ADVERSE REACTIONS
Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare (See OVERDOSAGE).

OVERDOSAGE
Signs 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 Overdosage: Dosage should be reduced or therapy temporarily discontinued signs and symptoms of overdosage appear.

Treatment may be reinstituted at a lower dosage. In normal individuals, normal hypothalamic-pituitary-thyroid axis function is restored in 6 to 8 weeks after thyroid suppression.

Treatment of acute massive thyroid hormone overdosage is aimed at reducing gastrointestinal absorption of the drugs and counteracting central and peripheral effects, mainly those of increased sympathetic activity. Vomiting may be induced initially if further gastrointestinal 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 if congestive heart failure develops. Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed. Antiadrenergic 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/day, initially, especially when no contraindications exist for its use.

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 condition, 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, with increments which depend on the cardiovascular status of the patient. The usual starting dose is 30 mg, with increment of 15 mg every 2 to 3 weeks. A lower starting dosage, 15 mg/day, is recommended in patients with longstanding myxedema, particularly if cardiovascular impairment is suspected, in which cause extreme caution is recommended. The appearance of angina is an indication for reduction in dosage. Most patients require 60–120 mg/day. Failure to respond to doses of 180 mg suggests lack of compliance or malabsorption. Maintenance dosages 60–120 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 is 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. 1 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 / 15-30 mg / 4.8-6 mg
6-12 months / 30-45 mg / 3.6-4.8 mg
1-5 years / 45-60 mg / 3.3-6 mg
6-12 years / 60-90 mg / 2.4-3 mg
Over 12 years / Over 90 mg / 1.2-1.8 mg

HOW SUPPLIED:

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

32.5 mg (1/2 gr.) in bottles of 100 Count (NDC 64727-7070-1), 990 Count Polybags (NDC 64727-7070-3), 1,000 Count (NDC 64727-7070-2), 1,008 Count Polybags (NDC 64727-7070-8)

65 mg (1 gr.) in bottles of 100 Count (NDC 64727-7073-1), 990 Count Polybags (NDC 64727-7073-3), 1,000 Count (NDC 64727-7073-2), 1,008 Count Polybags (NDC 64727-7073-8)

130 mg (2 gr.) in bottles of 100 Count (NDC 64727-7080-1), 990 Count Polybags (NDC 64727-7080-3),1,000 Count (NDC 64727-7080-2), 1,008 Count Polybags (NDC 64727-7080-8)

STORAGE: Store at controlled room temperature; 15°-30°C (59°-86°F)
Dispense in tight, light-resistant containers as defined in the USP/NF.

Rx Only.

Distributed by:

WesternResearch Laboratories
2404 West 12th Street, Suite 4, Tempe, Arizona 85281
623.879.8535 • Toll-Free 1.877.797.7997 • Fax 623.879.8683
www.wrlonline.com

R070906/01

Kilde: http://www.wes-throid.com/docs/WT_Prescribe_Info.pdf