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Levo-t

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Last Updated: 06 November 2020

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General | Latest Info

LEVO-T replacement for hormone that is normally produced by your thyroid gland used to treat hypothyroidism. LEVO-T is also used to treat or prevent goiter, which can be caused by hormone imbalances, radiation treatment, surgery, or cancer. LEVO-T is available in generic form. Common side effects of LEVO-T include hair loss during the first few months of treatment. This side effect of LEVO-T is usually temporary as your body adjusts to this medication. Other side effects of LEVO-T include: allergic reactions, abdominal pain, nausea, vomiting, diarrhea, fever, joint pain, and wheezing dosage of LEVO-T is individualize. LEVO-T may interact with lithium, amiodarone, antidepressants, or radiation therapy with iodine. Many other drugs can interact with LEVO-T. Tell your doctor all the medications and supplements you take. Other drugs can be taken while taking LEVO-T, but they must be taken 4 hours before, or 4 hours after taking LEVO-T. Consult your doctor. Current information shows LEVO-T may be used during pregnancy. Tell your doctor if you are pregnant because your dose may need to be adjust. This medication pass into breast milk but is unlikely to harm nursing infant. Consult your doctor before breastfeeding. Our LEVO-T side Effects Drug Center provides a comprehensive view of available Drug Information on potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Uses

Adverse reactions associated with LEVO-T therapy are primarily those of hyperthyroidism due to therapeutic overdosage. They include the following: general: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal: tremors, muscle weakness, muscle spasm Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory: dyspnea Gastrointestinal: diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic: hair loss, flushing, rash Endocrine: decrease bone mineral density Reproductive: menstrual irregularities, impaired fertility seizures have been report rarely with institution of levothyroxine therapy. Pseudotumor cerebri and slip capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of epiphyses in children with resultant compromise adult height. Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include urticaria, pruritus, skin rash, flushing, angioedema, various Gastrointestinal symptoms, fever, arthralgia, serum sickness, and wheezing. Hypersensitivity to levothyroxine itself is not known to occur. Read entire FDA prescribing Information for LEVO-T

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Side Effects

Adverse reactions associated with LEVO-T therapy are primarily those of hyperthyroidism due to therapeutic overdosage. They include the following: general: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal: tremors, muscle weakness, muscle spasm Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory: dyspnea Gastrointestinal: diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic: hair loss, flushing, rash Endocrine: decrease bone mineral density Reproductive: menstrual irregularities, impaired fertility seizures have been report rarely with institution of Levothyroxine therapy.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Mechanism of Action

Levothyroxine is a synthetic version of the principle Thyroid hormone, thyroxine that is made and released by the Thyroid gland. Thyroid hormone increases the metabolic rate of cells of all tissues in the body. In fetus and newborn, thyroid hormone is important for growth and development of all tissues, including bones and the brain. In adults, Thyroid hormones help to maintain brain function, utilization of food, and body temperature, among other effects. GENERIC AVAILABLE: Yes. GENERIC and branded tablets of Levothyroxine may differ: in amount of Levothyroxine they contain, absorption of Levothyroxine into the body, and distribution of Levothyroxine throughout the body. This means that ingestion of 1 mg of GENERIC Levothyroxine may not have the same effect on the body as 1 mg of another GENERIC or branded Levothyroxine. Practically speaking, this means that when changing between Levothyroxine manufactured by different pharmaceutical companies, change in dose may be necessary to maintain the desired effect or to prevent toxicity. When switching between brands or generics, it is important to ensure that both preparations are equivalent or to check blood thyroid levels weekly. For adult hypothyroidism, Levothyroxine is start at 12. 5-125 mcg / day administer orally. Starting doses and dose changes may differ with individual patients based upon age, presence of cardiovascular disease, development of tolerance, side effects of medication, and blood levels of Thyroid hormone. It may take one to three weeks after initiating therapy with Levothyroxine or changing dose before effects are see. The goal of replacement therapy is to maintain normal blood thyroxine level. Initiation or discontinuation of therapy with Levothyroxine in diabetic patients may create a need for an increase or decrease in the required dose of insulin and / or antidiabetic Drug,. Levothyroxine may increase the effect of blood thinners such as warfarin. Therefore, monitoring of blood clotting is necessary, and a decrease in the dose of warfarin may be necessary. Intravenous Administration of epinephrine to patients with coronary artery disease may lead to complications ranging from difficulty in breathing to heart attack. These complications may occur more frequently among patients also taking Levothyroxine. Therefore, careful observation is needed when intravenous epinephrine is given to patients receiving Levothyroxine who also have coronary artery disease. Converting state of hypothyroidism to a normal state with Levothyroxine may decrease actions of certain beta-blocking drugs,. It may be necessary, therefore, to change the dose of beta-blocker. For the same reason, dose of digoxin, drug used to manage heart failure or irregular heart rhythm, also may need to be change. Converting hypothyroidism to euthyroid state with Levothyroxine may increase the blood level of theophylline, and it may be necessary to change the dose of theophylline. Taking Levothyroxine at the same time as calcium carbonate, ferrous sulfate, cholestyramine or colestipol may decrease the effect of Levothyroxine and lead to hypothyroidism. This occurs because Levothyroxine binds to these drugs and is not absorb.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

DOSAGE AND ADMINISTRATION

Table 1. LEVO-T Dosing Guidelines for Pediatric Hypothyroidism

AGEDaily Dose Per Kg Body Weight
0-3 months10-15 mcg/kg/day
3-6 months8-10 mcg/kg/day
6-12 months6-8 mcg/kg/day
1-5 years5-6 mcg/kg/day
6-12 years4-5 mcg/kg/day
Greater than 12 years but growth and puberty incomplete2-3 mcg/kg/day
Growth and puberty complete1.6 mcg/kg/day

In patients with congenital Hypothyroidism, assess the adequacy of replacement therapy by measuring both serum TSH and total or free-T4. Monitor TSH and total or free-T4 in children as follow: 2 and 4 weeks after initiation of treatment, 2 weeks after any change in dosage, and then every 3 to 12 months thereafter following dose stabilization until Growth is Complete. Poor compliance or abnormal values may necessitate more frequent monitoring. Perform routine clinical examination, including assessment of development, mental and physical growth, and bone maturation, at regular intervals. While the general aim of therapy is to normalize serum TSH level, TSH may not Normalize in some patients due to in utero Hypothyroidism causing resetting of pituitary-thyroid feedback. Failure of serum T4 to increase into the upper half of normal range within 2 weeks of initiation of LEVO-T therapy and / or of serum TSH to decrease below 20 IU per liter within 4 weeks may indicate child is not receiving adequate therapy. Assess compliance, dose of medication administer, and method of administration prior to increasing the dose of LEVO-T.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

HOW SUPPLIED

Table 1. LEVO-T Dosing Guidelines for Pediatric Hypothyroidism

AGEDaily Dose Per Kg Body Weight
0-3 months10-15 mcg/kg/day
3-6 months8-10 mcg/kg/day
6-12 months6-8 mcg/kg/day
1-5 years5-6 mcg/kg/day
6-12 years4-5 mcg/kg/day
Greater than 12 years but growth and puberty incomplete2-3 mcg/kg/day
Growth and puberty complete1.6 mcg/kg/day

Levothyroxine is contraindicate in any patient with known hypersensitivity to Levothyroxine or any of its excipients; however, there is no well-document evidence in literature of true allergic or idiosyncratic reactions to Thyroid hormone. Hypersensitivity reactions to inactive ingredients have occurred in patients treated with Thyroid hormone products. Levothyroxine injection and tablets are synthetically derive and may be used in patients allergic to desiccated Thyroid or Thyroid extract derive from pork or beef. Levothyroxine is contraindicate for use in patients with diagnosed but untreated adrenal insufficiency. Initiation of Thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate acute adrenal crisis in patients with adrenal insufficiency due to an increase in the body's demand for adrenal hormones. Treat Patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with Levothyroxine. Serum TSH is not a reliable measure of Levothyroxine dose adequacy in patients with secondary Hypothyroidism or tertiary Hypothyroidism and should not be used to monitor therapy. Inappropriate TSH may be see if Hypothyroidism is caused by TSH deficiency, and TSH will not Normalize with Thyroid treatment. Use serum Free-T4 level to monitor for adequacy of therapy in this patient population. Many authorities recommend lower initial dosages and slower titration of Thyroid Hormones in patients with cardiac disease and coronary artery disease. Thyroid Hormones such as Levothyroxine should be used with great caution in patients where integrity of the cardiovascular system is suspect. All Levothyroxine dosage formulations are cardiostimulatory and should be used with great caution in patients with angina pectoris, uncontrolled hypertension, cardiac arrhythmias, CAD, previous history of acute myocardial infarction, or current acute myocardial infarction. If adverse cardiac symptoms develop or worsen during treatment, reduce or withhold Levothyroxine and cautiously restart at lower dose. Over-treatment with Thyroid Hormones may cause cardiac stimulation and lead to increased heart rate, cardiac wall thickening, and increased cardiac contractility, which may precipitate angina or cardiac arrhythmias. Concomitant administration of Levothyroxine with vasopressors or sympathomimetic agents may precipitate coronary insufficiency and associate symptoms, particularly in myxedematous patients or those with CAD. Fluid therapy should be administered with great care to prevent cardiac decompensation. In Patients with compromised cardiac function, use Thyroid Hormones in conjunction with careful cardiac monitoring. A lower starting dose is recommended in adult and pediatric patients at risk for heart failure or sensitive to Thyroid stimulation. Careful monitoring is also recommended during surgery, as some anesthetic agents may induce changes in heart rate or blood pressure when administered with Thyroid Hormones. Levothyroxine therapy can worsen glycemic control in patients with diabetes mellitus, and result in increased antidiabetic agent or insulin requirements. Effects see are poorly understood and depend upon a variety of factors such as dose and type of Thyroid preparations and endocrine status of the patient. Blood glucose should be monitored closely during concomitant therapy, particularly during initiation, dose adjustments, or discontinuation of therapy. Levothyroxine should not be used for obesity treatment or weight loss.


General Administration Information

Administer on an empty stomach, at least 30 to 60 minutes before breakfast. Administer at least 4 hours apart from medications or food known to decrease absorption, and 4 hours apart from enteral feedings; evaluate need for dose adjustments when patient is regularly administering their dose within 1 hour of certain foods that may affect absorption. Soybean flour, cotton seed meal, walnuts, and dietary fiber decrease Levothyroxine absorption. Bioavailability is best when administered in a fasting state. May be administered intravenously or by intramuscular Injection. Intravenous routes are prefer. Visually inspect parenteral products for particulate matter and discoloration before administration whenever solution and container permit. Reconstitution: Reconstitute by aseptically adding 5 mL of preservative-free 0. 9 % Sodium Chloride Injection, USP to vial of lyophilized Levothyroxine Sodium for Injection. Do not use other solutions to Reconstitute. Shake well to dissolve completely. The resultant solution will have final concentration as follow: approximately 20 mcg / mL for 100 mcg vial. Approximately 40 mcg / mL for 200 mcg vial. Approximately 100 mcg / mL for 500 mcg vial. The Reconstitute Injection is preservative free and is stable for 4 hours; unused portions should be discard. Levothyroxine oral solution may be administered in water or directly into the mouth. To administer in water, squeeze the contents of 1 single unit-dose ampule into a glass or cup containing water and stir. Do not dilute with any liquid other than water. Preparation should be administered immediately and consumed in its entirety to ensure all of the dose is receive. Rinse glass or cup with additional water and drink contents to ensure the entire dose is take. To administer directly, either squeeze it into your mouth or onto a spoon and immediately consume. Storage: Store unopened oral solution ampules in original container at 77 degrees F; excursions are permitted to 59 to 86 degrees F. Discard any unused ampules 15 days after opening pouch. Extemporaneous preparation of 25 mcg / mL Levothyroxine oral suspension: NOTE: Levothyroxine is not available as an FDA-approve oral suspension. With mortar and pestle, grind twenty-five 0. 1 mg Levothyroxine tablets into fine powder. In a separate container, measure 40 mL of glycerol. Add a small amount of glycerol to fine powder and mix into a uniform paste. Add geometric amounts of glycerol until the suspension is pourable. Transfer suspension to calibrated 100 mL amber bottle. In approximately 10 mL portions, rinse the mortar with remaining glycerol and transfer washings into amber bottle, trying to leave no Levothyroxine in the mortar. Add water to amber bottle to bring total volume to 100 mL. Label bottle appropriately, including'shake well before each use' and 'Refrigerate'. Suspension is stable for 8 days when stored at approximately 4 degrees C.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

CLINICAL PHARMACOLOGY

LEVO-T contains synthetic crystalline L-3 3', 55'-tetraiodothyronine Sodium salt. Synthetic T4 is chemically identical to that produced in human Thyroid gland. Levothyroxine Sodium has an empirical formula of C 15 H 10 I 4 NNaO 4 x H 2 O, molecular weight of 798. 86 g / mol, and structural formula as show: LEVO-T tablets For Oral Administration are supplied in 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 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 color additives by tablet strength: Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine and L-thyroxine diffuse into the cell nucleus and bind to Thyroid receptor proteins attach to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins. Physiological actions of Thyroid hormones are produced predominantly by T3, majority of which is derived from T4 by deiodination in peripheral tissues. Oral Levothyroxine Sodium is a synthetic T4 hormone that exerts the same physiologic effect as endogenous T4, thereby maintaining normal T4 levels when deficiency is PRESENT. Absorption of orally Administer T4 from gastrointestinal tract ranges from 40 % to 80 %. The majority of LEVO-T dose is absorbed from the jejunum and upper ileum. The relative bioavailability of LEVO-T tablets, compared to equal nominal dose of Oral Levothyroxine Sodium solution, is approximately 99 %. T4 Absorption is increased by fasting, and decrease in malabsorption syndromes and by certain foods such as soybeans. Dietary fiber decreases bioavailability of T4. Absorption may also decrease WITH age. In addition, many drugs and foods affect T4 Absorption. Circulating Thyroid hormones are greater than 99 % bound to plasma proteins, including thyroxine-binding globulin, thyroxine-binding prealbumin, and albumin, whose capacities and affinities vary for each hormone. The higher affinity of both TBG and TBPA for T4 partially explains higher serum levels, slower metabolic clearance, and longer half-life of T4 compared to T3. Protein-bound Thyroid hormones exist in reverse equilibrium WITH small amounts of free hormone. Only unbound hormone is metabolically active. Many drugs and physiologic conditions affect the binding of Thyroid hormones to serum proteins. Thyroid hormones do not readily cross the placental barrier. T4 is slowly eliminate. The major pathway of Thyroid hormone metabolism is through sequential deiodination. Approximately 80 % of circulating T3 is derived from peripheral T4 by monodeiodination. Liver is a major site of degradation for both T4 and T3, WITH T4 deiodination also occurring at a number of additional sites, including kidney and other tissues. Approximately 80 % of the daily dose of T4 is deiodinated to yield equal amounts of T3 and reverse T3. T3 and rT3 are further deiodinated to diiodothyronine.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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