Thyroid (armour) 1.5gr (90mg) 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
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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 medicine is a natural thyroid hormone replacement. It contains both T4 and T3 hormones, which your body needs to regulate metabolism, energy, and many other functions. It's used when your own thyroid gland doesn't produce enough hormones (hypothyroidism).
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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, away from 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 medicine exactly as prescribed by your doctor, usually once a day on an empty stomach, at least 30-60 minutes before breakfast or other medications.
  • Do not take with calcium, iron, antacids, or fiber supplements. Separate by at least 4 hours.
  • Do not stop taking this medicine without consulting your doctor, even if you feel better. This is usually a lifelong treatment.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as they can interact with thyroid hormones.
  • Regular blood tests (TSH, Free T4, Free T3) are essential to ensure you are on the correct dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 15-30 mg (0.25-0.5 grain) orally once daily, titrated by 15 mg increments every 2-3 weeks. Maintenance dose typically 60-120 mg (1-2 grains) once daily. The specified dose of 1.5gr (90mg) is a common maintenance dose.
Dose Range: 15 - 180 mg

Condition-Specific Dosing:

hypothyroidism: Individualized based on clinical response and laboratory parameters (TSH, Free T4, Free T3). Administer on an empty stomach, at least 30-60 minutes before breakfast.
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Pediatric Dosing

Neonatal: Initial 7.5-15 mg (0.125-0.25 grain) orally once daily, or 4-6 mg/kg/day for congenital hypothyroidism. Titrate based on TSH and clinical response.
Infant: Initial 7.5-15 mg (0.125-0.25 grain) orally once daily. Titrate based on TSH and clinical response.
Child: Initial 15-30 mg (0.25-0.5 grain) orally once daily. Titrate based on TSH and clinical response.
Adolescent: Initial 30-60 mg (0.5-1 grain) orally once daily. Titrate based on TSH and clinical response.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required.
Severe: No specific dose adjustment generally required, but monitor closely for signs of over- or under-treatment.
Dialysis: No specific dose adjustment generally required, but monitor closely.

Hepatic Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required.
Severe: No specific dose adjustment generally required, but monitor closely for signs of over- or under-treatment.

Pharmacology

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Mechanism of Action

Desiccated thyroid provides exogenous thyroid hormones, primarily L-thyroxine (T4) and L-triiodothyronine (T3), in a natural ratio. These hormones bind to nuclear thyroid hormone receptors, regulating gene expression and metabolic processes throughout the body. T4 is converted to the more active T3 in peripheral tissues.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; T4 approximately 48-80%, T3 approximately 95%.
Tmax: T4: 2-4 hours; T3: 1-2 hours.
FoodEffect: Food, especially fiber, soy, and certain supplements (calcium, iron), can decrease absorption. Should be taken on an empty stomach.

Distribution:

Vd: T4: 10-13 L; T3: 0.46 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 systems facilitate entry into the brain.

Elimination:

HalfLife: T4: 6-7 days; T3: 1-2 days.
Clearance: T4: 1.1 L/day; T3: 2.3 L/day.
ExcretionRoute: Primarily renal (conjugated metabolites), with some fecal excretion (unabsorbed drug and biliary excretion).
Unchanged: Less than 1% of T4 and T3 are excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Days to weeks (due to T4 component's half-life and need for T4 to T3 conversion).
PeakEffect: Clinical effects typically peak within 3-4 weeks after initiation or dose adjustment.
DurationOfAction: Weeks (due to T4 component's long half-life).

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including desiccated thyroid, 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 Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:

  • Symptoms of too much medicine (hyperthyroidism): fast heartbeat, chest pain, shortness of breath, nervousness, sweating, tremors, weight loss, diarrhea, insomnia.
  • Symptoms of too little medicine (hypothyroidism): extreme tiredness, weight gain, constipation, feeling cold, dry skin, hair loss, depression, slow heartbeat.
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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:
+ Overactive thyroid gland (hyperthyroidism)
+ Weak adrenal gland (adrenal insufficiency)

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

To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 to experience the full effects of this medication.

If you have diabetes (high blood sugar), consult with your doctor, as this drug may occasionally affect blood sugar control. As a result, your diabetes medications may need to be adjusted. Adhere to your doctor's instructions for monitoring your blood sugar levels and undergo blood work and other laboratory tests as directed.

If you are taking biotin or a product containing biotin, discontinue its 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, discuss any concerns 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. Inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby with your doctor.
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Overdose Information

Overdose Symptoms:

  • Palpitations, tachycardia, arrhythmias (e.g., atrial fibrillation)
  • Chest pain (angina), myocardial infarction
  • Tremor, nervousness, anxiety, insomnia
  • Diarrhea, abdominal cramps
  • Weight loss, increased appetite
  • Heat intolerance, sweating
  • Fever
  • Seizures (rare)
  • Thyroid storm (severe, life-threatening)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including beta-blockers for cardiac effects, and measures to reduce absorption if recent ingestion.

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., Warfarin): May enhance anticoagulant effect, requiring dose reduction of anticoagulant.
  • Digitalis glycosides (e.g., Digoxin): Thyroid hormones may decrease therapeutic effect of digitalis; increased digitalis dose may be needed.
  • Antidiabetic agents (e.g., Insulin, Metformin): Thyroid hormones may increase blood glucose levels, requiring increased dose of antidiabetic agent.
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Moderate Interactions

  • Calcium carbonate/supplements, Iron supplements, Antacids (aluminum/magnesium hydroxide), Sucralfate, Bile acid sequestrants (Cholestyramine, Colestipol), Proton pump inhibitors (PPIs): May decrease absorption of thyroid hormones. Separate administration by at least 4 hours.
  • Soy products, Dietary fiber: May decrease absorption of thyroid hormones. Separate administration.
  • Amiodarone, Beta-blockers (e.g., Propranolol), Propylthiouracil (PTU), Methimazole: May alter thyroid hormone metabolism or peripheral conversion of T4 to T3.
  • Carbamazepine, Phenytoin, Phenobarbital, Rifampin: May increase metabolism of thyroid hormones, requiring increased thyroid hormone dose.
  • Estrogens (oral), Selective Estrogen Receptor Modulators (SERMs): May increase TBG levels, increasing thyroid hormone requirements.
  • Androgens, Anabolic steroids, Asparaginase, Glucocorticoids: May decrease TBG levels, decreasing thyroid hormone requirements.
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Minor Interactions

  • Not available

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 levels of active T4.

Timing: Prior to initiation of therapy.

Free Triiodothyronine (Free T3)

Rationale: Assesses circulating levels of active T3, particularly relevant for desiccated thyroid due to its T3 content.

Timing: Prior to initiation of therapy (optional, but recommended for NDT).

Clinical Symptoms of Hypothyroidism

Rationale: To establish baseline symptom severity and guide therapy.

Timing: Prior to initiation of therapy.

Cardiac status (ECG, history of cardiovascular disease)

Rationale: To assess risk for adverse cardiac events, especially in elderly or those with pre-existing heart conditions.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Thyroid Stimulating Hormone (TSH)

Frequency: Every 6-8 weeks until stable, then every 6-12 months.

Target: Typically 0.4-4.0 mIU/L, but individualized based on patient's age, comorbidities, and clinical response. Some patients on NDT may have suppressed TSH with normal Free T3/T4.

Action Threshold: If TSH is outside target range, adjust dose. If TSH is suppressed but Free T3/T4 are normal, consider clinical picture and Free T3/T4 levels.

Free Thyroxine (Free T4)

Frequency: Every 6-8 weeks until stable, then every 6-12 months.

Target: Within normal reference range.

Action Threshold: If outside target range, adjust dose in conjunction with TSH and Free T3.

Free Triiodothyronine (Free T3)

Frequency: Every 6-8 weeks until stable, then every 6-12 months (especially for NDT).

Target: Within normal reference range.

Action Threshold: If outside target range, adjust dose in conjunction with TSH and Free T4. High Free T3 may indicate over-replacement, even with normal TSH.

Clinical Symptoms (e.g., fatigue, weight, mood, heart rate)

Frequency: At every visit.

Target: Resolution or significant improvement of hypothyroid symptoms.

Action Threshold: Persistent symptoms or development of hyperthyroid symptoms (e.g., palpitations, anxiety, weight loss) warrant dose adjustment and further lab evaluation.

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Symptom Monitoring

  • Symptoms of hypothyroidism (e.g., fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, bradycardia).
  • Symptoms of hyperthyroidism (e.g., palpitations, tachycardia, anxiety, nervousness, tremor, weight loss, heat intolerance, 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 for the mother and impaired neurocognitive development in the fetus. Dose requirements often increase during pregnancy (by 25-50% or more).

Trimester-Specific Risks:

First Trimester: Crucial for fetal brain development. Inadequate maternal thyroid hormone can lead to irreversible neurodevelopmental deficits.
Second Trimester: Continued need for adequate thyroid hormone for fetal growth and development.
Third Trimester: Continued need for adequate thyroid hormone.
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Lactation

Thyroid hormones are excreted in breast milk in minimal amounts and are generally considered safe for nursing infants. No adverse effects on the infant have been reported with maternal use of thyroid hormones at replacement doses.

Infant Risk: L1 (Safest)
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Pediatric Use

Essential for normal growth and development, including brain maturation. Dosing is weight-based and requires careful titration and monitoring to avoid over- or under-treatment, which can have significant long-term consequences (e.g., intellectual disability, growth retardation).

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Monitor closely for cardiac side effects (e.g., angina, arrhythmias).

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 and T3, which may appeal to patients seeking a 'natural' option or those who feel suboptimal on levothyroxine alone.
  • Dosing is typically in grains (gr) or milligrams (mg), with 1 grain = 60 mg.
  • Monitoring can be more complex than with levothyroxine. While TSH is still the primary marker, Free T3 and Free T4 levels are often monitored, and TSH may be suppressed even with appropriate dosing due to the direct T3 content.
  • Patients should be advised to take the medication consistently at the same time each day, on an empty stomach, and separate from interacting substances.
  • The ratio of T4 to T3 in desiccated thyroid is approximately 4:1 by weight, which is different from the physiological production ratio in humans (closer to 14:1 T4:T3).
  • Consistency between batches and manufacturers of desiccated thyroid has historically been a concern, though quality control has improved.
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Alternative Therapies

  • Levothyroxine (synthetic T4, e.g., Synthroid, Levoxyl, Tirosint)
  • Liothyronine (synthetic T3, e.g., Cytomel, Triostat) - typically used as an adjunct or for specific conditions like myxedema coma.
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Cost & Coverage

Average Cost: $30 - $70 per 30 tablets (90mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand), Tier 1 (Generic NDT)
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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 your medication, don't hesitate to reach out to 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 medication taken, the amount, and the time it happened.