Levothyroxine 0.05mg (50mcg) 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 replacement
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Pharmacologic Class
Thyroid hormones
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Pregnancy 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?

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 function properly, regulating your metabolism, energy levels, and other important body processes.
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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 you're taking one of these products, be sure to take it with a full glass of water. Check with your pharmacist if you're unsure.
If you need to, you can crush your tablet and mix it with 1 or 2 teaspoons (5 or 10 mL) of water. Take your dose immediately after mixing, and do not store the mixture 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 your medication.
If you're taking other medications, they may need to be taken at a different time than your current medication. Check with your doctor or pharmacist to determine the best schedule.
Certain foods, such as soybean flour (found in infant formula), may affect how your 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're feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from heat and light. Do not store it in a bathroom.
If your medication comes in a blister pack, do not remove it from the pack until you're 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's 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, preferably 30-60 minutes before breakfast, with a full glass of water.
  • Take at the same time each day to maintain consistent levels.
  • Avoid taking with food, calcium supplements, iron supplements, antacids, or certain other medications (e.g., sucralfate, bile acid sequestrants) for at least 4 hours (some recommend 6-12 hours for certain interactions).
  • Do not switch between different brands or generic versions without consulting your doctor, as formulations can vary slightly.
  • Inform your doctor if you become pregnant, as your dose may need to be increased.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 12.5-25 mcg/day, titrated by 12.5-25 mcg increments every 4-6 weeks. Maintenance: 100-125 mcg/day (average).
Dose Range: 12.5 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 1.6 mcg/kg/day (based on ideal body weight). Elderly or cardiac disease: Initial: 12.5-25 mcg/day.
myxedemaComa: IV: 200-500 mcg loading dose, then 100-300 mcg daily until stable.
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Pediatric Dosing

Neonatal: Initial: 10-15 mcg/kg/day. Adjust based on TSH/T4.
Infant: 0-3 months: 10-15 mcg/kg/day. 3-6 months: 8-10 mcg/kg/day. 6-12 months: 6-8 mcg/kg/day.
Child: 1-5 years: 5-6 mcg/kg/day. 6-12 years: 4-5 mcg/kg/day.
Adolescent: 12-17 years: 2-3 mcg/kg/day or 1.6 mcg/kg/day (adult dose).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.
Dialysis: No adjustment needed; not significantly dialyzable.

Hepatic Impairment:

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

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

Absorption:

Bioavailability: 48-79% (variable, affected by food and other drugs)
Tmax: 2-4 hours
FoodEffect: Decreased absorption when taken with food, certain foods (e.g., soy formula, fiber) and supplements (e.g., calcium, iron) can significantly reduce absorption.

Distribution:

Vd: 10-13 L
ProteinBinding: >99% (primarily to thyroxine-binding globulin, thyroxine-binding prealbumin, and albumin)
CnssPenetration: Limited (T3 crosses BBB more readily than T4)

Elimination:

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

OnsetOfAction: Gradual, effects seen over several weeks (due to long half-life and need for TSH suppression)
PeakEffect: 4-6 weeks (after reaching steady state)
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

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 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, or anxious
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 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:

  • Symptoms of too much medication (hyperthyroidism): rapid heart rate, palpitations, chest pain, shortness of breath, nervousness, irritability, insomnia, tremor, excessive sweating, heat intolerance, weight loss, diarrhea.
  • Symptoms of too little medication (hypothyroidism): 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 symptoms you experienced.
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 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

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

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, stop using them 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 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.

Special Considerations for Children

If your child is taking this medication and experiences weight changes, consult with your doctor, as the dosage may need to be adjusted. Never give your child more of this medication than prescribed, as this can 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 with your doctor to discuss any concerns.
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Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia
  • Arrhythmias
  • Chest pain
  • Tremor
  • Nervousness
  • Insomnia
  • Diarrhea
  • Weight loss
  • Fever
  • Seizures (rare)
  • Cardiac arrest (rare)

What to Do:

Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is symptomatic and supportive, often involving beta-blockers for cardiac symptoms and measures to reduce absorption if recent ingestion.

Drug Interactions

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Major Interactions

  • Warfarin (increased anticoagulant effect)
  • Antidiabetic agents (may increase blood glucose, requiring dose adjustment)
  • Amiodarone (can cause hypo- or hyperthyroidism, alters T4 to T3 conversion)
  • Bile acid sequestrants (e.g., Cholestyramine, Colestipol - reduced absorption of levothyroxine)
  • Ion exchange resins (e.g., Kayexalate - reduced absorption of levothyroxine)
  • Proton pump inhibitors (e.g., Omeprazole - reduced absorption of levothyroxine)
  • Sucralfate (reduced absorption of levothyroxine)
  • Iron supplements (reduced absorption of levothyroxine)
  • Calcium supplements (reduced absorption of levothyroxine)
  • Antacids (aluminum and magnesium containing - reduced absorption of levothyroxine)
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Moderate Interactions

  • Estrogens (oral) / Oral Contraceptives (increase TBG, may increase levothyroxine requirement)
  • Androgens / Anabolic steroids (decrease TBG, may decrease levothyroxine requirement)
  • Glucocorticoids (may alter thyroid hormone metabolism)
  • Beta-blockers (may reduce peripheral conversion of T4 to T3)
  • Phenytoin, Carbamazepine, Rifampin (increase levothyroxine metabolism)
  • Sertraline (may increase levothyroxine requirement)
  • Soy products (can decrease absorption of levothyroxine)
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Minor Interactions

  • Dietary fiber (can decrease absorption of levothyroxine)

Monitoring

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Baseline Monitoring

TSH (Thyroid-Stimulating Hormone)

Rationale: To confirm diagnosis of hypothyroidism and establish baseline for treatment.

Timing: Prior to initiation of therapy.

Free T4 (Free Thyroxine)

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

TSH (Thyroid-Stimulating Hormone)

Frequency: Every 4-6 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 etiology of hypothyroidism).

Action Threshold: TSH outside target range; adjust dose by 12.5-25 mcg.

Free T4 (Free Thyroxine)

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

Target: 0.8-1.8 ng/dL (or within normal reference range).

Action Threshold: Free T4 outside target range; adjust dose.

Clinical symptoms of hypo- or hyperthyroidism

Frequency: At every visit.

Target: Resolution of hypothyroid symptoms without development of hyperthyroid symptoms.

Action Threshold: Persistent hypothyroid symptoms or new hyperthyroid symptoms; adjust dose and recheck labs.

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Symptom Monitoring

  • Fatigue
  • Weight gain
  • Constipation
  • Cold intolerance
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Anxiety
  • Palpitations
  • Tremor
  • Heat intolerance
  • Weight loss (unintended)
  • Diarrhea
  • Tachycardia
  • Insomnia

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), especially in the first trimester. Close monitoring of TSH levels (every 4-6 weeks) and dose adjustments are crucial to ensure adequate thyroid hormone for fetal development.

Trimester-Specific Risks:

First Trimester: Increased dose often required. Inadequate maternal thyroid hormone can lead to adverse fetal neurodevelopmental outcomes.
Second Trimester: Continued monitoring and dose adjustment.
Third Trimester: Continued monitoring and dose adjustment.
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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 critical for normal growth and neurodevelopment. Regular monitoring of TSH and T4 is essential. Infants with congenital hypothyroidism require prompt and adequate treatment to prevent 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. Dose titration should be slower and more cautious. Monitor for cardiac symptoms.

Clinical Information

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Clinical Pearls

  • Always take levothyroxine on an empty stomach, 30-60 minutes before breakfast, with water. Consistency in timing is key.
  • Separate administration from calcium, iron, antacids, and other interacting medications by at least 4 hours (some recommend longer).
  • TSH is the primary lab test for monitoring, but Free T4 may be useful in specific situations (e.g., central hypothyroidism, TSH suppression).
  • Patients with cardiac disease or who are elderly should start on lower doses and titrate slowly to avoid precipitating cardiac events.
  • Symptoms of hypothyroidism can overlap with other conditions; ensure TSH is adequately controlled before attributing symptoms to other causes.
  • Patients should be advised against using levothyroxine for weight loss due to the black box warning and potential for serious adverse effects.
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Alternative Therapies

  • Liothyronine (T3, Cytomel, Triostat - used in specific cases, e.g., myxedema coma, or as an adjunct)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 50mcg)
Generic Available: Yes
Insurance Coverage: Tier 1 (generic) or Tier 2/3 (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 this 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 overdose, including the medication taken, the amount, and the time it occurred.