SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Armour Thyroid vs. Synthroid - How do they compare? Initiate Synthroid therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease [see Dosage and Administration (2.3), Use in Specific Populations (8.5)]. The majority of the SYNTHROID dose is absorbed from the jejunum and upper ileum. McKesson Shop Products Shop by Category . Monitor patients receiving concomitant SYNTHROID and sympathomimetic agents for signs and symptoms of coronary insufficiency. The major pathway of thyroid hormone metabolism is through sequential deiodination. Instruct patients to take Synthroid as a single dose, preferably on an empty stomach, one-half to one hour before breakfast. In addition, confusion and disorientation may occur. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with SYNTHROID, Table 5. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. Consumption of certain foods may affect SYNTHROID absorption thereby necessitating adjustments in dosing [see Dosage and Administration (2.1)]. Dosage form: tablet * Dosages greater than 200 mcg/day are seldom required. Consider the potential for food or drug interactions and adjust the administration or dosage of SYNTHROID as needed [see Dosage and Administration (2.1), Drug Interactions (7.1), and Clinical Pharmacology (12.3)]. 0074-7148-90, Phenobarbital has been shown to reduce the response to thyroxine. 0074-6624-90, (current), levothyroxine sodium 0.025 MG Oral Tablet [Synthroid], levothyroxine sodium 0.075 MG Oral Tablet [Synthroid], levothyroxine sodium 0.112 MG Oral Tablet [Synthroid], levothyroxine sodium 0.125 MG Oral Tablet [Synthroid], levothyroxine sodium 0.15 MG Oral Tablet [Synthroid], levothyroxine sodium 0.175 MG Oral Tablet [Synthroid], levothyroxine sodium 0.3 MG Oral Tablet [Synthroid], levothyroxine sodium 0.025 MG Oral Tablet, levothyroxine sodium 0.075 MG Oral Tablet, levothyroxine sodium 0.125 MG Oral Tablet, levothyroxine sodium 0.05 MG Oral Tablet [Synthroid], levothyroxine sodium 0.112 MG Oral Tablet, levothyroxine sodium 0.175 MG Oral Tablet, levothyroxine sodium 0.1 MG Oral Tablet [Synthroid], levothyroxine sodium 0.2 MG Oral Tablet [Synthroid], levothyroxine sodium 0.088 MG Oral Tablet, levothyroxine sodium 0.137 MG Oral Tablet, levothyroxine sodium 0.137 MG Oral Tablet [Synthroid], levothyroxine sodium 0.088 MG Oral Tablet [Synthroid], Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. is this? 10 AluminumLake, D&C Yellow No. Actions of particular beta-adrenergic antagonists may be impaired when a hypothyroid patient is converted to the euthyroid state. 0074-7148-19, Continued administration results in a decrease in serum T4 and normal FT4 and TSH concentrations. RxNorm, Primary, Secondary, and Tertiary Hypothyroidism in Pediatric Patients. 0074-5182-71, SYNTHROID may accelerate the onset of action of tricyclics. In addition, many drugs and foods affect T4 absorption [see Drug Interactions (7)]. Concurrent use of tyrosine-kinase inhibitors such as imatinib may cause hypothyroidism. Overtreatment or undertreatment with Synthroid may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, gastrointestinal function, and glucose and lipid metabolism in adult or pediatric patients. The general aim of therapy is to normalize the serum TSH level. Toxic effects may include increased risk of cardiac arrhythmias and central nervous system stimulation. An inadequate response to daily dosages greater than 300 mcg/day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors [see Dosage and Administration (2.1) and Drug Interactions (7)]. Measure and evaluate unbound (free) hormone and/or determine the free-T4 index (FT4I) in this circumstance. Over-treatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. To enroll patients in the Synthroid Delivers Program, HCPs simply choose Synthroid Delivers Pharmacy in their EMR, obtain the patient's consent to receive a text or call, and confirm the patient's cell phone number in the EMR. Studies to evaluate mutagenic potential and animal fertility have not been performed. View Labeling Archives, Inform patients that it may take several weeks before they notice an improvement in symptoms. 0074-6594-71, Monitor serum TSH every 4 weeks and adjust SYNTHROID dosage until serum TSH is within normal trimester-specific range. 1 Levothyroxine is prescribed for people with an underactive thyroid, a condition known as hypothyroidism. 0074-4552-11, Atrial arrhythmias can occur in elderly patients. 1 Aluminum Lake, FD&C Blue No. New onset hypothyroidism (TSH 10 mIU per liter). SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of levothyroxine have not been performed. An inadequate response to daily dosages greater than 300 mcg/day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors [see Dosage and Administration (2.1) and Drug Interactions (7)]. Should you take your thyroid medication at night? All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Hypothyroidism - SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic . 0074-4552-71, * Adjust dosage based on clinical response and laboratory parameters, Pre-existing primary hypothyroidism with serum TSH above normal trimester-specific range, Pre-pregnancy dosage may increase during pregnancy. 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. The recommended daily dosage of SYNTHROID in pregnant patients is described in Table 3. (, Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. Citations, Report Adverse The general aim of therapy is to normalize the serum TSH level. Learn More > Resources for Your Patients Helpful resources you can download for your patients including information on the Before Breakfast Club patient support program. Synthroid (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. SYNTHROID Dosing Guidelines for Hypothyroidism in Pediatric Patients, Table 3. Many drugs can exert effects on thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to SYNTHROID (Tables 5 to 8). Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of levothyroxine have not been performed. FDA Safety Recalls, Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown: Synthroid tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with SYNTHROID [see Contraindications (4)]. APPLICATION FOR Synthroid (levothyroxine sodium tablets, USP) and Gengraf Capsules (cyclosporine capsules, USP) myAbbVie Assist provides free medicines to qualifying patients. Potential impact: Administration of these enzyme inhibitors decreases the peripheral conversion of T4 to T3, leading to decreased T3 levels. Monitor serum free-T4 levels and maintain in the upper half of the normal range in these patients. Administer SYNTHROID at least 4 hours apart from these agents. Use the serum free-T4 level to titrate SYNTHROID dosing until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range, 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. Concurrent use of sympathomimetics and Synthroid may increase the effects of sympathomimetics or thyroid hormone. TSH Suppression in Well-differentiated Thyroid Cancer in Adult and Pediatric Patients. Potential impact: Concurrent use may reduce the efficacy of SYNTHROID by binding and delaying or preventing absorption, potentially resulting in hypothyroidism. 0074-4341-90, Approximately 20% of T4 is eliminated in the stool. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Serum TSH levels should be monitored and the SYNTHROID dosage adjusted during pregnancy. 0074-5182-90, Furosemide competes for T4-binding sites on TBG, prealbumin, and albumin, so that a single high dose can acutely lower the total T4 level. Photo: Andreas Neumann. We comply with the HONcode standard for trustworthy health information. Pregnancy, infectious hepatitis, estrogens, estrogen-containing oral contraceptives, and acute intermittent porphyria increase TBG concentration. When and how patients take their medication can affect the way the body absorbs it so resources encouraging patients to establish and follow to their a daily routine are . For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org. 0074-9296-90. Do not administer in foods that decrease absorption of SYNTHROID, such as soybean-based infant formula [see Drug Interactions (7.9)]. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma. 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. Levothyroxine is a synthetic (man-made) version of thyroxine, or T4, the main hormone that is made and released by your thyroid gland. Grapefruit juice may delay the absorption of levothyroxine and reduce its bioavailability. 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. 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