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Latest & greatest articles for levothyroxine
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Levothyroxine Sodium for Injection Drug Approval Package: Levothyroxine Sodium NDA #202231 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Levothyroxine Sodium for Injection, 100 mcg, 200 mcg, and 500 mcg vials Company: APP Pharmaceuticals, LLC Application No.: 202231 Approval Date: 06/24/2011 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF
Triiodothyronine levels in athyreotic individuals during levothyroxine therapy. Thyroidal production of triiodothyronine (T3) is absent in athyreotic patients, leading to the suggestion that T3 deficiency may be unavoidable during levothyroxine (LT4) therapy. However, trials evaluating therapy with combined LT4 and T3 have failed to demonstrate any consistent advantage of combination therapy.To determine whether T3 levels in patients treated with LT4 therapy were truly lower than in the same
Timing and magnitude of increases in levothyroxine requirements during pregnancy in women with hypothyroidism. Hypothyroidism during pregnancy has been associated with impaired cognitive development and increased fetal mortality. During pregnancy, maternal thyroid hormone requirements increase. Although it is known that women with hypothyroidism should increase their levothyroxine dose during pregnancy, biochemical hypothyroidism occurs in many. In this prospective study we attempted (...) to identify precisely the timing and amount of levothyroxine adjustment required during pregnancy.Women with hypothyroidism who were planning pregnancy were observed prospectively before and throughout their pregnancies. Thyroid function, human chorionic gonadotropin, and estradiol were measured before conception, approximately every two weeks during the first trimester, and monthly thereafter. The dose of levothyroxine was increased to maintain the thyrotropin concentration at preconception values
Combined levothyroxine plus liothyronine compared with levothyroxine alone in primary hypothyroidism: a randomized controlled trial. Standard therapy for patients with primary hypothyroidism is replacement with synthetic thyroxine, which undergoes peripheral conversion to triiodothyronine, the active form of thyroid hormone. Within the lay population and in some medical communities, there is a perception that adding synthetic triiodothyronine, or liothyronine, to levothyroxine improves (...) the symptoms of hypothyroidism despite insufficient evidence to support this practice.To evaluate the benefits of treating primary hypothyroidism with levothyroxine plus liothyronine combination therapy vs levothyroxine monotherapy.Randomized, double-blind, placebo-controlled trial conducted from May 2000 to February 2002 at a military treatment facility that serves active duty and retired military personnel and their family members. The trial included a total of 46 patients aged 24 to 65 years
The effect of levothyroxine therapy on bone mineral density: a systematic review of the literature Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Starting dose of levothyroxine for the treatment of congenital hypothyroidism: a systematic review Starting dose of levothyroxine for the treatment of congenital hypothyroidism: a systematic review Starting dose of levothyroxine for the treatment of congenital hypothyroidism: a systematic review Hrytsiuk I, Gilbert R, Logan S, Pindoria S, Brook C G Authors' objectives To determine the effect of levothyroxine sodium starting dose on cognitive development, growth or behaviour in children (...) of levothyroxine. Participants included in the review Children with congenital hypothyroidism, as identified by neonatal screening, whose global or cognitive development had been assessed using a population-standardised measure. The children included in the review were aged between 1 and 14 years. Outcomes assessed in the review First, the authors compared standardised doses of levothyroxine treatment with the mean standardised development scores in cohorts with different starting doses of levothyroxine
Suppressive therapy with levothyroxine for solitary thyroid nodules: a double-blind controlled clinical study and cumulative meta-analyses Suppressive therapy with levothyroxine for solitary thyroid nodules: a double-blind controlled clinical study and cumulative meta-analyses Suppressive therapy with levothyroxine for solitary thyroid nodules: a double-blind controlled clinical study and cumulative meta-analyses Zelmanovitz F, Genro S, Gross J L Authors' objectives To assess the effect (...) of suppressive doses of levothyroxine (T4) on the volume of benign solitary thyroid nodules (STN) and bone mineral density (BMD). Searching The authors searched the MEDLINE electronic database (January 1985 to December 1997). No further search details are reported. Study selection Study designs of evaluations included in the review Prospective controlled clinical trials with a sufficient dose of T4 for TSH suppression. Additional study inclusion criteria were: 1. A minimum study period of 6 months. 2. STN
Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. To compare relative bioavailability of Synthroid, Levoxine (Levoxine has been renamed Levoxyl), and 2 generic levothyroxine sodium preparations.Single-blind (primary investigators blinded), randomized, 4-way crossover trial.Ambulatory care.Twenty-two women with hypothyroidism who were clinically and chemically euthyroid and were receiving levothyroxine sodium, 0.1 or 0.15 mg.All patients received (...) each of the 4 levothyroxine products for 6-week periods in the same dosage as their prestudy regimen with no washout period. The order of the drug sequences was randomly determined before study initiation.Area under the curve, time to peak serum concentrations, and peak serum concentrations of thyroxine, triiodothyronine, and free thyroxine index for all 4 products.All data analyses were completed prior to unblinding of the product codes. No significant differences between the 4 products were found
Effects of restricting levothyroxine dosage strength availability Effects of restricting levothyroxine dosage strength availability Effects of restricting levothyroxine dosage strength availability Ain K B, Pucino F, Csako G, Wesley R A, Drass J A, Clark C, Ketteridge P, Crawford K, Banks S M, Dorworth T E Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results (...) and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Prescribing restricted versus nonrestricted dosage strength of levothyroxine to patients requiring thyroid hormone replacement or suppression of thyrotropin (TSH). The nonrestricted use of levothyroxine consisted of tablets containing 25, 50, 75, 100, 112, 125, 150, 175, 200, and 300 micrograms, while in the restricted-use, only five dosage strengths (25, 50, 100, 125, 150
Suppressive therapy with levothyroxine for solitary thyroid nodules. A double-blind controlled clinical study. Thyroid nodules are present in up to 50 percent of adults in the fifth decade of life. Patients are often treated with thyroxine in order to reduce the size of the nodule, but the efficacy of thyrotropin-suppressive therapy with thyroxine remains uncertain. In this study, 53 patients with a colloid solitary thyroid nodule confirmed by biopsy were randomly assigned in a double-blind (...) manner to receive placebo (n = 25) or levothyroxine (n = 28) for six months. Before treatment, pertechnetate-99m thyroid scanning showed that 22 percent of the nodules were functional, 25 percent hypofunctional, and 53 percent nonfunctional. High-resolution (10-MHz) sonography was used to measure the size of the nodules before and after treatment. Suppression of thyrotropin release was confirmed in the levothyroxine-treated group by the administration of thyrotropin-releasing hormone; thyrotropin