Tirosint-Sol 125mcg/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 hormone
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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 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.
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 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 exactly as prescribed, usually once a day in the morning, on an empty stomach, at least 30-60 minutes before breakfast.
  • Wait at least 4 hours after taking Tirosint-SOL before taking any iron supplements, calcium supplements, antacids, or other medications that can interfere with absorption.
  • Do not mix Tirosint-SOL with other liquids or food. Administer directly into the mouth or with a spoon.
  • Do not stop taking this medication without talking to your doctor, even if you feel better. Lifelong therapy is often required.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with levothyroxine.
  • Maintain a consistent diet; avoid sudden changes in soy intake or high-fiber foods, as they can affect absorption.
  • Store at room temperature, away from light and moisture.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized, typically 1.6 mcg/kg/day orally once daily. Initial dose often 25-50 mcg/day, adjusted by 12.5-25 mcg increments every 4-6 weeks based on TSH levels.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 1.6 mcg/kg/day. Elderly or cardiac disease: 12.5-25 mcg/day, titrate slowly.
myxedema_coma: IV formulation preferred. Oral: Not suitable for acute myxedema coma.
thyroid_stimulating_hormone_suppression: Higher doses may be required, individualized based on target TSH.
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Pediatric Dosing

Neonatal: Initial: 10-15 mcg/kg/day. Adjust based on TSH and T4 levels.
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 adult dose (1.6 mcg/kg/day).
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed. Monitor thyroid function tests closely.

Pharmacology

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Mechanism of Action

Levothyroxine (T4) is a synthetic form of the naturally occurring thyroid hormone, thyroxine. It is converted to its active metabolite, liothyronine (T3), in peripheral tissues. T3 then enters the cell nucleus and binds to thyroid hormone receptors, which regulate gene expression and protein synthesis, thereby controlling metabolism, growth, and development.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60-80% (variable, influenced by food, other medications, and gastrointestinal conditions). Tirosint-SOL may have more consistent absorption due to its simple formulation.
Tmax: Approximately 2-4 hours (for T4).
FoodEffect: Absorption is decreased by food. Should be taken on an empty stomach, at least 30-60 minutes before breakfast, and at least 4 hours apart from other medications/supplements that interfere with absorption.

Distribution:

Vd: Approximately 10-13 L (for T4).
ProteinBinding: Greater than 99% (primarily to thyroxine-binding globulin (TBG), transthyretin, and albumin).
CnssPenetration: Limited (T4 crosses the blood-brain barrier to a limited extent, but T3 is more readily transported).

Elimination:

HalfLife: Approximately 6-7 days (euthyroid individuals); 9-10 days (hypothyroid); 3-4 days (hyperthyroid).
Clearance: Approximately 0.05-0.06 L/hour (euthyroid).
ExcretionRoute: Primarily renal (approximately 80% as metabolites), with some fecal excretion.
Unchanged: Less than 1% (T4) is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects typically seen within 3-5 days, but full therapeutic effect may take several weeks.
PeakEffect: Peak TSH suppression typically occurs 4-6 weeks after initiation or dose change.
DurationOfAction: Long, due to 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 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, 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 experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, 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 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): rapid heart rate, palpitations, chest pain, nervousness, tremors, excessive sweating, heat intolerance, unexplained weight loss, diarrhea, insomnia.
  • Symptoms of too little thyroid hormone (hypothyroidism) if dose is too low or missed: extreme fatigue, weight gain, constipation, cold intolerance, 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, 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 for you 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 continuous treatment, do not allow your supply of this medication to run out. You may not experience the full effects of this medication for several weeks.

If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar control. Your doctor may need to adjust your diabetes medications. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as advised.

When taking biotin or products containing biotin, stop using them 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 risk factors with your doctor, who can help determine if you are at a higher risk of osteoporosis.

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.

Special Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

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

Pediatric Patients

When administering this medication to a child, monitor their weight changes and consult your doctor, as the dosage may need to be adjusted. Never give your child more than the prescribed dose, 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 consult your doctor to discuss the potential risks and benefits.
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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)
  • Cardiac arrest (rare)

What to Do:

Seek immediate medical attention or call a poison control center (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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Contraindicated Interactions

  • Uncorrected adrenal insufficiency (risk of acute adrenal crisis)
  • Acute myocardial infarction (unless due to hypothyroidism)
  • Untreated thyrotoxicosis
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Major Interactions

  • Amiodarone (alters thyroid hormone metabolism)
  • Antacids (aluminum, magnesium, calcium) - decrease absorption
  • Bile acid sequestrants (cholestyramine, colestipol) - decrease absorption
  • Cation exchange resins (sodium polystyrene sulfonate) - decrease absorption
  • Iron supplements - decrease absorption
  • Sucralfate - decrease absorption
  • Proton pump inhibitors (PPIs) - decrease absorption (due to increased gastric pH)
  • Soy products - decrease absorption
  • Orlistat - decrease absorption
  • Warfarin (enhances anticoagulant effect)
  • Antidiabetic agents (may increase blood glucose, requiring dose adjustment)
  • Sympathomimetics (increased risk of cardiac effects)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) - may increase levothyroxine requirements
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Moderate Interactions

  • Estrogens (increase TBG, may increase levothyroxine requirements)
  • Androgens (decrease TBG, may decrease levothyroxine requirements)
  • Glucocorticoids (may inhibit TSH secretion and T4 to T3 conversion)
  • Beta-blockers (may decrease T4 to T3 conversion)
  • Carbamazepine, Phenytoin, Rifampin (increase levothyroxine metabolism)
  • Sertraline (may increase levothyroxine requirements)
  • Dietary fiber (may decrease absorption)
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Minor Interactions

  • Coffee (may decrease absorption, separate administration)
  • Grapefruit juice (potential minor effect on 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 assess baseline thyroid hormone levels.

Timing: Prior to initiation of therapy.

Cardiac status (ECG, history of cardiac disease)

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

Timing: Prior to initiation, particularly in at-risk patients.

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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: Typically 0.4-4.0 mIU/L (individualized based on patient age, comorbidities, and specific clinical goals).

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

Free Thyroxine (Free T4)

Frequency: May be monitored with TSH, especially in central hypothyroidism or when TSH is unreliable.

Target: Typically 0.8-1.8 ng/dL (individualized).

Action Threshold: Adjust dose if Free T4 is outside target range.

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

Frequency: At each visit.

Target: Resolution or improvement of hypothyroid symptoms.

Action Threshold: Consider dose adjustment or further investigation if symptoms persist despite adequate lab values.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Memory impairment
  • Muscle aches
  • Hoarseness
  • Swelling (myxedema)
  • Palpitations (sign of overtreatment)
  • Nervousness (sign of overtreatment)
  • Tremor (sign of overtreatment)
  • Heat intolerance (sign of overtreatment)

Special Patient Groups

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Pregnancy

Levothyroxine is safe and essential during pregnancy. Hypothyroidism must be treated adequately to prevent adverse maternal and fetal outcomes. Dose requirements often increase during pregnancy (by 25-50% or more) due to increased TBG and fetal thyroid hormone needs.

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism in the first trimester is associated with increased risk of miscarriage, preterm birth, preeclampsia, and impaired neurocognitive development in the offspring.
Second Trimester: Continued need for increased dose. Fetal thyroid gland begins to function, but still relies on maternal T4.
Third Trimester: Continued need for increased dose. Close monitoring of TSH is crucial throughout pregnancy.
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Lactation

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not clinically significant to the infant. It is considered safe for use by nursing mothers.

Infant Risk: L1 (Safest) - No known adverse effects on breastfed infants. May even be beneficial for infants with congenital hypothyroidism if maternal dose is high enough to provide some T4.
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Pediatric Use

Dosing is weight-based and higher per kg than in adults, especially in neonates and infants, due to rapid growth and development. Regular monitoring of TSH and T4 is critical to ensure proper neurocognitive development. Tirosint-SOL may be particularly useful for pediatric patients due to its liquid formulation and ease of administration.

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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, to avoid precipitating cardiac events. Dose titration should be slower and more cautious. Monitor for signs of overtreatment (e.g., angina, arrhythmias).

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is an oral solution of levothyroxine, which may be beneficial for patients with absorption issues (e.g., gastric bypass, celiac disease, lactose intolerance) or those who have difficulty swallowing pills, as it contains fewer excipients than tablet formulations.
  • Always administer Tirosint-SOL on an empty stomach, at least 30-60 minutes before breakfast, and at least 4 hours apart from interacting medications/supplements.
  • Consistency is key: take the medication at the same time each day and avoid missing doses.
  • TSH is the primary lab test for monitoring, but Free T4 may be useful in certain situations (e.g., central hypothyroidism, pregnancy, or when TSH is suppressed).
  • Patients should be educated on symptoms of both under- and over-treatment.
  • The black box warning regarding use for weight loss in euthyroid patients is critical to emphasize.
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Alternative Therapies

  • Levothyroxine tablets (Synthroid, Levoxyl, Unithroid, Euthyrox, Tirosint)
  • Liothyronine (Cytomel, Triostat) - T3 hormone, shorter half-life, used in specific cases or in combination with levothyroxine.
  • Desiccated thyroid extract (Armour Thyroid, Nature-Throid) - natural thyroid hormone from porcine glands, contains both T4 and T3.
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Cost & Coverage

Average Cost: $50 - $200+ per 30ml bottle (depending on strength)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (brand name), Tier 1 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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.