DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Levothroid (Levothyroxine Sodium) - Summary

 
 



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.


See all Levothroid indications & dosage >>

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).

more studies >>

Clinical Trials Related to Levothroid (Levothyroxine)

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.

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

Generic vs. Name-Brand Levothyroxine [Recruiting]
This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.

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.

more trials >>

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 / COMMENTS

Based 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.

See all Levothroid reviews / ratings >>

Page last updated: 2013-02-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014