Euthyrox 0.088mg (88mcg) Tablets

Manufacturer PROVELL PHARMACEUTICALS 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.
đŸˇī¸
Drug Class
Thyroid hormone replacement
đŸ§Ŧ
Pharmacologic Class
Thyroid hormones
🤰
Pregnancy Category
Category A
✅
FDA Approved
Jul 1955
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

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. If your thyroid doesn't make enough hormone (a condition called hypothyroidism), this medicine helps bring your hormone levels back to normal, which can improve symptoms like tiredness, weight gain, and feeling cold.
📋

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 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 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 for your medications.
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 your medication 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.
💡

Lifestyle & Tips

  • Take on an empty stomach, preferably 30-60 minutes before breakfast, with a full glass of water. This helps your body absorb the medicine better.
  • Do not take with other medications, vitamins, or supplements (especially iron, calcium, antacids) within 4 hours of taking levothyroxine, as they can interfere with absorption.
  • Take consistently at the same time each day.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid sudden changes in diet, especially large amounts of soy products or high-fiber foods, as they can affect absorption.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Highly individualized, typically 1.6 mcg/kg/day orally once daily. Euthyrox 0.088mg (88mcg) is a specific strength used as part of this individualized regimen.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism_initial: Starting dose typically 1.6 mcg/kg/day. For elderly or patients with cardiac disease, initial dose 12.5-25 mcg/day, titrated slowly.
myxedema_coma: IV administration, 200-500 mcg loading dose, then 100-300 mcg daily until oral therapy can be resumed.
thyroid_cancer_suppression: Higher doses to suppress TSH, typically 2.0-2.7 mcg/kg/day.
đŸ‘ļ

Pediatric Dosing

Neonatal: 10-15 mcg/kg/day for congenital hypothyroidism, adjusted based on TSH/T4.
Infant: 6-8 mcg/kg/day (1-3 months), 5-6 mcg/kg/day (3-6 months), 4-5 mcg/kg/day (6-12 months).
Child: 3-4 mcg/kg/day (1-5 years), 2-3 mcg/kg/day (6-12 years).
Adolescent: 1.6 mcg/kg/day (12-17 years, or until growth is complete).
âš•ī¸

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 removed by dialysis.

Hepatic Impairment:

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

Pharmacology

đŸ”Ŧ

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 specific thyroid hormone receptors, which regulate gene expression. This process controls numerous cellular metabolic processes, including protein synthesis, oxygen consumption, and carbohydrate and lipid metabolism. It is essential for normal growth, development, and metabolism.
📊

Pharmacokinetics

Absorption:

Bioavailability: 48-79% (highly variable, affected by food and other drugs)
Tmax: 2-4 hours
FoodEffect: Decreased absorption when taken with food, especially fiber, soy, calcium, iron, and certain medications. Should be taken on an empty stomach, 30-60 minutes before breakfast.

Distribution:

Vd: 10-13 L
ProteinBinding: >99% (primarily to thyroxine-binding globulin (TBG), transthyretin, and albumin)
CnssPenetration: Limited (T4 crosses BBB, but T3 is more active in CNS)

Elimination:

HalfLife: 6-7 days (euthyroid), 9-10 days (hypothyroid), 3-4 days (hyperthyroid)
Clearance: 0.05-0.06 L/hr
ExcretionRoute: Primarily renal (approximately 80% as metabolites), with some fecal excretion (approximately 20% as unchanged drug or metabolites).
Unchanged: Approximately 20% (fecal)
âąī¸

Pharmacodynamics

OnsetOfAction: Gradual, several days to weeks
PeakEffect: 3-4 weeks (due to long half-life and need for TSH suppression)
DurationOfAction: Several weeks after discontinuation due to long half-life

Safety & Warnings

âš ī¸

BLACK BOX WARNING

Thyroid hormones, including Euthyrox, 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.
âš ī¸

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 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
+ 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 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Symptoms of too much medicine (hyperthyroidism): fast or irregular heartbeat, chest pain, shortness of breath, nervousness, tremors, sweating, heat intolerance, unexplained weight loss, diarrhea, insomnia.
  • Symptoms of too little medicine (hypothyroidism): extreme tiredness, unexplained weight gain, constipation, feeling cold, dry skin, hair loss, depression.
📋

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 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

Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
âš ī¸

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 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.

If you take biotin or any 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.

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.

For children taking this medication, monitor their weight changes and consult your doctor, as the dose may need to be adjusted. Never give your child more than the prescribed dose, as this can increase the risk of severe side effects. In some cases, this medication may affect growth in children and teens, and regular growth checks may be necessary. Consult your doctor to discuss any concerns.
🆘

Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia
  • Arrhythmias
  • Chest pain (angina)
  • Tremors
  • Nervousness
  • Irritability
  • Insomnia
  • Diarrhea
  • Weight loss
  • Increased appetite
  • Fever
  • Heat intolerance
  • Sweating

What to Do:

Seek immediate medical attention or call a poison control center (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

🔴

Major Interactions

  • Amiodarone (can cause hypo- or hyperthyroidism)
  • Antacids (aluminum, magnesium, calcium) - decrease absorption
  • Bile acid sequestrants (cholestyramine, colestipol) - decrease absorption
  • Cation exchange resins (sevelamer, patiromer) - decrease absorption
  • Iron supplements - decrease absorption
  • Sucralfate - decrease absorption
  • Proton pump inhibitors (PPIs) - may decrease absorption
  • Soy products - decrease absorption
  • Orlistat - decrease absorption
  • Warfarin (may enhance anticoagulant effect)
  • Sympathomimetics (increased risk of cardiac adverse effects)
  • Insulin/Oral Hypoglycemics (may increase insulin/hypoglycemic requirements)
🟡

Moderate Interactions

  • Anticonvulsants (carbamazepine, phenytoin, phenobarbital) - increase metabolism
  • Rifampin - increase metabolism
  • Estrogens (oral) - increase TBG, requiring higher levothyroxine dose
  • Androgens - decrease TBG, requiring lower levothyroxine dose
  • Beta-blockers (may decrease conversion of T4 to T3)
  • Corticosteroids (may decrease conversion of T4 to T3)
  • Digoxin (may decrease digoxin levels)
  • SSRIs (sertraline) - may affect thyroid hormone levels
đŸŸĸ

Minor Interactions

  • Dietary fiber (may decrease absorption)
  • Coffee (may decrease absorption)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary diagnostic test for hypothyroidism and to guide initial dosing.

Timing: Before initiating therapy

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid hormone levels.

Timing: Before initiating therapy

Cardiac status (ECG, history)

Rationale: To assess for underlying cardiac disease, especially in elderly or those with known heart conditions, as thyroid hormone replacement can exacerbate cardiac symptoms.

Timing: Before initiating therapy, particularly in at-risk patients

📊

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)

Action Threshold: Adjust dose if TSH is outside target range; higher TSH indicates under-replacement, lower TSH indicates over-replacement.

Free Thyroxine (Free T4)

Frequency: May be monitored periodically, especially if TSH is discordant or in central hypothyroidism.

Target: 0.8-1.8 ng/dL

Action Threshold: Adjust dose if outside target range, in conjunction with TSH.

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

Frequency: At every visit.

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

Action Threshold: Evaluate for under- or over-replacement based on symptom profile.

đŸ‘ī¸

Symptom Monitoring

  • Symptoms of hypothyroidism (under-replacement): fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, bradycardia, muscle aches.
  • Symptoms of hyperthyroidism (over-replacement): palpitations, tachycardia, nervousness, irritability, tremors, heat intolerance, weight loss, diarrhea, insomnia, sweating.

Special Patient Groups

🤰

Pregnancy

Levothyroxine is considered safe and essential during pregnancy. Thyroid hormone requirements often increase during pregnancy, and inadequate treatment can lead to adverse maternal and fetal outcomes. Dosing adjustments are frequently needed.

Trimester-Specific Risks:

First Trimester: Increased maternal thyroid hormone requirements often begin early in pregnancy. Untreated maternal hypothyroidism in the first trimester is associated with impaired neurocognitive development in the fetus.
Second Trimester: Continued monitoring and dose adjustments are crucial.
Third Trimester: Dose requirements may continue to increase. Maternal hypothyroidism can lead to preeclampsia, gestational hypertension, placental abruption, and preterm birth.
🤱

Lactation

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, and it is not expected to cause adverse effects in breastfed infants. It is considered an L1 (safest) drug.

Infant Risk: Minimal to none.
đŸ‘ļ

Pediatric Use

Dosing is weight-based and higher per kg 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 critical for proper growth and neurocognitive development. Treatment is lifelong for congenital hypothyroidism.

👴

Geriatric Use

Elderly patients, especially those with underlying cardiac disease, should be started on lower initial doses (e.g., 12.5-25 mcg/day) and titrated slowly to avoid exacerbating cardiac symptoms. TSH monitoring remains the primary guide for dose adjustment.

Clinical Information

💎

Clinical Pearls

  • Levothyroxine is a narrow therapeutic index drug; small changes in dose can have significant effects on TSH levels.
  • 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.
  • Many medications and supplements interfere with levothyroxine absorption (e.g., calcium, iron, antacids, PPIs). Advise patients to separate administration by at least 4 hours.
  • Brand-name levothyroxine products (e.g., Euthyrox, Synthroid) are generally considered bioequivalent to generics, but some clinicians prefer to maintain patients on the same brand or generic manufacturer once stable due to potential minor differences in bioavailability.
  • TSH levels should be re-checked 4-6 weeks after any dose change to allow for steady-state levels to be achieved.
  • Patients with central hypothyroidism (pituitary/hypothalamic dysfunction) should be monitored with Free T4 levels, as TSH may not be a reliable indicator.
🔄

Alternative Therapies

  • Liothyronine (T3) - used for short-term TSH suppression or in specific cases of T4 to T3 conversion issues, but generally not for long-term monotherapy due to shorter half-life and fluctuating levels.
💰

Cost & Coverage

Average Cost: Varies widely by pharmacy and insurance plan per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 2 or 3 (brand)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.