Tirosint 88mcg 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 replacement
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Pharmacologic Class
Thyroid hormones
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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. It's used when your thyroid gland doesn't make enough of this hormone (a condition called hypothyroidism). Taking this medicine helps your body's metabolism work properly, affecting your energy, weight, body temperature, and many other 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.
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 the removed medication 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.
  • Wait at least 4 hours after taking levothyroxine before taking calcium, iron, antacids, or bile acid sequestrants.
  • Avoid taking with coffee, soy products, or high-fiber foods as they can interfere with absorption.
  • 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.
  • Report any new or worsening symptoms to your doctor.
  • Regular blood tests (TSH) are essential to ensure the correct dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose typically 1.6 mcg/kg/day orally once daily for primary hypothyroidism. Adjust by 12.5-25 mcg increments every 4-6 weeks based on TSH levels.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

primaryHypothyroidism: Initial: 1.6 mcg/kg/day. Maintenance: 100-125 mcg/day (average).
cardiacDisease: Initial: 12.5-25 mcg/day. Adjust slowly by 12.5-25 mcg increments every 6-8 weeks.
subclinicalHypothyroidism: Individualized, often 25-75 mcg/day, based on TSH and symptoms.
TSHSuppression: Higher doses, typically 2-2.5 mcg/kg/day, to achieve target TSH levels (e.g., <0.1 mIU/L for thyroid cancer).
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Pediatric Dosing

Neonatal: Congenital Hypothyroidism: Initial 10-15 mcg/kg/day. 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 years and older (growth and puberty complete): 2-3 mcg/kg/day or 1.6 mcg/kg/day (adult dose).
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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 then binds to thyroid hormone receptors in the cell nucleus, regulating gene expression and controlling numerous metabolic processes, including protein, carbohydrate, and lipid metabolism, and influencing growth and development.
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Pharmacokinetics

Absorption:

Bioavailability: 48-80% (highly variable, influenced by food, gastric pH, and other medications)
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, at least 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: Not available (highly variable)
ExcretionRoute: Primarily renal (conjugated metabolites), small amount in feces (unabsorbed or biliary excretion)
Unchanged: <1% (renal)
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects typically seen within 3-5 days, full therapeutic effect in 4-6 weeks.
PeakEffect: 4-6 weeks (due to long half-life and need to reach steady state)
DurationOfAction: Effects persist for several days after discontinuation due to long half-life.

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including Tirosint, 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, anxious, or restless
Shakiness
Trouble sleeping
Sensitivity to heat
Excessive sweating
Fever
Muscle cramps
Muscle weakness
Flushing
Bone pain
Changes in menstrual periods

Additional Side Effects in Children:

Hip or knee pain
Limping

Additional Side Effects 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 is not an exhaustive list of possible side effects. If you have questions or concerns, 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 overmedication (hyperthyroidism): Chest pain, rapid or irregular heartbeat, shortness of breath, excessive sweating, heat intolerance, nervousness, tremor, insomnia, diarrhea, significant weight loss.
  • Symptoms of undermedication (hypothyroidism): Persistent fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, memory problems.
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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 prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Any health problems you have

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 crucial that you 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 drug.

Special Considerations

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. Be sure to 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 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 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 with 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

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 to both you and your baby.

Pediatric Patients

If you are giving this medication to a child, consult with your doctor if the child's weight changes, 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. 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
  • Increased appetite
  • Fever
  • Heat intolerance
  • Seizures (rare)
  • Heart failure (rare, especially in elderly or those with underlying cardiac disease)

What to Do:

Seek immediate medical attention or call Poison Control at 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

  • Amiodarone (can cause hypo- or hyperthyroidism)
  • Oral anticoagulants (may increase anticoagulant effect)
  • Insulin/Oral Hypoglycemics (may increase insulin/hypoglycemic requirements)
  • Digoxin (may decrease digoxin levels)
  • Cholestyramine, Colestipol, Sevelamer, Sucralfate, Kayexalate (decrease levothyroxine absorption)
  • Iron supplements, Calcium supplements, Aluminum-containing antacids (decrease levothyroxine absorption)
  • Proton Pump Inhibitors (PPIs) and H2-blockers (reduce gastric acidity, impair absorption)
  • Orlistat (may decrease levothyroxine absorption)
  • Tyrosine Kinase Inhibitors (e.g., Sunitinib, Imatinib, Pazopanib) (can alter thyroid function, increase levothyroxine requirements)
  • Estrogens (increase TBG, may increase levothyroxine requirements)
  • Androgens/Anabolic Steroids (decrease TBG, may decrease levothyroxine requirements)
  • SSRIs (may affect thyroid function tests, usually not clinically significant)
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital (increase levothyroxine metabolism)
  • Beta-blockers (may decrease peripheral conversion of T4 to T3)
  • Glucocorticoids (may decrease peripheral conversion of T4 to T3)
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Moderate Interactions

  • Soy products (decrease absorption)
  • Dietary fiber (decrease absorption)
  • Coffee (decrease absorption)
  • Grapefruit juice (may affect absorption)
  • Certain foods (e.g., walnuts, cottonseed meal) (decrease absorption)

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary indicator of thyroid function and adequacy of levothyroxine replacement.

Timing: Before initiating therapy.

Free Thyroxine (Free T4)

Rationale: Measures unbound, active T4. Useful in certain conditions (e.g., central hypothyroidism, pregnancy).

Timing: Before initiating therapy.

Clinical Symptoms of Hypothyroidism

Rationale: To establish baseline and track improvement.

Timing: Before initiating 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: 0.4-4.0 mIU/L (for primary hypothyroidism, individualized for other conditions).

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

Free Thyroxine (Free T4)

Frequency: Consider if TSH is suppressed or elevated, or in central hypothyroidism, or during pregnancy.

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

Action Threshold: Adjust dose if Free T4 is outside target range, especially if TSH is not reliable.

Clinical Symptoms

Frequency: At each visit.

Target: Resolution of hypothyroid symptoms (e.g., fatigue, weight gain, constipation, cold intolerance).

Action Threshold: Consider dose adjustment if symptoms persist despite target TSH.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Constipation
  • Cold intolerance
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Memory impairment
  • Muscle aches
  • Menstrual irregularities
  • Nervousness
  • Palpitations
  • Tremor
  • Heat intolerance
  • Diarrhea
  • Insomnia

Special Patient Groups

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Pregnancy

Levothyroxine is Category A and is essential for fetal neurological development. 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. Dose adjustments are common.
Third Trimester: Dose requirements may continue to increase. Monitor TSH every 4-6 weeks.
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Lactation

Levothyroxine is compatible with breastfeeding (L1 - Safest). Minimal amounts are excreted into breast milk and do not adversely affect the infant.

Infant Risk: None known. Considered safe for the nursing infant.
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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 crucial to ensure proper growth and neurocognitive development. Congenital hypothyroidism requires prompt 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 cardiac disease, due to increased sensitivity to thyroid hormones and potential for cardiac adverse effects. Dose adjustments should be made in smaller increments and less frequently. Monitor for signs of cardiac toxicity.

Clinical Information

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Clinical Pearls

  • Tirosint capsules contain only levothyroxine, glycerin, and water, making them suitable for patients with sensitivities to common excipients found in tablet formulations (e.g., lactose, gluten, dyes).
  • Tirosint is available in a wide range of strengths, allowing for precise dose titration.
  • Consistency is key: Patients should take levothyroxine at the same time each day, on an empty stomach, and consistently with or without other medications/foods that affect absorption.
  • Patients should be advised not to switch between different levothyroxine products (brand to generic, or different generics) without consulting their physician, as bioavailability differences can necessitate dose adjustments.
  • TSH is the primary monitoring parameter for primary hypothyroidism. Free T4 is useful in central hypothyroidism, pregnancy, or when TSH is unreliable.
  • Symptoms of hyperthyroidism (overmedication) or persistent hypothyroidism (undermedication) should prompt TSH re-evaluation.
  • Educate patients about the black box warning regarding use for weight loss.
  • Many medications and supplements can interfere with levothyroxine absorption or metabolism; a thorough medication history is crucial.
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Alternative Therapies

  • Liothyronine (T3, Cytomel): Used less commonly, often for specific indications or in combination with levothyroxine.
  • 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 hormone content.
  • Levothyroxine/Liothyronine combination products (e.g., Thyrolar): Synthetic combination of T4 and T3.
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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), Tier 2 or 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.