Thyroid 1gr (60mg) Tablets

Manufacturer ANI PHARMACEUTICALS Active Ingredient Thyroid, Desiccated(THYE roid DES i kay tid) Pronunciation THYE-roid DES-ih-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
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 medication made from animal thyroid glands. It contains the same hormones (T4 and T3) that your own thyroid gland produces. It's used to replace these hormones when your body doesn't make enough, a condition called hypothyroidism. Taking this medication helps restore your body's metabolism and energy levels.
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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 start 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 have questions about disposing 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 this medication exactly as prescribed by your doctor, usually once daily on an empty stomach, at least 30-60 minutes before breakfast or any other medications/supplements.
  • Avoid taking calcium, iron, antacids, or fiber supplements within 4 hours of your thyroid medication, as they can interfere with absorption.
  • Do not stop taking this medication without consulting your doctor, even if you feel better. Thyroid hormone replacement is usually lifelong.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Report any new or worsening symptoms to your doctor, especially signs of too much thyroid hormone (e.g., fast heart rate, nervousness, weight loss) or too little (e.g., fatigue, weight gain, constipation).

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 15-30 mg (1/4 to 1/2 grain) orally once daily. Titrate by 15 mg increments every 2-3 weeks based on clinical response and laboratory parameters (TSH, Free T4). Maintenance: 60-120 mg (1-2 grains) daily, though doses can vary widely.
Dose Range: 15 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Individualized based on TSH and clinical response. Take on an empty stomach, at least 30-60 minutes before breakfast and other medications.
myxedema_coma: Not typically used for acute myxedema coma; IV levothyroxine and liothyronine are preferred.
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Pediatric Dosing

Neonatal: Initial: 15 mg (1/4 grain) daily, adjusted based on TSH and T4 levels. Doses are typically higher per kg in neonates and infants than in older children and adults.
Infant: Initial: 15 mg (1/4 grain) daily, adjusted based on TSH and T4 levels. Doses are typically higher per kg in neonates and infants than in older children and adults.
Child: Initial: 15-30 mg (1/4 to 1/2 grain) daily, adjusted based on TSH and T4 levels. Doses are typically higher per kg in younger children.
Adolescent: Initial: 30-60 mg (1/2 to 1 grain) daily, adjusted based on TSH and T4 levels. Doses are typically lower per kg than in younger children.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor thyroid function closely.
Moderate: No specific dose adjustment required, but monitor thyroid function closely.
Severe: No specific dose adjustment required, but monitor thyroid function closely.
Dialysis: No specific dose adjustment required. Thyroid hormones are not significantly dialyzable.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Thyroid, Desiccated provides exogenous thyroid hormones, primarily L-thyroxine (T4) and L-triiodothyronine (T3), in a physiological ratio. These hormones exert their effects by binding to specific nuclear thyroid hormone receptors, regulating gene expression and controlling numerous metabolic processes, including protein, fat, and carbohydrate metabolism, and influencing growth and development.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (approximately 48-80% for T4, higher for T3), influenced by gut motility, pH, and presence of food/other medications.
Tmax: T4: 2-4 hours; T3: 1-2 hours
FoodEffect: Food, especially high-fiber or calcium-rich foods, can significantly decrease absorption. Should be taken on an empty stomach.

Distribution:

Vd: T4: 10-12 L; T3: 40-50 L
ProteinBinding: T4: >99% (primarily to TBG, TTR, albumin); T3: ~99% (primarily to TBG, albumin)
CnssPenetration: Limited (T4 and T3 cross the blood-brain barrier, but transport mechanisms are involved)

Elimination:

HalfLife: T4: 6-7 days; T3: 1-2 days
Clearance: T4: ~1.1 L/day; T3: ~24 L/day
ExcretionRoute: Primarily renal (conjugated metabolites), some fecal excretion (unabsorbed drug and biliary excretion)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Gradual (days to weeks for full therapeutic effect due to T4 half-life and cellular response)
PeakEffect: Weeks (for TSH normalization and clinical symptom improvement)
DurationOfAction: Days (due to T4 half-life, though T3 effects are shorter-lived)

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 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

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, 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

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 is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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): Palpitations, rapid heart rate, chest pain, nervousness, irritability, insomnia, excessive sweating, heat intolerance, unexplained weight loss, tremor, 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, 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:
+ 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

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 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, discuss any concerns 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. 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 to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Signs and symptoms of hyperthyroidism: Palpitations, tachycardia, arrhythmias, chest pain, nervousness, irritability, insomnia, tremor, excessive sweating, heat intolerance, weight loss, diarrhea, menstrual irregularities, headache, fever.

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment may involve reducing absorption (e.g., activated charcoal if recent ingestion), symptomatic management (e.g., beta-blockers for cardiac symptoms), and supportive care.

Drug Interactions

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Major Interactions

  • Warfarin (increased anticoagulant effect)
  • Digitalis glycosides (decreased therapeutic effect)
  • Sympathomimetics (increased risk of cardiac effects)
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Moderate Interactions

  • Calcium carbonate/supplements (decreased thyroid hormone absorption)
  • Iron supplements (decreased thyroid hormone absorption)
  • Antacids (aluminum, magnesium, sucralfate) (decreased thyroid hormone absorption)
  • Bile acid sequestrants (cholestyramine, colestipol, sevelamer) (decreased thyroid hormone absorption)
  • Proton pump inhibitors (may alter gastric pH, affecting absorption)
  • Soy products/high-fiber diet (decreased thyroid hormone absorption)
  • Phenytoin, Carbamazepine, Rifampin (increased thyroid hormone metabolism)
  • Amiodarone, Beta-blockers, Glucocorticoids, Propylthiouracil (PTU), Methimazole (alter T4 to T3 conversion)
  • Sertraline (may increase thyroid hormone requirements)
  • Oral hypoglycemics/Insulin (may increase requirements)
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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.

Timing: Before initiation of therapy.

Free Thyroxine (Free T4)

Rationale: Assesses circulating unbound T4 levels.

Timing: Before initiation of therapy.

Free Triiodothyronine (Free T3)

Rationale: Assesses circulating unbound T3 levels, particularly relevant for NDT due to direct T3 content.

Timing: Before initiation of therapy (optional, but often done with NDT).

Clinical symptoms of hypothyroidism

Rationale: To establish baseline and track improvement.

Timing: Before initiation of therapy.

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Routine Monitoring

Thyroid Stimulating Hormone (TSH)

Frequency: Every 6-8 weeks during dose titration, then every 6-12 months once stable.

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 during dose titration, then every 6-12 months once stable.

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

Action Threshold: Adjust dose if Free T4 is consistently low or high, or if symptoms persist/worsen.

Free Triiodothyronine (Free T3)

Frequency: Every 6-8 weeks during dose titration, then every 6-12 months once stable (optional, but common with NDT).

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

Action Threshold: Adjust dose if Free T3 is consistently low or high, or if symptoms persist/worsen.

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.

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Symptom Monitoring

  • Hypothyroidism: Fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, bradycardia, muscle aches, menstrual irregularities.
  • Hyperthyroidism (due to overdose): Palpitations, tachycardia, nervousness, irritability, insomnia, weight loss, heat intolerance, sweating, tremor, diarrhea, menstrual irregularities.

Special Patient Groups

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Pregnancy

Thyroid hormone requirements often increase during pregnancy. It is crucial to continue thyroid hormone replacement and monitor thyroid function (TSH, Free T4) closely throughout pregnancy. Untreated hypothyroidism during pregnancy can lead to adverse maternal and fetal outcomes. Thyroid, Desiccated 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: Essential for fetal neurological development. Untreated maternal hypothyroidism poses significant risks (e.g., miscarriage, preterm birth, impaired neurodevelopment).
Second Trimester: Continued monitoring and dose adjustment as needed.
Third Trimester: Continued monitoring and dose adjustment as needed.
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Lactation

Thyroid hormones are excreted in breast milk in minimal amounts that are not expected to cause adverse effects in the nursing infant. It is considered compatible with breastfeeding (L1).

Infant Risk: Low risk; generally considered safe for the infant.
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Pediatric Use

Dosing is weight-based and requires careful titration and monitoring of TSH and Free T4 to ensure proper growth and neurodevelopment. Overtreatment can lead to craniosynostosis in infants and premature epiphyseal closure in children. Undertreatment can lead to impaired physical and mental development.

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Geriatric Use

Older adults may be more sensitive to the effects of thyroid hormones, particularly cardiac effects. Lower starting doses and slower titration are often recommended. Co-morbidities and polypharmacy should be considered.

Clinical Information

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Clinical Pearls

  • Thyroid, Desiccated contains both T4 and T3. While TSH is the primary monitoring parameter, some clinicians also monitor Free T3 due to the direct T3 content, aiming for levels in the upper half of the reference range.
  • Consistency is key: Advise patients to take the medication at the same time each day, consistently on an empty stomach, to optimize absorption and maintain stable hormone levels.
  • Educate patients about potential drug-food and drug-drug interactions that can impair absorption (e.g., calcium, iron, antacids, soy, fiber). Separate administration by at least 4 hours.
  • Patients switching from levothyroxine to desiccated thyroid may require careful dose conversion and close monitoring, as the T3 component can lead to more rapid changes in symptoms and lab values.
  • Symptoms of hyperthyroidism (e.g., palpitations, nervousness, weight loss) indicate potential overtreatment and require immediate dose adjustment.
  • This medication is not for weight loss in euthyroid individuals and can be dangerous if misused for this purpose.
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Alternative Therapies

  • Levothyroxine (synthetic T4, e.g., Synthroid, Levoxyl, Tirosint) - most commonly prescribed.
  • Liothyronine (synthetic T3, e.g., Cytomel) - typically used in combination with levothyroxine or for specific conditions.
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Cost & Coverage

Average Cost: Varies widely by brand and pharmacy (e.g., $20-$100+) per 30 tablets (60mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 2 or 3 (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 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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.