed infant and no available information on the effects of levothyroxine on milk production. Adequate levothyroxine treatment during lactation may normalize milk production in hypothyroid lactating mothers. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LEVOXYL and any potential adverse effects on the breastfed infant from LEVOXYL or from the underlying maternal condition.8.4 Pediatric UseThe initial dose of LEVOXYL varies with age and body weight. Dosing adjustments are based on an assessment of the individual patient's clinical and laboratory parameters [see Dosage and Administration (2.3, 2.4)].In children in whom a diagnosis of permanent hypothyroidism has not been established, discontinue LEVOXYL for a trial period, but only after the
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