Thyroid 1.5gr (90mg) Tablets

Manufacturer ANI PHARMACEUTICALS Active Ingredient Thyroid, Desiccated(THYE roid DES i kay tid) Pronunciation THYE-roid DESS-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 combination)
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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 1.5gr (90mg) Tablets contain natural thyroid hormones (T3 and T4) from animal thyroid glands. It's used to replace the hormones your own thyroid gland isn't making enough of, helping your body's metabolism work properly. This medication helps 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 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 medication once daily, preferably in the morning, on an empty stomach, at least 30-60 minutes before breakfast or any other medications/supplements (especially calcium, iron, antacids).
  • Take it at the same time each day for consistent absorption.
  • Do not stop taking this medication without consulting your doctor, as it is usually a lifelong treatment.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with thyroid hormones.
  • Regular blood tests (TSH, Free T4) are necessary to ensure you are on the correct dose.
  • Maintain a balanced diet; avoid excessive intake of foods that can interfere with thyroid function (e.g., large amounts of soy, cruciferous vegetables, though usually not an issue with stable dosing).

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 15-30 mg (0.25-0.5 grain) orally once daily. Titrate by 15-30 mg every 2-4 weeks based on clinical response and laboratory parameters (TSH, Free T4). Maintenance: 60-120 mg (1-2 grains) orally once daily. The 90mg (1.5 grain) dose is a common maintenance dose.
Dose Range: 15 - 200 mg

Condition-Specific Dosing:

elderly_cardiac_disease: Initial: 15 mg (0.25 grain) orally once daily, titrate slowly.
myxedema_coma: Not suitable for acute treatment; IV levothyroxine is preferred.
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Pediatric Dosing

Neonatal: Initial: 4-6 mg/kg/day orally. Adjust based on clinical and laboratory response. (Note: Dosing often expressed in levothyroxine equivalents for consistency, e.g., 15-30 mcg/kg/day levothyroxine for congenital hypothyroidism).
Infant: Initial: 3-5 mg/kg/day orally. Adjust based on clinical and laboratory response.
Child: Initial: 2-4 mg/kg/day orally. Adjust based on clinical and laboratory response.
Adolescent: Initial: 1-2 mg/kg/day orally. Adjust based on clinical and laboratory response, similar to adult titration.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.
Dialysis: No specific dose adjustment required; not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required, but monitor closely.
Severe: No specific dose adjustment required, but monitor closely as metabolism may be altered. Use with caution.

Pharmacology

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Mechanism of Action

Thyroid, desiccated, is a natural product derived from porcine thyroid glands, containing both levothyroxine (T4) and liothyronine (T3) in a physiological ratio. These hormones exert their metabolic effects through control of DNA transcription and protein synthesis. They bind to specific nuclear thyroid hormone receptors, regulating gene expression and influencing various cellular processes, including metabolism, growth, and development.
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Pharmacokinetics

Absorption:

Bioavailability: T4: Approximately 40-80% (variable); T3: Approximately 95%
Tmax: T4: 2-4 hours; T3: 1-2 hours
FoodEffect: Food, especially fiber, calcium, and iron, can decrease absorption. Should be taken on an empty stomach.

Distribution:

Vd: T4: 10-12 L; T3: 0.4-0.6 L/kg
ProteinBinding: T4: >99% (primarily to thyroxine-binding globulin [TBG], transthyretin, and albumin); T3: ~99% (less avidly than T4)
CnssPenetration: Limited (T3 crosses BBB more readily than T4)

Elimination:

HalfLife: T4: Approximately 6-7 days; T3: Approximately 1 day
Clearance: T4: 1.1 L/day; T3: 2.3 L/day
ExcretionRoute: Primarily renal (conjugated metabolites); some biliary excretion with enterohepatic recirculation.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Slow (days to weeks for full therapeutic effect due to T4 component)
PeakEffect: Weeks (for TSH suppression and clinical symptom improvement)
DurationOfAction: Long (due to T4 component's long half-life)

Safety & Warnings

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Side Effects

Serious 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 medical attention immediately:

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 change
Diarrhea, stomach cramps, or vomiting
Feeling irritable, nervous, excitable, anxious, or experiencing 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, 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 a comprehensive list of all possible side effects. 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:

  • Symptoms of too much thyroid hormone (hyperthyroidism): rapid heart rate, palpitations, chest pain, nervousness, tremor, excessive sweating, heat intolerance, unexplained weight loss, diarrhea, insomnia.
  • Symptoms of too little thyroid hormone (hypothyroidism) despite medication: persistent fatigue, weight gain, cold intolerance, constipation, dry skin, hair loss, depression.
  • Seek immediate medical attention if you experience chest pain, shortness of breath, or severe palpitations.
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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 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. You may need to wait 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. Follow 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 before 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, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia (rapid heart rate)
  • Arrhythmias (irregular heartbeat)
  • Chest pain (angina)
  • Tremor
  • Nervousness
  • Irritability
  • Insomnia
  • Excessive sweating
  • Heat intolerance
  • Diarrhea
  • Weight loss
  • Fever
  • Seizures (rare)
  • Heart failure (in susceptible individuals)

What to Do:

Contact your doctor or emergency services immediately. In case of suspected overdose, call a poison control center at 1-800-222-1222. Treatment is symptomatic and supportive, often involving reducing absorption (if recent ingestion) and managing cardiac symptoms (e.g., beta-blockers).

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., Warfarin): May increase anticoagulant effect by increasing catabolism of vitamin K-dependent clotting factors. Monitor INR/PT closely.
  • Digitalis glycosides (e.g., Digoxin): May decrease therapeutic effect of digitalis due to increased metabolism or altered receptor sensitivity. Monitor digoxin levels and clinical response.
  • Sympathomimetics (e.g., Epinephrine, Norepinephrine): Increased risk of coronary insufficiency in patients with coronary artery disease.
  • Insulin/Oral Hypoglycemics: May increase requirements for antidiabetic agents due to increased glucose production. Monitor blood glucose.
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Moderate Interactions

  • Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol): May decrease absorption of thyroid hormones. Administer thyroid hormone at least 4 hours before or after.
  • Ion Exchange Resins (e.g., Sevelamer, Patiromer): May decrease absorption. Separate administration by several hours.
  • Sucralfate: May decrease absorption. Separate administration by several hours.
  • Iron supplements, Calcium supplements, Antacids (containing aluminum or magnesium): May decrease absorption. Separate administration by at least 4 hours.
  • Proton Pump Inhibitors (PPIs) / H2 Blockers: May alter gastric pH, potentially affecting absorption. Monitor thyroid function.
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital: May increase metabolism of thyroid hormones, leading to increased dose requirements. Monitor thyroid function.
  • Estrogens (oral), Selective Estrogen Receptor Modulators (SERMs): May increase TBG levels, leading to increased thyroid hormone requirements. Monitor thyroid function.
  • Androgens, Anabolic Steroids: May decrease TBG levels, potentially decreasing thyroid hormone requirements. Monitor thyroid function.
  • Beta-blockers (e.g., Propranolol): May decrease peripheral conversion of T4 to T3. Monitor thyroid function.
  • Amiodarone: Can cause hypo- or hyperthyroidism and inhibit T4 to T3 conversion. Monitor thyroid function closely.
  • Corticosteroids: Can inhibit T4 to T3 conversion. Monitor thyroid function.
  • SSRIs (e.g., Sertraline): May increase thyroid hormone requirements. Monitor thyroid function.
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Minor Interactions

  • Dietary Fiber: Can bind thyroid hormones and reduce absorption. Take consistently with or without fiber.

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 symptom severity and guide treatment goals.

Timing: Before initiation of therapy.

Cardiac Status (ECG, history of CAD)

Rationale: To assess risk for adverse cardiac events, especially in elderly or those with pre-existing heart disease.

Timing: Before initiation of therapy, especially in older adults or those with cardiac risk factors.

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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 age, comorbidities, and etiology of hypothyroidism).

Action Threshold: If TSH is outside target range, adjust dose and recheck in 6-8 weeks.

Free Thyroxine (Free T4)

Frequency: Often checked concurrently with TSH, especially during titration or if TSH is suppressed.

Target: Typically within the upper half of the reference range, but can vary.

Action Threshold: If Free T4 is high with suppressed TSH, consider dose reduction. If low with elevated TSH, consider dose increase.

Clinical Symptoms (e.g., fatigue, weight, mood, cold intolerance)

Frequency: At every visit.

Target: Resolution or significant improvement of hypothyroid symptoms.

Action Threshold: Persistent symptoms may indicate need for dose adjustment or evaluation for other causes.

Heart Rate and Rhythm

Frequency: At every visit.

Target: Normal sinus rhythm, heart rate 60-100 bpm.

Action Threshold: Tachycardia, palpitations, or arrhythmias may indicate overtreatment.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia or tachycardia
  • Palpitations
  • Nervousness or irritability
  • Tremor
  • Heat intolerance
  • Diarrhea
  • Insomnia

Special Patient Groups

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Pregnancy

Category A. 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 child. Increased doses are often required during pregnancy due to increased TBG levels and placental deiodination.

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 increased dose; fetal thyroid gland begins to function, but still relies on maternal thyroid hormones.
Third Trimester: Dose requirements typically remain elevated. Monitor TSH every 4-6 weeks throughout pregnancy.
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Lactation

L1 (Safest). Thyroid hormones are minimally excreted into breast milk and are considered compatible with breastfeeding. No adverse effects on the infant have been reported.

Infant Risk: Minimal to none. Considered safe for nursing infants.
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Pediatric Use

Essential for normal growth and development. Dosage is weight-based and adjusted frequently, especially in infants and young children, to maintain TSH and Free T4 within target ranges. Overtreatment can lead to craniosynostosis in infants and accelerated bone maturation/premature epiphyseal closure in children. Undertreatment leads to impaired physical and mental development.

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Geriatric Use

Lower starting doses are recommended, especially in patients with pre-existing cardiac disease, due to increased sensitivity to thyroid hormones and a higher risk of adverse cardiovascular effects. Dose titration should be slower and more cautious. Monitor for signs of cardiac toxicity (e.g., angina, arrhythmias).

Clinical Information

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Clinical Pearls

  • Desiccated thyroid contains both T4 and T3, which can lead to more variable TSH levels compared to levothyroxine monotherapy. Some patients may have suppressed TSH but normal Free T4/T3 due to the direct T3 component.
  • Always take on an empty stomach, consistently at the same time each day, separated from food and other medications/supplements by at least 30-60 minutes.
  • Not interchangeable unit-for-unit with levothyroxine. 60 mg (1 grain) of desiccated thyroid is roughly equivalent to 100 mcg of levothyroxine, but individual patient response varies.
  • Patients switching from levothyroxine to desiccated thyroid or vice versa require careful monitoring and dose adjustment.
  • Educate patients that this medication is not for weight loss in euthyroid individuals and can cause serious side effects if misused for this purpose.
  • Monitor for symptoms of both hypo- and hyperthyroidism, as clinical picture is crucial in addition to lab values.
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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, Triostat): Used for short-term TSH suppression or in combination with levothyroxine for specific cases.
  • Levothyroxine/Liothyronine combination products (e.g., Thyrolar): Synthetic combination of T4 and T3 in a fixed ratio.
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Cost & Coverage

Average Cost: $20 - $60 per 30 tablets (90mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic preferred)
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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 your 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 medication taken, the amount, and the time it happened.