Tirosint-Sol 75mcg/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
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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 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 your doctor or pharmacist for guidance on the best time to take them.
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.

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.
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 or any other food or medication. Consistency is key.
  • Do not mix Tirosint-SOL with other liquids or food. Administer directly into the mouth or dilute in water only.
  • Separate administration of Tirosint-SOL from calcium, iron, antacids, proton pump inhibitors, and bile acid sequestrants by at least 4 hours.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with levothyroxine.
  • Do not stop taking this medication without consulting your doctor, even if you feel better. Lifelong therapy is often required.
  • Store at room temperature, away from light and moisture. Do not freeze.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 1.6 mcg/kg/day orally once daily. Titrate 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. Maintenance: 25-300 mcg/day. Adjust based on TSH.
myxedemaComa: Not typically used for acute myxedema coma; IV levothyroxine is preferred. If oral, much higher doses (e.g., 300-500 mcg initial, then 50-100 mcg daily) are used with caution.
thyroidCancerTSHSuppression: Higher doses (e.g., 2-2.5 mcg/kg/day) to suppress TSH to <0.1 mIU/L or lower, depending on risk.
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day orally once daily (0-3 months).
Infant: 6-8 mcg/kg/day orally once daily (3-6 months); 5-6 mcg/kg/day (6-12 months).
Child: 4-5 mcg/kg/day orally once daily (1-5 years); 2-3 mcg/kg/day (6-12 years).
Adolescent: 2-3 mcg/kg/day orally once daily (12-17 years, during growth); 1.6 mcg/kg/day (after growth completion).
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor TSH closely.
Moderate: No specific adjustment needed, but monitor TSH closely.
Severe: No specific adjustment needed, but monitor TSH closely. Impaired T4 to T3 conversion may occur.

Pharmacology

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Mechanism of Action

Levothyroxine (T4) is a synthetic form of the natural thyroid hormone, thyroxine. It is converted to its active metabolite, liothyronine (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% (average 60-80%), varies by formulation and presence of food/other medications.
Tmax: 2-4 hours (for T4); 24-48 hours (for T3, due to peripheral conversion).
FoodEffect: Decreased absorption when taken with food, certain medications (e.g., calcium, iron, antacids, PPIs, sucralfate, bile acid sequestrants). Tirosint-SOL may have less variability with food than tablet forms, but still recommended to take on an empty stomach.

Distribution:

Vd: 0.11 L/kg
ProteinBinding: >99% (primarily to thyroxine-binding globulin [TBG], transthyretin, and albumin).
CnssPenetration: Limited (due to high protein binding).

Elimination:

HalfLife: 6-7 days (euthyroid); 9-10 days (hypothyroid); 3-4 days (hyperthyroid).
Clearance: Approximately 0.05 L/hr/kg.
ExcretionRoute: Renal (approximately 80% of metabolites), biliary/fecal (approximately 20% of metabolites).
Unchanged: <1% (T4) and <0.1% (T3) excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects typically seen within 3-5 days, full therapeutic effect may take 4-6 weeks.
PeakEffect: 4-6 weeks (when steady-state TSH levels are achieved).
DurationOfAction: Long (due to long half-life), effects persist for several days after discontinuation.

Safety & Warnings

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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 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. 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 for advice:

* 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, 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, anxiety, tremors, insomnia, weight loss, diarrhea.
  • Symptoms of too little thyroid hormone (hypothyroidism) despite treatment: persistent fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, muscle aches.
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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 allergies or sensitivities

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.

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 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 making it more difficult to become pregnant or father a child. If you plan to conceive, consult with 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 a change in weight, 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. Consult with your doctor to discuss any concerns.
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Overdose Information

Overdose Symptoms:

  • Signs and symptoms of hyperthyroidism: headache, irritability, nervousness, sweating, tachycardia, arrhythmias, increased bowel motility, menstrual irregularities, tremors, insomnia, heat intolerance, fever, weight loss, chest pain, palpitations.

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is symptomatic and supportive, and may include beta-blockers for cardiac effects, and measures to reduce absorption if recent ingestion.

Drug Interactions

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Major Interactions

  • Amiodarone (may alter thyroid function, requiring dose adjustment)
  • Oral anticoagulants (may increase anticoagulant effect, requiring INR monitoring and dose adjustment)
  • Sympathomimetics (e.g., decongestants, amphetamines - increased risk of cardiac adverse effects)
  • Antidiabetic agents (may increase insulin/oral hypoglycemic requirements)
  • Digoxin (may decrease digoxin levels, requiring monitoring)
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Moderate Interactions

  • Calcium carbonate/supplements (decreased levothyroxine absorption; separate by 4 hours)
  • Iron supplements (decreased levothyroxine absorption; separate by 4 hours)
  • Antacids (aluminum, magnesium, simethicone - decreased levothyroxine absorption; separate by 4 hours)
  • Proton pump inhibitors (PPIs) (may decrease levothyroxine absorption; separate by 4 hours)
  • Sucralfate (decreased levothyroxine absorption; separate by 4 hours)
  • Bile acid sequestrants (cholestyramine, colestipol, colesevelam - decreased levothyroxine absorption; separate by 4-6 hours)
  • Soy products (may decrease levothyroxine absorption)
  • Dietary fiber (may decrease levothyroxine absorption)
  • Orlistat (may decrease levothyroxine absorption)
  • Estrogens (oral) / Selective Estrogen Receptor Modulators (SERMs) (increase TBG, requiring higher levothyroxine dose)
  • Androgens / Anabolic steroids (decrease TBG, requiring lower levothyroxine dose)
  • Glucocorticoids (may inhibit TSH secretion and T4 to T3 conversion)
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital (increase levothyroxine metabolism, requiring higher dose)
  • Sertraline (may increase levothyroxine requirements)
  • Imatinib, Sunitinib (may increase levothyroxine requirements)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib, sorafenib - may increase levothyroxine requirements)
  • Propylthiouracil (PTU) / Methimazole (inhibit T4 to T3 conversion and thyroid hormone synthesis)
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Minor Interactions

  • Coffee (may decrease absorption; separate by 30-60 minutes)

Monitoring

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Baseline Monitoring

TSH (Thyroid-Stimulating Hormone)

Rationale: To confirm diagnosis of hypothyroidism and establish baseline.

Timing: Prior to initiation of therapy.

Free T4 (Free Thyroxine)

Rationale: To assess baseline thyroid hormone levels.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To establish baseline symptom severity.

Timing: Prior to initiation of therapy.

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Routine Monitoring

TSH (Thyroid-Stimulating Hormone)

Frequency: Every 4-6 weeks after any dose change until stable, then annually once stable.

Target: 0.4-4.0 mIU/L (for primary hypothyroidism, target often 0.5-2.5 mIU/L); specific targets vary based on patient age, comorbidities, and underlying condition (e.g., thyroid cancer suppression).

Action Threshold: If TSH is high, increase dose; if TSH is low (suppressed), decrease dose. Adjust by 12.5-25 mcg increments.

Free T4 (Free Thyroxine)

Frequency: May be monitored with TSH, especially if central hypothyroidism is suspected or TSH is unreliable.

Target: 0.8-1.8 ng/dL (typical reference range).

Action Threshold: If TSH is normal but Free T4 is low, consider malabsorption or non-compliance. If Free T4 is high, consider over-replacement.

Clinical symptoms of hypo/hyperthyroidism

Frequency: At every visit.

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

Action Threshold: Persistent hypothyroid symptoms (fatigue, weight gain, constipation, cold intolerance) or new hyperthyroid symptoms (palpitations, anxiety, weight loss, heat intolerance) warrant TSH/Free T4 re-evaluation and dose adjustment.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Constipation
  • Cold or heat intolerance
  • Dry skin
  • Hair loss
  • Muscle aches or weakness
  • Depression or anxiety
  • Memory problems
  • Bradycardia or tachycardia
  • Palpitations
  • Tremors
  • Nervousness
  • Insomnia
  • Diarrhea

Special Patient Groups

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Pregnancy

Levothyroxine requirements typically increase during pregnancy. It is essential to maintain euthyroid status for both maternal and fetal health. Category A: Studies in pregnant women have not shown an increased risk of fetal abnormalities.

Trimester-Specific Risks:

First Trimester: Increased levothyroxine dose often needed early in pregnancy due to increased TBG and fetal thyroid hormone demand. Untreated maternal hypothyroidism can lead to adverse fetal neurodevelopmental outcomes.
Second Trimester: Continued monitoring and dose adjustment as needed.
Third Trimester: Continued monitoring and dose adjustment as needed. TSH should be monitored every 4-6 weeks throughout pregnancy.
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Lactation

Levothyroxine is compatible with breastfeeding. Minimal amounts are excreted into breast milk, and it does not adversely affect the nursing infant.

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

Dosing is weight-based and critical for normal growth and neurodevelopment. Regular monitoring of TSH and Free T4 is essential. Tirosint-SOL is particularly useful in pediatric patients due to its liquid formulation and lack of common excipients.

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Geriatric Use

Lower initial doses (e.g., 12.5-25 mcg/day) are often recommended, especially in patients with underlying cardiovascular disease, due to increased sensitivity to thyroid hormones and potential for cardiac adverse effects. Gradual titration is important. Monitor for cardiac symptoms.

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is a liquid formulation of levothyroxine, which may be beneficial for patients with swallowing difficulties, malabsorption issues, or allergies/sensitivities to common excipients (e.g., lactose, gluten, dyes) found in tablet formulations.
  • Unlike tablet forms, Tirosint-SOL does not contain excipients that can bind levothyroxine, potentially leading to more consistent absorption, though it should still be taken on an empty stomach.
  • The 75mcg/ml concentration allows for flexible and precise dosing, especially useful for pediatric patients or those requiring small dose adjustments.
  • Patients switching from other levothyroxine formulations to Tirosint-SOL should have their TSH levels re-checked in 4-6 weeks, as absorption characteristics may differ.
  • Emphasize strict adherence to administration instructions (empty stomach, separate from other medications) to ensure consistent absorption and therapeutic effect.
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Alternative Therapies

  • Other levothyroxine tablet formulations (e.g., Synthroid, Levoxyl, Unithroid, Tirosint capsules)
  • Liothyronine (T3) - used in specific cases, often in combination with levothyroxine, or for myxedema coma.
  • Desiccated thyroid extract (e.g., Armour Thyroid, NP Thyroid) - natural thyroid hormone containing both T4 and T3.
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Cost & Coverage

Average Cost: $50 - $200+ per 30ml bottle (75mcg/ml)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred brand or non-preferred brand, depending on insurance plan). Generic levothyroxine is 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 this 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.