Armour Thyroid

Name: Armour Thyroid

What is the most important information I should know about desiccated Armour Thyroid (thyroid)?

You may not be able to use this medicine if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

Call your doctor if you have signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual.

Commonly used brand name(s)

In the U.S.

  • Armour Thyroid
  • Nature-Throid NT-1
  • Nature-Throid NT-1/2
  • Nature-Throid NT-2
  • Nature-Throid NT-3
  • Nature-Thyroid
  • Westhroid

Available Dosage Forms:

  • Tablet
  • Capsule

Therapeutic Class: Thyroid Supplement

Proper Use of thyroid

This section provides information on the proper use of a number of products that contain thyroid. It may not be specific to Armour Thyroid. Please read with care.

This medicine usually needs to be taken for life. Do not stop taking this medicine or change your doses without first checking with your doctor. It may take several weeks before you start to notice an improvement in your symptoms .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablet):
    • For the treatment of hypothyroidism:
      • Adults—At first, 30 milligrams (mg) once a day. Then, your doctor may increase your dose a little at a time up to the usual maintenance dose of 60 to 120 mg a day. A lower starting dose of 15 mg/day may be given to patients for certain conditions.
      • Children 0 to 6 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 15 to 30 mg once a day.
      • Children 6 to 12 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 30 to 45 mg once a day.
      • Children 1 to 5 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 45 to 60 mg once a day.
      • Children 6 to 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 60 to 90 mg once a day.
      • Children over 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is over 90 mg once a day .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

DRUG: GENERAL, STORAGE DRUG: GENERAL, STORAGE

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Headache.
  • Shortness of breath.
  • Feeling nervous and excitable.
  • Shakiness.
  • Not able to sleep.
  • Bothered by heat.
  • Sweating a lot.
  • Feeling more or less hungry.
  • A big weight gain or loss.
  • Loose stools (diarrhea).
  • Throwing up.
  • Grouchy or touchy.
  • Fever.
  • Stomach cramps.
  • Leg cramps.
  • Feeling very tired or weak.
  • Period (menstrual) changes. These include spotting between cycles or very light periods.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Armour Thyroid or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Armour Thyroid. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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 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.

HypothyroidismTherapy 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, with increments of 15 mg every 2 to 3 weeks. A lower starting dosage, 15 mg/day, is recommended in patients with long-standing myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended. The appearance of angina is an indication for a reduction in dosage. Most patients require 60 to 120 mg/day. Failure to respond to doses of 180 mg suggests lack of compliance or malabsorption. Maintenance dosages 60 to 120 mg/day usually result in normal serum T4 and T3 levels. Adequate therapy usually results in normal TSH and T4 levels after 2 to 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 ComaMyxedema 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 CancerExogenous 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 TherapyAdministration 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 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 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 DosagePediatric 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 Tablets
Dose per day Daily dose per kg of body weight
0-6 mos 15-30 mg 4.8-6 mg
6-12 mos 30-45 mg 3.6-4.8 mg
1-5 yrs 45-60 mg 3-3.6 mg
6-12 yrs 60-90 mg 2.4-3 mg
Over 12 yrs Over 90 mg 1.2-1.8 mg

Principal Display Panel – 240 mg Bottle Label

NDC 0456-0463-01

Armour ® Thyroid

(thyroid tablets, USP)

FOREST

4 GRAIN (240 mg)

Each tablet contains:

levothyroxine (T4) 152 mcg

liothyronine (T3) 36 mcg

100 TABLETS

FOREST PHARMACEUTICALS, INC.

Subsidiary of Forest Laboratories, Inc.

St. Louis, MO 63045

What is desiccated thyroid (armour thyroid, nature-throid, westhroid)?

Desiccated (dried) thyroid is a combination of hormones that are normally produced by your thyroid gland to regulate the body's energy and metabolism. Desiccated thyroid is given when the thyroid does not produce enough of this hormone on its own.

Desiccated thyroid treats hypothyroidism (low thyroid hormone). Desiccated thyroid is also used to treat or prevent goiter (enlarged thyroid gland), and is also given as part of a medical tests for thyroid disorders.

Desiccated thyroid should not be used to treat obesity or weight problems.

Desiccated thyroid may also be used for purposes not listed in this medication guide.

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