BOX WARNING
WARNING: Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. 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.
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SYNTHROID SUMMARY
SYNTHROID® (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland.
Levothyroxine sodium is used for the following indications: Hypothyroidism --As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
Pituitary TSH Suppression --In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic lymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
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SYNTHROID NEWS HIGHLIGHTS Media Articles Related to Synthroid (Levothyroxine)
levothyroxine sodium, Synthroid, Levoxyl, Levothroid, Unithroid
Source: MedicineNet Hypothyroidism During Pregnancy Specialty [2007.11.16]
Title: levothyroxine sodium, Synthroid, Levoxyl, Levothroid, Unithroid
Category: Medications
Created: 12/31/1997
Last Editorial Review: 11/16/2007
Synthroid and Meridia
Source: MedicineNet sibutramine Specialty [2006.11.14]
Title: Synthroid and Meridia
Category: Ask The Experts
Created: 1/29/2001 6:21:00 PM
Last Editorial Review: 11/14/2006
Published Studies Related to Synthroid (Levothyroxine)
Lipid profile in different degrees of hypothyroidism and effects of levothyroxine replacement in mild thyroid failure. [2008.04]
The aim of this study was to evaluate the lipid profile of patients with different degrees of hypothyroidism and the effect of levothyroxine [generic for Synthroid] replacement in subclinical hypothyroidism (SH). Initially, a cross-sectional study was performed with 226 participants [SH = 133 participants, manifest hypothyroidism (MH) = 23 participants, and euthyroidism (EU) = 70 participants]...
Levothyroxine in euthyroid autoimmune thyroiditis and type 1 diabetes: a randomized, controlled trial. [2007.05]
CONTEXT: Patients with type 1 diabetes (T1D) have an increased risk of autoimmune thyroiditis (AIT). OBJECTIVE: Our objective was to determine whether levothyroxine [generic for Synthroid] (l-T(4)) treatment prevents the clinical manifestation of AIT in euthyroid subjects with T1D... CONCLUSIONS: In this study in euthyroid patients with AIT and T1D, l-T(4) treatment reduced thyroid volume but had no effect on thyroid function and serum autoantibody levels.
Levothyroxine in euthyroid autoimmune thyroiditis and type 1 diabetes: a randomised, controlled trial. [2007.02.13]
Context: Patients with type 1 diabetes (T1D) have an increased risk of autoimmune thyroiditis (AIT). Objective: To determine whether L-T4 treatment prevents the clinical manifestation of AIT in euthyroid subjects with T1D.Conclusions: In this study in euthyroid patients with AIT and T1D, L-T4 treatment reduced thyroid volume but had no effect on thyroid function and serum autoantibody levels.
Comparative bioavailability of different formulations of levothyroxine and liothyronine in healthy volunteers. [2006.12]
OBJECTIVE: To evaluate the relative bioavailability of T4 sodium and liothyronine sodium (T3), administered in single doses as oral solution (drops) and tablet forms, according to two separate study protocols... CONCLUSIONS: The bioavailability of the two oral solutions (T4-Ibsa and T3-Ibsa oral solutions) and the corresponding tablet forms (Eutirox 100 and Ti-tre tablets) were confirmed and they can be considered bioequivalent and therapeutically interchangeable.
A bioequivalence study of levothyroxine tablets versus an oral levothyroxine solution in healthy volunteers. [2006.04]
Probably for genetic reasons a substantial part of the Greek population requires Levothyroxine [generic for Synthroid] treatment. Since commercially available Levothyroxine was first marketed, the manufacture and storage of the drug in tablet form has been complicated and difficult; and as cases of therapeutic failure have frequently been reported following treatment with this medicinal agent, quality control is an essential factor...
Clinical Trials Related to Synthroid (Levothyroxine)
Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x
200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine
healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label,
randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D.
Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that
90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for
the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total
L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are
bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200
μg) dose under fasting conditions
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x
300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose
pharmacokinetic parameters for baseline corrected total L-thyroxine and non-baseline
corrected total L-triiodothyronine were calculated using noncompartmental techniques.
Fasting Study of Levothyroxine Sodium Tablets 300 Mcg to Synthroid® Tablets 300 Mcg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600
mcg dose (2 × 300 mcg) administered under fasting conditions.
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
sodium 300 μg tablets to Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x
300 μg) dose administered in healthy adult volunteers under fasting conditions. Statistical
analysis of the data revealed that 90% confidence intervals were within the acceptable
bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr
and LNCPEAK for baseline corrected total levothyroxine.
Phase 4 Study in Secondary Hypothyroidism: Body Weight Adapted Thyroxin Treatment and Triiodothyronine Supplementation [Completed]
The purpose of this study is to determine whether a body weight adjusted dose of thyroxin is
superior to treatment guided by laboratory results of thyroxin hormones in patients with
central hypothyroidism. Moreover beneficial effects of triiodthyronine supplementation are
investigated.
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SYNTHROID PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 35 ratings/reviews, Synthroid has an overall score of 8.34. The effectiveness score is 8.17 and the side effect score is 9.26. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Synthroid review by 34 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Hypothyroidism |
| Dosage & duration: | | .5 mcg (dosage frequency: daily) for the period of 3+ years |
| Other conditions: | | Low blood sugar |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Increased energy, ability to focus, and increased ability to lose weight. Patient suffered fewer low blood sugar episodes. Thirty pounds of weight were lost in the first year. |
| Side effects: | | None, other than those stated above in the treatment benefits. |
| Comments: | | Patient has Hashimotos disease. Prescribed synthroid. Patient also working to follow a low carb diet, regular exercise, and normal sleep. Over time, synthroid dosage has increased, to 112 mcg per day from the original dose of 50. This is some cause of concern re: progression of the disease, but so far, no alternative approach/therapy seems to counteract this progression. Blood work required every 6 months in order to help ensure proper dosage. |
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| | Synthroid review by 57 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Hypothyroidism |
| Dosage & duration: | | 100mcg (dosage frequency: once daily) for the period of Since menopause in 2002 |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | The treatment bendfits consisted of bringing the thyroid test results into the normal range for the TSH and T4 tests for a post-menopausal woman. |
| Side effects: | | There were no treatment side effects noted. |
| Comments: | | Treatment consists of one 100mcg tablet taken early AM on an empty stomach with 8oz of water with no food for one hour after dose. |
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| | Synthroid review by 39 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | after birth thyroid not working to mormal levelc |
| Dosage & duration: | | 50mcg (dosage frequency: 1 tablet a day f) for the period of 3 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | no benefit still tired short of breath losing hair can't lose weigth loss of libido |
| Side effects: | | no side effect no benefits |
| Comments: | | after blood test was given levothyroxine 50mcg 1 tablet a day to conteract over tiredness loss of hair weight problem and loss of libido. This treatment is for life but I had so far no benefit after over 3 years. I can not stop it as I was explain that it could go worth. No other treatment are available and no cause of this problem can be explained. |
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Page last updated: 2008-06-22
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