Euthyrox 0.137mg (137mcg) Tab

Manufacturer PROVELL Active Ingredient Levothyroxine Tablets(lee voe thye ROKS een) Pronunciation lee voe thye ROKS een
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 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
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Pregnancy Category
Category A
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FDA Approved
Aug 1965
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Levothyroxine is a medicine that replaces a hormone normally made by your thyroid gland. It's used to treat an underactive thyroid (hypothyroidism). Taking it helps your body's metabolism work properly, reducing symptoms like tiredness, weight gain, and feeling cold.
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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.

Take your medication on an empty stomach, at least 30 to 60 minutes before breakfast.
Some brands of this medication may be more likely to cause choking, gagging, or trouble swallowing. If this is the case, you must take it with a full glass of water. Check with your pharmacist to see if this applies to your specific product.
If you need to, you can crush the tablet and mix it with 1 or 2 teaspoons (5 or 10 mL) of water. Take the dose immediately after mixing, and do not store it for future use.

Important Interactions to Consider

Do not take iron products, antacids containing aluminum or magnesium, or calcium carbonate within 4 hours before or 4 hours after taking this medication.
If you take other medications, they may need to be taken at a different time than this one. Consult with your doctor or pharmacist to determine the best schedule.
Certain foods, such as soybean flour (found in infant formula), may affect how this medication works in your body. Discuss this with your doctor.
If you regularly drink grapefruit juice or eat grapefruit, talk to your doctor about potential interactions.

Using the Correct Form of Your Medication

There are different brands and forms of this medication. Do not switch between them without consulting your doctor.
Continue taking your medication as directed by your doctor or healthcare provider, even if you feel well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Protect it from heat and light.
If your medication comes in a blister pack, do not remove it until you are ready to take it. Do not store the removed medication for future use.

What to Do If You Miss a Dose

Take a missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and return to 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, typically 30-60 minutes before breakfast, with a full glass of water.
  • Avoid taking with food, iron, calcium, antacids, or other medications within 4 hours (some sources recommend 2 hours, others 4 hours, or even longer for specific drugs like bile acid sequestrants).
  • Take at the same time each day for consistent absorption.
  • Do not switch brands or generic formulations without consulting your doctor, as different products may have different bioavailabilities.
  • Continue taking as prescribed, even if you feel better. This is usually a lifelong medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 1.7 mcg/kg/day orally once daily. Maintenance: 100-125 mcg/day orally once daily (average).
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism_initial: 25-50 mcg/day, titrate by 12.5-25 mcg every 4-6 weeks based on TSH.
myxedema_coma: 300-500 mcg IV loading dose, then 50-100 mcg IV daily.
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day orally once daily (congenital hypothyroidism).
Infant: 6-8 mcg/kg/day orally once daily (0-3 months); 5-6 mcg/kg/day (3-6 months); 4-5 mcg/kg/day (6-12 months).
Child: 3-4 mcg/kg/day orally once daily (1-5 years); 2-3 mcg/kg/day (6-12 years).
Adolescent: 1.7 mcg/kg/day orally once daily (growth completed).
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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; not significantly dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed; monitor thyroid function closely.
Confidence: Medium

Pharmacology

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Mechanism of Action

Levothyroxine (T4) is a synthetic form of the natural thyroid hormone, thyroxine. It is converted to its active metabolite, liothyronine (T3), in peripheral tissues. T3 and T4 act on thyroid hormone receptors in the cell nucleus to regulate gene expression, controlling metabolism, growth, and development.
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Pharmacokinetics

Absorption:

Bioavailability: 48-80% (average 70-80%)
Tmax: 2-4 hours
FoodEffect: Decreased absorption when taken with food, certain medications (e.g., iron, calcium, antacids, bile acid sequestrants, proton pump inhibitors). Should be taken on an empty stomach.

Distribution:

Vd: Approximately 10-13 L
ProteinBinding: >99% (primarily to thyroxine-binding globulin, transthyretin, and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 6-7 days (euthyroid); 9-10 days (hypothyroid); 3-4 days (hyperthyroid)
Clearance: Approximately 0.05 L/hr
ExcretionRoute: Renal (approximately 80% of metabolites), fecal (approximately 20% of metabolites)
Unchanged: <1% (renal)
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects may take several days to weeks.
PeakEffect: Clinical steady state achieved in 4-6 weeks.
DurationOfAction: Long, due to long half-life.

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including levothyroxine, alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. 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 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 immediately or seek emergency 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 or loss of consciousness
+ 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
Changes in appetite
Unintentional weight changes
Diarrhea, stomach cramps, or vomiting
Mood changes, such as feeling irritable, nervous, excitable, anxious, or restless
Shakiness
Trouble sleeping
Sensitivity to heat
Excessive sweating
Fever
Muscle cramps
Muscle weakness
Flushing
Bone pain
Changes in menstrual periods (in women)
In children: hip or knee pain, or a limp
In infants: changes in the shape of the head and face

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 symptoms that bother you or 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 an exhaustive list of 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): Fast or irregular heartbeat, chest pain, shortness of breath, excessive sweating, heat intolerance, nervousness, tremor, insomnia, unexplained weight loss, diarrhea.
  • Symptoms of too little thyroid hormone (hypothyroidism, if dose is too low or missed): Extreme fatigue, increased weight gain, constipation, feeling cold, dry skin, hair loss, depression.
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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
+ Difficulty swallowing
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins

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

Important Information for All Patients Taking This Medication

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 medication to run out. You may not experience the full effects of this medication for several weeks.

If you have diabetes (high blood sugar), consult with your doctor, as this medication may affect your blood sugar control. Your doctor may need to adjust your diabetes medications. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as advised.

When taking biotin or products containing biotin, discontinue use at least 2 days before having your thyroid levels checked to ensure accurate test results.

Potential Risks and Side Effects

High doses of this medication may increase the risk of developing weak bones (osteoporosis), particularly after menopause. Discuss your risk factors with your doctor, who can help determine if you are at higher risk.

This medication may also affect fertility, potentially leading to difficulties in getting pregnant or fathering a child. If you plan to conceive, consult with your doctor before starting treatment.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy, Breastfeeding, and Pediatric Use

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication to you and your baby.

When administering this medication to children, monitor their weight changes and consult with your doctor, as the dosage may need to be adjusted. Never exceed the recommended dose, as this may increase the risk of severe side effects. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks. Consult with your doctor to discuss any concerns.
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Overdose Information

Overdose Symptoms:

  • Acute overdose: Palpitations, tachycardia, nervousness, tremor, insomnia, sweating, fever, weight loss, diarrhea, chest pain, shortness of breath, confusion, disorientation, seizures, coma (rare).

What to Do:

Call 911 or your local emergency number immediately. For non-emergencies, call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, may include beta-blockers for cardiovascular effects.

Drug Interactions

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Major Interactions

  • Amiodarone (can cause hypo- or hyperthyroidism, alter T4/T3 conversion)
  • Warfarin (may increase anticoagulant effect)
  • Antidiabetic agents (may increase insulin/oral hypoglycemic requirements)
  • Ion exchange resins (e.g., Cholestyramine, Colestipol, Sevelamer, Patiromer - reduce absorption of levothyroxine)
  • Sucralfate (reduces absorption)
  • Proton pump inhibitors (e.g., Omeprazole, Pantoprazole - may reduce absorption)
  • Iron supplements (reduce absorption)
  • Calcium supplements (reduce absorption)
  • Aluminum-containing antacids (reduce absorption)
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Moderate Interactions

  • Estrogens (increase TBG, may increase levothyroxine requirement)
  • Androgens (decrease TBG, may decrease levothyroxine requirement)
  • Glucocorticoids (may inhibit TSH secretion and T4 to T3 conversion)
  • Beta-blockers (may decrease T4 to T3 conversion)
  • Phenytoin, Carbamazepine, Rifampin (increase levothyroxine metabolism)
  • Sertraline (may increase levothyroxine requirement)
  • Imatinib, Sunitinib (may increase levothyroxine requirement)
  • Orlistat (may reduce absorption)
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Minor Interactions

  • Dietary fiber (may reduce absorption)

Monitoring

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Baseline Monitoring

Thyroid-stimulating hormone (TSH)

Rationale: To confirm diagnosis of hypothyroidism and establish baseline.

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid hormone levels.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline symptom severity.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Thyroid-stimulating hormone (TSH)

Frequency: Every 4-6 weeks until euthyroid, then every 6-12 months or as clinically indicated.

Target: 0.4-4.0 mIU/L (individualized based on age, comorbidities, and specific condition).

Action Threshold: Adjust dose if TSH is outside target range.

Free Thyroxine (Free T4)

Frequency: May be monitored if TSH is suppressed or in central hypothyroidism, or if TSH is not reliable.

Target: 0.8-1.8 ng/dL (or laboratory specific reference range).

Action Threshold: Adjust dose if Free T4 is outside target range.

Clinical symptoms of hypo/hyperthyroidism

Frequency: At every visit.

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

Action Threshold: Adjust dose if symptoms persist or new symptoms emerge.

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Symptom Monitoring

  • Hypothyroidism: Fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, bradycardia, depression, muscle aches, menstrual irregularities.
  • Hyperthyroidism (overdose/over-treatment): Palpitations, tachycardia, nervousness, tremor, insomnia, weight loss, heat intolerance, diarrhea, sweating, chest pain, shortness of breath.

Special Patient Groups

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Pregnancy

Levothyroxine is safe and essential during pregnancy. Thyroid hormone requirements often increase during pregnancy (by 25-50% or more) due to increased TBG, placental deiodination, and fetal thyroid hormone needs. Close monitoring of TSH is crucial.

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 offspring.
Second Trimester: Continued need for increased dose; fetal thyroid gland begins to function.
Third Trimester: Continued need for increased dose; essential for fetal brain development.
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Lactation

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not clinically significant to the infant.

Infant Risk: L1 (Safest)
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Pediatric Use

Dosing is weight-based and higher per kg than in adults, especially in infants, due to higher metabolic rates and rapid growth. Regular monitoring of TSH and Free T4 is critical to ensure proper growth and neurodevelopment. Crushing tablets and mixing with a small amount of water or breast milk/formula for administration is common.

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Geriatric Use

Lower initial doses are typically recommended due to increased sensitivity to thyroid hormones and higher prevalence of underlying cardiovascular disease. Gradual titration is important to avoid cardiac adverse effects. Monitor TSH and clinical response closely.

Clinical Information

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Clinical Pearls

  • Consistency is key: Take levothyroxine at the same time every day, preferably in the morning on an empty stomach, 30-60 minutes before food or other medications.
  • Avoid taking with calcium, iron, antacids, or bile acid sequestrants; separate by at least 4 hours.
  • Do not switch between different brands or generic formulations without consulting your healthcare provider, as bioavailability can vary, potentially requiring dose adjustment.
  • Full therapeutic effect may take 4-6 weeks to be observed, and TSH levels should be rechecked at this time.
  • Patients with pre-existing cardiovascular disease should start with lower doses and titrate slowly to avoid exacerbation of cardiac symptoms.
  • Symptoms of over-treatment (hyperthyroidism) or under-treatment (hypothyroidism) should be reported to the healthcare provider immediately.
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Alternative Therapies

  • Liothyronine (T3) - used in specific cases, e.g., myxedema coma, or for short-term TSH suppression.
  • Desiccated Thyroid Extract (DTE) - derived from porcine thyroid glands, contains both T4 and T3.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (for 137mcg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (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 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 occurred.