May 27, 2017
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"The US Food and Drug Administration (FDA) has approved calcifediol (Rayaldee, Opko Health, Inc) for the treatment of adults with secondary hyperparathyroidism (SHPT) associated with vitamin D insufficiency (serum total 25-hydroxyvitamin D "...



How Supplied


  1. As replacement of 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, the 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 anatomy.


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 parenteral nutrition). Intramuscular administration is not advisable because of reported poor absorption.


Therapy is usually instituted using low doses, with increments which depend on the cardiovascular status of the patient. The usual starting dose is 32.5 mg, with increment of 16.25 mg every 2 to 3 weeks. A lower starting dosage, 16.25 mg/day, is recommended in patients with longstanding myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended. The appearance of angina is an indication for reduction in dosage. Most patients require 65 - 130 mg/day. Failure to respond to doses of 195 mg suggests lack of compliance or malabsorption. Maintenance dosages 65 - 130 mg/day usually result in normal serum T4 and T3 levels. Adequate therapy usually results in normal TSH and T4 levels after 2 or 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 (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 levothyroxine (T4) and liothyronine (T3) is suspected.

Myxedema Coma

Myxedema coma is usually precipitated in the hypothyroid patient of longstanding 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. Levothyroxine (T4) and Liothyronine (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 than those used for replacement therapy are required. Medullary carcinoma of the thyroid is usually unresponsive to this therapy.

Thyroid Suppression Therapy

Administration of thyroid hormone in doses higher than those produced physiologically by the gland results in suppression of the production of endogenous hormone. This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism, in whom base line laboratory tests appear normal, or to demonstrate thyroid gland autonomy in patients with Grave's ophthalmopathy. 131I uptake is determined before and after the administration of the exogenous hormone. A fifty percent or greater suppression of uptake indicates a normal thyroid pituitary axis, and thus rules out thyroid gland autonomy.

For adults, the usual suppressive dose of levothyroxine (T4) is 1.56 mg/kg of body weight per day given for 7 to 10 days. These doses usually yield normal serum T4 and T3 levels and lack of response to TSH.

Thyroid hormones should be administered cautiously to patients in whom there is strong suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone effects will be additive to the endogenous source.

Pediatric Dosage

Pediatric dosage should follow the recommendations summarized in Table 1. In infants with congenital hypothyroidism, therapy with full doses should be instituted as soon as the diagnosis has been made.

TABLE 1: Recommended Pediatric Dosage for Congenital Hypothyroidism

Age Dose per day Daily dose per kg of body weight
0 - 6 months 16.25 - 32.5 mg 4.8-6.0 mg
6 - 12 months 32.5 - 48.75 mg 3.6-4.8 mg
1 - 5 years 48.75 - 65 mg 3.0-3.6 mg
6 - 12 years 65 - 97.5 mg 2.4-3.0 mg
Over 12 years Over 97.5 mg 1.2-1.8 mg


Westhroid™ (Thyroid USP) Tablets are supplied as follows:

16.25 mg. (1/4 gr.) in bottles of 30 Count (NDC 64727-7065-4), 60 Count (NDC 64727-7065-5), 90 Count (NDC 64727-7065-6), 100 Count (NDC 64727-7065-1), 1,000 Count (NDC 64727-7065-2), 990 Count (NDC 64727-7065-3) & 1,008 Count (NDC 64727-7065-8)

32.5 mg. (½ gr.) in bottles of 30 Count (NDC 64727-7070-4), 60 Count (NDC 64727-7070-5), 90 Count (NDC 64727-7070-6), 100 Count (NDC 64727-7070-1), 1,000 Count (NDC 64727-7070-2), 990 Count (NDC 64727-7070-3) & 1,008 Count (NDC 64727-7070-8)

48.75 mg. (3/4 gr.) in bottles of 30 Count (NDC 64727-7072-4), 60 Count (NDC 64727-7072-5), 90 Count (NDC 64727-7072-6), 100 Count (NDC 64727-7072-1), 1,000 Count (NDC 64727-7072-2), 990 Count (NDC 64727-7072-3) & 1,008 Count (NDC 64727-7072-8)

65 mg. (1 gr.) in bottles of 30 Count (NDC 64727-7073-4), 60 Count (NDC 64727-7073-5), 90 Count (NDC 64727-7073-6), 100 Count (NDC 64727-7073-1), 1,000 Count (NDC 64727-7073-2), 990 Count (NDC 64727-7073-3) & 1,008 Count (NDC 64727-7073-8)

81.25 mg. (1 1/4 gr.) in bottles of 30 Count (NDC 64727-7074-4), 60 Count (NDC 64727-7074-5), 90 Count (NDC 64727-7074-6), 100 Count (NDC 64727-7074-1), 1,000 Count (NDC 64727-7074-2), 990 Count (NDC 64727-7074-3) & 1,008 Count (NDC 64727-7074-8)

97.5 mg. (1 ½ gr.) in bottles of 30 Count (NDC 64727-7075-4), 60 Count (NDC 64727-7075-5), 90 Count (NDC 64727-7075-6), 100 Count (NDC 64727-7075-1), 1,000 Count (NDC 64727-7075-2), 990 Count (NDC 64727-7075-3) & 1,008 Count (NDC 64727-7075-8)

113.75 mg. (1 3/4 gr.) in bottles of 30 Count (NDC 64727-7078-4), 60 Count (NDC 64727-7078-5), 90 Count (NDC 64727-7078-6), 100 Count (NDC 64727-7078-1), 1,000 Count (NDC 64727-7078-2), 990 Count (NDC 64727-7078-3) & 1,008 Count (NDC 64727-7078-8)

130 mg. (2 gr.) in bottles of 30 Count (NDC 64727-7080-4), 60 Count (NDC 64727-7080-5), 90 Count (NDC 64727-7080-6), 100 Count (NDC 64727-7080-1), 1,000 Count (NDC 64727-7080-2), 990 Count (NDC 64727-7080-3) & 1,008 Count (NDC 64727-7080-8)

146.25 mg. (2 1/4 gr.) in bottles of 30 Count (NDC 64727-7085-4), 60 Count (NDC 64727-7085-5), 90 Count (NDC 64727-7085-6), 100 Count (NDC 64727-7085-1), 1,000 Count (NDC 64727-7085-2), 990 Count (NDC 64727-7085-3) & 1,008 Count (NDC 64727-7085-8)

162.5 mg. (2 ½ gr.) in bottles of 30 Count (NDC 64727-7090-4), 60 Count (NDC 64727-7090-5), 90 Count (NDC 64727-7090-6), 100 Count (NDC 64727-7090-1), 1,000 Count (NDC 64727-7090-2), 990 Count (NDC 64727-7090-3) & 1,008 Count (NDC 64727-7090-8)

195 mg. (3 gr.) in bottles of 30 Count (NDC 64727-7095-4), 60 Count (NDC 64727-7095-5), 90 Count (NDC 64727-7095-6), 100 Count (NDC 64727-7095-1), 1,000 Count (NDC 64727-7095-2), 990 Count (NDC 64727-7095-3) & 1,008 Count (NDC 64727-7095-8)

260 mg. (4 gr.) in bottles of 30 Count (NDC 64727-7100-4), 60 Count (NDC 64727-7100-5), 90 Count (NDC 64727-7100-6), 100 Count (NDC 64727-7100-1), 1,000 Count (NDC 64727-7100-2), 990 Count (NDC 64727-7100-3) & 1,008 Count (NDC 64727-7100-8)

325 mg. (5 gr.) in bottles of 30 Count (NDC 64727-7150-4), 60 Count (NDC 64727-7150-5), 90 Count (NDC 64727-7150-6), 100 Count (NDC 64727-7150-1), 1,000 Count (NDC 64727-7150-2), 990 Count (NDC 64727-7150-3) & 1,008 Count (NDC 64727-7150-8)


Store at controlled room temperature; 15°-30°C (59°-86°F)

Dispense in tight, light-resistant containers as defined in the USP/NF

Distributed by: RLC Labs, Cave Creek, AZ 85331.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/27/2013

How Supplied

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