Thyroid (armour) 5gr (300mg) 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 medication is a natural thyroid hormone replacement. It contains both T4 and T3 hormones, which are the same hormones your own thyroid gland makes. It's used to treat an underactive thyroid (hypothyroidism) by replacing the hormones your body isn't making enough of. This helps regulate your body's metabolism, energy levels, and many other functions.
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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 exactly as prescribed by your doctor, usually once daily on an empty stomach, at least 30-60 minutes before breakfast or at bedtime (3-4 hours after the last meal).
  • Do not take this medication at the same time as calcium supplements, iron supplements, antacids, or fiber supplements. Separate by at least 4 hours.
  • Do not stop taking this medication without consulting your doctor, even if you feel better. Thyroid hormone replacement is usually a lifelong therapy.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with thyroid hormones.
  • Regular blood tests (TSH, Free T4) are essential to ensure you are on the correct dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 15-30 mg (1/4 to 1/2 grain) orally once daily; Titration: Increase by 15 mg increments every 2-3 weeks until desired response is achieved. Maintenance: 60-180 mg (1-3 grains) orally once daily. The dose of 300mg (5 grains) is a high maintenance dose, typically reserved for severe cases or specific patient needs, and should only be reached by gradual titration.
Dose Range: 15 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Individualized based on patient response and laboratory parameters (TSH, free T4).
myxedema_coma: Requires intravenous thyroid hormone, not oral desiccated thyroid.
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Pediatric Dosing

Neonatal: Initial: 15 mg/day; Titration based on clinical response and laboratory values (TSH, T4).
Infant: Initial: 15-30 mg/day; Titration based on clinical response and laboratory values (TSH, T4).
Child: Initial: 30-60 mg/day; Titration based on clinical response and laboratory values (TSH, T4).
Adolescent: Initial: 30-60 mg/day; Titration based on clinical response and laboratory values (TSH, T4).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: No specific adjustment needed; thyroid hormones are not significantly dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Desiccated thyroid contains both levothyroxine (T4) and liothyronine (T3), mimicking the natural thyroid hormones produced by the human thyroid gland. 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, fat, and carbohydrate metabolism, and influencing growth and development.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (T4: 48-80%, T3: 95%)
Tmax: T4: 2-4 hours; T3: 2-4 hours
FoodEffect: Food, certain medications (e.g., calcium, iron, antacids, fiber) can decrease absorption. Should be taken on an empty stomach, at least 30-60 minutes before breakfast.

Distribution:

Vd: T4: 10-13 L; T3: 0.46 L
ProteinBinding: T4: >99% (primarily to thyroxine-binding globulin, transthyretin, albumin); T3: >99% (less avidly than T4)
CnssPenetration: Limited (primarily via active transport mechanisms)

Elimination:

HalfLife: T4: Approximately 7 days; T3: Approximately 1 day
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: Minimal
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Pharmacodynamics

OnsetOfAction: Gradual, over several days to weeks (due to T4 component's long half-life and conversion to T3).
PeakEffect: Clinical effects typically seen within 3-4 weeks of initiating therapy or dose adjustment.
DurationOfAction: Long-acting due to T4 component (effects persist for weeks after discontinuation).

Safety & Warnings

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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 heartbeat 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 for guidance:

* Hair loss (often 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 not mentioned here. If you have questions or concerns about side effects, consult 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 thyroid hormone (hyperthyroidism): rapid or irregular heartbeat, chest pain, shortness of breath, nervousness, irritability, tremors, excessive sweating, heat intolerance, unexplained weight loss, diarrhea, insomnia.
  • Symptoms of too little thyroid hormone (hypothyroidism, if dose is too low or missed): extreme tiredness, weight gain, constipation, dry skin, hair loss, feeling cold, depression, slow heart rate.
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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, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems

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. 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 recommended.

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, if you have concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia
  • Arrhythmias (e.g., atrial fibrillation)
  • Chest pain (angina)
  • Tremors
  • Nervousness
  • Insomnia
  • Diaphoresis (excessive sweating)
  • Heat intolerance
  • Weight loss
  • Diarrhea
  • Vomiting
  • Headache
  • Fever
  • Seizures (rare)
  • Coma (rare)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management typically involves supportive care, reducing absorption (if recent ingestion), and symptomatic treatment (e.g., beta-blockers for cardiac symptoms).

Drug Interactions

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Major Interactions

  • Amiodarone (can alter thyroid function)
  • Anticoagulants (e.g., Warfarin - increased anticoagulant effect)
  • Cholestyramine, Colestipol, Sevelamer (decreased thyroid hormone absorption)
  • Iron supplements, Calcium supplements, Antacids (aluminum, magnesium, calcium salts - decreased thyroid hormone absorption)
  • Sucralfate (decreased thyroid hormone absorption)
  • Orlistat (decreased thyroid hormone absorption)
  • Proton Pump Inhibitors (PPIs) and H2 Blockers (may alter gastric pH, affecting absorption)
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital (increased thyroid hormone metabolism)
  • Sertraline (may increase thyroid hormone requirements)
  • Tyrosine Kinase Inhibitors (e.g., Sunitinib, Imatinib - may increase thyroid hormone requirements)
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Moderate Interactions

  • Beta-blockers (may decrease conversion of T4 to T3)
  • Estrogens (oral - may increase thyroid hormone requirements by increasing TBG)
  • Androgens (may decrease thyroid hormone requirements by decreasing TBG)
  • Corticosteroids (may inhibit T4 to T3 conversion)
  • Digoxin (decreased digoxin levels in hyperthyroid state, may require dose adjustment)
  • Insulin/Oral Hypoglycemics (may increase requirements for these drugs)
  • Tricyclic Antidepressants (increased risk of cardiac arrhythmias and CNS excitation)
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Minor Interactions

  • Dietary fiber (may decrease absorption)

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.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline and track improvement.

Timing: Prior to initiation of therapy.

Cardiac status (ECG, history of cardiovascular disease)

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

Timing: Prior to initiation of therapy, particularly with higher doses.

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Routine Monitoring

Thyroid Stimulating Hormone (TSH)

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

Target: 0.4-4.0 mIU/L (or individualized target based on patient age and comorbidities).

Action Threshold: TSH outside target range; adjust dose.

Free Thyroxine (Free T4)

Frequency: Every 6-8 weeks after initiation or dose change, then annually once stable (often alongside TSH).

Target: 0.8-1.8 ng/dL (or within upper half of reference range).

Action Threshold: Free T4 outside target range, especially if TSH is also abnormal; adjust dose.

Clinical symptoms (e.g., fatigue, weight, mood, cold intolerance, heart rate)

Frequency: At every visit.

Target: Resolution or improvement of hypothyroid symptoms without developing hyperthyroid symptoms.

Action Threshold: Persistent hypothyroid symptoms or emergence of hyperthyroid symptoms; consider dose adjustment or further investigation.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold or heat intolerance
  • Constipation or diarrhea
  • Dry skin/hair loss
  • Muscle aches/weakness
  • Depression/anxiety
  • Changes in heart rate (bradycardia or tachycardia)
  • Tremors
  • Nervousness/irritability
  • Sleep disturbances

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 both mother and baby. Desiccated thyroid 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). Dose requirements often increase during pregnancy.

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.
Second Trimester: Continued need for adequate thyroid hormone levels; dose adjustments may be necessary.
Third Trimester: Continued need for adequate thyroid hormone levels; dose adjustments may be necessary. Monitor TSH every 4-6 weeks.
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Lactation

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

Infant Risk: Low risk (L1)
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Pediatric Use

Essential for normal growth and development. Dosage is individualized based on age, weight, and clinical and laboratory response. Under-treatment can lead to impaired physical and mental development. Over-treatment can lead to craniosynostosis in infants and accelerated bone maturation and epiphyseal closure in children.

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Geriatric Use

Elderly patients may be more sensitive to the effects of thyroid hormones, particularly cardiac effects. Initial doses should be lower, and dose increases should be more gradual. Close monitoring for cardiac symptoms is crucial.

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 and T3, which may be preferred by some patients over levothyroxine (T4 only) due to perceived better symptom control, though evidence is mixed.
  • Dosing is highly individualized; monitor TSH and free T4, but also clinical symptoms.
  • Consistency in administration (e.g., same time daily, empty stomach, separated from interacting substances) is crucial for stable absorption.
  • Patients switching from levothyroxine to desiccated thyroid (or vice versa) require careful dose conversion and close monitoring.
  • The potency of desiccated thyroid can vary slightly between batches and manufacturers, though regulatory standards aim to minimize this.
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Alternative Therapies

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

Average Cost: $50 - $150+ per 30 tablets (300mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic desiccated thyroid); Tier 2 or Tier 3 (for brand-name Armour Thyroid)
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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 details. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.