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Author: Admin | 2025-04-28
Breakfast. (2.1) •Administer at least 4 hours before or after drugs that are known to interfere with absorption. (2.1) •Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. (2.1) •Advise patients to stop biotin and biotin-containing supplements at least 2 days before assessing TSH and/or T4 levels. (2.2) •Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medications. Peak therapeutic effect may not be attained for 4-6 weeks. (2.2) •See full prescribing information for dosing in specific patient populations. (2.3) •Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status. (2.4) 2.1 Important Administration Instructions Administer levothyroxine sodium tablets as a single daily dose, on an empty stomach, one-half to one hour before breakfast. Administer levothyroxine sodium tablets at least 4 hours before or after drugs known to interfere with levothyroxine sodium tablets absorption [see Drug Interactions (7.1)]. Evaluate the need for dosage adjustments when regularly administering within one hour of certain foods that may affect levothyroxine sodium tablets absorption [see Dosage and Administration (2.2 and 2.3), Drug Interactions (7.9) , and Clinical Pharmacology (12.3)]. Administer levothyroxine sodium tablets to pediatric patients who cannot swallow intact tablets by crushing the tablet, suspending the freshly crushed tablet in a small amount (5 to 10 mL) of water and immediately administering the suspension by spoon or dropper. Ensure the patient ingests the full amount of the suspension. Do not store the suspension. Do not administer in foods that decrease absorption of levothyroxine sodium tablets, such as soybean-based infant formula [see Drug Interactions (7.9)]. 2.2 Important Considerations for Dosing The dosage of levothyroxine sodium tablets for hypothyroidism or pituitary TSH suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated [see Dosage and Administration (2.3), Warnings and Precautions (5), and Drug Interactions (7)]. Dosing must be individualized to account for these factors and dosage adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4)]. For adult patients with primary hypothyroidism, titrate until the patient is clinically euthyroid and the serum TSH returns to normal [see Dosage and Administration (2.3)]. For secondary or tertiary hypothyroidism, serum TSH is not
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