Thyroid (armour) 0.25gr (15mg) 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 T4 and T3 hormones. It's used to treat an underactive thyroid gland (hypothyroidism) by replacing the hormones your body isn't making enough of. It helps regulate your body's metabolism, energy levels, and other important 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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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 (at least 3 hours after the last meal).
  • Do not take with food, especially high-fiber foods, or with calcium, iron, or antacid supplements, as these can interfere with absorption. Separate by at least 4 hours.
  • Do not stop taking this medication without consulting your doctor, even if you feel better. Lifelong treatment is often necessary.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with thyroid hormones.
  • This medication is NOT for weight loss. Using it for weight loss can cause serious and life-threatening side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient response and laboratory parameters (TSH, free T4). Initial dose typically 15-30 mg/day, adjusted in 15 mg increments every 2-3 weeks. Maintenance dose commonly 60-120 mg/day.
Dose Range: 15 - 240 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 15-30 mg/day. Maintenance: 60-120 mg/day, adjusted based on TSH and clinical response. Administer once daily, preferably 30-60 minutes before breakfast.
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Pediatric Dosing

Neonatal: Initial: 7.5-15 mg/day (or 4.8-6 mg/kg/day for congenital hypothyroidism). Adjust based on TSH and clinical response.
Infant: Initial: 7.5-15 mg/day (or 4.8-6 mg/kg/day for congenital hypothyroidism). Adjust based on TSH and clinical response.
Child: Initial: 15-30 mg/day. Adjust based on TSH and clinical response. Dosing is weight-based and highly individualized.
Adolescent: Initial: 30-60 mg/day. Adjust based on TSH and clinical response. Dosing is individualized.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment typically required, but monitor thyroid function closely.
Moderate: No specific dose adjustment typically required, but monitor thyroid function closely.
Severe: No specific dose adjustment typically required, but monitor thyroid function closely.
Dialysis: No specific dose adjustment typically required, but monitor thyroid function closely.

Hepatic Impairment:

Mild: No specific dose adjustment typically required, but monitor thyroid function closely.
Moderate: No specific dose adjustment typically required, but monitor thyroid function closely.
Severe: No specific dose adjustment typically required, but monitor thyroid function closely.

Pharmacology

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Mechanism of Action

Desiccated thyroid 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 nuclear thyroid hormone receptors, leading to gene expression modulation and protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; T4 absorption is approximately 70-80%, T3 absorption is approximately 95%.
Tmax: T4: 2-4 hours; T3: 2-4 hours.
FoodEffect: Food, especially fiber, calcium, and iron, can decrease absorption. Should be taken on an empty stomach.

Distribution:

Vd: T4: Approximately 10-12 L; T3: Approximately 0.5-1 L.
ProteinBinding: Highly protein-bound (>99%) to thyroid-binding globulin (TBG), transthyretin (prealbumin), and albumin.
CnssPenetration: Limited, but active transport mechanisms facilitate entry into the CNS.

Elimination:

HalfLife: T4: Approximately 7 days; T3: Approximately 1 day.
Clearance: Variable, influenced by age, thyroid status, and other medications.
ExcretionRoute: Primarily renal (conjugated metabolites) and biliary (enterohepatic recirculation).
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Clinical effects are gradual, typically observed over several weeks due to the long half-life of T4.
PeakEffect: Full therapeutic effect may take 4-6 weeks after initiating therapy or changing dose.
DurationOfAction: Long, due to the prolonged half-life of T4.

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 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

Serious 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
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 may only have mild 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): rapid heart rate, palpitations, chest pain, nervousness, tremor, insomnia, excessive sweating, heat intolerance, unexplained weight loss, diarrhea.
  • Symptoms of too little thyroid hormone (hypothyroidism) despite treatment: persistent fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, 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:
+ 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 safe treatment, 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

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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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 before 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, plan to become pregnant, or are breastfeeding. Your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Signs and symptoms of hyperthyroidism (e.g., palpitations, tachycardia, arrhythmias, chest pain, nervousness, tremor, insomnia, sweating, heat intolerance, weight loss, diarrhea, vomiting, fever, seizures, psychosis, shock, coma).

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Management is supportive and symptomatic, often involving beta-blockers for cardiac effects and measures to reduce absorption if recent ingestion.

Drug Interactions

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Major Interactions

  • Amiodarone (can alter thyroid function and response)
  • Oral anticoagulants (e.g., Warfarin - increased anticoagulant effect)
  • Sympathomimetics (e.g., decongestants - increased risk of cardiac effects)
  • Insulin/Oral Hypoglycemics (may increase insulin/hypoglycemic requirements)
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Moderate Interactions

  • Antacids (aluminum, magnesium, calcium), Sucralfate, Cholestyramine, Colestipol, Sevelamer, Lanthanum (decrease absorption of thyroid hormones - separate administration by 4 hours)
  • Iron supplements (decrease absorption - separate administration by 4 hours)
  • Proton pump inhibitors (e.g., Omeprazole - may decrease absorption)
  • Soy products (may decrease absorption)
  • Certain anticonvulsants (e.g., Phenytoin, Carbamazepine - may increase thyroid hormone metabolism)
  • Rifampin (may increase thyroid hormone metabolism)
  • Estrogens/Oral Contraceptives (may increase TBG, requiring higher thyroid hormone dose)
  • Androgens/Anabolic Steroids (may decrease TBG, requiring lower thyroid hormone dose)
  • Beta-blockers (may decrease peripheral conversion of T4 to T3)
  • Corticosteroids (may inhibit TSH secretion and peripheral conversion of T4 to T3)
  • Digoxin (may decrease digoxin levels)
  • SSRIs (e.g., Sertraline - may increase thyroid hormone requirements)
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Minor Interactions

  • Dietary fiber (can decrease absorption)

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 hormone levels.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline symptom severity and guide treatment goals.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Thyroid Stimulating Hormone (TSH)

Frequency: Every 4-6 weeks until stable, then annually or as clinically indicated.

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

Action Threshold: Values outside target range indicate need for dose adjustment.

Free Thyroxine (Free T4)

Frequency: May be monitored with TSH, especially if TSH is suppressed or if patient has central hypothyroidism.

Target: Reference range (e.g., 0.8-1.8 ng/dL), individualized.

Action Threshold: Values outside target range may indicate need for dose adjustment.

Clinical symptoms of hypo- or hyperthyroidism

Frequency: At every visit.

Target: Resolution or improvement of hypothyroid symptoms; absence of hyperthyroid symptoms.

Action Threshold: Persistence of hypothyroid symptoms or emergence of hyperthyroid symptoms indicates need for dose adjustment or further evaluation.

Heart rate and rhythm

Frequency: At every visit, especially during dose titration.

Target: Normal sinus rhythm, appropriate heart rate.

Action Threshold: Tachycardia, palpitations, or arrhythmias may indicate over-replacement.

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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, sweating)

Special Patient Groups

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Pregnancy

Thyroid hormone requirements often increase during pregnancy. It is crucial to continue thyroid hormone replacement therapy throughout pregnancy and to monitor thyroid function (TSH) closely, adjusting the dose as needed to maintain euthyroidism. Untreated hypothyroidism during pregnancy can lead to adverse maternal and fetal outcomes.

Trimester-Specific Risks:

First Trimester: Crucial for fetal neurological development. Untreated maternal hypothyroidism can lead to impaired neurocognitive development in the fetus.
Second Trimester: Continued need for adequate thyroid hormone levels for fetal growth and development.
Third Trimester: Continued need for adequate thyroid hormone levels.
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Lactation

Thyroid hormones are excreted in breast milk in minimal amounts and are generally considered safe for use during breastfeeding. No adverse effects on the infant have been reported.

Infant Risk: Low risk.
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Pediatric Use

Dosing is weight-based and highly individualized. Regular monitoring of TSH and clinical status is essential to ensure proper growth and development. Under-treatment can lead to irreversible intellectual disability and growth retardation, while over-treatment can lead to craniosynostosis and accelerated bone maturation.

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Geriatric Use

Elderly patients may be more sensitive to the effects of thyroid hormones, particularly cardiac effects. A lower initial dose and slower titration are recommended. Close monitoring for cardiac symptoms (e.g., angina, arrhythmias) is important.

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 (levothyroxine) and T3 (liothyronine), unlike synthetic levothyroxine which contains only T4.
  • Dosing is highly individualized and requires careful titration based on TSH levels and clinical response. TSH may be suppressed even when the patient is euthyroid on desiccated thyroid due to the direct T3 content.
  • Patients should be advised to take the medication consistently at the same time each day, preferably on an empty stomach, to optimize absorption.
  • Not indicated for weight loss; misuse can lead to serious adverse effects.
  • Patients transitioning from levothyroxine to desiccated thyroid, or vice versa, require careful monitoring and dose adjustment due to differences in T4:T3 ratios and absorption characteristics.
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Alternative Therapies

  • Levothyroxine (synthetic T4, e.g., Synthroid, Levoxyl, Tirosint)
  • Liothyronine (synthetic T3, e.g., Cytomel)
  • Synthetic T4/T3 combination products (e.g., Thyrolar, or compounded T4/T3)
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (15mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic or brand)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.