Tirosint-Sol 112mcg/ml Oral Sol

Manufacturer IBSA PHARMA Active Ingredient Levothyroxine Oral Solution (Tirosint-SOL)(lee voe thye ROKS een) Pronunciation LEE-voe-THY-roks-een (TIE-roe-sint SOL)
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
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 doesn't make 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 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 bathrooms.
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, at least 30-60 minutes before breakfast, or at bedtime (3-4 hours after your last meal). Consistency is key.
  • Do not take with food, as food can significantly reduce absorption.
  • Separate administration from calcium, iron, antacids, and other interacting medications by at least 4 hours (or as advised by your doctor).
  • 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: Initial dose typically 1.6 mcg/kg/day orally once daily, adjusted based on TSH levels. For patients with cardiac disease or elderly, start with 12.5-25 mcg/day.
Dose Range: 12.5 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 1.6 mcg/kg/day. Maintenance: Adjusted to achieve euthyroid state (TSH 0.4-4.0 mIU/L).
myxedemaComa: IV formulation used, not oral solution. Oral solution not suitable for acute, severe conditions.
thyroidCancerSuppression: Higher doses (e.g., 2.0-2.5 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 (for congenital hypothyroidism).
Infant: 6-8 mcg/kg/day orally once daily (for 6-12 months).
Child: 4-6 mcg/kg/day orally once daily (for 1-5 years); 3-5 mcg/kg/day (for 6-12 years).
Adolescent: 2-3 mcg/kg/day orally once daily (for >12 years and during puberty); adult dose (1.6 mcg/kg/day) once growth is complete.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment needed.
Moderate: No specific dose adjustment needed.
Severe: No specific dose adjustment needed, but monitor TSH/fT4 closely.
Dialysis: No specific dose adjustment needed; levothyroxine is highly protein-bound and not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment needed.
Moderate: No specific dose adjustment needed.
Severe: No specific dose adjustment needed, but monitor TSH/fT4 closely as severe liver disease may affect protein binding and T4 to T3 conversion.

Pharmacology

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Mechanism of Action

Levothyroxine (T4) is a synthetic thyroid hormone that is chemically identical to the naturally occurring hormone produced by the thyroid gland. 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 metabolism, growth, and development.
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Pharmacokinetics

Absorption:

Bioavailability: 48-80% (variable, decreased by food, certain medications, and gastric pH changes). Tirosint-SOL may have more consistent absorption due to its liquid formulation and lack of excipients.
Tmax: 2-4 hours
FoodEffect: Significantly decreased absorption when taken with food. Should be taken on an empty stomach, at least 30-60 minutes before breakfast, or at bedtime (3-4 hours after last meal).

Distribution:

Vd: 0.13 L/kg
ProteinBinding: >99% (primarily to thyroid-binding globulin [TBG], transthyretin [TTR], and albumin)
CnssPenetration: Limited (primarily as T3 after conversion from T4)

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 conjugated metabolites), Biliary/Fecal (approximately 20% of conjugated metabolites)
Unchanged: <1% (renal)
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Pharmacodynamics

OnsetOfAction: Gradual, clinical effects typically seen within 3-5 days, but full therapeutic effect may take 4-6 weeks due to long half-life and need for steady-state.
PeakEffect: 4-6 weeks (after reaching steady-state)
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 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 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. Many people experience no side effects or only 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 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, 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, excessive sweating, heat intolerance, nervousness, tremors, 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, 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 the 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. This will help prevent any potential interactions or adverse effects.
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Precautions & Cautions

Important Information for 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 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.

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

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 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 than the prescribed dose, 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 your doctor to discuss potential growth effects and monitoring requirements.
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Overdose Information

Overdose Symptoms:

  • Headache
  • Irritability
  • Nervousness
  • Sweating
  • Diarrhea
  • Palpitations
  • Tachycardia (rapid heart rate)
  • Arrhythmias
  • Tremor
  • Insomnia
  • Chest pain
  • Fever
  • Heat intolerance

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is symptomatic and supportive, often involving beta-blockers for cardiac effects.

Drug Interactions

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Contraindicated Interactions

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

  • Bile acid sequestrants (e.g., cholestyramine, colestipol)
  • Ion exchange resins (e.g., sevelamer, patiromer)
  • Calcium carbonate/supplements
  • Iron supplements
  • Antacids (aluminum and magnesium hydroxide)
  • Proton pump inhibitors (PPIs)
  • Sucralfate
  • Soy products/soy formula
  • Dietary fiber
  • Orlistat
  • Amiodarone
  • Phenytoin
  • Carbamazepine
  • Rifampin
  • Sertraline
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib, sorafenib)
  • Oral anticoagulants (e.g., warfarin) - potentiates effect
  • Digoxin - may decrease digoxin levels
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Moderate Interactions

  • Estrogens (oral contraceptives, hormone replacement therapy) - increase TBG, may increase levothyroxine requirement
  • Androgens - decrease TBG, may decrease levothyroxine requirement
  • Corticosteroids - may affect thyroid hormone metabolism
  • Beta-blockers (e.g., propranolol) - may inhibit T4 to T3 conversion
  • Salicylates (>2g/day) - may displace thyroid hormones from protein binding
  • Furosemide (>80mg IV) - may displace thyroid hormones from protein binding
  • Insulin/Oral hypoglycemics - may increase requirement for these drugs
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Minor Interactions

  • Certain foods (e.g., grapefruit juice - inconsistent evidence, but caution advised)

Monitoring

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Baseline Monitoring

Thyroid-stimulating hormone (TSH)

Rationale: Primary diagnostic and monitoring tool for hypothyroidism.

Timing: Before initiation of therapy.

Free Thyroxine (Free T4)

Rationale: Assesses circulating unbound T4 levels, useful in certain conditions (e.g., central hypothyroidism, pregnancy, or when TSH is unreliable).

Timing: Before initiation of therapy.

Clinical assessment of thyroid status

Rationale: To identify signs and symptoms of hypo- or hyperthyroidism.

Timing: Before initiation and periodically during therapy.

Cardiac status (ECG, history of cardiac disease)

Rationale: To assess risk for adverse cardiac events, especially in elderly or those with pre-existing heart conditions, as thyroid hormones increase cardiac workload.

Timing: Before initiation, especially in older adults or those with cardiac risk factors.

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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 (for primary hypothyroidism, target may vary based on patient factors and guidelines).

Action Threshold: Adjust dose if TSH is outside target range; consider dose reduction if TSH is suppressed (<0.1 mIU/L) in non-cancer patients.

Free Thyroxine (Free T4)

Frequency: May be checked with TSH if TSH is abnormal, or in specific situations (e.g., central hypothyroidism, pregnancy, non-compliance concerns).

Target: 0.8-1.8 ng/dL (reference range may vary by lab).

Action Threshold: Adjust dose if Free T4 is outside target range, especially if TSH is also abnormal.

Clinical symptoms

Frequency: At every visit.

Target: Resolution of hypothyroid symptoms (fatigue, weight gain, constipation, cold intolerance) and absence of hyperthyroid symptoms (palpitations, anxiety, weight loss, heat intolerance).

Action Threshold: Investigate new or persistent symptoms; may indicate need for dose adjustment or evaluation for other conditions.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Constipation or diarrhea
  • Cold or heat intolerance
  • Dry skin or excessive sweating
  • Hair loss
  • Muscle aches or weakness
  • Changes in mood (depression, anxiety, irritability)
  • Palpitations or rapid heart rate
  • Tremors
  • Sleep disturbances
  • Menstrual irregularities

Special Patient Groups

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Pregnancy

Levothyroxine is essential for normal fetal development and should be continued throughout pregnancy. Thyroid hormone requirements often increase during pregnancy, necessitating dose adjustments. Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism during early pregnancy is associated with increased risk of miscarriage, premature birth, low birth weight, and impaired neurocognitive development in the child. Levothyroxine is safe and necessary.
Second Trimester: Maternal thyroid hormone requirements typically increase, requiring dose adjustments. Close monitoring of TSH is crucial.
Third Trimester: Continued monitoring and dose adjustment as needed. Adequate maternal thyroid hormone is vital for fetal brain development.
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Lactation

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

Infant Risk: Low risk. No adverse effects reported in breastfed infants.
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Pediatric Use

Dosing is weight-based and crucial for normal growth and development, especially neurocognitive development in infants and young children with congenital hypothyroidism. Close monitoring of TSH and clinical status is essential. Tirosint-SOL may be particularly useful for infants and children who cannot swallow pills or have absorption issues.

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Geriatric Use

Elderly patients may be more sensitive to the effects of levothyroxine, particularly cardiac effects. Initial doses should be lower (e.g., 12.5-25 mcg/day) and titrated slowly with careful monitoring of TSH and cardiac status. Higher prevalence of underlying cardiac disease in this population necessitates caution.

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is a liquid formulation of levothyroxine that may offer more consistent absorption compared to tablet forms, especially in patients with gastrointestinal absorption issues (e.g., celiac disease, lactose intolerance, gastric bypass surgery, or those on proton pump inhibitors).
  • Always take levothyroxine on an empty stomach, preferably 30-60 minutes before breakfast, or at bedtime (3-4 hours after the last meal) to maximize absorption and minimize interactions.
  • Consistency in timing and relation to meals/other medications is more important than the exact time of day.
  • Do not switch between different brands or formulations of levothyroxine without consulting a healthcare provider, as bioavailability can vary, potentially requiring dose adjustments.
  • Patients should be educated on the symptoms of both hypo- and hyperthyroidism, and to report any new or worsening symptoms.
  • The black box warning regarding use for weight loss is critical; emphasize that levothyroxine is not for weight reduction in euthyroid individuals and can be dangerous if misused.
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Alternative Therapies

  • Other levothyroxine formulations (tablets, capsules - e.g., Synthroid, Levoxyl, Unithroid, Tirosint capsules)
  • Liothyronine (T3) - synthetic T3, used in specific cases or in combination with T4 (e.g., Cytomel)
  • Desiccated thyroid extract (e.g., Armour Thyroid, NP Thyroid) - natural thyroid hormones (T4 and T3), derived from porcine thyroid glands.
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Cost & Coverage

Average Cost: Highly variable, typically higher than generic tablets per 30 ml bottle (multiple doses)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (brand name), Tier 1 (generic tablets)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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.