Armour Thyroid

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking these medications within 4 hours before or after you take desiccated thyroid.

Avoid taking an antacid within 4 hours before or after you take desiccated thyroid. Some antacids can make it harder for your body to absorb desiccated thyroid.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

• Changes in appetite
• changes in menstrual periods
• chest pain
• diarrhea
• fast or irregular heartbeat
• fever
• hand tremors
• headache
• irritability
• leg cramps
• nervousness
• sensitivity to heat
• shortness of breath
• sweating
• trouble sleeping
• vomiting
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to add thyroid hormone to the body.
• It is used to treat or prevent an enlarged thyroid.
• It is used to manage thyroid cancer.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Some foods like soybean flour (infant formula) may change how Armour Thyroid works in your body. Talk with your doctor.
• Do not take colesevelam, colestipol, or cholestyramine within 4 hours of this medicine.
• Keep taking Armour Thyroid as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Take this medicine at the same time of day.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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

Signs and SymptomsExcessive 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 OverdosageDosage should be reduced or therapy temporarily discontinued if 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.

Other adjunctive measures may include administration of cholestyramine to interfere with thyroxine absorption, and glucocorticoids to inhibit conversion of T4 to T3.

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

Armour Thyroid tablets 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

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.

Forest Pharmaceuticals, Inc.
A Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045

© 2016 Allergan. All rights reserved.
ARMOUR® is a registered trademark of Forest Laboratories, LLC an Allergan affiliate.

Revised: August 2012
73195US10

Applies to thyroid desiccated: compounding powder, oral capsule, oral tablet

General

Adverse reactions other than those attributable to hyperthyroidism due to therapeutic overdose are rare. Excessive doses may result in a hypermetabolic state resembling in every respect the condition of endogenous origin.[Ref]

If sings and symptoms of overdosage appear, the dosage should be reduced or therapy temporarily discontinued and may be reinstituted at a lower dosage. Normal hypothalamic-pituitary-thyroid axis function has been restored in 6 to 8 weeks after thyroid suppression.[Ref]

Some side effects of Armour Thyroid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Small amounts of thyroid desiccated are excreted into human milk. Adverse effects in the nursing infant are unlikely. The manufacturer recommends that caution be used when administering thyroid desiccated to nursing women.

Substance Name

Thyroid

CAS Registry Number

8028-36-2

Drug Class

Thyroid Hormones