Tirosint-Sol 150mcg/ml Oral Sol

Manufacturer IBSA 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
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Pharmacologic Class
Thyroid hormone replacement
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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 your body normally makes, called thyroid hormone. It's used when your thyroid gland isn't making enough of this hormone, a condition called hypothyroidism. Taking this medicine 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 to you and follow the instructions closely.

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 that contain 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 (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 different 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.
Store 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 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 Tirosint-SOL once daily, preferably in the morning, on an empty stomach, at least 30-60 minutes before breakfast.
  • Wait at least 3-4 hours after taking Tirosint-SOL before taking any other medications or supplements, especially antacids, iron, calcium, or sucralfate.
  • Do not mix Tirosint-SOL with other liquids or food.
  • Store at room temperature, away from light and moisture.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.
  • 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 (based on ideal body weight) for primary hypothyroidism. Highly individualized based on TSH levels and clinical response. Titrate in 12.5 to 25 mcg increments every 4 to 6 weeks.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

elderly_cardiac_disease: Initial dose 12.5-25 mcg/day, titrate slowly.
subclinical_hypothyroidism: Initial dose 25-75 mcg/day, titrate to normalize TSH.
myxedema_coma: Loading dose 200-500 mcg IV, then 50-100 mcg IV daily.
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day (0-3 months)
Infant: 6-8 mcg/kg/day (3-6 months); 5-7 mcg/kg/day (6-12 months)
Child: 4-5 mcg/kg/day (1-5 years); 3-4 mcg/kg/day (6-12 years)
Adolescent: 2-3 mcg/kg/day (12-17 years); or 1.6 mcg/kg/day if growth and puberty are complete.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, monitor TSH.
Moderate: No specific adjustment needed, monitor TSH.
Severe: No specific adjustment needed, monitor TSH.
Dialysis: No specific adjustment needed, monitor TSH. Levothyroxine is highly protein-bound and not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed, monitor TSH.
Moderate: No specific adjustment needed, monitor TSH.
Severe: No specific adjustment needed, monitor TSH.

Pharmacology

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Mechanism of Action

Levothyroxine (L-thyroxine) is a synthetic form of thyroxine (T4), a naturally occurring thyroid hormone. It is converted to its active metabolite, 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, fat, and carbohydrate metabolism, and influencing growth and development.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-80% (variable, influenced by food and other medications). Tirosint-SOL formulation may offer more consistent absorption.
Tmax: 2-4 hours
FoodEffect: Food significantly decreases absorption. Tirosint-SOL should be taken on an empty stomach, at least 30-60 minutes before breakfast, and at least 3-4 hours apart from other medications or supplements.

Distribution:

Vd: Approximately 10-13 L
ProteinBinding: >99% (primarily to thyroxine-binding globulin [TBG], transthyretin, and albumin)
CnssPenetration: Limited (T4 crosses BBB poorly, T3 crosses better)

Elimination:

HalfLife: Approximately 7 days (range 6-10 days)
Clearance: Approximately 0.05 L/hr/kg
ExcretionRoute: Renal (approximately 80% as metabolites) and biliary/fecal (approximately 20% as metabolites)
Unchanged: <1% (renal)
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects typically observed within 3-5 days, but full therapeutic effect may take several weeks.
PeakEffect: Peak TSH suppression or normalization typically occurs within 4-6 weeks of initiating or changing dose.
DurationOfAction: Long, due to long half-life, allowing once-daily dosing.

Safety & Warnings

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BLACK BOX WARNING

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
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

Serious 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 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 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. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

* Hair loss (usually temporary and resolves on its own within the first few months of treatment)

This is not an exhaustive list of all possible side effects. 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 medicine (hyperthyroidism): fast heart rate, palpitations, nervousness, sweating, weight loss, tremor, diarrhea, insomnia.
  • Symptoms of too little medicine (hypothyroidism): extreme tiredness, weight gain, constipation, feeling cold, dry skin, hair loss, depression, slow heart rate.
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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 concerns

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. This will help prevent any potential interactions or adverse effects.
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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 continuous 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 with 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 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 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 for both you and your baby.

Pediatric Patients

If you are giving this medication to a child and their weight changes, consult with your doctor, as the dosage may need to be adjusted. Never give your child more of this 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, and your doctor can provide guidance on monitoring your child's growth.
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Overdose Information

Overdose Symptoms:

  • Signs and symptoms of hyperthyroidism (e.g., palpitations, tachycardia, arrhythmias, chest pain, shortness of breath, tremor, headache, nervousness, irritability, insomnia, excessive sweating, heat intolerance, fever, weight loss, diarrhea, vomiting, seizures, psychosis, shock, coma).

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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Contraindicated Interactions

  • Acute myocardial infarction (in euthyroid patients)
  • Uncorrected adrenal insufficiency
  • Untreated thyrotoxicosis
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Major Interactions

  • Antacids (aluminum, magnesium, calcium carbonate): Decreased levothyroxine absorption.
  • Iron supplements: Decreased levothyroxine absorption.
  • Calcium supplements: Decreased levothyroxine absorption.
  • Sucralfate: Decreased levothyroxine absorption.
  • Cholestyramine, Colestipol: Decreased levothyroxine absorption.
  • Proton pump inhibitors (PPIs): May decrease levothyroxine absorption due to increased gastric pH.
  • Soy products, dietary fiber: Decreased levothyroxine absorption.
  • Orlistat: Decreased levothyroxine absorption.
  • Certain anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital): Increased levothyroxine metabolism.
  • Rifampin: Increased levothyroxine metabolism.
  • Sertraline: May increase levothyroxine requirements.
  • Estrogens (oral): Increase TBG, leading to increased levothyroxine requirements.
  • Androgens, anabolic steroids: Decrease TBG, potentially decreasing levothyroxine requirements.
  • Glucocorticoids: May decrease TBG and inhibit T4 to T3 conversion.
  • Beta-blockers: May inhibit peripheral conversion of T4 to T3.
  • Oral anticoagulants (e.g., warfarin): Levothyroxine may enhance anticoagulant effect, requiring dose reduction of anticoagulant.
  • Insulin, oral hypoglycemics: Levothyroxine may increase blood glucose, requiring increased antidiabetic medication dose.
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Moderate Interactions

  • Amiodarone: Can cause hypo- or hyperthyroidism; may alter levothyroxine requirements.
  • Iodine-containing products: Can affect thyroid function.
  • Lithium: Can cause hypothyroidism.
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib): May increase levothyroxine requirements.
  • Propylthiouracil (PTU), Methimazole: Inhibit thyroid hormone synthesis and T4 to T3 conversion.
  • Salicylates (>2g/day): May inhibit protein binding of thyroid hormones.
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Minor Interactions

  • Caffeine: Minimal interaction, but consistency is key.

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary diagnostic and monitoring tool for hypothyroidism.

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: Assesses circulating unbound T4 levels, useful in central hypothyroidism or when TSH is unreliable.

Timing: Prior to initiation of therapy.

Clinical assessment (symptoms of hypo/hyperthyroidism)

Rationale: To establish baseline symptoms and guide therapy.

Timing: Prior to initiation of 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 (or individualized target based on patient age, comorbidities, and specific condition, e.g., TSH suppression for thyroid cancer).

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

Free Thyroxine (Free T4)

Frequency: Consider if TSH is abnormal, in central hypothyroidism, or if clinical symptoms don't correlate with TSH.

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 also abnormal or in central hypothyroidism.

Clinical assessment (symptoms of hypo/hyperthyroidism)

Frequency: At each visit, especially during dose titration.

Target: Resolution of hypothyroid symptoms without development of hyperthyroid symptoms.

Action Threshold: Adjust dose 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, irritability, weight loss, heat intolerance, tremor, diarrhea, insomnia)

Special Patient Groups

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Pregnancy

Levothyroxine is essential for maintaining maternal and fetal euthyroid status during pregnancy. Hypothyroidism during pregnancy can lead to adverse maternal and fetal outcomes. Increased levothyroxine dose is often required during pregnancy (typically 25-50% increase) due to increased TBG and fetal thyroid hormone requirements. Monitor TSH every 4-6 weeks.

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 dose; fetal thyroid gland begins to function, but maternal thyroid hormone remains crucial.
Third Trimester: Continued need for increased dose; monitor TSH closely.
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Lactation

Levothyroxine is considered compatible with breastfeeding. Minimal amounts are excreted into breast milk, and it is not expected to cause adverse effects in breastfed infants. Maternal levothyroxine requirements may decrease postpartum.

Infant Risk: L1 (Safest)
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Pediatric Use

Dosing is weight-based and higher per kilogram than in adults, especially in infants and young children, due to rapid growth and development. Adequate thyroid hormone is critical for normal growth, bone maturation, and central nervous system development. Close monitoring of TSH and Free T4 is essential.

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Geriatric Use

Lower initial doses (e.g., 12.5-25 mcg/day) are often recommended, especially in patients with underlying cardiac disease, due to increased sensitivity to thyroid hormones and potential for cardiac adverse effects. Titrate slowly with careful monitoring of TSH and cardiac status.

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is a liquid formulation that may be beneficial for patients with swallowing difficulties, feeding tubes, or those with absorption issues due to gastrointestinal conditions or multiple interacting medications.
  • Consistency is paramount: take the medication at the same time each day, on an empty stomach, and consistently separate from food and other medications/supplements.
  • Do not switch between different brands or formulations of levothyroxine without consulting a healthcare provider, as bioavailability can vary, requiring dose adjustments.
  • Patients should be educated on symptoms of both hypo- and hyperthyroidism, as dose adjustments are common.
  • The long half-life means that changes in dose will take several weeks to reflect in TSH levels.
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Alternative Therapies

  • Levothyroxine tablets (e.g., Synthroid, Levoxyl, Unithroid, generic levothyroxine)
  • Levothyroxine capsules (Tirosint)
  • Liothyronine (T3) (Cytomel, Triostat) - typically used in combination with levothyroxine or for specific conditions like myxedema coma, not as monotherapy for routine hypothyroidism.
  • Desiccated thyroid extract (Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from animal thyroid glands.
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Cost & Coverage

Average Cost: Highly variable, typically higher than generic tablets. per 30 mL bottle (150 mcg/mL)
Insurance Coverage: Tier 2 or 3 (brand-name specialty medication), may require prior authorization.
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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 details. 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 information about the medication taken, the amount, and the time it happened.