Thyroid (armour) 3gr (180mg) 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
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Pharmacologic Class
Thyroid hormone replacement
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Pregnancy 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 your body's metabolism work properly.
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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 precisely. 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, as this may affect how the medication works.

Interactions with Other Medications and Foods

Avoid taking colesevelam, colestipol, or cholestyramine within 4 hours before or after taking this medication. Additionally, some foods like soybean flour (found in infant formula) may interact with this medication. Discuss any concerns 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're unsure about the best way to dispose 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 to make up for the missed one.
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Lifestyle & Tips

  • Take this medication once daily, preferably in the morning, on an empty stomach, at least 30-60 minutes before breakfast or any other medications/supplements.
  • Avoid taking with calcium, iron, antacids, or fiber supplements, as they can interfere with absorption. Separate doses by at least 4 hours.
  • Do not stop taking this medication without consulting your doctor, even if you feel better. It is usually a lifelong treatment.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with thyroid hormones.
  • Maintain a consistent diet; large changes in soy intake can affect absorption.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on patient response and laboratory parameters (TSH, free T4). Typical starting dose is 15-30 mg (1/4 to 1/2 grain) daily, titrated in 15 mg increments every 2-3 weeks. Maintenance dose typically ranges from 60-120 mg (1-2 grains) daily. 180mg (3 grains) is a high maintenance dose.
Dose Range: 15 - 180 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 15-30 mg daily, titrated every 2-3 weeks. Maintenance: 60-120 mg daily. Max: Up to 180 mg or more if clinically indicated and monitored.
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Pediatric Dosing

Neonatal: Congenital Hypothyroidism: 2.4-4.8 mg/kg/day (equivalent to 4-8 mcg T4/kg/day). Initial dose typically 15 mg (1/4 grain) daily, adjusted based on TSH and T4 levels.
Infant: Congenital Hypothyroidism: 2.4-4.8 mg/kg/day (equivalent to 4-8 mcg T4/kg/day). Initial dose typically 15 mg (1/4 grain) daily, adjusted based on TSH and T4 levels.
Child: Hypothyroidism: Initial 15 mg (1/4 grain) daily, adjusted based on TSH and T4 levels. Doses typically range from 30-120 mg (1/2 to 2 grains) daily.
Adolescent: Hypothyroidism: Similar to adult dosing, individualized based on TSH and T4 levels.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor for signs of over- or under-treatment.

Pharmacology

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Mechanism of Action

Thyroid, Desiccated provides exogenous thyroid hormones, levothyroxine (T4) and liothyronine (T3), which are identical to those naturally produced by the human thyroid gland. These hormones regulate metabolism, growth, and development by binding to thyroid hormone receptors in the cell nucleus, modulating gene expression and protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (48-80% for T4, 95% for T3), influenced by food and other medications.
Tmax: T4: 2-4 hours; T3: 2-4 hours.
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: 10-13 L; T3: 0.46 L/kg.
ProteinBinding: Highly protein bound (>99%) to thyroid-binding globulin (TBG), transthyretin (TTR), and albumin.
CnssPenetration: Limited, but active transport mechanisms 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), some biliary excretion.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Days to weeks (due to T4 component and need for TSH suppression/normalization). T3 component provides more rapid onset of some effects.
PeakEffect: Weeks (for full therapeutic effect and TSH normalization).
DurationOfAction: Days to weeks (due to long half-life of T4).

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 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

As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, 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 heart rate, palpitations, chest pain, nervousness, tremor, insomnia, excessive sweating, heat intolerance, unexplained weight loss, diarrhea.
  • Symptoms of too little thyroid hormone (hypothyroidism) if dose is too low: persistent fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression.
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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 adjust 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 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. 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 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 to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia (rapid heart rate)
  • Arrhythmias (irregular heartbeat)
  • Chest pain (angina)
  • Nervousness
  • Irritability
  • Insomnia
  • Tremor
  • Increased sweating
  • Heat intolerance
  • Weight loss
  • Diarrhea
  • Vomiting
  • Fever
  • Seizures (rare)
  • Coma (rare)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management typically involves supportive care, reducing absorption (if recent ingestion), and managing symptoms (e.g., beta-blockers for cardiac effects).

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., Warfarin): Increased anticoagulant effect due to increased catabolism of vitamin K-dependent clotting factors. Requires INR monitoring and potential dose reduction of anticoagulant.
  • Digitalis Glycosides (e.g., Digoxin): Reduced therapeutic effect of digitalis due to increased metabolism. May require increased digitalis dose.
  • Antidiabetic Agents (Insulin, Oral Hypoglycemics): Increased blood glucose levels due to increased metabolic rate. May require increased antidiabetic dose.
  • Cholestyramine, Colestipol, Sevelamer, Sucralfate, Calcium Carbonate, Iron Salts, Aluminum Hydroxide: Decreased absorption of thyroid hormones. Administer thyroid hormone at least 4 hours before or after these agents.
  • Proton Pump Inhibitors (PPIs) / H2 Blockers: May reduce gastric acidity, potentially impairing absorption of thyroid hormones. Monitor TSH levels.
  • Soy-containing products: May decrease absorption of thyroid hormones. Advise consistent intake or separation of doses.
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Moderate Interactions

  • Amiodarone: Can cause hypo- or hyperthyroidism and alter thyroid hormone metabolism.
  • Beta-blockers: May reduce the conversion of T4 to T3.
  • Estrogens (Oral): May increase TBG levels, requiring higher thyroid hormone doses.
  • Androgens/Anabolic Steroids: May decrease TBG levels, potentially requiring lower thyroid hormone doses.
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital: May increase metabolism of thyroid hormones, requiring higher doses.
  • SSRIs (e.g., Sertraline): May increase thyroid hormone requirements in some patients.
  • Tyrosine Kinase Inhibitors (e.g., Sunitinib, Imatinib): Can cause hypothyroidism, requiring dose adjustment of thyroid hormone.
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Minor Interactions

  • Dietary Fiber: May decrease absorption if taken concurrently.

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: To assess baseline thyroid function and confirm diagnosis of hypothyroidism.

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid function.

Timing: Prior to initiation of therapy.

Triiodothyronine (T3) (Total or Free)

Rationale: To assess baseline T3 levels, especially relevant for desiccated thyroid.

Timing: Prior to initiation of therapy.

Cardiac Status (ECG, history of cardiovascular disease)

Rationale: To identify pre-existing cardiac conditions that may be exacerbated by thyroid hormone replacement.

Timing: Prior to initiation, especially in elderly or those with cardiac risk factors.

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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 (individualized based on patient age, comorbidities, and clinical response).

Action Threshold: Adjust dose if TSH is outside target range or if symptoms persist/worsen.

Free Thyroxine (Free T4)

Frequency: Every 6-8 weeks until stable, then every 6-12 months (often alongside TSH).

Target: Typically within the upper half of the reference range.

Action Threshold: Adjust dose if levels are consistently low or high, especially if TSH is also abnormal.

Free Triiodothyronine (Free T3)

Frequency: Consider periodically, especially if symptoms persist despite normal TSH/Free T4, or if using desiccated thyroid.

Target: Typically within the upper half of the reference range.

Action Threshold: Consider dose adjustment if levels are consistently low or high, especially if TSH is also abnormal.

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

Frequency: At every visit.

Target: Resolution of hypothyroid symptoms, absence of hyperthyroid symptoms.

Action Threshold: Adjust dose if symptoms of hypo- or hyperthyroidism are present.

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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, nervousness, tremor, weight loss, heat intolerance, diarrhea, insomnia, chest pain)

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 child. 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).

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 child. Thyroid hormone requirements often increase during pregnancy.
Second Trimester: Continued monitoring and dose adjustment are crucial. Fetal thyroid gland begins to function in the second trimester, but maternal thyroid hormones are still vital.
Third Trimester: Dose adjustments may continue to be necessary. Monitor TSH and free T4/T3 regularly.
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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 evidence of risk to the infant.
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Pediatric Use

Crucial for normal growth and development, especially neurological development in infants and young children. Dosing is weight-based and requires careful monitoring of TSH and free T4/T3 to ensure adequate replacement and prevent over- or under-treatment. Untreated congenital hypothyroidism can lead to irreversible intellectual disability.

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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 titration should be slower and more cautious. Monitor for signs of cardiac dysfunction (e.g., angina, arrhythmias).

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 and T3. While T4 is a prohormone converted to T3, direct T3 supplementation can lead to higher peak T3 levels and a shorter half-life compared to levothyroxine alone.
  • Patients transitioning from levothyroxine to desiccated thyroid or vice versa require careful dose conversion and close monitoring of TSH, free T4, and free T3.
  • The potency of desiccated thyroid can vary slightly between batches and manufacturers due to its natural origin, though standardization efforts aim to minimize this.
  • Always take on an empty stomach, consistently, and separate from interacting medications/supplements to ensure consistent absorption.
  • Monitor clinical symptoms closely in addition to lab values, as some patients may feel better on desiccated thyroid despite similar TSH levels compared to levothyroxine.
  • Educate patients that this medication is not for weight loss and misuse can lead to serious adverse effects.
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Alternative Therapies

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

Average Cost: Varies widely by pharmacy and strength. Check current pricing. per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic, Tier 2 or 3 for brand. Coverage varies by insurance plan.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.