Drugplain

Armour Thyroid 15 mg/1

THYROID, PORCINE · TABLET · Allergan, Inc.

1 Recall on Record
Plain English

Armour Thyroid is a tablet containing thyroid, porcine at 15 mg/1, taken oral. Manufactured by Allergan, Inc..

Key Facts

Brand Name
Armour Thyroid
Generic Name
THYROID, PORCINE
NDC Code (Product)
0456-0457
Manufacturer
Allergan, Inc.
Strength
15 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Marketing Start
04/01/1996

Recall History

1 Recall on Record
Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue1,040 reports
drug ineffective902 reports
headache789 reports
nausea782 reports
pain578 reports
dizziness544 reports
diarrhoea510 reports
off label use488 reports
feeling abnormal464 reports
arthralgia439 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Armour Thyroid (thyroid tablets, USP) are indicated: 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, 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.

Dosage & Administration

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. Biotin supplementation may interfere with immunoassays for TSH, T4, and T3, resulting in erroneous thyroid hormone test results. Inquire whether patients are taking biotin or biotin-containing supplements. If so, advise them to stop biotin supplementation at least 2 days before assessing TSH and/or T4 levels (see PRECAUTIONS). 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, with increments which depend on the cardiovascular status of the patient. The usual starting dose is 30 mg Armour Thyroid (thyroid tablets, USP), with increments of 15 mg every 2 to 3 weeks. A lower starting dosage, 15 mg/day, is recommended in patients with long-standing myxe

Warnings

WARNINGS

Contraindications

CONTRAINDICATIONS Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. There is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

Adverse Reactions

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 ).

Frequently Asked Questions

What is Armour Thyroid used for?

Armour Thyroid contains THYROID, PORCINE. It is a tablet taken oral. Consult your doctor for specific uses.

Is Armour Thyroid a controlled substance?

Armour Thyroid is not classified as a controlled substance by the DEA.

What is the generic name for Armour Thyroid?

The generic name for Armour Thyroid is THYROID, PORCINE. There are 7 other brand versions of THYROID, PORCINE.

What is the NDC code for Armour Thyroid 15 mg/1?

The NDC (National Drug Code) for Armour Thyroid 15 mg/1 is 0456-0457, listed by Allergan, Inc..