Thyroid 2gr (120mg) 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 made from animal thyroid glands. It contains both T4 and T3 hormones, which are essential for your body's metabolism, energy, and overall function. It's used to treat an underactive thyroid (hypothyroidism) where your body doesn't make enough of its own thyroid hormones.
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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. Certain foods, such as 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, 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 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 in the morning on an empty stomach, at least 30-60 minutes before food or other medications.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.
  • Avoid taking calcium, iron, antacids, or bile acid sequestrants within 4 hours of your thyroid medication, as they can interfere with absorption.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with thyroid hormones.
  • Maintain a consistent diet; excessive intake of soy products or high-fiber foods may affect absorption.
  • Regular blood tests (TSH, Free T4) are crucial to ensure you are on the correct dose.
  • Report any new or worsening symptoms to your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 30 mg (0.5 gr) once daily, titrated every 2-3 weeks. Maintenance: 60-120 mg (1-2 gr) once daily. The 120mg (2gr) strength is a common maintenance dose.
Dose Range: 15 - 180 mg

Condition-Specific Dosing:

hypothyroidism: Individualized based on patient response and laboratory parameters (TSH, Free T4). Administer once daily, preferably in the morning on an empty stomach, at least 30-60 minutes before food.
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Pediatric Dosing

Neonatal: Initial: 15 mg (0.25 gr) once daily, adjusted based on TSH and T4. Higher doses per kg may be needed than in adults.
Infant: Initial: 15 mg (0.25 gr) once daily, adjusted based on TSH and T4. Typical range: 30-45 mg (0.5-0.75 gr) daily.
Child: Initial: 15-30 mg (0.25-0.5 gr) once daily, adjusted based on TSH and T4. Typical range: 45-90 mg (0.75-1.5 gr) daily.
Adolescent: Initial: 30-60 mg (0.5-1 gr) once daily, adjusted based on TSH and T4. Typical range: 60-120 mg (1-2 gr) daily.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: No specific adjustment needed. Thyroid hormones are not significantly dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Caution advised, monitor closely. Metabolism may be altered, but specific dose adjustments are not well-defined.

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). These hormones exert their metabolic effects through control of DNA transcription and protein synthesis. They regulate multiple metabolic processes, including carbohydrate, lipid, and protein metabolism, and are essential for normal growth and development, particularly of the central nervous system and bone.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (48-80% for T4, 95% for T3)
Tmax: T4: 2-4 hours; T3: 1-2 hours
FoodEffect: Decreased absorption with food, especially fiber, soy, and certain supplements (calcium, iron). Should be taken on an empty stomach.

Distribution:

Vd: T4: 10-12 L; T3: 0.46 L/kg
ProteinBinding: T4: >99% (primarily to TBG, transthyretin, albumin); T3: >99% (primarily to TBG)
CnssPenetration: Limited (T4 and T3 cross the blood-brain barrier, but transport mechanisms are complex)

Elimination:

HalfLife: T4: 6-7 days; T3: 1-2 days
Clearance: T4: 1.1 L/day; T3: 2.3 L/day
ExcretionRoute: Renal (approximately 80% as metabolites), biliary/fecal (approximately 20%)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Gradual, over several days to weeks (due to T4 component)
PeakEffect: Weeks (for full therapeutic effect)
DurationOfAction: Days to weeks (due to long half-life of T4)

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 slightly higher dose of thyroid hormone may be associated with a slightly greater risk of adverse effects, especially in patients with cardiovascular 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 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
Mood changes, such as feeling irritable, nervous, excitable, anxious, or restless
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 unusual 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 not mentioned here. 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:

  • Chest pain
  • Rapid or irregular heartbeat (palpitations)
  • Shortness of breath
  • Excessive sweating
  • Tremor
  • Nervousness or irritability
  • Unexplained weight loss
  • Diarrhea
  • Fever
  • Heat intolerance
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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, both past and present

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.
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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 instructed 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 to 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
  • Fever
  • Heat intolerance
  • Weight loss

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For non-emergencies, call Poison Control at 1-800-222-1222. Management typically involves supportive care, reduction or temporary discontinuation of the drug, and symptomatic treatment (e.g., beta-blockers for cardiac symptoms).

Drug Interactions

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Major Interactions

  • Warfarin (increased anticoagulant effect)
  • Antidiabetic agents (may increase blood glucose, requiring dose adjustment of antidiabetic agent)
  • Catecholamines (increased risk of cardiac arrhythmias and hypertension)
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Moderate Interactions

  • Bile acid sequestrants (e.g., cholestyramine, colestipol) - decreased thyroid hormone absorption
  • Ion exchange resins (e.g., sevelamer, patiromer) - decreased thyroid hormone absorption
  • Sucralfate - decreased thyroid hormone absorption
  • Antacids (aluminum and magnesium hydroxide) - decreased thyroid hormone absorption
  • Iron supplements - decreased thyroid hormone absorption
  • Calcium supplements - decreased thyroid hormone absorption
  • Soy products/high-fiber diet - decreased thyroid hormone absorption
  • Proton pump inhibitors (e.g., omeprazole) - may decrease thyroid hormone absorption
  • Estrogens (oral) - increased TBG, may increase thyroid hormone requirements
  • Androgens - decreased TBG, may decrease thyroid hormone requirements
  • Beta-blockers (e.g., propranolol) - may inhibit T4 to T3 conversion
  • Amiodarone - complex effects on thyroid function, may inhibit T4 to T3 conversion
  • Iodine-containing agents - may affect thyroid function
  • SSRIs (e.g., sertraline) - may increase thyroid hormone requirements
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) - may increase thyroid hormone requirements
  • Rifampin, Carbamazepine, Phenytoin, Phenobarbital - increased thyroid hormone metabolism
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Minor Interactions

  • Dietary fiber (excessive intake) - may reduce absorption

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary indicator of thyroid function and adequacy of replacement therapy.

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: Assesses circulating unbound T4 levels.

Timing: Prior to initiation of therapy.

Free Triiodothyronine (Free T3)

Rationale: Assesses circulating unbound T3 levels. Less commonly used for routine monitoring but can be helpful in specific cases with desiccated thyroid.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline and track improvement.

Timing: Prior to 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 or if symptoms persist/worsen.

Free Thyroxine (Free T4)

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

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

Action Threshold: Adjust dose if Free T4 is outside target range or if symptoms persist/worsen.

Clinical symptoms of hypothyroidism/hyperthyroidism

Frequency: At every visit.

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

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

Heart rate, blood pressure

Frequency: At every visit.

Target: Normal limits.

Action Threshold: Monitor for signs of hyperthyroidism (tachycardia, palpitations, hypertension).

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia or tachycardia
  • Palpitations
  • Nervousness
  • Irritability
  • Tremor
  • Heat intolerance
  • Diarrhea
  • Muscle weakness
  • Menstrual irregularities

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 for both mother and baby. Thyroid, Desiccated is Category A, meaning adequate and well-controlled studies in pregnant women 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 often increase during pregnancy.

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 fetus.
Second Trimester: Continued need for adequate thyroid hormone levels for fetal brain development.
Third Trimester: Continued need for adequate thyroid hormone levels for fetal growth and development. Dose adjustments may be necessary throughout pregnancy.
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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 infant have been reported with maternal therapeutic doses. It is important for the mother to maintain euthyroid status for her own health and to support lactation.

Infant Risk: L1 (Safest - no increase in adverse effects in infants)
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Pediatric Use

Dosing is individualized based on age, weight, and TSH/T4 levels. Higher doses per kg may be required in infants and young children due to faster metabolism. Regular monitoring of growth, development, and thyroid function tests is crucial. Crushing tablets and mixing with a small amount of water or breast milk/formula for administration to infants is common.

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Geriatric Use

Older adults may be more sensitive to the effects of thyroid hormones, particularly cardiac effects. A lower initial dose and slower titration may be appropriate. Close monitoring for cardiovascular symptoms is recommended.

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 and T3, which may be preferred by some patients who feel better on a combination product compared to levothyroxine (T4 only).
  • The potency of desiccated thyroid can vary slightly between batches and manufacturers, requiring careful monitoring when switching brands or formulations.
  • 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.
  • Educate patients about potential drug and food interactions that can impair absorption (e.g., calcium, iron, antacids, soy, high-fiber foods).
  • Regular monitoring of TSH and Free T4 is essential to ensure appropriate dosing and prevent overtreatment or undertreatment.
  • Caution should be exercised in patients with pre-existing cardiovascular disease, as overtreatment can exacerbate cardiac symptoms.
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Alternative Therapies

  • Levothyroxine (synthetic T4, e.g., Synthroid, Levoxyl, Tirosint) - most commonly prescribed thyroid hormone replacement.
  • Liothyronine (synthetic T3, e.g., Cytomel) - typically used in specific situations, often as an adjunct to levothyroxine, or for short-term TSH suppression.
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Cost & Coverage

Average Cost: $20 - $60 per 30 tablets (120mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 (Brand)
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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 safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 details about the medication taken, the amount, and the time it happened.