Tirosint-Sol 13mcg/ml Oral Sol

Manufacturer IBSA PHARMA Active Ingredient Levothyroxine Oral Solution (Tirosint-SOL)(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
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. People take it when their thyroid gland doesn't make enough of this hormone (a condition called 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 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. Check 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 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

If you miss a dose, take it 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, at least 30-60 minutes before breakfast and any other medications or supplements.
  • Take it consistently at the same time each day.
  • Do not mix Tirosint-SOL with other liquids or food.
  • Separate administration from calcium, iron, antacids, and other interacting medications by at least 4 hours.
  • 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.
  • Regular blood tests (TSH) are necessary to ensure the correct dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized; typical initial dose for primary hypothyroidism is 1.6 mcg/kg/day (based on ideal body weight). Initial doses often 25-50 mcg/day, titrated by 12.5-25 mcg increments every 4-6 weeks based on TSH levels.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

cardiacDisease: Initial dose 12.5-25 mcg/day, titrate slowly with 12.5 mcg increments every 6-8 weeks.
myxedemaComa: Initial loading dose 200-500 mcg IV, then 100-300 mcg IV daily until patient can take oral therapy.
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day (0-3 months)
Infant: 6-8 mcg/kg/day (3-6 months); 5-6 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 once growth is complete
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific dose adjustment guidelines; monitor TSH and clinical response.
Moderate: No specific dose adjustment guidelines; monitor TSH and clinical response. May require lower doses due to altered metabolism.
Severe: No specific dose adjustment guidelines; monitor TSH and clinical response. May require lower doses due to altered metabolism.

Pharmacology

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Mechanism of Action

Levothyroxine (T4) is a synthetic thyroid hormone that is chemically identical to the naturally occurring hormone. It is converted to its active metabolite, liothyronine (T3), in peripheral tissues. T3 enters the cell nucleus and binds to thyroid hormone receptors, which then bind to specific DNA sequences (thyroid hormone response elements) to regulate gene expression, thereby controlling protein synthesis and metabolic processes.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-80% (variable, influenced by food, other drugs, and gastrointestinal conditions). Tirosint-SOL may offer more consistent absorption due to its liquid formulation and lack of excipients.
Tmax: 2-4 hours
FoodEffect: Food, especially fiber, soy, and certain minerals (calcium, iron), significantly decreases absorption. Should be taken on an empty stomach.

Distribution:

Vd: 10-13 L
ProteinBinding: >99% (primarily to thyroxine-binding globulin (TBG), transthyretin, and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 7 days (euthyroid); 9-10 days (hypothyroid); 3-4 days (hyperthyroid)
Clearance: Approximately 0.05 L/hour
ExcretionRoute: Primarily renal (conjugated metabolites), with some fecal excretion (unabsorbed drug and biliary excretion of conjugated metabolites).
Unchanged: <1% (renal)
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Pharmacodynamics

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

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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, or anxious
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 notice 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)
Other side effects not listed here

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of too much thyroid hormone (hyperthyroidism): rapid heart rate, palpitations, chest pain, shortness of breath, excessive sweating, heat intolerance, nervousness, tremor, insomnia, weight loss, diarrhea.
  • Symptoms of too little thyroid hormone (hypothyroidism): extreme tiredness, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, slow heart rate.
  • Seek immediate medical attention if you experience chest pain, shortness of breath, or severe palpitations.
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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 safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, 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 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, and ask about any concerns you may have.

This medication may also affect fertility, potentially leading to difficulties in getting pregnant or fathering a child. If you plan to become pregnant or father a child, consult with your doctor before starting this medication.

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 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 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:

  • Palpitations
  • Tachycardia
  • Arrhythmias
  • Chest pain
  • Tremor
  • Nervousness
  • Insomnia
  • Diaphoresis
  • Heat intolerance
  • Weight loss
  • Diarrhea
  • Vomiting
  • Fever
  • Seizures (rare)
  • Heart failure (rare)

What to Do:

Contact a poison control center immediately (Call 1-800-222-1222). Treatment is symptomatic and supportive, including reducing absorption (e.g., activated charcoal if recent ingestion), and managing cardiovascular effects (e.g., beta-blockers for tachycardia). Discontinuation or dose reduction of levothyroxine may be necessary.

Drug Interactions

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Major Interactions

  • Amiodarone (alters thyroid hormone metabolism)
  • Oral anticoagulants (e.g., warfarin - enhances anticoagulant effect)
  • Ion exchange resins (e.g., cholestyramine, colestipol - reduce absorption)
  • Sucralfate (reduces absorption)
  • Proton pump inhibitors (e.g., omeprazole - may reduce absorption)
  • Iron supplements (reduce absorption)
  • Calcium supplements (reduce absorption)
  • Aluminum-containing antacids (reduce absorption)
  • Sevelamer (reduces absorption)
  • Orlistat (reduces absorption)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib - may increase levothyroxine requirements)
  • Phenytoin, Carbamazepine, Rifampin (increase levothyroxine metabolism)
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Moderate Interactions

  • Beta-blockers (may reduce T4 to T3 conversion)
  • Estrogens (increase TBG, increasing levothyroxine requirements)
  • Androgens (decrease TBG, decreasing levothyroxine requirements)
  • Corticosteroids (may alter thyroid hormone metabolism)
  • Antidiabetic agents (may increase insulin/oral hypoglycemic requirements)
  • Digoxin (may decrease digoxin levels)
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Minor Interactions

  • Dietary fiber (may reduce absorption)

Monitoring

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Baseline Monitoring

Thyroid-stimulating hormone (TSH)

Rationale: To confirm diagnosis of hypothyroidism and establish baseline.

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid hormone levels, especially in central hypothyroidism or when TSH is unreliable.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline symptom severity and guide treatment goals.

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 (individualized 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.

Clinical symptoms of hypothyroidism/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.

Free Thyroxine (Free T4)

Frequency: Consider if TSH is suppressed, in central hypothyroidism, or if TSH is unreliable.

Target: Within normal reference range (e.g., 0.8-1.8 ng/dL), or individualized.

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

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Symptom Monitoring

  • Fatigue
  • Weight gain
  • Constipation
  • Cold intolerance
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Anxiety
  • Palpitations
  • Tremor
  • Heat intolerance
  • Diarrhea
  • Weight loss
  • Tachycardia
  • Insomnia

Special Patient Groups

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Pregnancy

Levothyroxine is the drug of choice for hypothyroidism during pregnancy. Thyroid hormone requirements typically increase during pregnancy, often by 25-50% or more. Close monitoring of TSH is essential.

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism is associated with increased risk of miscarriage, preterm birth, preeclampsia, and impaired neurocognitive development in the fetus. Levothyroxine is safe and essential.
Second Trimester: Continued need for increased dose. Fetal thyroid gland begins to function, but maternal thyroid hormone is still crucial for fetal brain development.
Third Trimester: Dose requirements remain elevated. Monitor TSH every 4-6 weeks throughout pregnancy.
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Lactation

Levothyroxine is considered safe during breastfeeding. Minimal amounts are excreted into breast milk, and it does not adversely affect the infant.

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

Dosing is weight-based and generally higher per kilogram in younger children due to higher metabolic rates and rapid growth. Close monitoring of TSH and clinical status is crucial to ensure proper growth and neurocognitive development. Tirosint-SOL may be particularly useful for infants and children who cannot swallow tablets or have absorption issues.

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Geriatric Use

Lower initial doses (e.g., 12.5-25 mcg/day) are recommended, especially in patients with underlying cardiovascular disease, due to increased sensitivity to thyroid hormones. Titration should be slower and more cautious, with smaller increments. Monitor for cardiac symptoms.

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is a liquid formulation that may be beneficial for patients with swallowing difficulties, malabsorption issues, or sensitivities to excipients found in tablet formulations.
  • Always take levothyroxine on an empty stomach, ideally 30-60 minutes before breakfast, and separate from other medications and supplements by at least 4 hours.
  • Consistency is key: take it at the same time each day and avoid switching between different brands or formulations without consulting your doctor, as bioavailability can vary.
  • TSH is the primary lab test for monitoring, but Free T4 may be useful in specific situations (e.g., central hypothyroidism, TSH suppression therapy).
  • Patients often require dose adjustments during pregnancy, with aging, or if starting/stopping interacting medications.
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Alternative Therapies

  • Other levothyroxine sodium formulations (tablets, capsules like Tirosint)
  • Liothyronine (T3) (e.g., Cytomel, Triostat) - typically used in specific situations or in combination with levothyroxine.
  • Desiccated thyroid extract (e.g., 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 $50-$200+ per 30mL bottle (13mcg/mL)
Generic Available: Yes
Insurance Coverage: Tier 2-3 (Brand name), Tier 1 (Generic tablets)
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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 taken, the amount, and the time it happened.