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Thyroid (armour) 1gr (60mg) Tabs

Manufacturer ALLERGAN Active Ingredient Thyroid, Desiccated(THYE roid DES i kay tid) Pronunciation THYE-roid DES-i-kay-tid
WARNING: Do not use this drug for weight loss. Severe and sometimes deadly side effects may happen with this drug if it is taken in large doses or with other drugs for weight loss. If you have questions, talk with the doctor. @ COMMON USES: 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.
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Drug Class
Thyroid hormone replacement
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Pharmacologic Class
Thyroid hormones (T3 and T4)
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Pregnancy Category
Category A
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a natural thyroid hormone replacement that contains both T3 and T4 hormones, similar to what your body naturally produces. It's used to treat an underactive thyroid (hypothyroidism) to help restore your body's metabolism and energy levels.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. It's best to take this medication on an empty stomach.

Important Notes About Different Brands and Forms

There are various brands and forms of this medication available. Do not switch between different brands or forms without consulting your doctor first.

Interactions with Other Medications and Foods

Do not take colesevelam, colestipol, or cholestyramine within 4 hours before or 4 hours after taking this medication. Additionally, some foods like soybean flour (found in infant formula) may affect how this medication works in your body. Discuss this with your doctor.

Establishing a Routine

Take your medication at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take this medication on an empty stomach, preferably 30-60 minutes before breakfast, with a full glass of water.
  • Avoid taking this medication at the same time as iron supplements, calcium supplements, antacids, or certain cholesterol-lowering drugs (like cholestyramine). Separate doses by at least 4 hours.
  • Maintain a consistent diet; large changes in fiber or soy intake can affect absorption.
  • Do not stop taking this medication without consulting your doctor, even if you feel better. This is usually a lifelong treatment.
  • Do not use this medication for weight loss if your thyroid function is normal, as it can cause serious side effects.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on patient response and laboratory parameters (TSH, Free T4). Common maintenance dose for hypothyroidism is 60-120 mg (1-2 grains) daily.
Dose Range: 15 - 300 mg

Condition-Specific Dosing:

hypothyroidism_initial: Initial: 15-30 mg (1/4 to 1/2 grain) daily, increased by 15 mg increments every 2-3 weeks until desired response is achieved.
myxedema_initial: Initial: 15 mg (1/4 grain) daily, increased slowly to avoid cardiac complications.
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Pediatric Dosing

Neonatal: Initial: 15 mg (1/4 grain) daily, adjusted based on TSH and T4 levels. Higher doses per kg may be required than in adults.
Infant: Initial: 15 mg (1/4 grain) daily, adjusted based on TSH and T4 levels. Higher doses per kg may be required than in adults.
Child: Initial: 15-30 mg (1/4 to 1/2 grain) daily, adjusted based on TSH and T4 levels. Doses are typically weight-based (e.g., 4-5 mcg T4 equivalent/kg/day for infants, decreasing with age).
Adolescent: Initial: 30-60 mg (1/2 to 1 grain) daily, adjusted based on TSH and T4 levels.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment typically required.
Moderate: No specific dose adjustment typically required.
Severe: No specific dose adjustment typically required. Monitor thyroid function closely.
Dialysis: No specific dose adjustment typically required. Monitor thyroid function closely.

Hepatic Impairment:

Mild: No specific dose adjustment typically required.
Moderate: No specific dose adjustment typically required.
Severe: No specific dose adjustment typically required. Monitor thyroid function closely, as metabolism may be altered.

Pharmacology

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Mechanism of Action

Thyroid, Desiccated, provides exogenous sources of both levothyroxine (T4) and liothyronine (T3) in a natural ratio. These hormones exert their physiological effects by binding to thyroid hormone receptors in the cell nucleus, regulating gene expression and controlling numerous metabolic processes, including protein synthesis, carbohydrate and lipid metabolism, and cellular respiration. They are essential for normal growth, development, and metabolism.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; T4 approximately 48-80%, T3 approximately 95%.
Tmax: T4: 2-4 hours; T3: 2-4 hours (for the T3 component of desiccated thyroid).
FoodEffect: Food, especially fiber, soy, and calcium, can decrease absorption. Should be taken on an empty stomach, at least 30-60 minutes before breakfast.

Distribution:

Vd: T4: 10-12 L; T3: 0.4-0.6 L/kg.
ProteinBinding: T4: >99% (primarily to thyroxine-binding globulin [TBG], transthyretin, and albumin); T3: ~99% (less avidly than T4).
CnssPenetration: Limited, but active transport mechanisms allow some penetration.

Elimination:

HalfLife: T4: Approximately 6-7 days; T3: Approximately 1 day.
Clearance: T4: 1.1 L/day; T3: 2.3 L/day.
ExcretionRoute: Primarily renal (conjugated metabolites), some biliary excretion with enterohepatic recirculation.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Days to weeks (due to T4 component's long half-life and need for TSH suppression). T3 component has a faster onset (hours).
PeakEffect: Weeks (for full therapeutic effect and TSH stabilization).
DurationOfAction: Weeks (due to T4 component's long half-life).
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including Thyroid, Desiccated, should not be used for the treatment of obesity or for weight reduction. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
 Fast or abnormal heartbeat
Shortness of breath
 Sudden weight gain or swelling in the arms or legs
Headache
 Feeling tired or weak
Shakiness
 Trouble sleeping
Sensitivity to heat
 Excessive sweating
Changes in appetite
 Unintentional weight changes
Diarrhea
 Stomach cramps
Vomiting
 Irritability, nervousness, excitability, anxiety, or other mood changes
Fever
 Muscle cramps
Muscle weakness
 Flushing
Bone pain
 Changes in menstrual periods

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

* Hair loss (usually temporary and resolves on its own within the first few months of treatment)

Reporting Side Effects

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat (palpitations)
  • Excessive sweating
  • Tremor
  • Nervousness or anxiety
  • Unexplained weight loss
  • Diarrhea
  • Fever
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
 Certain health conditions, including:
+ An overactive thyroid gland
+ A weak adrenal gland

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure your safety, please disclose all of the following to your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications you are taking
 Any natural products or vitamins you are using
* All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication with your other drugs and health conditions.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure uninterrupted treatment, do not allow your supply of this drug to run out. Please note that it may take several weeks for the full effects of this medication to become apparent.

If you have diabetes (high blood sugar), consult with your doctor, as this drug may occasionally affect blood sugar control. Your doctor may need to adjust your diabetes medications. Be sure to monitor your blood sugar levels as directed by your doctor and undergo regular blood work and other laboratory tests as scheduled.

If you are taking biotin or any products containing biotin, discontinue use at least 2 days prior to having your thyroid levels checked. This medication is derived from pork (pig) thyroid tissue, which carries a minimal risk of transmitting a viral disease. Although no cases have been reported, if you have concerns, discuss them with your doctor.

If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Headache
  • Irritability
  • Nervousness
  • Sweating
  • Diarrhea
  • Tachycardia (rapid heart rate)
  • Arrhythmias (irregular heart rhythm)
  • Chest pain
  • Tremor
  • Insomnia
  • Heat intolerance
  • Weight loss

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management may include supportive care, beta-blockers for cardiac symptoms, and discontinuation of the drug.

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., Warfarin): May increase anticoagulant effect by increasing catabolism of vitamin K-dependent clotting factors. Requires close INR monitoring and potential dose reduction of anticoagulant.
  • Sympathomimetics (e.g., Epinephrine, Norepinephrine): Increased risk of coronary insufficiency in patients with coronary artery disease due to additive effects.
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Moderate Interactions

  • Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol): May decrease absorption of thyroid hormones. Administer thyroid hormone at least 4 hours before or after sequestrants.
  • Ion Exchange Resins (e.g., Kayexalate, Sevelamer): May decrease absorption. Separate administration by several hours.
  • Iron Supplements, Calcium Carbonate, Aluminum/Magnesium-containing Antacids, Sucralfate: May decrease absorption. Administer thyroid hormone at least 4 hours apart.
  • Proton Pump Inhibitors (e.g., Omeprazole): May decrease absorption due to altered gastric pH. Monitor thyroid function.
  • Certain Anticonvulsants (e.g., Phenytoin, Carbamazepine, Phenobarbital): May increase metabolism of thyroid hormones, leading to increased dose requirements.
  • Rifampin: May increase metabolism of thyroid hormones.
  • Beta-blockers: Thyroid hormones may decrease the effectiveness of beta-blockers.
  • Antidiabetic Agents (Insulin, Oral Hypoglycemics): Thyroid hormones may increase blood glucose levels, requiring increased doses of antidiabetic agents.
  • Estrogens/Oral Contraceptives: May increase TBG levels, leading to increased thyroid hormone requirements.
  • Androgens/Anabolic Steroids: May decrease TBG levels, potentially decreasing thyroid hormone requirements.
  • Amiodarone: Can cause both hypo- and hyperthyroidism; may alter thyroid hormone metabolism.
  • SSRIs (e.g., Sertraline): May increase thyroid hormone requirements.
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Minor Interactions

  • Dietary Fiber: May decrease absorption if consumed concurrently.
  • Soy Products: May decrease absorption if consumed concurrently.

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary indicator of thyroid function and adequacy of replacement therapy.

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: Assesses circulating unbound T4 levels.

Timing: Prior to initiation of therapy.

Symptoms of Hypothyroidism

Rationale: Clinical assessment is crucial for guiding therapy.

Timing: Prior to initiation of therapy.

Cardiac Status (ECG, history)

Rationale: To assess for underlying cardiac disease, especially in elderly or those with risk factors, as thyroid hormones can exacerbate cardiac conditions.

Timing: Prior to initiation of therapy, particularly in older patients or those with known cardiovascular disease.

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Routine Monitoring

Thyroid Stimulating Hormone (TSH)

Frequency: Every 6-8 weeks after initiation or dose change, then every 6-12 months once stable.

Target: Typically 0.4-4.0 mIU/L (individualized based on patient age, comorbidities, and specific clinical situation).

Action Threshold: TSH outside target range; adjust dose.

Free Thyroxine (Free T4)

Frequency: Every 6-8 weeks after initiation or dose change, then every 6-12 months once stable (often monitored with TSH).

Target: Typically 0.8-1.8 ng/dL (individualized).

Action Threshold: Free T4 outside target range; adjust dose.

Symptoms of Hypo/Hyperthyroidism

Frequency: At every clinical visit.

Target: Resolution of hypothyroid symptoms without development of hyperthyroid symptoms.

Action Threshold: Persistence of hypothyroid symptoms or emergence of hyperthyroid symptoms; adjust dose.

Heart Rate/Rhythm

Frequency: At every clinical visit.

Target: Normal sinus rhythm, appropriate heart rate.

Action Threshold: Tachycardia, palpitations, arrhythmias; may indicate overtreatment.

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Symptom Monitoring

  • Fatigue
  • Weight gain
  • Constipation
  • Cold intolerance
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Memory impairment
  • Nervousness
  • Irritability
  • Heat intolerance
  • Palpitations
  • Tremor
  • Weight loss (unintended)
  • Diarrhea
  • Insomnia

Special Patient Groups

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Pregnancy

Thyroid hormone replacement is essential during pregnancy for both maternal and fetal health. Hypothyroidism during pregnancy can lead to adverse outcomes. Thyroid, Desiccated, is Category A, meaning adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester (and there is no evidence of risk in later trimesters). Thyroid hormone requirements often increase during pregnancy, requiring dose adjustments.

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism in the first trimester is associated with increased risk of miscarriage, preterm birth, and impaired neurocognitive development in the offspring. Adequate thyroid hormone levels are crucial for fetal brain development.
Second Trimester: Continued need for adequate thyroid hormone levels. Fetal thyroid gland begins to function, but maternal thyroid hormones remain important.
Third Trimester: Continued need for adequate thyroid hormone levels. Monitor TSH and Free T4 regularly (e.g., every 4-6 weeks) and adjust dose as needed.
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Lactation

Thyroid hormones are excreted in breast milk in minimal amounts and are generally considered compatible with breastfeeding. No adverse effects on the infant have been reported with maternal therapeutic doses.

Infant Risk: L1 (Safest) - No observed adverse effect on the infant.
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Pediatric Use

Dosing is individualized based on age, weight, and severity of hypothyroidism. Infants and young children typically require higher doses per kilogram of body weight than adults. Close monitoring of TSH and Free T4 is essential to ensure normal growth and neurocognitive development. Tablets can be crushed and mixed with a small amount of water or formula for administration to infants.

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Geriatric Use

Lower initial doses are often recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Titrate dose slowly and monitor for cardiac symptoms. TSH target ranges may be slightly higher in very elderly patients.

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 and T3. While T4 is converted to T3 in the body, some patients report feeling better on desiccated thyroid than on levothyroxine (T4 only), though scientific evidence for superior efficacy is limited.
  • Due to the presence of T3, TSH levels may be suppressed even when the patient is clinically euthyroid and Free T4 levels are within range. Clinical assessment and Free T4 are often more important than TSH alone when monitoring patients on desiccated thyroid.
  • Consistency in administration (e.g., always on an empty stomach, same time each day) is crucial for stable absorption.
  • Patients switching from levothyroxine to desiccated thyroid (or vice versa) require careful dose conversion and close monitoring.
  • Educate patients about the black box warning regarding weight loss and the potential for serious side effects if misused.
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Alternative Therapies

  • Levothyroxine (synthetic T4, e.g., Synthroid, Levoxyl, Tirosint)
  • Liothyronine (synthetic T3, e.g., Cytomel, Triostat)
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Cost & Coverage

Average Cost: $20 - $60 per 30 tablets (60mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often preferred over synthetic T3/T4 combinations by some plans)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.