Thyroid 0.25gr (15mg)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 (T4 and T3)
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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?

Desiccated thyroid is a medication that replaces the hormones normally made by your thyroid gland. It contains both T4 and T3 hormones, which are important for your body's energy, metabolism, and overall function. It's used to treat an underactive thyroid (hypothyroidism).
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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, 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 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 or at bedtime (at least 3 hours after the last meal).
  • Take at the same time each day for consistent absorption.
  • Avoid taking with calcium, iron, antacids, or fiber supplements within 4 hours of your thyroid medication.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's TSH and clinical response. Common starting dose is 15-30 mg (0.25-0.5 grain) orally once daily, titrated every 4-6 weeks.
Dose Range: 15 - 180 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 15-30 mg (0.25-0.5 grain) orally once daily. Titrate by 15 mg increments every 4-6 weeks based on TSH and clinical response. Maintenance: 60-120 mg (1-2 grains) daily, but can vary widely.
myxedemaComa: Not typically used for acute myxedema coma; IV levothyroxine and liothyronine are preferred.
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Pediatric Dosing

Neonatal: Initial: 7.5-15 mg (0.125-0.25 grain) orally once daily. Dosing is weight-based and titrated to TSH. (e.g., 4.8-6 mg/kg/day for congenital hypothyroidism, then adjusted).
Infant: Initial: 7.5-15 mg (0.125-0.25 grain) orally once daily. Dosing is weight-based and titrated to TSH.
Child: Initial: 15-30 mg (0.25-0.5 grain) orally once daily. Dosing is weight-based and titrated to TSH.
Adolescent: Initial: 30-60 mg (0.5-1 grain) orally once daily. Titrated to TSH and clinical response.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment required, monitor TSH and clinical response.
Moderate: No specific adjustment required, monitor TSH and clinical response.
Severe: No specific adjustment required, monitor TSH and clinical response.
Dialysis: No specific adjustment required, monitor TSH and clinical response.

Hepatic Impairment:

Mild: No specific adjustment required, monitor TSH and clinical response.
Moderate: No specific adjustment required, monitor TSH and clinical response.
Severe: No specific adjustment required, monitor TSH and clinical response.

Pharmacology

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Mechanism of Action

Desiccated thyroid provides exogenous thyroid hormones, primarily L-thyroxine (T4) and L-triiodothyronine (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 (approximately 48-80% for T4, 95% for T3), influenced by food and other medications.
Tmax: T4: 2-4 hours; T3: 1-2 hours
FoodEffect: Decreased absorption when taken with food, fiber, or certain medications (e.g., calcium, iron, antacids).

Distribution:

Vd: T4: 10-13 L; T3: 0.46 L/kg
ProteinBinding: T4: >99% (primarily to thyroxine-binding globulin [TBG], transthyretin, and albumin); T3: ~99%
CnssPenetration: Limited (T4 and T3 cross the blood-brain barrier to varying degrees)

Elimination:

HalfLife: T4: 6-7 days (euthyroid), 9-10 days (hypothyroid), 3-4 days (hyperthyroid); T3: ~1 day
Clearance: T4: 1.1 L/day; T3: 2.3 L/day
ExcretionRoute: Renal (approximately 80% as metabolites), fecal (approximately 20% as unchanged drug and metabolites, including enterohepatic recirculation)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects may take several days to weeks due to T4 conversion to T3 and T4's long half-life.
PeakEffect: Weeks to achieve steady state and full therapeutic effect.
DurationOfAction: Weeks (due to long half-life of T4)

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including desiccated thyroid, 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 Attention Immediately

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 medical help right away:

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 unusual symptoms, 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, 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:

  • Symptoms of too much thyroid hormone (hyperthyroidism): rapid heart rate, palpitations, chest pain, shortness of breath, excessive sweating, heat intolerance, nervousness, anxiety, tremors, insomnia, weight loss, diarrhea.
  • Symptoms of too little thyroid hormone (hypothyroidism): extreme 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 your safety, please 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

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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. 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 a product containing biotin, discontinue its 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:

  • Palpitations
  • Tachycardia
  • Arrhythmias (e.g., atrial fibrillation)
  • Chest pain (angina)
  • Shortness of breath
  • Nervousness, anxiety, irritability
  • Tremors
  • Insomnia
  • Excessive sweating, heat intolerance
  • Weight loss
  • Diarrhea
  • Vomiting
  • Fever
  • Seizures (rare)
  • Coma (rare)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and may include beta-blockers for cardiac symptoms, and measures to reduce absorption if recent ingestion.

Drug Interactions

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Contraindicated Interactions

  • Not recommended for weight reduction in euthyroid patients or for treatment of obesity.
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Major Interactions

  • Warfarin (increased anticoagulant effect)
  • Antidiabetic agents (increased blood glucose, may require increased antidiabetic dose)
  • Digoxin (decreased digoxin levels)
  • Cholestyramine, Colestipol, Sevelamer, Sucralfate, Calcium Carbonate, Iron Salts, Aluminum Hydroxide (decreased thyroid hormone absorption)
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists (decreased thyroid hormone absorption due to altered gastric pH)
  • Tyrosine Kinase Inhibitors (e.g., imatinib, sunitinib) (may alter thyroid function, requiring dose adjustment)
  • Amiodarone (may cause hypo- or hyperthyroidism, alters T4 to T3 conversion)
  • Beta-blockers (may decrease T4 to T3 conversion)
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Moderate Interactions

  • Estrogens (increased TBG, may increase thyroid hormone requirements)
  • Androgens (decreased TBG, may decrease thyroid hormone requirements)
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital (increased thyroid hormone metabolism, may increase thyroid hormone requirements)
  • SSRIs (may alter thyroid function tests, clinical significance varies)
  • Corticosteroids (may inhibit TSH secretion and T4 to T3 conversion)
  • Iodine-containing products (may affect thyroid function)
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Minor Interactions

  • Dietary fiber (may decrease absorption)
  • Soy products (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: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: Assesses circulating unbound T4 levels.

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.

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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, but individualized based on patient age, comorbidities, and specific clinical goals (e.g., lower range for thyroid cancer patients).

Action Threshold: If TSH is outside target range, adjust dose and re-check in 4-6 weeks. If TSH is suppressed or elevated, assess for symptoms of hyper/hypothyroidism.

Free Thyroxine (Free T4)

Frequency: May be checked with TSH, especially if TSH is abnormal or if central hypothyroidism is suspected.

Target: Within normal reference range (e.g., 0.8-1.8 ng/dL), but interpretation should be in conjunction with TSH and clinical status.

Action Threshold: If outside normal range, adjust dose and re-check with TSH.

Clinical Symptoms (e.g., fatigue, weight, mood, heart rate)

Frequency: At every visit.

Target: Resolution or significant improvement of hypothyroid symptoms without developing hyperthyroid symptoms.

Action Threshold: Presence of persistent hypothyroid symptoms or emergence of hyperthyroid symptoms warrants TSH/Free T4 re-evaluation and dose adjustment.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold or heat intolerance
  • Constipation or diarrhea
  • Dry skin or hair loss
  • Bradycardia or tachycardia
  • Depression or anxiety
  • Muscle aches or weakness
  • 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 therapy throughout pregnancy to ensure proper fetal development and maternal health. TSH levels should be monitored closely (e.g., every 4-6 weeks) and dose adjusted to maintain TSH in the lower half of the reference range for pregnancy (typically 0.1-2.5 mIU/L in the first trimester, 0.2-3.0 mIU/L in the second, and 0.3-3.0 mIU/L in the third).

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism in the first trimester is associated with increased risk of miscarriage, preterm birth, preeclampsia, and impaired neurocognitive development in the offspring.
Second Trimester: Continued risk of adverse maternal and fetal outcomes if hypothyroidism is not adequately treated.
Third Trimester: Continued risk of adverse maternal and fetal outcomes if hypothyroidism is not adequately treated.
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Lactation

Thyroid hormones are excreted in breast milk in small amounts, but are generally considered safe for the nursing infant. Maternal thyroid hormone replacement is essential for the mother's health and does not pose a significant risk to the infant at therapeutic doses. Monitoring of infant thyroid function is not routinely required unless there are clinical concerns.

Infant Risk: Low
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Pediatric Use

Essential for normal growth and development. Dosing is weight-based and titrated to TSH and clinical response. Under-treatment can lead to irreversible intellectual disability (cretinism) if congenital hypothyroidism is not treated promptly. Over-treatment can lead to craniosynostosis in infants and accelerated bone maturation and growth plate fusion in children.

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Geriatric Use

Older adults may be more sensitive to the effects of thyroid hormones, particularly cardiac effects. A lower starting dose and slower titration are recommended. Co-morbidities, especially cardiovascular disease, should be considered. TSH targets may be slightly higher in very elderly patients.

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 and T3, unlike levothyroxine which is T4 only. This can lead to more rapid onset of T3 effects and potentially higher peak T3 levels.
  • Patients transitioning from levothyroxine to desiccated thyroid, or vice versa, require careful dose conversion and close monitoring of TSH and clinical symptoms.
  • Consistency in administration (time of day, relation to food/other medications) is crucial for stable absorption and TSH levels.
  • Patients should be educated on symptoms of both under- and over-treatment to facilitate timely dose adjustments.
  • Not all patients feel better on desiccated thyroid compared to levothyroxine, and individual response varies. Shared decision-making with the patient is important.
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Alternative Therapies

  • Levothyroxine (synthetic T4, most common and preferred first-line treatment)
  • Liothyronine (synthetic T3, used in specific cases or in combination with levothyroxine)
  • Combination therapy of Levothyroxine and Liothyronine (synthetic T4/T3 combination)
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Cost & Coverage

Average Cost: Varies, generally inexpensive per 30 tablets
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 is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it is a good idea to consult with your pharmacist for more details. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and support. 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 information about the medication taken, the amount, and the time it was taken, as this will aid in providing you with the appropriate care and treatment.