Thyroid Hormone Replacement Therapy
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. The recommended starting daily dosage of SYNTHROID in pediatric patients with primary, secondary, or tertiary hypothyroidism is based on body weight and changes with age as described in Table 2. 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). Titrate the dosage (every 2 weeks) as needed based on serum TSH or free- T4 until the patient is euthyroid see Important Considerations For Dosing.
6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement
- However, you may not be able to take this medicine if you have certain medical conditions.
- 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).
- Seizures occurred in a 3-year-old child ingesting 3.6 mg of levothyroxine.
- This is not a complete list of side effects and others may occur.
- Because of the increased prevalence of cardiovascular disease among the elderly, initiate SYNTHROID at less than the full replacement dose see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS.
SYNTHROID increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state or when the SYNTHROID dose is increased. Closely monitor coagulation tests to permit appropriate and timely dosage adjustments. Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products.
Drug Summary
The hypothalamus, located in the brain, produces thyrotropin-releasing hormone (TRH) that tells the pituitary gland to make thyroid-stimulating hormone (TSH). TSH is produced by a small gland in the brain called the pituitary and can be measured by a common blood test. No matter how much you already know, it’s important to keep learning about your condition. The better you understand hypothyroidism, the better prepared you are to manage it. Join the Before Breakfast Club for resources to help you stay on track with treatment as well as ways to save on your Synthroid prescription.
Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Assess the adequacy of therapy by periodic assessment of laboratory tests and clinical evaluation. Persistent clinical and laboratory evidence of hypothyroidism despite an apparent adequate replacement dose of SYNTHROID may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors. Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing SYNTHROID see Drug Interactions (7.2). 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).
Stop biotin and biotin-containing supplements for at least 2 days before assessing TSH and/or T4 levels see DRUG INTERACTIONS. Many drugs can inhibit Synthroid’s adsorption by the body; other medications may increase or decrease its effectiveness once it is adsorbed. Providing a complete list of medications to the doctor will help with getting the correct dose established for each individual patient. Synthroid should not be used to treat obesity or weight problems. Dangerous side effects or death can occur from the misuse of levothyroxine, especially if you are taking any other weight-loss medications or appetite suppressants. Synthroid is a prescription medicine used to treat hypothyroidism (low thyroid hormone).
Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with SYNTHROID see CONTRAINDICATIONS. For pregnant patients with pre-existing hypothyroidism, measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at minimum, during each trimester of pregnancy. In pregnant patients with primary hypothyroidism, maintain serum TSH in the trimester-specific reference range. SYNTHROID is 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.
- Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive SYNTHROID therapy.
- Monitor patients receiving concomitant SYNTHROID and sympathomimetic agents for signs and symptoms of coronary insufficiency.
- Initiate appropriate supportive treatment as dictated by the patient’s medical status.
- Since postpartum TSH levels are similar to preconception values, the SYNTHROID dosage should return to the pre-pregnancy dose immediately after delivery see Dosage and Administration (2.3).
Synthroid is a thyroid medicine that replaces a synthroid competitors hormone normally produced by your thyroid gland to regulate the body’s energy and metabolism. You never have to worry about getting a different medication because your prescription will never be filled with a generic levothyroxine sodium medication. You are encouraged to report negative side effects of prescription drugs to the FDA. Closely monitor infants during the first 2 weeks of SYNTHROID therapy for cardiac overload and arrhythmias.
The liver is the major site of degradation for both T4 and T3, with T4 deiodination also occurring at a number of additional sites, including the kidney and other tissues. Approximately 80% of the daily dose of T4 is deiodinated to yield equal amounts of T3 and reverse T3 (rT3). Thyroid hormones are also metabolized via conjugation with glucuronides and sulfates and excreted directly into the bile and gut where they undergo enterohepatic recirculation. Oral levothyroxine sodium is a synthetic T4 hormone that exerts the same physiologic effect as endogenous T4, thereby maintaining normal T4 levels when a deficiency is present.
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In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
HypothyroidismSYNTHROID® (levothyroxine sodium) tablets, for oral use is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. The general aim of therapy is to normalize the serum TSH level. TSH may not normalize in some patients due to in utero hypothyroidism causing a resetting of pituitary-thyroid feedback. Assess compliance, dose of medication administered, and method of administration prior to increasing the dose of SYNTHROID see Warnings and Precautions (5.1) and Use in Specific Populations (8.4).