Thyroid 0.5gr (30mg) Tablets

Manufacturer ANI PHARMACEUTICALS 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?

Thyroid, Desiccated is a natural thyroid hormone replacement medicine. It contains both T3 and T4 hormones, which are normally made by your thyroid gland. 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 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 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 medicine exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor.
  • Take it on an empty stomach, typically 30-60 minutes before breakfast, with a full glass of water. Avoid taking it with food, especially high-fiber foods, calcium, or iron supplements, as these can interfere with absorption.
  • Do not switch between different brands of desiccated thyroid or between desiccated thyroid and synthetic thyroid hormones (like levothyroxine) without your doctor's guidance, as doses may not be equivalent and require re-monitoring.
  • Report any new or worsening symptoms to your doctor, especially signs of overactive thyroid (e.g., palpitations, nervousness, weight loss, heat intolerance) or underactive thyroid (e.g., fatigue, weight gain, cold intolerance).
  • 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: 30 mg (0.5 grain) orally once daily. Titrate in 15 mg (0.25 grain) increments every 2-3 weeks based on clinical response and laboratory parameters (TSH, free T4). Maintenance: 60-120 mg (1-2 grains) daily.
Dose Range: 15 - 180 mg

Condition-Specific Dosing:

hypothyroidism: Initial 30 mg daily, adjusted by 15 mg increments every 2-3 weeks. Usual maintenance 60-120 mg daily. Higher doses may be required for some patients.
myxedema_coma: Not typically used; IV levothyroxine is preferred.
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Pediatric Dosing

Neonatal: Not established. Dosing is highly individualized based on weight and TSH levels. Synthetic levothyroxine is generally preferred for congenital hypothyroidism.
Infant: Not established. Dosing is highly individualized based on weight and TSH levels. Synthetic levothyroxine is generally preferred for congenital hypothyroidism.
Child: Not established. Dosing is highly individualized based on weight and TSH levels. Synthetic levothyroxine is generally preferred.
Adolescent: Dosing is highly individualized, similar to adult titration, but starting with lower doses and titrating based on TSH and clinical response.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Thyroid, Desiccated provides exogenous thyroid hormones, primarily levothyroxine (T4) and liothyronine (T3), in a natural ratio. These hormones exert their physiological effects by binding to specific nuclear thyroid hormone receptors, which then interact with DNA to regulate gene expression. This leads to widespread effects on metabolism, growth, and development, including increased metabolic rate, oxygen consumption, protein synthesis, and carbohydrate and lipid metabolism.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (approximately 48-80% for T4 component, higher for T3 component). Absorption can be affected by food and other medications.
Tmax: T4: 2-4 hours; T3: 1-2 hours (after oral administration)
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: 0.4-0.6 L/kg
ProteinBinding: High (>99%) to thyroid-binding globulin (TBG), transthyretin (TTR), and albumin.
CnssPenetration: Limited, but active transport mechanisms exist for entry into the brain.

Elimination:

HalfLife: T4: 6-7 days; T3: 1-2 days
Clearance: T4: 1.2 L/day; T3: 2.5 L/day
ExcretionRoute: Primarily renal (conjugated metabolites), some fecal excretion.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Slow, clinical effects typically observed within days to weeks.
PeakEffect: Weeks (due to T4 half-life and conversion to T3).
DurationOfAction: Long, due to the 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

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, 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 possible side effects. 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:

  • Chest pain
  • Palpitations or rapid heart rate
  • Excessive sweating
  • Nervousness or irritability
  • Tremor
  • Unexplained weight loss
  • Diarrhea
  • Shortness of breath
  • Swelling in ankles or feet
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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, please inform 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 making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, 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, stop using it at least 2 days before 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, 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, as you will need to discuss the potential benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Headache
  • Irritability
  • Nervousness
  • Sweating
  • Diarrhea
  • Tachycardia (rapid heart rate)
  • Palpitations
  • Chest pain (angina)
  • Tremor
  • Insomnia
  • Heat intolerance
  • Fever
  • Weight loss

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., warfarin): May increase anticoagulant effect by increasing receptor sensitivity to anticoagulants. Requires careful INR monitoring and potential dose reduction of anticoagulant.
  • Cardiac glycosides (e.g., digoxin): Thyroid hormones may increase digoxin requirements or reduce its therapeutic effect. Monitor digoxin levels and clinical response.
  • Sympathomimetics (e.g., epinephrine, pseudoephedrine): Concomitant use may increase the risk of coronary insufficiency in patients with coronary artery disease.
  • Antidiabetic agents (insulin, oral hypoglycemics): Thyroid hormones may increase blood glucose levels, requiring increased doses of antidiabetic agents. Monitor blood glucose closely.
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Moderate Interactions

  • Cholestyramine, colestipol, sevelamer, sucralfate, calcium carbonate, iron supplements, aluminum-containing antacids: May decrease absorption of thyroid hormones. Administer thyroid hormone at least 4 hours before or after these agents.
  • Proton pump inhibitors (PPIs) and H2 blockers: May decrease gastric acidity, potentially impairing absorption of thyroid hormones. Monitor TSH levels.
  • Phenytoin, carbamazepine, rifampin, phenobarbital: May increase metabolism of thyroid hormones, leading to increased dose requirements. Monitor TSH.
  • Estrogens (oral contraceptives, hormone replacement therapy): May increase thyroid-binding globulin (TBG) levels, increasing bound T4 and potentially requiring higher thyroid hormone doses. Monitor TSH.
  • Androgens, anabolic steroids, asparaginase, glucocorticoids: May decrease TBG levels, potentially requiring lower thyroid hormone doses. Monitor TSH.
  • Beta-blockers: May decrease the peripheral conversion of T4 to T3. Also, thyroid hormones may reduce the effectiveness of beta-blockers.
  • Amiodarone: Contains iodine and can cause hypo- or hyperthyroidism. May alter thyroid hormone levels and metabolism.
  • Iodine-containing products (e.g., contrast agents): Can affect thyroid function.
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Minor Interactions

  • Dietary fiber: May decrease absorption of thyroid hormones.
  • Soy products: May decrease absorption of thyroid hormones.

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

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

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid hormone levels and aid in diagnosis.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline symptom severity and track improvement.

Timing: Prior to initiation of therapy.

Cardiac status (ECG, history of CAD)

Rationale: To assess cardiovascular risk, especially in elderly or those with pre-existing heart disease, as thyroid hormones can increase cardiac workload.

Timing: Prior to initiation of therapy, especially in at-risk patients.

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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: Typically 0.4-4.0 mIU/L (individualized based on patient factors, e.g., age, pregnancy status).

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

Free Thyroxine (Free T4)

Frequency: Often monitored with TSH, especially during initial titration or if TSH is suppressed.

Target: Typically 0.8-1.8 ng/dL (individualized).

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

Clinical symptoms of hypo/hyperthyroidism

Frequency: At every visit.

Target: Resolution of hypothyroid symptoms without development of hyperthyroid symptoms.

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

Weight

Frequency: At every visit.

Target: Stable weight, or weight loss if obesity was a symptom of hypothyroidism.

Action Threshold: Significant unexplained weight changes may indicate over- or under-treatment.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia (hypo) or Tachycardia (hyper)
  • Nervousness/Irritability
  • Heat intolerance
  • Tremor
  • Diarrhea
  • Palpitations
  • Chest pain (angina)

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. Untreated hypothyroidism during pregnancy can lead to adverse maternal and fetal outcomes. Dosage adjustments should be made based on frequent monitoring of TSH levels (typically every 4-6 weeks).

Trimester-Specific Risks:

First Trimester: Essential 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 to support fetal growth and development.
Third Trimester: Continued need for adequate thyroid hormone levels. TSH levels should be monitored closely.
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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 nursing infant have been reported with maternal therapeutic doses.

Infant Risk: L1 (Safest)
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Pediatric Use

Dosing is highly individualized and based on age, weight, and TSH levels. Synthetic levothyroxine is generally preferred for congenital hypothyroidism due to more predictable potency and easier monitoring. Careful monitoring of growth, development, and thyroid function tests is essential.

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Geriatric Use

Lower initial doses are often recommended for elderly patients, especially those with underlying cardiovascular disease, due to increased sensitivity to thyroid hormones and potential for cardiac adverse effects. Gradual titration and close monitoring of cardiac status and thyroid function tests are crucial.

Clinical Information

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Clinical Pearls

  • Thyroid, Desiccated contains both T4 and T3 hormones, unlike synthetic levothyroxine (T4 only). This can be a consideration for patients who report persistent symptoms on levothyroxine alone, though evidence for superior outcomes is mixed.
  • Potency of desiccated thyroid can vary slightly between batches and manufacturers, necessitating careful monitoring when switching brands.
  • Patients should be advised to take the medication consistently at the same time each day, preferably in the morning on an empty stomach, to optimize absorption.
  • Not indicated for weight loss or obesity treatment. Misuse can lead to serious and life-threatening cardiovascular events.
  • Patients with pre-existing cardiovascular disease should be started on lower doses and titrated very slowly to avoid exacerbating cardiac symptoms.
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Alternative Therapies

  • Levothyroxine (synthetic T4, e.g., Synthroid, Levoxyl, Unithroid)
  • Liothyronine (synthetic T3, e.g., Cytomel, Triostat)
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (30mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 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 it's a good idea to check with your pharmacist. 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.