Tirosint-Sol 37.5mcg/ml Oral Sol

Manufacturer IBSA PHARMA Active Ingredient Levothyroxine Oral Solution (Tirosint-SOL)(lee voe thye ROKS een) Pronunciation LEE-voe-THY-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
Aug 2016
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tirosint-SOL is a liquid medicine that replaces a hormone normally made by your thyroid gland. It's used to treat an underactive thyroid (hypothyroidism). It helps your body's metabolism work properly.
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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 medication and follow the instructions precisely.

Take your medication on an empty stomach, 15 minutes before breakfast.
You can take the medication directly in your mouth or mix it with water. If mixing with water, empty the contents into a cup with water and squeeze the container over the cup at least 5 times until no more medication comes out. Stir well.
Take your dose immediately after mixing. Do not store the mixture for future use.
Rinse the cup with more water and drink.
Take your medication with water only; do not take it with other drinks.

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 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 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 brands or forms 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.
Keep your medication in its foil pouch until you are ready to use it.

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 resume your regular schedule.
* Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take Tirosint-SOL once a day, preferably in the morning, at least 30-60 minutes before breakfast or any other medications/supplements.
  • Take it on an empty stomach to ensure proper absorption.
  • Do not mix the solution with other liquids or food.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
  • Store at room temperature, away from light and moisture.
  • 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 interfere with levothyroxine absorption or effectiveness.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose typically 1.6 mcg/kg/day for primary hypothyroidism, adjusted based on TSH levels.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

elderly: Initial dose 25-50 mcg/day, or 1 mcg/kg/day, with gradual titration.
cardiacDisease: Initial dose 12.5-25 mcg/day, with careful titration and cardiac monitoring.
subclinicalHypothyroidism: Initial dose 25-75 mcg/day, adjusted to normalize TSH.
myxedemaComa: Loading dose 300-500 mcg IV, followed by daily IV doses.
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day for congenital hypothyroidism, adjusted based on TSH and T4.
Infant: 6-8 mcg/kg/day for 6-12 months, adjusted based on TSH and T4.
Child: 4-6 mcg/kg/day for 1-5 years; 3-5 mcg/kg/day for 6-12 years, adjusted based on TSH and T4.
Adolescent: 2-3 mcg/kg/day for >12 years (or during puberty), adjusted based on TSH and T4.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, monitor thyroid function.
Moderate: No specific dose adjustment required, monitor thyroid function.
Severe: No specific dose adjustment required, monitor thyroid function.
Dialysis: No specific dose adjustment required, monitor thyroid function.

Hepatic Impairment:

Mild: No specific dose adjustment required, monitor thyroid function.
Moderate: No specific dose adjustment required, monitor thyroid function.
Severe: No specific dose adjustment required, monitor thyroid function.

Pharmacology

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Mechanism of Action

Levothyroxine (T4) is a synthetic form of the naturally occurring 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 are involved in normal metabolism, growth, and development, and are essential for maintaining the normal function of virtually all organ systems.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-80% (variable, Tirosint-SOL may have more consistent absorption due to formulation)
Tmax: 2-4 hours
FoodEffect: Significantly decreased absorption when taken with food; should be taken on an empty stomach.

Distribution:

Vd: 0.13 L/kg
ProteinBinding: >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/hr (euthyroid)
ExcretionRoute: Renal (approximately 80% of metabolites), fecal (approximately 20% of metabolites)
Unchanged: Less than 1% (renal)
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Pharmacodynamics

OnsetOfAction: Gradual, effects typically seen within 3-5 days, full therapeutic effect may take 4-6 weeks.
PeakEffect: Peak therapeutic effect typically observed 4-6 weeks after initiation or dose adjustment.
DurationOfAction: Due to long half-life, effects persist for several weeks after discontinuation.

Safety & Warnings

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BLACK BOX WARNING

Thyroid hormones, including Tirosint-SOL, 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 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 irritability, nervousness, excitability, or 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 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 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 too much thyroid hormone (hyperthyroidism): fast heart rate, chest pain, nervousness, sweating, tremors, weight loss, diarrhea, insomnia.
  • Symptoms of too little thyroid hormone (hypothyroidism) despite treatment: persistent fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression.
  • Signs of allergic reaction: rash, itching, swelling (especially of the 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:
+ Overactive thyroid gland (hyperthyroidism)
+ Weak adrenal gland (adrenal insufficiency)

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure your safety, please disclose all of the following to your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems, including any medical conditions or allergies

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so.
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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 run out of this medication, as it may take several weeks to experience its full effects.

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 recommended.

If you take biotin or 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 of developing osteoporosis.

This medication may also affect fertility, potentially leading to difficulties 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 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 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 give your child more 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, so consult your doctor to determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia
  • Arrhythmias
  • Chest pain (angina)
  • Tremor
  • Nervousness
  • Irritability
  • Insomnia
  • Diaphoresis (sweating)
  • Heat intolerance
  • Weight loss
  • Diarrhea
  • Vomiting
  • Fever
  • Seizures (rare)
  • Heart failure (rare, especially in elderly or those with cardiac disease)

What to Do:

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

Drug Interactions

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Contraindicated Interactions

  • Untreated thyrotoxicosis
  • Acute myocardial infarction
  • Uncorrected adrenal insufficiency
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Major Interactions

  • Warfarin (increased anticoagulant effect)
  • Amiodarone (can cause hypo- or hyperthyroidism)
  • Certain antidiabetic agents (may increase insulin/oral hypoglycemic requirements)
  • Ion exchange resins (e.g., cholestyramine, colestipol, sevelamer, patiromer - reduce absorption)
  • Sucralfate (reduces absorption)
  • Proton pump inhibitors (may reduce absorption)
  • H2 receptor blockers (may reduce absorption)
  • Antacids (aluminum and magnesium containing - reduce absorption)
  • Iron supplements (reduce absorption)
  • Calcium supplements (reduce absorption)
  • Orlistat (reduces absorption)
  • Soy products (reduce absorption)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib - may increase levothyroxine requirements)
  • Ritonavir (may increase levothyroxine requirements)
  • Phenytoin, Carbamazepine, Rifampin (increase levothyroxine metabolism)
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Moderate Interactions

  • Beta-blockers (may reduce conversion of T4 to T3)
  • Estrogens (increase TBG, may increase levothyroxine requirements)
  • Androgens (decrease TBG, may decrease levothyroxine requirements)
  • Corticosteroids (may inhibit TSH secretion and T4 to T3 conversion)
  • Salicylates (>2g/day - may inhibit protein binding)
  • SSRIs (may affect thyroid function tests, usually not clinically significant)
  • Tricyclic antidepressants (increased sensitivity to TCAs)
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Minor Interactions

  • Dietary fiber (may 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: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: To establish baseline thyroid function and aid in diagnosis.

Timing: Prior to initiation of therapy.

Cardiac status (ECG, clinical assessment)

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

Timing: Prior to initiation, particularly with higher starting doses.

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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 (or individualized target based on patient age, comorbidities, and etiology of hypothyroidism).

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

Free Thyroxine (Free T4)

Frequency: May be checked with TSH, especially if TSH is suppressed or in central hypothyroidism.

Target: 0.8-1.8 ng/dL (or within normal reference range).

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

Clinical symptoms of hypo/hyperthyroidism

Frequency: At every visit.

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

Action Threshold: Evaluate for dose adjustment or other causes if symptoms persist or new symptoms develop.

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Symptom Monitoring

  • Symptoms of hypothyroidism (e.g., fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, bradycardia)
  • Symptoms of hyperthyroidism (e.g., palpitations, tachycardia, nervousness, tremor, weight loss, heat intolerance, diarrhea, insomnia, sweating)

Special Patient Groups

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Pregnancy

Levothyroxine is essential for normal fetal development and is safe to use during pregnancy. Thyroid hormone requirements often increase during pregnancy, typically by 25-50% or more. Close monitoring of TSH levels is crucial.

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 increased dosage; fetal thyroid gland begins to function, but maternal thyroid hormone remains important.
Third Trimester: Continued need for increased dosage; essential for continued fetal brain development.
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Lactation

Levothyroxine is considered compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not expected to cause adverse effects in the infant.

Infant Risk: L1 (Safest) - No known risk to the infant; considered safe.
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Pediatric Use

Dosing is weight-based and higher per kg than in adults due to higher metabolic rates. Crucial for normal growth and neurocognitive development. Regular monitoring of TSH and T4 is essential to ensure adequate replacement and prevent developmental delays.

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Geriatric Use

Lower starting doses are recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiac disease. Gradual titration is important, with careful monitoring for cardiac symptoms. TSH target ranges may be slightly higher for older adults.

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is an oral solution formulation of levothyroxine, which may be beneficial for patients with absorption issues (e.g., gastric bypass, celiac disease), dysphagia, or those requiring tube feeding, as it is free of common excipients like lactose, gluten, and dyes.
  • Always administer Tirosint-SOL on an empty stomach, at least 30-60 minutes before food or other medications, to optimize absorption. Consistency in timing is key.
  • Do not switch between different levothyroxine formulations (e.g., tablet to solution, or different brands) without consulting a healthcare provider, as bioavailability can vary, requiring TSH re-monitoring and potential dose adjustment.
  • Patients should be advised to separate administration of levothyroxine from calcium, iron, antacids, and bile acid sequestrants by at least 4 hours, and from sucralfate by at least 2 hours.
  • Symptoms of over-replacement (hyperthyroidism) can mimic anxiety or cardiac issues; symptoms of under-replacement (hypothyroidism) can be subtle and attributed to aging or other conditions.
  • TSH levels are the primary guide for dose adjustment in primary hypothyroidism. Free T4 may be monitored in central hypothyroidism or if TSH is suppressed.
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Alternative Therapies

  • Levothyroxine sodium tablets (e.g., Synthroid, Levoxyl, Unithroid, generic levothyroxine)
  • Levothyroxine sodium capsules (Tirosint)
  • Liothyronine (T3) (Cytomel, Triostat)
  • Liotrix (T4/T3 combination) (Thyrolar)
  • Desiccated thyroid extract (Armour Thyroid, NP Thyroid)
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Cost & Coverage

Average Cost: Varies widely by dose and pharmacy, typically $50-$150+ per 30 ml bottle (37.5 mcg/ml)
Generic Available: Yes
Insurance Coverage: Often Tier 2 or 3 for brand-name Tirosint-SOL, while generic levothyroxine tablets are typically Tier 1.
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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 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.