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Thyrolar
Overview
What is Thyrolar?
Thyrolar Tablets (Liotrix Tablets, USP) contain triiodothyronine (T3 liothyronine) sodium and tetraiodothyronine (T4 levothyroxine) sodium in the amounts listed in the section. (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.)
The inactive ingredients are calcium phosphate, colloidal silicon dioxide, corn starch, lactose, and magnesium stearate. The tablets also contain the following dyes: Thyrolar 1/4 - FD&C Blue #1 and FD&C Red #40; Thyrolar 1/2 - FD&C Red #40 and D&C Yellow #10; Thyrolar 1 - FD&C Red #40; Thyrolar 2 - FD&C Blue #1, FD&C Red #40, and D&C Yellow #10; Thyrolar 3 - FD&C Red #40 and D&C Yellow #10.
STRUCTURAL FORMULAS
What does Thyrolar look like?
What are the available doses of Thyrolar?
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What should I talk to my health care provider before I take Thyrolar?
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How should I use Thyrolar?
The dosage of Thyrolar Tablets (Liotrix Tablets, USP) is determined by the indication and must in every case be individualized according to patient response and laboratory findings.
Thyroid hormones are given orally. In acute, emergency conditions, injectable sodium levothyroxine may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition. Intramuscular administration is not advisable because of reported poor absorption.
Hypothyroidism—Therapy is usually instituted using low doses with increments which depend on the cardiovascular status of the patient. The usual starting dose is one tablet of Thyrolar ½ with increments of one tablet of Thyrolar ¼ every 2 to 3 weeks. A lower starting dosage, one tablet of Thyrolar ¼/day, is recommended in patients with long-standing myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended. The appearance of angina is an indication for a reduction in dosage. Most patients require one tablet of Thyrolar 1 to one tablet of Thyrolar 2 per day. Failure to respond to doses of one tablet of Thyrolar 3 suggests lack of compliance or malabsorption. Maintenance dosages of one tablet of Thyrolar 1 to one tablet of Thyrolar 2 per day usually result in normal serum levothyroxine (T4) and triiodothyronine (T3) levels. Adequate therapy usually results in normal TSH and T4 levels after 2 to 3 weeks of therapy.
Readjustment of thyroid hormone dosage should be made within the first four weeks of therapy, after proper clinical and laboratory evaluations, including serum levels of T4, bound and free, and TSH.
T3 may be used in preference to levothyroxine (T4) during radio-isotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration. It may also be preferred when impairment of peripheral conversion of T4 and T3 is suspected.
What interacts with Thyrolar?
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What are the warnings of Thyrolar?
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What are the precautions of Thyrolar?
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What are the side effects of Thyrolar?
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What should I look out for while using Thyrolar?
Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. There is no well documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.
Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. 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.
The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.
What might happen if I take too much Thyrolar?
How should I store and handle Thyrolar?
Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Thyrolar Tablets (Liotrix Tablets, USP) are available in five potencies coded as follows: Supplied in bottles of 100, two-layered compressed tablets. Tablets should be stored at cold temperature, between 36˚F and 46˚F (2˚C and 8˚C) in a tight, light-resistant container. Note: (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.) FOREST PHARMACEUTICALS, INC.A Subsidiary of Forest Laboratories, Inc.St. Louis, MO 63045 Rev. January 2010RMC #1436 © 2010 Forest Laboratories, Inc. Thyrolar Tablets (Liotrix Tablets, USP) are available in five potencies coded as follows: Supplied in bottles of 100, two-layered compressed tablets. Tablets should be stored at cold temperature, between 36˚F and 46˚F (2˚C and 8˚C) in a tight, light-resistant container. Note: (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.) FOREST PHARMACEUTICALS, INC.A Subsidiary of Forest Laboratories, Inc.St. Louis, MO 63045 Rev. January 2010RMC #1436 © 2010 Forest Laboratories, Inc. Thyrolar Tablets (Liotrix Tablets, USP) are available in five potencies coded as follows: Supplied in bottles of 100, two-layered compressed tablets. Tablets should be stored at cold temperature, between 36˚F and 46˚F (2˚C and 8˚C) in a tight, light-resistant container. Note: (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.) FOREST PHARMACEUTICALS, INC.A Subsidiary of Forest Laboratories, Inc.St. Louis, MO 63045 Rev. January 2010RMC #1436 © 2010 Forest Laboratories, Inc. Thyrolar Tablets (Liotrix Tablets, USP) are available in five potencies coded as follows: Supplied in bottles of 100, two-layered compressed tablets. Tablets should be stored at cold temperature, between 36˚F and 46˚F (2˚C and 8˚C) in a tight, light-resistant container. Note: (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.) FOREST PHARMACEUTICALS, INC.A Subsidiary of Forest Laboratories, Inc.St. Louis, MO 63045 Rev. January 2010RMC #1436 © 2010 Forest Laboratories, Inc. Thyrolar Tablets (Liotrix Tablets, USP) are available in five potencies coded as follows: Supplied in bottles of 100, two-layered compressed tablets. Tablets should be stored at cold temperature, between 36˚F and 46˚F (2˚C and 8˚C) in a tight, light-resistant container. Note: (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.) FOREST PHARMACEUTICALS, INC.A Subsidiary of Forest Laboratories, Inc.St. Louis, MO 63045 Rev. January 2010RMC #1436 © 2010 Forest Laboratories, Inc. Thyrolar Tablets (Liotrix Tablets, USP) are available in five potencies coded as follows: Supplied in bottles of 100, two-layered compressed tablets. Tablets should be stored at cold temperature, between 36˚F and 46˚F (2˚C and 8˚C) in a tight, light-resistant container. Note: (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.) FOREST PHARMACEUTICALS, INC.A Subsidiary of Forest Laboratories, Inc.St. Louis, MO 63045 Rev. January 2010RMC #1436 © 2010 Forest Laboratories, Inc. Thyrolar Tablets (Liotrix Tablets, USP) are available in five potencies coded as follows: Supplied in bottles of 100, two-layered compressed tablets. Tablets should be stored at cold temperature, between 36˚F and 46˚F (2˚C and 8˚C) in a tight, light-resistant container. Note: (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.) FOREST PHARMACEUTICALS, INC.A Subsidiary of Forest Laboratories, Inc.St. Louis, MO 63045 Rev. January 2010RMC #1436 © 2010 Forest Laboratories, Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The steps in the synthesis of the thyroid hormones are controlled by thyrotropin (Thyroid Stimulating Hormone, TSH) secreted by the anterior pituitary. This hormone's secretion is in turn controlled by a feedback mechanism effected by the thyroid hormones themselves and by thyrotropin releasing hormone (TRH), a tripeptide of hypothalamic origin. Endogenous thyroid hormone secretion is suppressed when exogenous thyroid hormones are administered to euthyroid individuals in excess of the normal gland's secretion.
The mechanisms by which thyroid hormones exert their physiologic action are not well understood. These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate, and the metabolism of carbohydrates, lipids, and proteins. Thus, they exert a profound influence on every organ system in the body and are of particular importance in the development of the central nervous system.
The normal thyroid gland contains approximately 200 mcg of levothyroxine (T4) per gram of gland, and 15 mcg of triiodothyronine (T3) per gram. The ratio of these two hormones in the circulation does not represent the ratio in the thyroid gland, since about 80 percent of peripheral triiodothyronine comes from monodeiodination of levothyroxine. Peripheral monodeiodination of levothyroxine at the 5 position (inner ring) also results in the formation of reverse triiodothyronine (T3), which is calorigenically inactive.
Triiodothyronine (T3) levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “low triiodothyronine syndrome.”
Non-Clinical Toxicology
Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. There is no well documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. 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.
The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.
Drug Interactions—Oral Anticoagulants—Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors. If oral anticoagulants are also being given, compensatory increases in clotting factor synthesis are impaired. Patients stabilized on oral anticoagulants who are found to require thyroid replacement therapy should be watched very closely when thyroid is started. If a patient is truly hypothyroid, it is likely that a reduction in anticoagulant dosage will be required. No special precautions appear to be necessary when oral anticoagulant therapy is begun in a patient already stabilized on maintenance thyroid replacement therapy.
General—Thyroid hormones should be used with great caution in a number of circumstances where the integrity of the cardiovascular system, particularly the coronary arteries, is suspected. These include patients with angina pectoris or the elderly, in whom there is a greater likelihood of occult cardiac disease. In these patients therapy should be initiated with low doses, i.e., one tablet of Thyrolar ½ or Thyrolar ¼. When, in such patients, a euthyroid state can only be reached at the expense of an aggravation of the cardiovascular disease, thyroid hormone dosage should be reduced.
Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes insipidus or adrenal cortical insufficiency aggravates the intensity of their symptoms. Appropriate adjustments of the various therapeutic measures directed at these concomitant endocrine diseases are required. The therapy of myxedema coma requires simultaneous administration of glucocorticoids (See ).
Hypothyroidism decreases and hyperthyroidism increases the sensitivity to oral anticoagulants. Prothrombin time should be closely monitored in thyroid treated patients on oral anticoagulants and dosage of the latter agents adjusted on the basis of frequent prothrombin time determinations. In infants, excessive doses of thyroid hormone preparations may produce craniosynostosis.
During postmarketing surveillance, the following events have been observed to have occured in patients administered Thyrolar: fatigue, sluggishness, increase in weight, alopecia, palpitations, dry skin, urticaria, headache, hyperhidrosis, pruritus, asthenia, increased blood pressure, arthralgia, myalgia, tremor, hypothyroidism, increase in TSH, decrease in TSH, nausea, chest pain, hypersensitivity, keratoconjunctivitis sicca, increased heart rate, irregular heart rate, anxiety, depression, and insomnia.
Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare (See ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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