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LEVO-T
Overview
What is LEVO-T?
LEVO-T (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C
H
I
NNaO
H
O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:
LEVO-T tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each LEVO-T tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:
What does LEVO-T look like?
What are the available doses of LEVO-T?
Tablets: 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 mcg (
)
What should I talk to my health care provider before I take LEVO-T?
Pregnancy may require the use of higher doses of LEVO-T. (
,
)
How should I use LEVO-T?
Hypothyroidism
LEVO-T is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Take LEVO-T with a full glass of water as the tablet may rapidly disintegrate
Administer LEVO-T as a single daily dose, on an empty stomach, one-half to one hour before breakfast.
Administer LEVO-T at least 4 hours before or after drugs known to interfere with LEVO-T absorption
.
Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect LEVO-T absorption
and
.
Administer LEVO-T to infants and children who cannot swallow intact tablets by crushing the tablet, suspending the freshly crushed tablet in a small amount (5 to 10 mL or 1 to 2 teaspoons) of water and immediately administering the suspension by spoon or dropper. Do not store the suspension. Do not administer in foods that decrease absorption of LEVO-T, such as soybean-based infant formula
.
What interacts with LEVO-T?
Sorry No Records found
What are the warnings of LEVO-T?
Sorry No Records found
What are the precautions of LEVO-T?
Sorry No Records found
What are the side effects of LEVO-T?
Sorry No records found
What should I look out for while using LEVO-T?
LEVO-T is contraindicated in patients with uncorrected adrenal insufficiency
.
Thyroid hormones, including Levo-T, 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
.
What might happen if I take too much LEVO-T?
The signs and symptoms of overdosage are those of hyperthyroidism
and
. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures occurred in a 3-year-old child ingesting 3.6 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium.
Reduce the LEVO-T dose or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status.
For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.
How should I store and handle LEVO-T?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.LEVO-T (levothyroxine sodium, USP) tablets are supplied as follows:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.
The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.
Non-Clinical Toxicology
LEVO-T is contraindicated in patients with uncorrected adrenal insufficiency .Thyroid hormones, including Levo-T, 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 .
Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Over-treatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. Initiate LEVO-T therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease .
Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive LEVO-T therapy. Monitor patients receiving concomitant LEVO-T and sympathomimetic agents for signs and symptoms of coronary insufficiency.
If cardiac symptoms develop or worsen, reduce the LEVO-T dose or withhold for one week and restart at a lower dose.
Adverse reactions associated with LEVO-T therapy are primarily those of hyperthyroidism due to therapeutic overdosage , . They include the following:
Seizures have been reported rarely with the institution of levothyroxine therapy.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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