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Levothyroxine Sodium Anhydrous

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Last Updated: 20 October 2020

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General | Latest Info

In younger patients, and in the absence of heart disease, Serum LEVOTHYROXINE level of 70 TO 160 nanomols per litre, or Serum thyrotrophin level of less than 5 milli-units per litre should be target. Pre-therapy ECG is valuable because ECG changes due to hypothyroidism may be confused with ECG evidence of Cardiac ischaemia. If a rapid increase in metabolism is produce, dosage MUST be reduce, or withheld, FOR day or two, and then re-start at a lower dose level. For patients over 50 years, initially, it is not advisable to exceed 50 micrograms daily. In this condition, daily dose may be increased by 50 micrograms at intervals every 3-4 weeks, until stable Thyroxine levels are attain. The final daily dose may be up to 50 TO 200 micrograms. Where there is Cardiac Disease, 25 micrograms daily or 50 micrograms on alternate days is more suitable. In these conditions, daily dose may be increased by 25 micrograms at intervals of every 4 weeks, until stable Thyroxine levels are attain. The final daily dose may be up to 50 TO 200 micrograms. For patients aged over 50 years, With or Without Cardiac Disease, clinical response is probably more acceptable criteria of dosage rather than serum levels. Maintenance dose is generally 100 TO 150 micrograms per m body surface area. Dose FOR children depends on their age, weight and condition being treat. Regular Monitoring using Serum TSH levels, as in adults, is required TO make sure he / she gets the right dose. Infants should be given a total daily dose at least half hour before the first meal of day. For neonates and infants with congenital hypothyroidism, where rapid replacement is important, initial recommended dosage is 10 TO 15 micrograms per kg BW per day FOR first 3 months. Thereafter, dose should be adjusted individually according to clinical findings and Thyroid Hormone and TSH values. For children with acquired hypothyroidism, initial recommended dosage is 12. 5-50 micrograms per day. Dose should be increased gradually every 2-4 weeks according TO clinical findings and Thyroid Hormone and TSH values until full replacement dose is reach initial recommended dosage is 25 micrograms daily. In such conditions, daily dose may be increased by 25 micrograms at intervals of every 2-4 weeks, until mild symptoms of hyperthyroidism are see. The Dose will then be reduced slightly. In children under 5 years of age, administration of whole tablets is not recommend. It is also not recommended that tablets are crushed and dispersed in water or OTHER liquids, owing to limited solubility, which could lead to dosing inaccuracy. In this age group, it is preferable to administer approved oral solution of LEVOTHYROXINE. Patients with panhypopituitarism or OTHER causes predisposing TO adrenal insufficiency may react TO LEVOTHYROXINE treatment, and it is advisable TO start corticosteroid therapy before giving LEVOTHYROXINE TO such patients.

* 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

Product Labeler Information

In general, signs and symptoms of overdosage with LEVOTHYROXINE are those of hyperthyroidism. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been report. Excessive doses of LEVOTHYROXINE SODIUM FOR INJECTION are associated with cardiac complications in patients with underlying cardiac disease. Levothyroxine SODIUM FOR INJECTION should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur. To obtain up-TO-date information about treatment of overdose, good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in patient. In the event of overdose, appropriate supportive treatment should be initiated as dictated by the patient's medical status. Levothyroxine SODIUM FOR INJECTION contains synthetic crystalline LEVOTHYROXINE SODIUM salt. Levothyroxine SODIUM has an empirical formula of C 15 H 10 I 4 NNaO 4, and a molecular weight of 798. 85 g / mol, and the following structural formula: LEVOTHYROXINE SODIUM FOR INJECTION is sterile, preservative-free lyophilize powder consisting of active ingredient, LEVOTHYROXINE SODIUM, and excipients dibasic SODIUM phosphate heptahydrate, USP; mannitol, USP; and SODIUM hydroxide, NF in single dose amber glass vials. Levothyroxine SODIUM FOR INJECTION is available at three dosage strengths: 100 mcg per vial, 200 mcg per vial and 500 mcg per vial.


Dosage:

The suggested initial dose is 0. 5 To 3. 0 mg Levothyroxine Sodium per 100 lbs of body weight once per day or in divided doses. Response To administration of ThyroKare Powder should be evaluated clinically until an adequate maintenance dose is establish. In most horses, total daily dose of T-4 is in the range of 6 to 36 mg. Serum T-3 and T-4 values can vary greatly among inidividual horses on thyroid supplementation. Dosages should be individualized and animals should be monitored daily for clinical signs of hyperthyroidism or hypersensitivity. Thyrokare Powder can be administered by mixing daily dose in concentrate or by topping dressing on grain, preferably roll or ground. To facilitate proper adhesion of ThyroKare Powder to ration, slightly moisten grain with water or liquid supplement.

* 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

Initial intravenous loading Dose Of LEVOTHYROXINE SODIUM FOR INJECTION between 300 TO 500 mcg, followed by once daily intravenous maintenance doses between 50 and 100 mcg, should be administer, as clinically indicate, until the patient can tolerate oral therapy. Age, general physical condition, Cardiac Risk factors, and clinical severity of myxedema and duration of myxedema symptoms should be considered when determining starting and maintenance dosages of LEVOTHYROXINE SODIUM FOR INJECTION. Levothyroxine SODIUM FOR INJECTION produces a gradual Increase in Circulating concentrations Of Hormone With an approximate Half-Life Of 9 TO 10 days in hypothyroid patients. Daily Administration Of LEVOTHYROXINE SODIUM FOR INJECTION should be maintained until the patient is capable of tolerating oral dose and is clinically stable. For chronic treatment of hypothyroidism, oral dosage form of LEVOTHYROXINE should be used TO maintain euthyroid state. Relative bioavailability between LEVOTHYROXINE SODIUM FOR INJECTION and oral LEVOTHYROXINE products has not been establish. Base on medical practice, relative bioavailability between oral and intravenous Administration of LEVOTHYROXINE SODIUM FOR INJECTION is estimated TO be from 48 to 74%. Due to differences in absorption characteristics of patients and oral LEVOTHYROXINE Product formulations, TSH and Thyroid Hormone levels should be measured a few weeks after initiating oral LEVOTHYROXINE and dose adjusted accordingly. Intravenous LEVOTHYROXINE may be associated with Cardiac toxicity-including arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death-In elderly and in those with underlying Cardiovascular Disease. Therefore, cautious use, including doses at the lower end of the recommended range, may be warranted in these populations. Reconstitute Lyophilized LEVOTHYROXINE SODIUM FOR INJECTION by aseptically adding 5 mL Of 0. 9% SODIUM Chloride INJECTION, USP only. Shake Vial TO ensure complete mixing. The resultant solution will have final concentration of approximately 20 mcg per mL, 40 mcg per mL and 100 mcg per mL FOR 100 mcg, 200 mcg and 500 mcg vials, respectively. The Reconstitute Drug Product is preservative free and is stable FOR 4 hours. Discard any unused portion. Do not ADD LEVOTHYROXINE SODIUM FOR INJECTION TO OTHER IV FLUIDS. Parenteral Drug products should be inspected visually FOR particulate matter and discoloration prior TO Administration, whenever solution and container permit. In general, signs and symptoms of overdosage with LEVOTHYROXINE are those of hyperthyroidism. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been report. Excessive doses of LEVOTHYROXINE SODIUM FOR INJECTION are associated With Cardiac Complications in Patients With underlying Cardiac Disease. Levothyroxine SODIUM FOR INJECTION should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur. To obtain up-TO-date information about treatment of overdose, good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in patient. In the event of overdose, appropriate supportive treatment should be initiated as dictated by patients ' medical status.

* 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

In general, signs and symptoms of overdosage with LEVOTHYROXINE are those of hyperthyroidism. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been report. Excessive doses of LEVOTHYROXINE SODIUM FOR INJECTION are associated With Cardiac Complications in Patients With underlying Cardiac Disease. Levothyroxine SODIUM FOR INJECTION should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur. To obtain up-TO-date information about treatment of overdose, good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in patient.S In the event of overdose, appropriate supportive treatment should be initiated as dictated by patients ' medical status. Levothyroxine SODIUM FOR INJECTION contains synthetic crystalline LEVOTHYROXINE SODIUM salt. Levothyroxine SODIUM has an empirical formula of C 15 H 10 I 4 NNaO 4, and a molecular weight of 798. 85 g / mol, and the following structural formula: LEVOTHYROXINE SODIUM FOR INJECTION is sterile, preservative-free lyophilize powder consisting of active ingredient, LEVOTHYROXINE SODIUM, and excipients dibasic SODIUM phosphate heptahydrate, USP; mannitol, USP; and SODIUM hydroxide, NF in Single Dose amber glass vials. Levothyroxine SODIUM FOR INJECTION is available at two dosage strengths: 100 mcg per Vial and 200 mcg per Vial. Package LABEL-PRINCIPAL DISPLAY-LEVOTHYROXINE 100 mcg Single Dose Vial LABEL PACKAGE LABEL-PRINCIPAL DISPLAY-LEVOTHYROXINE 100 mcg Single Dose Vial Carton Panel

* 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

PRECAUTIONS

Levothyroxine is used to treat underactive Thyroid. It replaces or provides more Thyroid hormone, which is normally produced by Thyroid gland. Low Thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation / medications or removed by surgery. Having enough Thyroid hormones is important FOR maintaining normal mental and physical activity. In children, having enough Thyroid hormones is important for normal mental and physical development. This medication is also used to treat OTHER types of Thyroid disorders. This medication should not be used TO treat infertility unless it is caused by low Thyroid hormone levels. Read Patient Information Leaflet if available from your pharmacist before you start taking LEVOTHYROXINE and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily on an empty stomach, 30 minutes TO 1 hour before breakfast. Take this medication with a full glass of water unless your doctor directs you otherwise. If you are taking capsule form OF this medication, swallow it whole. Do not split, crush, or chew. People who cannot swallow capsules whole should use tablet form OF medication. For infants or children who cannot swallow whole tablets, crush the tablet and mix in 1 TO 2 teaspoons of water, and give using a spoon or dropper right away. Do not prepare supply in advance or mix tablets in soy infant formula. Consult your pharmacist FOR more information. Dosage is based on your age, weight, medical condition, laboratory test results, and response TO treatment. Use this medication regularly in order TO get the most benefit from it. To help you remember, take it at same time each day. Do not stop taking this medication without first consulting with your doctor. Thyroid replacement treatment is usually taken FOR life. There are different brands OF LEVOTHYROXINE available. Do not change brands without first consulting your doctor or pharmacist. Certain medications can decrease the amount of Thyroid hormone that is absorbed by your body. If you are taking any OF these drugs, separate them from this medication for at least 4 hours. Symptoms of low Thyroid hormone levels include tiredness, muscle aches, constipation, dry skin, weight gain, slow heartbeat, or sensitivity TO cold. Tell your doctor if your condition worsens or persists after several weeks of taking this medication.


ADVERSE REACTIONS

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 Levothyroxine sodium tablets therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease [See Dosage and Administration, use in Specific Populations. Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive Levothyroxine sodium tablets therapy. Monitor patients receiving concomitant Levothyroxine sodium tablets and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiac symptoms develop or worsen, reduce the Levothyroxine sodium tablets dose or withhold for one week and restart at a lower dose.

* 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

Thyroid hormone synthesis and secretion is regulated by the hypothalamic pituitary-Thyroid axis. Thyrotropin releasing hormone release from the hypothalamus stimulates secretion of thyrotropin stimulating hormone from the anterior pituitary. Tsh, in turn, is physiologic stimulus FOR synthesis and secretion of Thyroid hormones, T 4 and T 3, by Thyroid gland. Circulating Serum T 3 and T 4 levels exert feedback effect on both TRH and TSH secretion. When Serum T 3 and T 4 levels increase, TRH and TSH secretion decrease. When thyroid hormone levels decrease, TRH and TSH secretion increases. Tsh is used for diagnosis of hypothyroidism and evaluation of LEVOTHYROXINE therapy adequacy with OTHER laboratory and clinical data. There are drugs known TO affect thyroid hormones and TSH by various mechanisms and those examples are diazepam, ethioamide, lovastatin, metoclopramide, 6-mercaptopurine, nitroprusside, perphenazine, and thiazide diuretics. Some drugs may cause transient decrease in TSH secretion without hypothyroidism and those drugs are dopamine, glucocorticoids and octreotide. Thyroid hormones regulate multiple metabolic processes and play an essential role in normal growth and development, and normal maturation of the central nervous system and bone. Metabolic actions of Thyroid hormones include augmentation of cellular respiration and thermogenesis, as well as metabolism of proteins, carbohydrates and lipids. Protein anabolic effects of Thyroid hormones are essential for normal growth and development.

* 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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