Thyroid (armour) 0.5gr (30mg) 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
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 normally made by your thyroid gland. It's used to treat an underactive thyroid (hypothyroidism) to help your body function properly, regulating your energy, metabolism, and other body processes.
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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, as this may affect how the medication works.

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, such as 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 any 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 on an empty stomach, at least 30-60 minutes before breakfast, and at least 4 hours apart from calcium, iron, antacids, or bile acid sequestrants.
  • Take consistently at the same time each day.
  • Do not stop taking this medication without consulting your doctor.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Maintain a balanced diet; avoid excessive intake of soy products or high-fiber foods around the time of dosing.
  • Regular blood tests (TSH, Free T4) are essential to ensure the correct dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 30 mg (0.5 grain) once daily. Titrate by 15 mg (0.25 grain) increments every 2-3 weeks. Maintenance: 60-120 mg (1-2 grains) once daily.
Dose Range: 15 - 180 mg

Condition-Specific Dosing:

hypothyroidism: Initial 30 mg (0.5 grain) daily, increasing by 15 mg (0.25 grain) every 2-3 weeks until euthyroid state is achieved. Average maintenance dose is 60-120 mg (1-2 grains) daily. Doses up to 180 mg (3 grains) or more may be required.
myxedema_coma: Not suitable for acute treatment of myxedema coma due to slow onset of action.
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Pediatric Dosing

Neonatal: Initial 7.5-15 mg (0.125-0.25 grain) daily, adjusted based on clinical response and laboratory tests (TSH, Free T4).
Infant: Initial 7.5-15 mg (0.125-0.25 grain) daily, adjusted based on clinical response and laboratory tests (TSH, Free T4).
Child: Initial 15 mg (0.25 grain) daily, adjusted based on clinical response and laboratory tests (TSH, Free T4).
Adolescent: Initial 30 mg (0.5 grain) daily, adjusted based on clinical response and laboratory tests (TSH, Free T4).
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Thyroid hormones (T3 and T4) exert their physiologic actions through control of DNA transcription and protein synthesis. Desiccated thyroid provides both levothyroxine (T4) and liothyronine (T3) in a natural ratio, mimicking endogenous thyroid hormone production. T4 is converted to T3 in peripheral tissues; T3 is the more metabolically active hormone.
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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, preferably 30-60 minutes before breakfast.

Distribution:

Vd: T4: 10-12 L; T3: 0.46 L/kg.
ProteinBinding: T4: >99% (primarily to Thyroxine-binding globulin (TBG), Transthyretin, Albumin); T3: ~80% (less tightly bound than T4).
CnssPenetration: Yes, both T3 and T4 cross the blood-brain barrier, with T3 being more active in the CNS.

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 fecal excretion.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Gradual, effects may not be apparent for several days to weeks.
PeakEffect: Weeks for full therapeutic effect (due to T4 half-life and conversion).
DurationOfAction: Weeks (due to T4 half-life).

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including Thyroid, Desiccated, should not be used for the treatment of obesity or for weight loss. 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. A reduced dose of thyroid hormone should be considered in patients with cardiac disease.
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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 for advice:

* 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 thyroid hormone (hyperthyroidism): rapid heart rate, palpitations, chest pain, excessive sweating, heat intolerance, nervousness, tremor, insomnia, unexplained weight loss, diarrhea.
  • Symptoms of too little thyroid hormone (hypothyroidism) if dose is too low: extreme fatigue, weight gain, cold intolerance, constipation, 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, 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 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 for the full effects of this medication to become apparent.

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

If you are taking biotin or any products containing biotin, discontinue use at least 2 days prior to having your thyroid levels checked to ensure accurate test results.

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 medication, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding, as you 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:

  • Headache
  • Irritability
  • Nervousness
  • Sweating
  • Tachycardia
  • Arrhythmias
  • Increased bowel motility
  • Menstrual irregularities
  • Tremor
  • Insomnia
  • Fever
  • Heat intolerance
  • Weight loss
  • Chest pain (angina pectoris)
  • Congestive heart failure
  • Shock (rare, severe cases)

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is symptomatic and supportive, including reducing absorption (gastric lavage, activated charcoal if recent ingestion), and managing cardiac effects (e.g., beta-blockers for tachycardia).

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., Warfarin): May potentiate anticoagulant effects, requiring dose reduction of anticoagulant.
  • Antidiabetic agents (e.g., Insulin, Metformin): May increase requirements for antidiabetic agents.
  • Cholestyramine, Colestipol, Sevelamer, Sucralfate, Calcium Carbonate, Iron Salts, Aluminum Hydroxide, Proton Pump Inhibitors: May decrease absorption of thyroid hormones. Administer at least 4 hours apart.
  • Amiodarone: Can cause hypo- or hyperthyroidism; complex interaction affecting thyroid hormone metabolism and action.
  • Phenytoin, Carbamazepine, Rifampin, Sertraline: May increase metabolism of thyroid hormones, requiring higher doses.
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Moderate Interactions

  • Beta-blockers: Thyroid hormones may decrease the effectiveness of beta-blockers.
  • Digitalis glycosides: Thyroid hormones may decrease the therapeutic effect of digitalis.
  • Estrogens/Oral Contraceptives: May increase TBG, leading to increased thyroid hormone requirements.
  • Androgens/Anabolic Steroids: May decrease TBG, leading to decreased thyroid hormone requirements.
  • Glucocorticoids: May inhibit T4 to T3 conversion.
  • Iodine-containing products: May affect thyroid function.
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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: Before initiation of therapy.

Free Thyroxine (Free T4)

Rationale: Assesses circulating unbound T4 levels.

Timing: Before initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline and monitor improvement.

Timing: Before initiation of therapy.

Cardiovascular status (ECG, heart rate, blood pressure)

Rationale: To assess for underlying cardiac disease, especially in elderly or those with known cardiac issues, as thyroid hormones can increase cardiac workload.

Timing: Before initiation of therapy.

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Routine Monitoring

Thyroid Stimulating Hormone (TSH)

Frequency: Every 6-8 weeks after initiation or dose change, then every 6-12 months once stable.

Target: 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; consider clinical symptoms.

Free Thyroxine (Free T4)

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

Target: 0.8-1.8 ng/dL (or laboratory reference range).

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

Clinical symptoms of hypo/hyperthyroidism

Frequency: At every visit.

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

Action Threshold: Adjust dose based on symptom profile, even if labs are borderline.

Heart rate and blood pressure

Frequency: At every visit.

Target: Normal range for age and patient.

Action Threshold: Monitor for tachycardia, palpitations, or hypertension, which may indicate overtreatment.

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Symptom Monitoring

  • Fatigue
  • Weight changes
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Memory impairment
  • Muscle aches
  • Nervousness
  • Palpitations
  • Heat intolerance
  • Tremor
  • Diarrhea
  • Weight loss (unexplained)
  • Insomnia
  • Tachycardia

Special Patient Groups

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Pregnancy

Thyroid hormone requirements often increase during pregnancy. It is crucial to continue and adjust thyroid hormone replacement therapy to maintain euthyroidism for both maternal and fetal health. Untreated hypothyroidism during pregnancy can lead to adverse outcomes.

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 monitoring and dose adjustment are necessary to maintain TSH within target range.
Third Trimester: Dose may need further adjustment. Close monitoring of TSH is essential throughout pregnancy and postpartum.
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Lactation

Thyroid hormones are minimally excreted into breast milk and are considered compatible with breastfeeding. No adverse effects on the infant have been reported with maternal therapeutic doses.

Infant Risk: L1 (Safest)
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Pediatric Use

Dosing is weight-based and requires careful titration based on TSH and Free T4 levels. Essential for normal growth and development. Untreated congenital hypothyroidism can lead to irreversible intellectual disability.

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Geriatric Use

Lower initial doses are often recommended due to increased sensitivity to thyroid hormones and higher prevalence of underlying cardiovascular disease. Gradual titration and careful monitoring for cardiac symptoms are 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), but its potency can be more variable than synthetic levothyroxine.
  • Patients switching from levothyroxine to desiccated thyroid or vice versa require careful dose conversion and close monitoring of TSH and Free T4.
  • The T4:T3 ratio in desiccated thyroid is approximately 4:1 by weight, but the biological potency ratio is different, making direct mg-to-mcg conversions complex.
  • Always take on an empty stomach to optimize absorption and ensure consistent levels.
  • Educate patients on symptoms of both under- and overtreatment to facilitate timely dose adjustments.
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Alternative Therapies

  • Levothyroxine (synthetic T4, e.g., Synthroid, Levoxyl, Unithroid): Most commonly prescribed thyroid hormone replacement.
  • Liothyronine (synthetic T3, e.g., Cytomel, Triostat): Used in specific cases, often in combination with levothyroxine, or for short-term TSH suppression.
  • Liotrix (synthetic T4/T3 combination, e.g., Thyrolar): Fixed ratio combination, less commonly used than levothyroxine or desiccated thyroid.
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Cost & Coverage

Average Cost: Varies widely, typically $20-$60 per 30 tablets (30mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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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 overdose, including the medication taken, the amount, and the time it occurred.