Levoxyl (Levothyroxine Sodium) - Summary

LEVOXYL SUMMARY

Levoxyl^®
(levothyroxine sodium tablets, USP)

LEVOXYL® (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.

See all Levoxyl indications & dosage >>

LEVOXYL NEWS HIGHLIGHTS

Media Articles Related to Levoxyl (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

more news >>

Published Studies Related to Levoxyl (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 Levoxyl] 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 Levoxyl] (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 Levoxyl] 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...

more studies >>

Clinical Trials Related to Levoxyl (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 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 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.

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.

more trials >>

LEVOXYL PATIENT REVIEWS / RATINGS / COMMENTS

Levoxyl review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hypothyroidism
Dosage & duration:		88mcg (dosage frequency: daily) for the period of year
Other conditions:		none
Other drugs taken:		multivitamin
		Reported Results
Benefits:		Alleviation of symptoms associated with hypothyroidism: weight gain, hair loss, fatigue, and so on. Further, medication was taken during pregnancy with no apparent ill effects to the fetus, and with the benefit of carrying to term with none of the adverse effects associated with hypothyroidism and pregnancy.
Side effects:		Did not note any side effects.
Comments:		Treatment of hypothyroidism is simple: one pill per day provides the thyroid hormones lacking. Furthermore, brand-name drugs are inexpensive, even when paid for out of pocket.

Levoxyl review by 47 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Hypothyroidism
Dosage & duration:		125MCG (dosage frequency: 1xday) for the period of 5yrs
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Treatment benefits are stabilized thyroid. Was having a weight issue, and with a blood test it was determined that the thyroid gland was "sluggish". I was very exhausted also and it has helped somewhat with fatigue.
Side effects:		dosing is extremely important as it takes many blood tests to determine correct dosage. Not having the dosage quite right will basically result in the same symptoms that you are having issues with. I have suffered basically no significant side effects other than that.
Comments:		Pill is taken early in the morning on an empty stomach. It is basically prescription iodine as hypothyroidism is basically an iodine deficiency. Symptoms that I experienced were basically weight gain and extreme fatigue. It's taken awhile to get the dosage correct, and after switching pharmacies and getting a different drug manufactured by another company, I feel that maybe another blood test is necessary to confirm that the new pills are as effective as the others I had been taking for 5 years.

Levoxyl review by 53 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hypothyroid
Dosage & duration:		100 mcg (dosage frequency: once a day) for the period of several years
Other conditions:		none
Other drugs taken:		cytomel - 25 mgg/day
		Reported Results
Benefits:		According to thyroid tests that I take every year, the combination of levothyroxine and cytomel are keeping my hypothyroid under control.
Side effects:		None that I am aware of.
Comments:		It took some trial and error to find the right combination of drugs to treat my hypothyroid, but once we started the combo of levothyroxine and cytomel, my tests show that everything is under control. I take the one pill of each one first thing in the morning with lots of water before eating anything. I have to wait 30 minutes before I eat breakfast. The hardest part is that I have to wait 2 hours before I take any calcium pills, which means I often forget to take my calcium.