SYNTHROID- levothyroxine sodium tablet

However, if the serum TSH has not risen to greater than 20 mU/L, levothyroxine treatment should be discontinued for another 30-day trial period followed by repeat serum T4 and TSH testing. Although thyroid hormones are excreted only minimally in human milk, caution should be exercised when SYNTHROID is administered to a nursing woman. However, adequate replacement doses of levothyroxine are generally needed to maintain normal lactation. Levothyroxine is generally continued for life in these patients see Warnings and Precautions (5.1).

• No adverse effects on the breastfed infant have been reported and there is no information on the effects of levothyroxine on milk production.
• Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease.
• The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state.
• The signs and symptoms of overdosage are those of hyperthyroidism see Warnings and Precautions (5) and Adverse Reactions (6).
• To minimize the risk of hyperactivity, start at one-fourth the recommended full replacement dosage, and increase on a weekly basis by one-fourth the full recommended replacement dosage until the full recommended replacement dosage is reached.

Treatment of Overdosage

Titrate the dosage (every 2 weeks) as needed based on serum TSH or free-T4 until the patient is euthyroid see Dosage and Administration ( 2.2). The recommended starting daily dosage of SYNTHROID in adults with primary, secondary, or tertiary hypothyroidism is based on age and comorbid cardiac conditions, as described in Table 1. Dosage titration is based on serum TSH or free-T4 see Dosage and Administration ( 2.2). In adult patients with primary hypothyroidism, monitor serum TSH levels after an interval of 6 to 8 weeks after any change in dosage. In patients on a stable and appropriate replacement dosage, evaluate clinical and biochemical response every 6 to 12 months and whenever there is a change in the patient’s clinical status. Titrate the dosage (every 2 weeks) as needed based on serum TSH or free-T4 until the patient is euthyroid see Dosage and Administration (2.2).

Caution should be exercised when administering SYNTHROID to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS ). Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks. The major pathway of thyroid hormone metabolism is through sequential deiodination. Approximately eighty-percent of circulating T3 is derived from peripheral T4 by monodeiodination.

Biochemical assessment incorporated measurement of serum TSH, T3, and T4. TSH lower limit of quantification was 0.2 mIU/L and upper limit of normal was 5.6 mIU/L, as indicated by the shaded area. Use the drop-down menu below to select your state and see the specific language required to prevent generic substitution. That’s because substitutions can be made at the pharmacy if the prescription is not properly protected with the Dispense as Written (DAW) state-specific language.

SYNTHROID has 12 precise dosing options2

Biotin supplementation may interfere with immunoassays for TSH, T4, and T3, resulting in erroneous thyroid hormone test results. Stop biotin and biotin-containing supplements for at least 2 days before assessing TSH and/or T4 levels seeDrug Interactions (7.10) . Inquire whether patients are taking biotin or biotin-containing supplements. If so, advise them to stop biotin supplementation at least 2 days before assessing TSH and/or T4 levels seeDosage and Administration (2.4)and Drug Interactions (7.10) . ​ Inquire whether patients are taking biotin or biotin-containing supplements. If so, advise them to stop biotin supplementation at least 2 days before assessing TSH and/or T4 levels see Dosage and Administration ( 2.4) and Drug Interactions ( 7.10).

Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered. Occasionally, chronic autoimmune thyroiditis may occur in association with other autoimmune disorders such as adrenal insufficiency, pernicious anemia, and insulin-dependent diabetes mellitus. Patients with concomitant adrenal insufficiency should be treated with replacement glucocorticoids prior to initiation of treatment with levothyroxine sodium.

Initiate levothyroxine sodium tablets therapy in synthroid production this population at lower doses than those recommended in younger individuals or in patients without cardiac disease see Dosage and Administration (2.3) and Use in Specific Populations (8.5) . In adult patients with primary (thyroidal) hypothyroidism, serum TSH levels (using a sensitive assay) alone may be used to monitor therapy. The frequency of TSH monitoring during levothyroxine dose titration depends on the clinical situation but it is generally recommended at 6-8 week intervals until normalization.

• Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption.
• Addition of SYNTHROID therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements.
• Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma.
• Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Phenobarbital increases L-thyroxine metabolism by inducing uridine 5’-diphospho-glucuronosyltransferase (UGT) and leads to lower T4 serum levels. Changes in thyroid status may occur if barbiturates are added or withdrawn from patients being treated for hypothyroidism. Rifampin has been shown to accelerate the metabolism of levothyroxine. 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 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).

Patients with Underlying Cardiovascular Disease

• Patients with coronary artery disease who are receiving SYNTHROID should be closely monitored for cardiac arrhythmias during surgical procedures.
• For patients at risk of atrial fibrillation or patients with underlying cardiac disease, start with a lower dosage and titrate the dosage more slowly to avoid exacerbation of cardiac symptoms.
• T4 absorption is increased by fasting, and decreased in malabsorption syndromes and by certain foods such as soybean infant formula.
• Levothyroxine sodium tablets may accelerate the onset of action of tricyclics.
• Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis.
• One is that the peak therapeutic effect of levothyroxine at a given dose may not be obtained for 4-6 weeks after medication is ingested.

And to adjust the dose based on periodic assessment of the patient’s clinical response and their laboratory values. The second is that Synthroid has a history, as physicians have been treating patients with hypothyroidism with Synthroid for over 65 years. Short-term administration of large doses of glucocorticoids may decrease serum T3 concentrations by 30% with minimal change in serum T4 levels. However, long-term glucocorticoid therapy may result in slightly decreased T3 and T4 levels due to decreased TBG production (See above). An initial increase in serum FT4 is followed by return of FT4 to normal levels with sustained therapeutic serum salicylate concentrations, although total T4 levels may decrease by as much as 30%. Levothyroxine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency see Warnings and Precautions (5.4) .

Drug-Food Interactions

Who are otherwise healthy non-elderly and have been hypothyroid for a few months. When prescribing SYNTHROID, protecting your script can ensure your patients receive SYNTHROID every time they refill their prescription. DAW codes are codes a pharmacy uses when filling your patient’s prescription. DAW-1 indicates that substitution is not allowed, based on the prescriber’s preference, and ensures your patient will receive the treatment you prescribe.