Thyroid (armour) 2gr (120mg) 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
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?

Desiccated thyroid is a natural medicine made from animal thyroid glands. It contains the same hormones (T4 and T3) that your own thyroid gland makes. It's used to replace these hormones when your body doesn't make enough, helping to regulate your metabolism, energy, and other body 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 first consulting your doctor.

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, certain 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 the 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 your medication exactly as prescribed, usually once daily on an empty stomach, at least 30-60 minutes before breakfast or at bedtime (3-4 hours after your last meal).
  • Do not take with calcium, iron, 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.
  • Report any new or worsening symptoms to your doctor.
  • Maintain a consistent diet and avoid excessive intake of foods that can interfere with thyroid function (e.g., soy, cruciferous vegetables in very large amounts, though usually not an issue with stable dosing).

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized, typically starting at 15-30 mg (1/4 to 1/2 grain) once daily, titrated every 2-3 weeks based on clinical response and laboratory parameters (TSH, free T4). Maintenance dose typically 60-120 mg (1-2 grains) daily. The specified 2gr (120mg) is a common maintenance dose.
Dose Range: 15 - 240 mg

Condition-Specific Dosing:

hypothyroidism: Initial dose 15-30 mg/day, increased by 15 mg increments every 2-3 weeks. Usual maintenance 60-120 mg/day.
myxedema_coma: Not typically used for acute myxedema coma; IV levothyroxine is preferred.
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Pediatric Dosing

Neonatal: Initial 7.5-15 mg (1/8 to 1/4 grain) daily, adjusted based on TSH and T4. Higher doses per kg are often required in infants and young children.
Infant: Initial 7.5-15 mg (1/8 to 1/4 grain) daily, adjusted based on TSH and T4.
Child: Initial 15-30 mg (1/4 to 1/2 grain) daily, adjusted based on TSH and T4.
Adolescent: Initial 30-60 mg (1/2 to 1 grain) daily, adjusted based on TSH and T4.
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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.
Dialysis: No specific dose adjustment generally required, but monitor thyroid function closely.

Hepatic Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required.
Severe: No specific dose adjustment generally required.

Pharmacology

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Mechanism of Action

Desiccated thyroid is a natural product derived from porcine thyroid glands, containing both levothyroxine (T4) and liothyronine (T3). It acts as a physiological replacement for endogenous thyroid hormones, binding to thyroid hormone receptors in the cell nucleus and regulating gene expression, thereby controlling metabolic processes, growth, and development.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: T4: 10-12 L; T3: 0.46 L/kg.
ProteinBinding: T4: >99% (primarily to thyroxine-binding globulin, transthyretin, and albumin); T3: ~80%.
CnssPenetration: Limited, but active transport systems facilitate entry into the brain.

Elimination:

HalfLife: T4: 6-7 days; T3: 1-2 days (for the T3 component).
Clearance: T4: 0.05-0.1 L/hour; T3: 2.5 L/hour.
ExcretionRoute: Primarily renal (conjugated metabolites), some fecal.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Days to weeks (due to T4 component's 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 half-life).

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including desiccated thyroid, alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. 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

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 attention immediately:

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, or 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:

* 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:

  • Symptoms of too much thyroid hormone (hyperthyroidism): Fast or irregular heartbeat, chest pain, shortness of breath, nervousness, tremors, sweating, heat intolerance, weight loss, diarrhea, insomnia.
  • Symptoms of too little thyroid hormone (hypothyroidism): Extreme tiredness, weight gain, constipation, feeling cold, dry skin, hair loss, depression, muscle aches, slowed thinking.
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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, tell your doctor and pharmacist about:
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, consult with your doctor to confirm it is safe for you 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. 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, 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, inform your doctor, as it is crucial to weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Signs and symptoms of hyperthyroidism (see above)
  • Headache
  • Irritability
  • Fever
  • Seizures (rare)
  • Coma (rare)

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222). Treatment is supportive and may include beta-blockers for cardiac symptoms, corticosteroids, and measures to reduce absorption if recent ingestion.

Drug Interactions

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Major Interactions

  • Warfarin (increased anticoagulant effect)
  • Antidiabetic agents (increased blood glucose, may require dose adjustment)
  • Cholestyramine, Colestipol, Sevelamer (decreased thyroid hormone absorption)
  • Sucralfate (decreased thyroid hormone absorption)
  • Ion exchange resins (e.g., Kayexalate) (decreased thyroid hormone absorption)
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Moderate Interactions

  • Antacids (aluminum, magnesium, calcium) (decreased thyroid hormone absorption)
  • Iron supplements (decreased thyroid hormone absorption)
  • Calcium supplements (decreased thyroid hormone absorption)
  • Proton pump inhibitors (may alter gastric pH, affecting absorption)
  • Estrogens (may increase TBG, requiring higher thyroid hormone dose)
  • Androgens (may decrease TBG, requiring lower thyroid hormone dose)
  • Beta-blockers (may decrease T4 to T3 conversion)
  • Amiodarone (can cause hypo- or hyperthyroidism)
  • Phenytoin, Carbamazepine, Rifampin (increased thyroid hormone metabolism)
  • Sertraline (may increase thyroid hormone requirements)
  • Imatinib, Sunitinib (may increase thyroid hormone requirements)
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Minor Interactions

  • Dietary fiber (may decrease absorption)

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: To confirm diagnosis of hypothyroidism and establish baseline for treatment.

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid hormone levels.

Timing: Prior to initiation of therapy.

Triiodothyronine (Total T3 or Free T3)

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

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline symptom severity.

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

Action Threshold: TSH outside target range indicates need for dose adjustment.

Free Thyroxine (Free T4)

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

Triiodothyronine (Total T3 or Free T3)

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

Target: Within reference range (e.g., Total T3 80-200 ng/dL, Free T3 2.3-4.2 pg/mL).

Action Threshold: Persistently low or high T3 levels, especially if symptomatic.

Clinical symptoms of hypo/hyperthyroidism

Frequency: At every visit.

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

Action Threshold: Persistence of hypothyroid symptoms or emergence of hyperthyroid symptoms.

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Symptom Monitoring

  • Hypothyroidism: Fatigue, weight gain, cold intolerance, constipation, dry skin, hair loss, depression, muscle aches, slowed heart rate, menstrual irregularities.
  • Hyperthyroidism (due to overtreatment): Palpitations, nervousness, tremors, weight loss, heat intolerance, diarrhea, insomnia, increased appetite, rapid heart rate, 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. 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 may increase during pregnancy.

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism can lead to impaired fetal neurodevelopment and increased risk of miscarriage. Thyroid hormone replacement is safe and necessary.
Second Trimester: Continued need for adequate thyroid hormone levels for fetal development. Dose adjustments may be necessary.
Third Trimester: Continued need for adequate thyroid hormone levels. Monitor TSH and adjust dose as needed.
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Lactation

Thyroid hormones are excreted in breast milk in minimal amounts and are generally considered safe for the nursing infant. It is important for the mother to maintain euthyroid status for her own health and to support lactation.

Infant Risk: L1 (Safest) - No adverse effects on the infant are expected with maternal therapeutic doses.
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Pediatric Use

Essential for normal growth and development. Untreated congenital hypothyroidism can lead to irreversible mental retardation and growth retardation. Dosing is weight-based and titrated to maintain TSH and T4 within target ranges. Higher doses per kg are typically required in infants and young children compared to adults.

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Geriatric Use

Lower starting doses are often recommended due to increased sensitivity to thyroid hormones and a higher prevalence of cardiovascular disease. Titration should be gradual with careful monitoring of cardiac status and thyroid function tests.

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 and T3. While TSH is the primary monitoring parameter, some clinicians also monitor Free T3, especially if symptoms persist despite normal TSH.
  • Patients should be advised to take the medication consistently at the same time each day, on an empty stomach, and separate from interacting substances (e.g., calcium, iron, antacids) by at least 4 hours.
  • The potency of desiccated thyroid can vary slightly between batches and manufacturers, which may necessitate careful monitoring when switching brands.
  • Not indicated for weight loss in euthyroid individuals; misuse can lead to serious adverse effects.
  • Patients with pre-existing cardiac conditions should be started on very low doses and titrated slowly to avoid exacerbating cardiac symptoms.
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Alternative Therapies

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

Average Cost: $20 - $60 per 30 tablets (120mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred brand/generic), varies by plan.
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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 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 details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.