Levothyroxine 0.175mg (175mcg) Tabs

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
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Pregnancy Category
Category A
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FDA Approved
Jan 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 when your thyroid gland doesn't make enough of this hormone (a condition called hypothyroidism). Taking this medicine helps your body work properly, regulating your energy, metabolism, and other important functions.
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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 right away after mixing, and do not store the mixture for future use.

Important Interactions to Consider

Do not take iron products, antacids that contain aluminum or magnesium, or calcium carbonate within 4 hours before or 4 hours after taking your medication.
If you take 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 different brands or forms 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 the bathroom.
Protect your medication from heat and light.
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 your medicine exactly as prescribed by your doctor, usually once a day in the morning.
  • Take it on an empty stomach, at least 30-60 minutes before breakfast or any other food, beverages (except water), or medications.
  • Take it with a full glass of water.
  • Do not take it at the same time as calcium supplements, iron supplements, antacids, or certain other medications. Separate these by at least 4 hours.
  • Do not switch between different brands or generic versions of levothyroxine without consulting your doctor, as formulations can vary and may require dose adjustment.
  • Continue taking this medication even if you feel well; it is usually a lifelong treatment.
  • Report any new or worsening symptoms to your doctor, especially signs of overactive thyroid (e.g., fast heartbeat, nervousness, sweating, weight loss) or underactive thyroid (e.g., fatigue, weight gain, constipation).

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized. For primary hypothyroidism, typical full replacement dose is 1.6 mcg/kg/day (e.g., 100-125 mcg/day for a 70kg adult). 175 mcg is a common maintenance dose for some patients.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial dose typically 25-50 mcg/day, adjusted by 12.5-25 mcg increments every 4-6 weeks based on TSH levels. Full replacement dose is 1.6 mcg/kg/day. For patients with cardiovascular disease, initial dose 12.5-25 mcg/day.
thyroidCancerSuppression: Higher doses (e.g., 2.0-2.5 mcg/kg/day) to suppress TSH to very low or undetectable levels.
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day (0-3 months), adjusted based on TSH and T4.
Infant: 6-8 mcg/kg/day (3-6 months); 5-7 mcg/kg/day (6-12 months), adjusted based on TSH and T4.
Child: 4-5 mcg/kg/day (1-5 years); 3-4 mcg/kg/day (6-12 years), adjusted based on TSH and T4.
Adolescent: 2-3 mcg/kg/day (12-17 years); 1.6 mcg/kg/day (growth and puberty complete), adjusted based on TSH and T4.
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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. Levothyroxine is highly protein-bound and not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Levothyroxine (L-thyroxine) is a synthetic form of thyroxine (T4), a hormone naturally produced by the thyroid gland. T4 is converted to its active metabolite, L-triiodothyronine (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, fat, and carbohydrate metabolism, and influencing growth and development.
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Pharmacokinetics

Absorption:

Bioavailability: 48-80% (average 70-80%), highly variable among individuals and affected by food, other medications, and gastrointestinal conditions.
Tmax: 2-4 hours (for T4); 24-48 hours (for T3, due to peripheral conversion).
FoodEffect: Food, especially fiber, soy, and calcium-rich foods, significantly decreases absorption. Should be taken on an empty stomach, typically 30-60 minutes before breakfast.

Distribution:

Vd: 10-13 L (0.13 L/kg).
ProteinBinding: >99% (primarily to thyroxine-binding globulin (TBG), but also to thyroxine-binding prealbumin (transthyretin) and albumin).
CnssPenetration: Limited (due to high protein binding), but active transport mechanisms exist for thyroid hormones to cross the blood-brain barrier.

Elimination:

HalfLife: Approximately 7 days (range 6-10 days); shorter in hyperthyroidism, longer in hypothyroidism.
Clearance: Approximately 0.05 L/hr/kg.
ExcretionRoute: Primarily renal (as T3 and T4 conjugates); approximately 20% excreted in feces.
Unchanged: <1% (of T4) excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Gradual, typically 3-5 days, but full therapeutic effect may take 4-6 weeks due to long half-life and need for steady-state levels.
PeakEffect: Peak therapeutic effect on TSH suppression is typically observed after 4-6 weeks of consistent dosing.
DurationOfAction: Due to its 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

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 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 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. Many people experience no side effects or only mild ones. If you notice 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, 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:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat (palpitations)
  • Excessive sweating
  • Tremor
  • Nervousness or anxiety
  • Insomnia
  • Unexplained weight loss
  • Diarrhea
  • Hair loss (especially early in treatment, usually temporary)
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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

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. This will help prevent potential interactions and ensure the safe use of this medication with your other treatments and health conditions.
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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 recommended.

If you are taking biotin or a product containing biotin, stop using 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 developing weak bones (osteoporosis), particularly after menopause. Discuss your risk factors with your doctor, who can help determine if you are at higher risk of osteoporosis.

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.

Special Considerations

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

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 with you, considering both your health and the baby's well-being.

Pediatric Patients

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, and your doctor will monitor your child's growth and development.
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Overdose Information

Overdose Symptoms:

  • Headache
  • Irritability
  • Nervousness
  • Sweating
  • Increased appetite
  • Weight loss
  • Diarrhea
  • Palpitations
  • Tachycardia (fast heart rate)
  • Arrhythmias (irregular heart rhythm)
  • Tremor
  • Insomnia
  • Fever
  • Heat intolerance
  • Chest pain (angina)
  • Heart failure (in susceptible patients)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve supportive care, beta-blockers for cardiac symptoms, and measures to reduce absorption if recent ingestion.

Drug Interactions

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Major Interactions

  • Amiodarone (can cause hypo- or hyperthyroidism, alters T4/T3 conversion)
  • Oral anticoagulants (e.g., Warfarin - levothyroxine may increase anticoagulant effect by increasing catabolism of vitamin K-dependent clotting factors)
  • Ion exchange resins (e.g., Cholestyramine, Colestipol, Sevelamer, Patiromer - significantly decrease levothyroxine absorption; separate administration by at least 4 hours)
  • Sucralfate (decreases levothyroxine absorption; separate administration by at least 4 hours)
  • Proton pump inhibitors (PPIs) (e.g., Omeprazole, Lansoprazole - may decrease levothyroxine absorption due to increased gastric pH; monitor TSH)
  • Antacids (e.g., Aluminum hydroxide, Calcium carbonate - decrease levothyroxine absorption; separate administration by at least 4 hours)
  • Iron supplements (decrease levothyroxine absorption; separate administration by at least 4 hours)
  • Calcium supplements (decrease levothyroxine absorption; separate administration by at least 4 hours)
  • Tyrosine kinase inhibitors (e.g., Sunitinib, Imatinib - may increase TSH levels and require increased levothyroxine dose)
  • Orlistat (may decrease levothyroxine absorption; separate administration by at least 4 hours)
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Moderate Interactions

  • Estrogens (e.g., Oral contraceptives, HRT - increase TBG, potentially increasing levothyroxine requirements)
  • Androgens (e.g., Testosterone - decrease TBG, potentially decreasing levothyroxine requirements)
  • Glucocorticoids (e.g., Prednisone - may decrease TSH secretion and alter T4/T3 conversion)
  • Beta-blockers (e.g., Propranolol - may inhibit peripheral conversion of T4 to T3)
  • Antidiabetic agents (e.g., Insulin, Metformin - levothyroxine may increase blood glucose; monitor glucose levels)
  • Digoxin (levothyroxine may decrease digoxin levels; monitor digoxin levels)
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital (induce hepatic metabolism of thyroid hormones, potentially increasing levothyroxine requirements)
  • Sertraline (may increase levothyroxine requirements, especially in patients on stable doses)
  • Soy products (may decrease levothyroxine absorption; separate administration)
  • Coffee (may decrease levothyroxine absorption; separate administration)
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Minor Interactions

  • Dietary fiber (may decrease absorption if taken concurrently)

Monitoring

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Baseline Monitoring

Thyroid-stimulating hormone (TSH)

Rationale: To establish baseline thyroid function and confirm diagnosis of hypothyroidism.

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid hormone levels, especially in central hypothyroidism or when TSH is unreliable.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To document baseline symptoms for future comparison and assessment of treatment efficacy.

Timing: Prior to initiation of 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: Typically 0.4-4.0 mIU/L for primary hypothyroidism (individualized based on patient age, comorbidities, and specific clinical goals). For thyroid cancer suppression, target may be <0.1 mIU/L or undetectable.

Action Threshold: If TSH is outside target range, adjust levothyroxine dose. If TSH is high, increase dose; if TSH is low, decrease dose.

Free Thyroxine (Free T4)

Frequency: May be monitored concurrently with TSH, especially if TSH is suppressed or in central hypothyroidism. Less frequently needed once stable.

Target: Within normal reference range (e.g., 0.8-1.8 ng/dL), but often in the upper half of the range when TSH is optimally suppressed.

Action Threshold: If Free T4 is low or high, adjust dose in conjunction with TSH.

Clinical symptoms of hypo/hyperthyroidism

Frequency: At every visit.

Target: Resolution of hypothyroid symptoms (e.g., fatigue, weight gain, constipation, cold intolerance) and absence of hyperthyroid symptoms (e.g., palpitations, anxiety, weight loss, heat intolerance).

Action Threshold: Persistent symptoms of hypothyroidism despite normal TSH may indicate need for further investigation or dose adjustment. Emergence of hyperthyroid symptoms indicates potential overtreatment.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Constipation or diarrhea
  • Cold or heat intolerance
  • Dry skin or hair loss
  • Muscle aches or weakness
  • Depression or anxiety
  • Memory impairment
  • Bradycardia or tachycardia
  • Palpitations
  • Tremor
  • Nervousness
  • Insomnia

Special Patient Groups

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Pregnancy

Levothyroxine is the drug of choice for hypothyroidism during pregnancy. Thyroid hormone requirements typically increase during pregnancy (by 25-50% or more) due to increased TBG, placental deiodination, and fetal thyroid hormone needs. Close monitoring of TSH (every 4-6 weeks) and dose adjustments are crucial to maintain maternal euthyroidism, which is essential for fetal neurodevelopment.

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 need for increased dose; fetal thyroid gland begins to function, but maternal thyroid hormones are still critical.
Third Trimester: Continued need for increased dose; maternal thyroid hormones remain important for fetal brain development.
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Lactation

Levothyroxine is considered safe during breastfeeding. Only small amounts are excreted into breast milk, and these amounts are not sufficient to cause adverse effects in the infant or affect infant thyroid function. It is compatible with breastfeeding.

Infant Risk: Minimal to no risk (L1).
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Pediatric Use

Dosing is weight-based and higher per kilogram than in adults, especially in infants and young children, due to higher metabolic rates and rapid growth. Regular monitoring of TSH and Free T4 is essential to ensure proper growth and neurodevelopment. Adherence is critical for preventing irreversible cognitive impairment in congenital hypothyroidism.

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Geriatric Use

Older patients, especially those with underlying cardiovascular disease, should be started on lower initial doses (e.g., 12.5-25 mcg/day) and titrated more slowly to avoid precipitating cardiac events. Monitor for symptoms of hyperthyroidism. TSH target ranges may be slightly higher in very elderly patients.

Clinical Information

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Clinical Pearls

  • Levothyroxine has a narrow therapeutic index; small dose changes can have significant effects on TSH.
  • Consistency is key: Advise patients to take the medication at the same time each day, preferably in the morning on an empty stomach, 30-60 minutes before food or other medications.
  • Avoid concurrent administration with calcium, iron, antacids, and certain other medications (separate by at least 4 hours).
  • Patients should be advised not to switch between different generic or brand formulations without consulting their physician, as bioequivalence can vary, potentially requiring dose adjustments.
  • Full therapeutic effect and TSH stabilization may take 4-6 weeks after a dose change.
  • Symptoms of hypothyroidism may take several weeks or months to fully resolve after achieving euthyroidism.
  • Educate patients on symptoms of both hypo- and hyperthyroidism to recognize potential under- or overtreatment.
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Alternative Therapies

  • Liothyronine (synthetic T3 - Cytomel, Triostat; shorter half-life, more potent, higher risk of fluctuations)
  • Desiccated thyroid extract (natural thyroid hormone from porcine glands, contains T4 and T3 - Armour Thyroid, Nature-Throid, NP Thyroid)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and generic manufacturer, typically $10-$50 per 30 tablets
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 is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.