Tirosint (Levothyroxine Sodium) - Summary

TIROSINT SUMMARY

TIROSINT™

TIROSINT™ (levothyroxine sodium) capsules are soft gelatin capsules to be orally administered, which contain synthetic 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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NEWS HIGHLIGHTS

Media Articles Related to Tirosint (Levothyroxine)

levothyroxine sodium, Synthroid, Levoxyl, Levothroid, Unithroid
Source: MedicineNet Pendred Syndrome Specialty [2007.11.16]
Title: levothyroxine sodium, Synthroid, Levoxyl, Levothroid, Unithroid
Category: Medications
Created: 12/31/1997
Last Editorial Review: 11/16/2007

Hypothyroidism
Source: MedicineNet Frostbite Specialty [2008.07.22]
Title: Hypothyroidism
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 7/22/2008

Preeclampsia Tied to Future Thyroid Issues (CME/CE)
Source: MedPage Today Endocrinology [2009.11.19]
Women who develop preeclampsia during pregnancy are at increased risk of hypothyroidism later in life, researchers said.

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Published Studies Related to Tirosint (Levothyroxine)

Chromosome translocation frequency after radioiodine thyroid remnant ablation: a comparison between recombinant human thyrotropin stimulation and prolonged levothyroxine withdrawal. [2009.09]
BACKGROUND: Thyroid remnant ablation of differentiated thyroid carcinoma (DTC) patients is traditionally performed after levothyroxine withdrawal. Recombinant human TSH (rhTSH) administration increases serum TSH levels without inducing hypothyroidism. AIM: The aim of the study was to investigate the frequency of chromosome translocations in DTC patients after the first (131)I therapeutic dose and compare the frequency of translocations between DTC patients off levothyroxine and those receiving rhTSH... CONCLUSIONS: Our preliminary data show that in hypothyroid status (131)I ablation therapy induces a higher translocation rate, especially in chromosomes 4 and 8. This finding, in agreement with previous dosimetric reports, suggests that whereas inducing a low extrathyroid exposure, rhTSH reduces the potential risk of chromosomal aberration associated with blood irradiation.

Serum leptin in overt and subclinical hypothyroidism: effect of levothyroxine treatment and relationship to menopausal status and body composition. [2009.05]
BACKGROUND: The relationship between thyroid status, including subclinical hypothyroidism (SH) and serum leptin is controversial or uncertain. Therefore we evaluated serum leptin in SH and overt hypothyroidism (OH) and determined the effects of levothyroxine (LT(4)) replacement on serum leptin in these disorders... CONCLUSIONS: Serum leptin concentrations are elevated in postmenopausal women with SH or OH. A relationship between thyroid status and serum leptin is further supported by the fact that LT(4) treatment, to restore the EU status, reduced serum leptin levels in OH in the absence of significant effects on BMI. In women, hypothyroidism influences either leptin secretion or degradation and this effect is more pronounced in postmenopausal than in premenopausal women.

Efficacy of combined levothyroxine and liothyronine as compared with levothyroxine monotherapy in primary hypothyroidism: a randomized controlled trial. [2009]
OBJECTIVES: To examine the efficacy of combination therapy with levothyroxine and liothyronine in improvement of general health, psychological problems, and metabolic status in primary hypothyroidism... CONCLUSIONS: The data do not support the hypothesis that combined therapy improves the well-being and general health of patients.

The effect of famotidine, esomeprazole, and ezetimibe on levothyroxine absorption. [2008.05]
Background: Recent literature describing the effect of gastric acid suppression on levothyroxine absorption has been inconsistent. Also, ezetimibe, a lipid-lowering compound that inhibits intestinal absorption of cholesterol, may interfere with levothyroxine absorption...

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 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]...

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Clinical Trials Related to Tirosint (Levothyroxine)

Thyroid Hormone Dose Adjustment in Pregnancy [Recruiting]
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy.

Combined Levothyroxine/Liothyronine Supplementation in Hypothyroid Patients With Brain Tumors [Recruiting]
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.

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.

Levothyroxine Treatment in Thyroid Benign Nodular Goiter [Recruiting]
We will study the effect of taking eltroxin at different time, i. e. fasting or postprandial periods. We will also study the effect of levothyroxin treatment in Chinese people

Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia [Recruiting]
In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.

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PATIENT REVIEWS / RATINGS / COMMENTS

Tirosint review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		low thyroid
Dosage & duration:		75 mg taken 1x day for the period of First prescribed 3/07, still take daily
Other conditions:		Occasional acid reflux
Other drugs taken:		None
		Reported Results
Benefits:		I had experienced decreased energy and increasing tiredness for several years. It got to the point I was taking naps for the first time since I was a small child, and still didn't feel refreshed. I also felt cold frequently and had put on a good 20 pounds in a year. When I went for my annual physical, my blood work came back with high cholesterol for the first time. I thought it was advancing middle age. Fortunately, my MD put it all together and ordered a thyroid test. I was very low. Within two weeks, I felt energized and my mood improved. I have shed some (not all, darn it) of the weight and my cholesterol score is lower.
Side effects:		I had none except for a few hot flashes (well past menopause) that went away in the first few weeks. I have never been a pill-taker for fear of side effects, but this was a good experience. Fortunately, the initial dose was effective and did not need adjustment.
Comments:		As I said, my doctor spotted the symptoms and ordered a thyroid test. When it came back very low, she prescribed 75 mg a day of levothyroxine, and I felt a little better almost immediately. Within 2 weeks, I felt younger, more energy, better mood and my weight gain stopped. I have enough energy to exercize and with only a slight shift in my fairly healthy diet to less fat and more fruits and vegetables, the weight has slowly come off. I have my thyroid checked every 6 months with good results so far. Between the medication and some dietary changes, my cholesterol is down from 230 to 206. I still have about 6 pounds to get back to my starting weight. Unless there's a permanent cure out there, I won't mind taking this little lifesaver forever.

Tirosint review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Fatigue, weight gain, depression
Dosage & duration:		.50 (dosage frequency: 1x/day in the a.m.) for the period of 4 weeks to as of 5/13/09
Other conditions:		Tension headaches, anxiety, OCD, depression
Other drugs taken:		Zoloft, Wellbutrin, Klonopin
		Reported Results
Benefits:		I have not noticed any benefits so far. My weight has remaind the same. The depression has not gotten noticeably better, and fatigue continues to be a problem.
Side effects:		I have not noticed any side effects thus far. I've been on the Synthroid for only 4 weeks, so it may not yet be at its full effectiveness. I've also just found out I should take it on an empty stomach and then wait an 30 min. to and hour prior to eating for it to be 100% effective.
Comments:		I am taking the Synthroid to increase metabolism, stop weight gain, help with depression, and to reduce fatigue. I have been complaining of chronic fatigue for 10 years, and the depression has been an issue for about the same length of time. The weight gain has occurred within the last 3 years and was significant (for me) within the last two years. My primary physician told me that my levels were within range; however, the NP I work for (a mental health nurse practitioner)reviewed the levels for depression and found the my levels were just below the norm, enough to make a difference.

Tirosint review by 29 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		hypothyroidism
Dosage & duration:		50mcg (dosage frequency: daily) for the period of 8 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		No improvement at all in symptoms.
Side effects:		Over the past few months I have developed borderline hypertension, increased bruising, my hair texture and skin continue to worsen.
Comments:		At 14 I was diagnosed with hyperthyroidism and this was corrected through medication (thyroid disorders are prevalent in my mother's family). I was diagnosed with hypothyroidism (TSH 14.5) this past December and evidence of an auto immune disorder. Since, I have been on 50mcg daily, my TSH tests normal but there has been no improvements in symptoms.