Levothyroxine 0.025mg (25mcg) Tab

Manufacturer MYLAN 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
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Pharmacologic Class
Thyroid replacement product
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Pregnancy Category
Category A
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FDA Approved
Jul 1955
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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 when your thyroid gland doesn't make enough of this hormone, a condition called hypothyroidism. Taking this medicine helps your body's metabolism work properly, improving 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 and Brand

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.
  • Take at the same time each day for consistent absorption.
  • Separate from calcium, iron, antacids, and bile acid sequestrants by at least 4 hours.
  • Avoid taking with soy products or high-fiber foods, as they can interfere with absorption.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.
  • Regular blood tests (TSH) are necessary to ensure the correct dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 1.7 mcg/kg/day (average 100-125 mcg/day) for primary hypothyroidism. Titrate by 12.5-25 mcg/day every 4-6 weeks until euthyroid state is achieved.
Dose Range: 12.5 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 1.7 mcg/kg/day. Maintenance: 50-200 mcg/day. Elderly/cardiac patients: Initial 12.5-25 mcg/day, titrate slowly.
myxedemaComa: IV: 200-500 mcg loading dose, then 50-100 mcg daily until patient can take oral.
TSHSuppression: Varies based on target TSH level (e.g., 2.0-2.6 mcg/kg/day for differentiated thyroid cancer suppression).
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day for congenital hypothyroidism (first 3 months).
Infant: 6-8 mcg/kg/day (3-12 months).
Child: 4-6 mcg/kg/day (1-5 years); 3-5 mcg/kg/day (6-12 years).
Adolescent: 2-3 mcg/kg/day (over 12 years, or until growth is complete).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, monitor thyroid function.
Moderate: No specific adjustment needed, monitor thyroid function.
Severe: No specific adjustment needed, monitor thyroid function.
Dialysis: Not significantly dialyzable. No specific adjustment needed, monitor thyroid function.

Hepatic Impairment:

Mild: No specific adjustment needed, monitor thyroid function.
Moderate: No specific adjustment needed, monitor thyroid function.
Severe: No specific adjustment needed, monitor thyroid function.

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 then binds to thyroid hormone receptors in the cell nucleus, regulating gene expression and controlling numerous metabolic processes, including protein, carbohydrate, and lipid metabolism, and influencing growth and development.
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Pharmacokinetics

Absorption:

Bioavailability: 40-80% (highly variable, influenced by food and other medications)
Tmax: 2-4 hours
FoodEffect: Decreased absorption with food, especially fiber, soy, and certain minerals (calcium, iron). Should be taken on an empty stomach.

Distribution:

Vd: 10-13 L
ProteinBinding: >99% (primarily to thyroxine-binding globulin (TBG), transthyretin, and albumin)
CnssPenetration: Limited (T3 penetrates better than T4)

Elimination:

HalfLife: 6-7 days (euthyroid); 9-10 days (hypothyroid); 3-4 days (hyperthyroid)
Clearance: Approximately 0.05 L/hr/kg
ExcretionRoute: Renal (approximately 80% of metabolites), fecal (approximately 20% of unchanged drug and metabolites)
Unchanged: Approximately 20% of the dose is excreted unchanged in feces.
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects may take several days to weeks.
PeakEffect: Peak therapeutic effect typically seen after 4-6 weeks of consistent dosing.
DurationOfAction: Long, due to long half-life; effects persist for several days after discontinuation.

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including levothyroxine, either 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 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 attention 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
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 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 is not an exhaustive list of possible side effects. 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 hyperthyroidism (too much thyroid hormone): rapid heart rate, palpitations, chest pain, excessive sweating, heat intolerance, nervousness, tremors, insomnia, weight loss, diarrhea.
  • Symptoms of hypothyroidism (too little thyroid hormone, if dose is too low): persistent fatigue, weight gain, constipation, cold intolerance, 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, 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

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 run out of this medication, as it may take several weeks to experience its full effects.

Special Considerations

If you have diabetes (high blood sugar), consult your doctor, as this medication may affect 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.

If you take biotin or products containing biotin, stop taking it 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 osteoporosis (weak bones), 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 your doctor before starting treatment.

Age-Related Considerations

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

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication for you and your baby.

Pediatric Patients

If your child is taking this medication and experiences weight changes, consult your doctor, as the dosage may need to be adjusted. Never give your child more than the prescribed dose, as this may increase the risk of severe side effects.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult your doctor to discuss any concerns.
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Overdose Information

Overdose Symptoms:

  • Headache
  • Irritability
  • Nervousness
  • Sweating
  • Diarrhea
  • Tachycardia (fast heart rate)
  • Arrhythmias (irregular heart beat)
  • Chest pain
  • Tremor
  • Insomnia
  • Fever
  • Heat intolerance

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Management is supportive and symptomatic, often involving beta-blockers for cardiac effects.

Drug Interactions

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Major Interactions

  • Bile acid sequestrants (e.g., cholestyramine, colestipol): Reduce levothyroxine absorption.
  • Ion exchange resins (e.g., sevelamer, patiromer): Reduce levothyroxine absorption.
  • Sucralfate: Reduces levothyroxine absorption.
  • Iron supplements: Reduce levothyroxine absorption.
  • Calcium supplements: Reduce levothyroxine absorption.
  • Antacids (aluminum, magnesium, simethicone): Reduce levothyroxine absorption.
  • Proton pump inhibitors (e.g., omeprazole): May reduce levothyroxine absorption.
  • H2 receptor blockers (e.g., cimetidine): May reduce levothyroxine absorption.
  • Orlistat: May reduce levothyroxine absorption.
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital: Increase levothyroxine metabolism.
  • Amiodarone: Can cause hypo- or hyperthyroidism, and alter T4 to T3 conversion.
  • Warfarin: Levothyroxine may potentiate anticoagulant effects, increasing bleeding risk.
  • Antidiabetic agents (insulin, oral hypoglycemics): Levothyroxine may increase blood glucose, requiring increased antidiabetic dose.
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Moderate Interactions

  • Soy products: May decrease levothyroxine absorption.
  • Dietary fiber: May decrease levothyroxine absorption.
  • Grapefruit juice: May decrease levothyroxine absorption.
  • Estrogens (oral): Increase TBG, potentially increasing levothyroxine requirements.
  • Androgens: Decrease TBG, potentially decreasing levothyroxine requirements.
  • Beta-blockers: May decrease conversion of T4 to T3.
  • Tricyclic antidepressants: Increased sensitivity to TCAs, increased risk of arrhythmias.
  • Digitalis glycosides: Decreased therapeutic effect of digitalis.
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Minor Interactions

  • Caffeine: No significant interaction, but some patients report increased anxiety.

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary diagnostic and monitoring tool for hypothyroidism.

Timing: Before initiating therapy.

Free Thyroxine (Free T4)

Rationale: Assesses circulating unbound T4 levels, useful in certain conditions (e.g., central hypothyroidism, pregnancy).

Timing: Before initiating therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline and track improvement.

Timing: Before initiating therapy.

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Routine Monitoring

Thyroid Stimulating Hormone (TSH)

Frequency: Every 4-6 weeks after initiation or dose change, then every 6-12 months once stable.

Target: 0.4-4.0 mIU/L (for primary hypothyroidism, target often 0.5-2.5 mIU/L). Target varies for TSH suppression.

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

Free Thyroxine (Free T4)

Frequency: May be checked with TSH, especially if TSH is suppressed or in central hypothyroidism.

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

Action Threshold: Adjust dose if Free T4 is outside target range, especially if TSH is not reliable.

Clinical symptoms (e.g., fatigue, weight, mood, energy)

Frequency: At each visit.

Target: Resolution or improvement of hypothyroid symptoms.

Action Threshold: Consider dose adjustment or further investigation if symptoms persist despite normal labs.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Memory impairment
  • Muscle aches
  • Menstrual irregularities

Special Patient Groups

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Pregnancy

Levothyroxine is Category A and is safe and essential during pregnancy. Thyroid hormone requirements often increase during pregnancy (by 25-50% or more) due to increased TBG and fetal needs. Close monitoring of TSH (every 4-6 weeks) 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 child.
Second Trimester: Continued need for increased dose; fetal thyroid gland begins to function, but maternal thyroid hormone is still critical.
Third Trimester: Continued need for increased dose; essential for fetal brain development.
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Lactation

Levothyroxine is compatible with breastfeeding (L1). Only small amounts are excreted into breast milk, which are not clinically significant to the infant.

Infant Risk: Low risk to infant.
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Pediatric Use

Dosing is weight-based and higher per kg than in adults, especially in neonates and infants, due to rapid growth and development. Regular monitoring of TSH and Free T4 is essential to ensure proper growth and neurocognitive development. Under-treatment can lead to irreversible intellectual disability.

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Geriatric Use

Lower initial doses (e.g., 12.5-25 mcg/day) are recommended, especially in patients with underlying cardiovascular disease, due to increased sensitivity to thyroid hormones and risk of cardiac adverse effects. Dose titration should be slower and more cautious. Monitor for cardiac symptoms.

Clinical Information

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Clinical Pearls

  • Take levothyroxine consistently at the same time each day, preferably 30-60 minutes before breakfast, with water, to maximize absorption.
  • Separate administration from calcium, iron, antacids, and other interacting medications by at least 4 hours.
  • Do not switch between different brands or generic formulations without consulting a healthcare provider, as bioequivalence can vary and may require dose adjustment.
  • Patients with central hypothyroidism (pituitary/hypothalamic dysfunction) should be monitored with Free T4 levels, as TSH may not be a reliable indicator.
  • Symptoms of over- or under-treatment can mimic other conditions; always correlate with TSH and Free T4 levels.
  • Weight loss is NOT an indication for levothyroxine in euthyroid individuals and can be dangerous.
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Alternative Therapies

  • Liothyronine (T3) - used in specific situations like myxedema coma or for short-term TSH suppression before radioactive iodine.
  • Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from porcine thyroid glands.
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (for 25mcg generic)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.