BOX WARNING
WARNING: Thyroid hormones, including LEVOTHROID
®
, 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.
|
| |
LEVOTHROID SUMMARY
LEVOTHROID® (levothyroxine sodium tablets, USP) contains 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.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Levothroid (Levothyroxine)
The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto's thyroiditis. [2011.07]
CONTEXT: No previous study determined monocyte- and lymphocyte-suppressing effects of levothyroxine and selenomethionine and assessed whether their coadministration is superior to treatment with only one of these drugs. OBJECTIVE: Our objective was to compare the effect of levothyroxine and selenomethionine on monocyte and lymphocyte cytokine release and systemic inflammation in patients with Hashimoto's thyroiditis... CONCLUSIONS: Despite affecting different types of inflammatory cells, levothyroxine and selenomethionine exhibit a similar systemic antiinflammatory effect in euthyroid females with Hashimoto's thyroiditis. This action, which correlates with a reduction in thyroid peroxidase antibody titers, may be associated with clinical benefits in the prevention and management of Hashimoto's thyroiditis, particularly in subjects receiving both agents.
Pharmacokinetic equivalence of a levothyroxine sodium soft capsule manufactured using the new food and drug administration potency guidelines in healthy volunteers under fasting conditions. [2011.06]
CONCLUSIONS: The levothyroxine soft capsule formulated with the stricter new potency guideline set forward by the Food and Drug Administration met equivalence criteria in terms of rate and extent of exposure under fasting conditions to the reference tablet formulation. Clinical doses of the capsule formulation can be given using any combination of the commercialized strengths.
Effect of levothyroxine treatment on in vitro fertilization and pregnancy outcome in infertile women with subclinical hypothyroidism undergoing in vitro fertilization/intracytoplasmic sperm injection. [2011.04]
OBJECTIVE: To investigate whether levothyroxine (LT4) treatment has beneficial effects on IVF results and pregnancy outcome in infertile patients with subclinical hypothyroidism undergoing IVF/intracytoplasmic sperm injection (ICSI)...
Metabolic effects of liothyronine therapy in hypothyroidism: a randomized,
double-blind, crossover trial of liothyronine versus levothyroxine. [2011]
CONCLUSIONS: The substitution of L-T(3) for L-T(4) at equivalent doses (relative
Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial. [2010.12.13]
BACKGROUND: Levothyroxine sodium is widely prescribed to treat primary hypothyroidism. There is consensus that levothyroxine should be taken in the morning on an empty stomach. A pilot study showed that levothyroxine intake at bedtime significantly decreased thyrotropin levels and increased free thyroxine and total triiodothyronine levels. To date, no large randomized trial investigating the best time of levothyroxine intake, including quality-of-life evaluation, has been performed... CONCLUSIONS: Levothyroxine taken at bedtime significantly improved thyroid hormone levels. Quality-of-life variables and plasma lipid levels showed no significant changes with bedtime vs morning intake. Clinicians should consider prescribing levothyroxine intake at bedtime. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN17436693 (NTR959).
Clinical Trials Related to Levothroid (Levothyroxine)
Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors [Terminated]
Primary Objectives:
1. Assess whether combined treatment with Levothyroxine and Liothyronine improves learning
and memory.
2. Explore the relationship between T3 treatment and other domains of cognitive function,
quality of life, and mood.
Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial [Recruiting]
Bioequivalence of Two Levothyroxine Tablet Formulations in Healthy Indian Volunteers [Completed]
GSK markets a drug called levothyroxine or T4 that is used to treat patients with
hypothyroidism. Till date, the active drug substance or active pharmaceutical ingredient
(API) for levothyroxine tablets marketed in India has been obtained from a particular
source. GSK India proposes to change the source of the API from the existing source to a new
source. Some patients may experience a change in clinical effect when switched from one
formulation to another. Therefore this study is being done to understand whether a change in
API in levothyroxine tablet has any impact on the clinical effect of the drug.
The purpose of this study is to:
See how quickly the levothyroxine tablet from the new source (single dose of 600mcg) enters
the bloodstream, is distributed in the body, broken down and removed compared to the
levothyroxine tablet from the existing source (single dose of 600mcg).
Study the effect of single 600mcg doses of levothyroxine tablet from new source and
levothyroxine tablet from existing source on TSH level in the blood.
Study the safety and side effects of single 600mcg doses of levothyroxine tablet from new
source and levothyroxine tablet from existing source.
Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment [Recruiting]
Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an
improvement of cognitive function, and an increase in sense of well-being/ quality of life
equivalently compared with L-T4.
Effect of Levothyroxine on Serum Adiponectin, Insulin Resistance and Cardiovascular Risk in Patients With Hypothyroidism [Not yet recruiting]
The aim of this study is to evaluate plasma adiponectin level, insulin resistance,
cardiovascular risk and their correlation (if any) in patients with hypothyroidism and also
to investigate the effect of levothyroxine on these parameters. The study may explore the
lacunae in present treatment protocol and can suggest the possibilities of add-on therapies
for a better management.
Reports of Suspected Levothroid (Levothyroxine) Side Effects
Blood Pressure Increased (8),
Hypertensive Crisis (7),
Drug Ineffective (6),
Dyspnoea (6),
Labile Hypertension (5),
Urinary Incontinence (5),
Headache (5),
Overdose (5),
Completed Suicide (5),
Cough (5), more >>
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Levothroid has an overall score of 9.67. The effectiveness score is 8.67 and the side effect score is 9.33. The scores are on ten point scale: 10 - best, 1 - worst.
| | Levothroid review by 53 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | hypothyroidism |
| Dosage & duration: | | 75 mcg per day (dosage frequency: daily) for the period of 5 ytears |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The treatment benefits were really not noticable because the condition of hypothyroidism ranges from non-symptomatic to many symptoms. At the time of diagnosis, I only had symptoms of mild fatigue which could have been the result of many other conditions |
| Side effects: | | There were really no overt, obvious side effects of the treatment. levothyroxine is known to cause insomnia. It may have been coincidence, but my sleeping habits deteriorated approximately at the same time I began therapy. I am currently in the process of reducing my dose to see if sleep habits improve, but lab values remain at good levels |
| Comments: | | As I mentioned above, my diagnosis was based almost exclusively on labratory tests. TSH and T4 (thyroid hormone) were found to be too high and too low, respectively. Relatively non-descript symptoms accompanied the list of complaints at the time of diagnosis. These symptoms improved somewhat after treatment. It is still to be determined if side effects will be improved on reduced dosage. |
|
| | Levothroid review by 46 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | hypothyroidism |
| Dosage & duration: | | .88mg taken once daily for the period of still take it |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I had felt very tired all the time before I started taking the medication. Also my skin and hair seemed to be very dry. I have noticed a significant improvement in my energy level since taking the medication. Also my skin and hair have both improved over time. |
| Side effects: | | I didn't have any side effects that I could associate with taking the medication. |
| Comments: | | I take the medication first thing in the morning about 30 minutes to an hour before I eat breakfast. |
|
| | Levothroid review by 46 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | hypothyroidism |
| Dosage & duration: | | .88mg taken once daily for the period of still take it |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I had felt very tired all the time before I started taking the medication. Also my skin and hair seemed to be very dry. I have noticed a significant improvement in my energy level since taking the medication. Also my skin and hair have both improved over time. |
| Side effects: | | I didn't have any side effects that I could associate with taking the medication. |
| Comments: | | I take the medication first thing in the morning about 30 minutes to an hour before I eat breakfast. |
|
|
|
Page last updated: 2013-02-10
|
