Armour Thyroid (Page 3 of 4)

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. 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 50% 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 mcg/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	Armour Thyroid (thyroid tablets, USP)
	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

Armour Thyroid (thyroid tablets, USP) are supplied as follows: 15 mg (1/4 grain) are available in bottles of 100 (NDC 0456-0457-01). 30 mg (1/2 grain) are available in bottles of 100 (NDC 0456-0458-01) and unit dose cartons of 100 (NDC 0456-0458-63). 60 mg (1 grain) are available in bottles of 100 (NDC 0456-0459-01) and unit dose cartons of 100 (NDC 0456-0459-63). 90 mg (1 1/2 grain) are available in bottles of 100 (NDC 0456-0460-01). 120 mg (2 grain) are available in bottles of 100 (NDC 0456-0461-01) and unit dose cartons of 100 (NDC 0456-0461-63). 180 mg (3 grain) are available in bottles of 100 (NDC 0456-0462-01). 240 mg (4 grain) are available in bottles of 100 (NDC 0456-0463-01). 300 mg (5 grain) are available in bottles of 100 (NDC 0456-0464-01). The bottles of 100 are special dispensing bottles with child-resistant closures.

Armour Thyroid (thyroid tablets, USP) are evenly colored, light tan, round tablets, with convex surfaces. One side is debossed with a mortar and pestle beneath the letter “A” on the top and strength code letters on the bottom as defined below

Strength	Code
¼ grain	TC
½ grain	TD
1 grain	TE
1 ½ grain	TJ
2 grain	TF
3 grain	TG (bisected)
4 grain	TH
5 grain	TI (bisected)

Note: (T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis.)

Store in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).

*Armour Thyroid (thyroid tablets, USP) has not been approved by FDA as a new drug .

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940

© 2019 Allergan. All rights reserved.
ARMOUR® is a registered trademark of Allergan Sales, LLC.
Allergan® and its designs are trademarks of Allergan Inc.

Revised: June 2018 v.1.0USPI0457

PRINCIPAL DISPLAY PANEL

NDC 0456-0457-01

Armour _® Thyroid

(thyroid tablets, USP)

¼ GRAIN (15 mg)

Each tablet contains:

levothyroxine (T₄ ) 9.5 mcg

liothyronine (T₃ ) 2.25 mcg

100 TABLETS

Allergan

PRINCIPAL DISPLAY PANEL

NDC 0456-0458-01

Armour _® Thyroid

(thyroid tablets, USP)

½ GRAIN (30 mg)

Each tablet contains:

levothyroxine (T₄ ) 19 mcg

liothyronine (T₃ ) 4.5 mcg

100 TABLETS

Allergan

PRINCIPAL DISPLAY PANEL

NDC 0456-0459-01

Armour _® Thyroid

(thyroid tablets, USP)

1 GRAIN (60 mg)

Each tablet contains:

levothyroxine (T₄ ) 38 mcg

liothyronine (T₃ ) 9 mcg

100 TABLETS

Allergan