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Thyroid Ingredients

Thyroid

Thyroid tablets (USP) for oral use are natural preparations derived from porcine thyroid glands (T3 liotllyronine is approximately four times as potent as T4 levothyroxine on a micro- gram for microgram basis). They provide 38-mcg levothyroxine (T4) and 9-mcg liothyronine (T3) per grain of thyroid. The inactive ingredient is microcystalline cellulose.

CLINICAL 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 affected 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 200mcg of levothyroxine (T4) per gram of gland and 15 mcg of liothyronine (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 liothyronine (T3) comes from monodeiodination of levothyroxine (T4). Peripheral monodeidination (T4) at the 5th position (inner ring) also results in the formation of reverse (T3), which is calorigenically inactive. Liothyronine (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 (T3) thyronine syndrome.

PHARMACOKINETICS:
Animal studies have shown that levothyroxine (T4) is only partia11y absorbed from the gastrointestinal tract. The degree of absorption is dependent on the vehicle used for its administration and by the character of the intestinal contents, the intestinal flora, including plasma protein, and soluble dietary factors, all of which bind thyroid and thereby makes it unavailable for diffusion. Only 41 percent is absorbed when given in a gelatin capsu1e as opposed to 74 percent absorption when given with an albumin carrier. Depending on other factors, absorption has varied from 48 to 79 percent of the administered dose. Fasting increases absorption Malabsorption syndromes, as well as dietary factors, (children's soybean formula, concomitant use of anionic exchange resins such as cholestyramine) cause excessive fecal loss. Liothyronine (T3) is almost totally absorbed, 95 percent in 4 hours. The hormones contained in the natural preparations are absorbed in a manner similar to the synthetic hormones. More than 99 percent of circulating hormones are bound 10 Serum proteins, including thyroid-binding globulin (TBg), thyroid-binding prealbumin (TBPA), and albumin (TBa), whose capacities and affinities vary for the hormones. The higher affinity levothyroxine (T4) for both TBg and TBPA as compared to liothyronine (T3) partially explains the higher serum levels and longer half-life of the former hormone, Both protein-bound hormones exist in reverse equilibrium with minute amounts of free hormone, the latter accounting for the metabolic activity. Deiodination of levothyroxine (T4) occurs at a number of sites, including liver kidney, and other tissues. The conjugated hormone, in the form of glucuronide or sulfate, is found in the bile and gut where it may complete an enterohepatic circulation. Eighty-five percent of levothyroxine (T4) metabolized daily is deiodinated.

INDICATIONS AND USAGE:
1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema and ordinary hypothyroidism in patients of any age (children, adults, and elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS).
2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter and in the management of thyroid cancer.
3. As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.

WARNINGS :
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.

PRECAUTIONS:
Information for the patients:- Patients on thyroid hormone preparations and parents of children on thyroid therapy should be informed that:
1. Replacement therapy is to be taken essentially for life, with the exception of cases of transient hypothyroidism, usually associated with thyroiditis, and in those patients receiving a therapeutic trial of the drug.
2. They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g. chest pain, increased pulse rate, palpitations, excessive sweating, heal intolerance, nervousness, or any other unusual event.
3. In case of concomitant diabetes mellitus, the daily dosage of anti diabetic medication may need re-adjustment as thyroid hormone replacement is achieved. If thyroid medication is stopped, a downward re-adjustment of the dosage of insulin or oral hypoglycemic agent may be necessary to avoid hypoglycemia. At all times, close monitoring of urinary glucose levels is mandatory in such patients.
4. In case of concomitant oral anticoagulant therapy, the prothrombin time should be measured frequently to determine if the dosage of oral anticoagulants is to be readjusted.
5. Partial loss of hair may be experienced by children in the first few months of thyroid therapy, but this is usually a transient phenomenon and later recovery is usually the rule.

ADVERSE REACTIOINS :
Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdose, either initially or during the maintenance period are rare (See OVER DOSAGE)

OVER DOSAGE:
Sign and symptoms- Excessive doses of thyroid result in a hypermetabolic state resembling in every respect the condition of endogenous origin. The condition may be self-induced. Treatment of over dosage- Dosage should be reduced or therapy temporarily discontinued if signs and symptoms of over dosage appear. Treatment may be re-instituted at a lower dosage. In normal individuals, normal hypothalamic pituitary thyroid axis functions is restored in 6 to 8 weeks after thyroid suppression. Treatment of acute massive thyroid hormone over dosage is aimed at reducing gastro intestinal absorption of the drugs and counteracting central and peripheral effects, mainly those of increased sympathetic activity. Vomiting may be induced initially if further gastro intestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions. Or loss of the gagging reflex. Treatment is symptomatic and supportive. Oxygen may be administered and ventilation maintained. Cardiac glycosides may be indicated of congestive heart failure develops. Measures to control fever, hypoglycemia or fluid loss should be instituted if needed. Anti adrenergic agents, particularly propranolol, have been used advantageously in the treatment of increased sympathetic activity. Propranolol may be administered intravenously at a dosage of 1 to 3 mg over a 10 minute period or orally, 80 to 160 mg per day, initially especially when no contraindications exits for its use. Other adjunctive measure may include administration of cholestyramine to interfere with thyroxine absorption, and glucocorticoids to inhibit conversion of T4 or T3.

DOSAGE AND ADMINISTRATION:
The dosage of thyroid hormones 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 levothyroxine sodium (T4) 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 the increments that depend on the cardiovascular status of the patient. The usual starting dose is 30 mg with increments of 15 mg every 2 to 3 weeks. A lower starting dosage, 15 mg per 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 60 to 120 mg per day. Failure to respond to doses of 180 mg suggests lack of compliance or malabsorption. Maintenance dosages 60 to 120 mg per day usually result in normal serum T4 and 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. Liothyronine may be used in preference to levothyroxine during radioisotope 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 levothyroxine and liothyronine is suspected.
Myxedema Coma: Myxedema coma is usually precipitated in the hypothyroid patient of long standing by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency. Therapy should be directed at the correction of electrolyte disturbances and possible infection besides the administration of thyroid hormones. Corticosteroids should be administered routinely. (T4) and (T3) may be administered via a nasogastric tube but the preferred route of administration of both hormones is intravenous. Levothyroxine sodium (T4) is given at a starting dose of 400 mcg (100 mcg / ml) given rapidly, and is usually well tolerated, even in the elderly. This initial dose is followed by daily supplements of 100 to 200 mcg given IV. Normal T4 levels are achieved in 24 hours followed in 3 days by threefold elevation of T3. Oral therapy with thyroid hormone would be resumed as soon as the clinical situation has been stabilized and the patient is able to take oral medication.
Thyroid Cancer: Exogenous thyroid hormone may produce regression of metastases from follicular and papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions with radioactive iodine. TSH should be suppressed to low or undetectable levels. Therefore, larger amounts of thyroid hormone that those used for replacement therapy are required. Medullary carcinoma of the thyroid is usually unresponsive to this therapy.
Pediatric Dosage: Pediatric dosage should follow the recommendations. In infants with congenital hypothyroidism, therapy with full doses should be instituted as soon as the diagnosis has been made.

Keep this and all other medicines safely out of the reach of children.

Product SKU Price Type Weight
Ingredients
Prescription Needed
Discreet Mail
THYROID (ARMOUR® 1/2-GRAIN)) THYRO-1-IAS
$59.99
Tablets 100 x30mg
N
N
THYROID (ARMOUR® 2-GRAIN) THYRO-2-IAS
$119.99
Tablets 100 x125mg
N
N

*** All Prices are subject to change based on the latest prices from IAS.

 

 

Thyroid Ingredients

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Thyroid

 

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