Tirosint 75mcg Capsules

Manufacturer IBSA PHARMA Active Ingredient Levothyroxine Capsules(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 hormone replacement
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Pregnancy Category
Category A
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FDA Approved
Aug 2000
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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 energy, metabolism, 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.
Swallow the capsule whole - do not chew, break, or crush it.
Avoid taking iron products, antacids containing 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. Consult with your doctor or pharmacist to determine the best schedule.
Certain foods, such as soybean flour (found in infant formula), may interact with your medication. Discuss this with your doctor.
If you regularly consume grapefruit juice or eat grapefruit, talk to your doctor about potential interactions.
Be aware that different brands and forms of this medication are available. Do not switch between them without consulting your doctor.

Continuing Your Medication

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.
Do not remove your medication from the blister pack until you are ready to take it. Take the medication immediately after opening the blister pack, and do not store it for future use.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume 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, at least 30-60 minutes before breakfast, with a full glass of water.
  • Avoid taking with other medications, especially calcium, iron, antacids, or sucralfate, for at least 4 hours.
  • Take at the same time each day to maintain consistent levels.
  • 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, as many can interact with levothyroxine.
  • Regular blood tests (TSH) are essential to ensure the correct dose.
  • Maintain a consistent diet; large changes in soy intake or fiber can affect absorption.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose typically 1.6 mcg/kg/day orally once daily for primary hypothyroidism. Doses are individualized based on TSH levels.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 1.6 mcg/kg/day orally once daily. Adjust by 12.5-25 mcg increments every 4-6 weeks based on TSH. Maintenance: 50-200 mcg/day.
subclinical_hypothyroidism: Initial: 25-75 mcg/day orally once daily. Adjust based on TSH.
thyroid_cancer_ts_suppression: Higher doses, typically 2.0-2.7 mcg/kg/day, to achieve TSH suppression (target TSH <0.1 mIU/L or lower depending on risk).
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Pediatric Dosing

Neonatal: Congenital Hypothyroidism: 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. Adjust based on TSH and T4.
Child: 1-5 years: 5-6 mcg/kg/day; 6-12 years: 4-5 mcg/kg/day. Adjust based on TSH and T4.
Adolescent: 12-17 years: 2-3 mcg/kg/day or 1.6 mcg/kg/day (full adult replacement dose). Adjust based on TSH and T4.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.
Dialysis: No specific dose adjustment required. Levothyroxine is highly protein-bound and not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required. Monitor thyroid function closely.

Pharmacology

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Mechanism of Action

Levothyroxine (T4) is a synthetic form of the natural thyroid hormone, L-thyroxine. It is converted to its active metabolite, L-triiodothyronine (T3), in peripheral tissues. T3 and T4 exert their metabolic effects through control of DNA transcription and protein synthesis. Thyroid hormones regulate multiple metabolic processes, including carbohydrate, lipid, and protein metabolism, and are essential for normal growth and development, especially of the central nervous system and bone.
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Pharmacokinetics

Absorption:

Bioavailability: 48-79%
Tmax: 2-4 hours
FoodEffect: Decreased absorption when taken with food, certain medications (e.g., calcium, iron, antacids, sucralfate, bile acid sequestrants, proton pump inhibitors). Should be taken on an empty stomach, at least 30-60 minutes before breakfast, and at least 4 hours apart from interacting medications.

Distribution:

Vd: 10-13 L
ProteinBinding: Greater than 99% (primarily to thyroxine-binding globulin [TBG], thyroxine-binding prealbumin [TBPA], and albumin)
CnssPenetration: Limited

Elimination:

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

OnsetOfAction: Gradual, over several days to weeks
PeakEffect: Clinical effects typically seen within 3-4 weeks, full therapeutic effect may take 4-6 weeks due to long half-life and tissue saturation.
DurationOfAction: Effects persist for several weeks after discontinuation due to long half-life.

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including Tirosint, 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

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 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 irritability, nervousness, excitability, anxiety, or other emotional changes
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 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:

  • Symptoms of hyperthyroidism (too much hormone): rapid heart rate, palpitations, chest pain, excessive sweating, heat intolerance, nervousness, tremor, insomnia, weight loss, diarrhea.
  • Symptoms of hypothyroidism (too little hormone): extreme fatigue, weight gain, constipation, dry skin, hair loss, feeling cold, depression, slow heart rate.
  • Allergic reaction: rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
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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, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins

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 allow your supply of this medication to run out. Please note that it may take several weeks to experience the full effects of this medication.

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. Be sure to monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as advised.

If you are taking biotin or a product 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 developing weak bones (osteoporosis), particularly after menopause. Discuss your individual 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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication to both you and your baby.

Pediatric Patients

If you are giving this medication to a child and their weight changes, consult your doctor, as the dosage may need to be adjusted. Never give your child more of this medication than prescribed, 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, so be sure to discuss this with your doctor.
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Overdose Information

Overdose Symptoms:

  • Signs and symptoms of hyperthyroidism: headache, irritability, nervousness, sweating, tachycardia, arrhythmias, increased bowel motility, menstrual irregularities, tremor, insomnia, heat intolerance, fever, weight loss, chest pain, palpitations.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is symptomatic and supportive, often involving beta-blockers for cardiac symptoms.

Drug Interactions

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Major Interactions

  • Amiodarone (may alter thyroid function)
  • Antacids (aluminum, magnesium, calcium-containing) - decrease absorption
  • Bile acid sequestrants (cholestyramine, colestipol) - decrease absorption
  • Cation-containing products (iron, calcium supplements) - decrease absorption
  • Orlistat - decrease absorption
  • Proton pump inhibitors (PPIs) - decrease absorption
  • Sucralfate - decrease absorption
  • Soy products - decrease absorption
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) - may alter thyroid function
  • Warfarin (may enhance anticoagulant effect)
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Moderate Interactions

  • Anticonvulsants (carbamazepine, phenytoin, phenobarbital) - increase metabolism of levothyroxine
  • Antidepressants (tricyclics, SSRIs) - may increase cardiac sensitivity to thyroid hormones
  • Beta-blockers - may decrease conversion of T4 to T3
  • Corticosteroids - may decrease TSH secretion and T4 to T3 conversion
  • Estrogens (oral) - increase TBG, requiring higher levothyroxine dose
  • Furosemide (>80 mg IV) - may displace T4 from protein binding
  • Iodine-containing products (e.g., contrast media) - may alter thyroid function
  • Lithium - may cause hypothyroidism
  • Metformin - may decrease TSH levels
  • Propylthiouracil (PTU) - inhibits T4 to T3 conversion
  • Rifampin - increases metabolism of levothyroxine
  • Ritonavir - may alter thyroid function
  • Statins (e.g., lovastatin, simvastatin) - may increase levothyroxine requirements
  • Theophylline - clearance may be altered by thyroid status
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Minor Interactions

  • Dietary fiber - may decrease absorption
  • Grapefruit juice - may decrease absorption (minor effect)

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary diagnostic and monitoring tool for hypothyroidism. Reflects the body's response to thyroid hormone levels.

Timing: Before initiating therapy.

Free Thyroxine (Free T4)

Rationale: Measures the unbound, active form of T4. Useful in assessing thyroid status, especially in central hypothyroidism or when TSH is unreliable.

Timing: Before initiating therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline symptom severity and track improvement.

Timing: Before initiating therapy.

Cardiac status (ECG, history of cardiovascular disease)

Rationale: To assess risk of adverse cardiac events, especially in elderly or those with pre-existing heart conditions, as thyroid hormone replacement can increase cardiac workload.

Timing: Before initiating therapy, particularly in older patients or those with cardiac risk factors.

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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); individualized for TSH suppression.

Action Threshold: If TSH is outside target range, adjust levothyroxine dose. If TSH is suppressed (<0.1 mIU/L) in non-cancer patients, consider dose reduction to avoid hyperthyroidism.

Free Thyroxine (Free T4)

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

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

Action Threshold: If Free T4 is outside target range, adjust levothyroxine dose.

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

Frequency: At each visit, especially during dose titration.

Target: Resolution or significant improvement of hypothyroid symptoms.

Action Threshold: Persistent or worsening symptoms may indicate inadequate dosing or other underlying issues.

Bone mineral density (DEXA scan)

Frequency: Periodically, especially in postmenopausal women or those on suppressive therapy, if concerns about long-term overtreatment.

Target: Normal bone density for age.

Action Threshold: Evidence of bone loss may warrant re-evaluation of levothyroxine dose to avoid iatrogenic hyperthyroidism.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia or tachycardia
  • Palpitations
  • Nervousness or irritability
  • Tremor
  • Heat intolerance
  • Diarrhea
  • Insomnia
  • Chest pain or discomfort

Special Patient Groups

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Pregnancy

Levothyroxine is essential for normal fetal development and is considered safe and necessary during pregnancy. Hypothyroidism during pregnancy can lead to adverse maternal and fetal outcomes. Dose requirements often increase during pregnancy.

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 offspring.
Second Trimester: Continued need for adequate thyroid hormone for fetal brain development.
Third Trimester: Dose may need to be further increased as pregnancy progresses. Monitor TSH every 4-6 weeks.
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Lactation

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

Infant Risk: L1 (Safest) - No adverse effects on the breastfed infant are expected with maternal use of levothyroxine.
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Pediatric Use

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

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Geriatric Use

Lower initial doses are often recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Gradual dose titration is important to avoid precipitating cardiac events. Monitor for signs of hyperthyroidism and cardiac symptoms.

Clinical Information

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Clinical Pearls

  • Levothyroxine is a narrow therapeutic index drug; small changes in dose can have significant effects.
  • Consistency is key: take at the same time each day, on an empty stomach, and consistently with or without other medications (though empty stomach is preferred).
  • Tirosint capsules may be preferred for patients with absorption issues or sensitivities to excipients found in tablet formulations, as they contain fewer inactive ingredients.
  • Patients should be advised to avoid switching between different brands or generic formulations without consulting their physician, as bioavailability can vary.
  • TSH levels should be monitored 4-6 weeks after any dose adjustment or change in formulation/brand.
  • Educate patients on symptoms of both hypo- and hyperthyroidism to recognize when their dose may be too low or too high.
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Alternative Therapies

  • Liothyronine (T3) - used in specific cases, often in combination with levothyroxine, but not as monotherapy for routine hypothyroidism.
  • Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from porcine thyroid glands. Dosing can be less precise and TSH levels may not be a reliable indicator of adequate replacement.
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Cost & Coverage

Average Cost: Varies widely by pharmacy and dosage, e.g., $30-$100+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic often Tier 1, brand Tier 2 or 3)
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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 medication taken, the amount, and the time it happened.