Euthyrox 88mcg Tablets

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 hormone
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Pregnancy Category
Category A
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FDA Approved
Jan 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. Your thyroid gland helps control your body's energy and metabolism. When your thyroid doesn't make enough of this hormone (a condition called hypothyroidism), this medicine helps bring your hormone levels back to normal, improving symptoms like tiredness, weight gain, and feeling cold.
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How to Use This Medicine

Taking Your Medication

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 medication. 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 from the pack 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 other medications, especially calcium, iron, antacids, or fiber supplements, for at least 4 hours.
  • Take at the same time each day for consistent absorption.
  • Do not switch between different brands or generic versions without consulting your doctor, as formulations can vary and affect absorption.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regular blood tests (TSH) are crucial to ensure the correct dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized, typically 1.6 mcg/kg/day orally once daily. Initial dose often 25-50 mcg/day, adjusted by 12.5-25 mcg increments every 4-6 weeks based on TSH levels.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 1.6 mcg/kg/day. Elderly or cardiac disease: Initial 12.5-25 mcg/day.
thyroid_stimulating_hormone_suppression: Higher doses may be required for TSH suppression in thyroid cancer.
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Pediatric Dosing

Neonatal: Initial: 10-15 mcg/kg/day orally once daily. Adjust based on TSH and 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 (full adult replacement dose).
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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.

Pharmacology

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Mechanism of Action

Levothyroxine sodium is a synthetic L-isomer of thyroxine (T4), which is converted to its active metabolite, L-triiodothyronine (T3), in peripheral tissues. T3 and T4 bind to thyroid hormone receptors in the cell nucleus and exert their metabolic effects through gene transcription and protein synthesis, regulating metabolism, growth, and development.
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Pharmacokinetics

Absorption:

Bioavailability: 48-80% (variable, affected by food and other medications)
Tmax: 2-4 hours
FoodEffect: Decreased absorption when taken with food, especially fiber, soy, calcium, iron. Should be taken on an empty stomach.

Distribution:

Vd: 0.13 L/kg
ProteinBinding: Greater than 99% (primarily to thyroxine-binding globulin (TBG), transthyretin, and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 7 days (range 6-10 days); shorter in hyperthyroidism, longer in hypothyroidism.
Clearance: Approximately 0.05 L/hr
ExcretionRoute: Primarily renal (conjugated metabolites), some fecal excretion.
Unchanged: Approximately 20% (fecal)
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects typically seen within 3-5 days, but full therapeutic effect may take 4-6 weeks.
PeakEffect: 4-6 weeks (after dose stabilization)
DurationOfAction: Approximately 7 days (due to long half-life)

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 Attention 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 help 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 heartbeat 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
Vomiting
Mood changes, such as:
+ Irritability
+ Nervousness
+ Excitability
+ Anxiety
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. 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 list is not exhaustive, and you may experience other side effects not mentioned here. 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:

  • Chest pain
  • Palpitations or rapid heart rate
  • Shortness of breath
  • Excessive sweating
  • Tremor
  • Nervousness or irritability
  • Insomnia
  • Diarrhea
  • Unexplained weight loss
  • Fever
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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 drugs 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.

Special Considerations

If you have diabetes (high blood sugar), consult 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 to assess your condition.

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 osteoporosis (weak bones), particularly after menopause. Discuss your individual risk factors with your doctor. Additionally, this medication may affect fertility, potentially leading to difficulties conceiving or fathering a child. If you plan to become pregnant or father a child, consult 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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to 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 administer 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, requiring regular growth checks. Consult your doctor to monitor your child's growth and development.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Amiodarone (can cause hypo- or hyperthyroidism, requiring dose adjustment)
  • Cholestyramine, Colestipol, Sevelamer (reduce absorption of levothyroxine)
  • Sucralfate (reduces absorption of levothyroxine)
  • Sodium Polystyrene Sulfonate (Kayexalate) (reduces absorption of levothyroxine)
  • Orlistat (may reduce absorption of levothyroxine)
  • Proton Pump Inhibitors (e.g., Omeprazole, Pantoprazole) (may reduce absorption of levothyroxine by increasing gastric pH)
  • H2 Blockers (e.g., Ranitidine, Cimetidine) (may reduce absorption of levothyroxine by increasing gastric pH)
  • Antacids (Aluminum, Magnesium, Calcium Carbonate) (reduce absorption of levothyroxine)
  • Iron supplements (reduce absorption of levothyroxine)
  • Calcium supplements (reduce absorption of levothyroxine)
  • Soy products (reduce absorption of levothyroxine)
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital (increase levothyroxine metabolism, requiring higher doses)
  • Warfarin (levothyroxine may enhance anticoagulant effect, requiring lower warfarin dose)
  • Insulin, Oral Hypoglycemics (levothyroxine may increase glucose requirements, requiring higher antidiabetic doses)
  • Digoxin (levothyroxine may decrease digoxin levels, requiring higher digoxin dose)
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Moderate Interactions

  • Beta-blockers (may reduce conversion of T4 to T3)
  • Estrogens (increase TBG, potentially increasing levothyroxine requirement)
  • Androgens (decrease TBG, potentially decreasing levothyroxine requirement)
  • SSRIs (may affect thyroid function tests, clinical significance varies)
  • Corticosteroids (may inhibit T4 to T3 conversion)
  • Iodine-containing products (can affect thyroid function)
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Minor Interactions

  • Dietary fiber (may slightly reduce absorption)

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

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

Timing: Before initiating therapy.

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid hormone levels.

Timing: Before initiating therapy.

Cardiac status (ECG, history of cardiac disease)

Rationale: To assess for underlying cardiac conditions, as thyroid hormone replacement can exacerbate cardiac symptoms.

Timing: Before initiating therapy, especially in elderly or those with known cardiac disease.

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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 may vary based on clinical condition (e.g., TSH suppression in thyroid cancer).

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

Free Thyroxine (Free T4)

Frequency: May be monitored 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, particularly if TSH is not reliable.

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

Frequency: At each visit.

Target: Resolution or improvement of hypothyroid symptoms.

Action Threshold: Consider dose adjustment or further investigation if symptoms persist despite adequate lab values.

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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
  • Nervousness
  • Palpitations
  • Tremor
  • Heat intolerance
  • Diarrhea
  • Insomnia

Special Patient Groups

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Pregnancy

Levothyroxine is essential for pregnant women with hypothyroidism. Untreated maternal hypothyroidism can lead to adverse pregnancy outcomes (e.g., miscarriage, preeclampsia) and impaired neurocognitive development in the fetus. Dose requirements often increase during pregnancy (by 25-50% or more) due to increased TBG and fetal thyroid hormone demand. TSH should be monitored frequently (e.g., every 4-6 weeks) and dose adjusted to maintain TSH within trimester-specific target ranges.

Trimester-Specific Risks:

First Trimester: Crucial for fetal neurodevelopment. Untreated hypothyroidism poses significant risks.
Second Trimester: Continued need for adequate thyroid hormone; dose adjustments likely.
Third Trimester: Continued need for adequate thyroid hormone; dose adjustments likely.
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Lactation

Levothyroxine is considered compatible with breastfeeding. It is naturally present in breast milk in small amounts, but these levels are not sufficient to affect infant thyroid function or provide adequate replacement for an infant with hypothyroidism. Maternal levothyroxine dose does not need to be adjusted for breastfeeding.

Infant Risk: L1 (Safest - no increase in adverse effects in infants)
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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 higher metabolic rates. Close monitoring of TSH and Free T4 is essential to ensure proper growth and neurodevelopment. Tablets can be crushed and suspended in a small amount of water or breast milk/formula and given by spoon or dropper; do not mix with soy formula.

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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 potential for exacerbation of cardiac conditions. Dose adjustments should be made in smaller increments and less frequently. TSH target range may be slightly higher (e.g., up to 6-7 mIU/L) in very elderly patients.

Clinical Information

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Clinical Pearls

  • Always take levothyroxine on an empty stomach, 30-60 minutes before food or other medications, to maximize absorption.
  • Consistency is key: take at the same time every day.
  • Avoid taking levothyroxine with calcium, iron, antacids, or fiber supplements; separate by at least 4 hours.
  • Patients should be advised against switching between different brands or generic formulations without consulting their physician, as bioequivalence can vary.
  • Full therapeutic effect may take 4-6 weeks, so dose adjustments are made gradually based on TSH levels.
  • Symptoms of over- or under-dosing can mimic other conditions; always correlate with TSH and Free T4 levels.
  • In pregnant women, levothyroxine dose requirements typically increase significantly; monitor TSH frequently.
  • Not for weight loss in euthyroid individuals; this is a black box warning.
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Alternative Therapies

  • Liothyronine (T3, Cytomel): Used in specific cases, often in combination with levothyroxine, or for short-term TSH suppression. Shorter half-life, more potent, higher risk of side effects.
  • Desiccated Thyroid Extract (Armour Thyroid, NP Thyroid): Natural thyroid hormone derived from porcine thyroid glands, containing both T4 and T3. Dosing can be less precise due to variable T4/T3 ratios.
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic), 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 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.