Tirosint-Sol 88mcg/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?

Levothyroxine is a medicine that replaces a hormone normally made by your thyroid gland. It's used to treat an underactive thyroid (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 precisely.

Take your medication on an empty stomach, 15 minutes before breakfast.
You can take the medication directly into your mouth or mix it with water. To mix 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 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 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 resume your regular schedule.
* Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take Tirosint-SOL once daily, preferably in the morning, on an empty stomach, at least 30-60 minutes before breakfast.
  • Do not mix Tirosint-SOL with water or other liquids. Administer directly into the mouth or onto a spoon.
  • Separate administration of Tirosint-SOL from calcium, iron, antacids, and other medications by at least 4 hours to ensure proper absorption.
  • Take consistently at the same time each day.
  • 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.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose typically 1.6 mcg/kg/day (based on ideal body weight) for primary hypothyroidism. Adjust dose by 12.5 to 25 mcg increments every 4 to 6 weeks until TSH is normalized. Average full replacement dose is 100-125 mcg/day.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 1.6 mcg/kg/day. Titrate based on TSH. For patients with cardiovascular disease or elderly, initial dose 12.5-25 mcg/day, titrate slowly.
myxedemaComa: IV formulation preferred, but if oral, much higher doses (e.g., 200-500 mcg loading dose) are used, followed by daily maintenance. Requires ICU setting.
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day (0-3 months), adjust based on TSH and T4.
Infant: 6-8 mcg/kg/day (3-6 months), 5-6 mcg/kg/day (6-12 months), adjust based on TSH and T4.
Child: 4-5 mcg/kg/day (1-5 years), 3-4 mcg/kg/day (6-12 years), adjust based on TSH and T4.
Adolescent: 2-3 mcg/kg/day (12-17 years), adjust based on TSH and T4. Once growth is complete, adult dosing may apply.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required. Monitor thyroid function tests closely.
Dialysis: No specific dose adjustment required. Levothyroxine is highly protein-bound and not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required. Monitor thyroid function tests closely, as metabolism may be altered.

Pharmacology

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Mechanism of Action

Levothyroxine (T4) is a synthetic form of the naturally occurring thyroid hormone, L-thyroxine. It is converted to its active metabolite, L-triiodothyronine (T3), in peripheral tissues. T3 and T4 exert their metabolic effects through control of DNA transcription and protein synthesis. They regulate multiple metabolic processes, including carbohydrate, protein, and lipid metabolism, and affect virtually every organ system, playing a critical role in normal development, growth, and metabolism.
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Pharmacokinetics

Absorption:

Bioavailability: 48-79% (variable, affected by food and other medications). Tirosint-SOL may have more consistent absorption due to its formulation.
Tmax: Approximately 2-4 hours (for oral solution, potentially faster than tablets).
FoodEffect: Significantly reduced absorption when taken with 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.

Distribution:

Vd: Approximately 10-13 L (for T4).
ProteinBinding: Greater than 99% (primarily to thyroxine-binding globulin (TBG), transthyretin (TTR), 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); can be shorter in hyperthyroidism (3-4 days) and longer in hypothyroidism (9-10 days).
Clearance: Approximately 0.05-0.07 L/kg/day.
ExcretionRoute: Primarily renal (approximately 80% of metabolites), with some fecal excretion (approximately 20%).
Unchanged: Less than 1% of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Slow, therapeutic effects are not immediate. Clinical improvement typically begins within 3-5 days, but full effect takes weeks.
PeakEffect: Peak therapeutic effect is usually observed 4-6 weeks after initiation of therapy or a dose change, due to the long half-life and time required to reach steady-state.
DurationOfAction: Long, due to the long half-life. Effects persist for several weeks after discontinuation.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Headache
Feeling tired or weak
Changes in appetite
Unintentional weight changes
Diarrhea, stomach cramps, or vomiting
Mood changes, such as irritability, nervousness, excitability, anxiety, or other emotional changes
Shakiness
Trouble sleeping
Sensitivity to heat
Excessive sweating
Fever
Muscle cramps
Muscle weakness
Flushing
Bone pain
Changes in menstrual periods (in women)
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 within the first few months of treatment)

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, shortness of breath, excessive sweating, heat intolerance, nervousness, tremor, 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.
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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 making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, 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 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. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as recommended.

If you take biotin or products 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 and address 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 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 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. Consult your doctor to discuss any concerns.
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Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia
  • Arrhythmias
  • Chest pain (angina)
  • Tremor
  • Nervousness
  • Insomnia
  • Diarrhea
  • Weight loss
  • Fever
  • Heat intolerance
  • Seizures (rare)
  • Heart failure (in susceptible individuals)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive and symptomatic, often involving beta-blockers for cardiac symptoms and measures to reduce absorption if recent ingestion.

Drug Interactions

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Major Interactions

  • Amiodarone (can cause hypo- or hyperthyroidism, alters T4 to T3 conversion)
  • Certain antiepileptic drugs (e.g., carbamazepine, phenytoin, phenobarbital - increase levothyroxine metabolism)
  • Rifampin (increases levothyroxine metabolism)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib - can affect thyroid function and increase levothyroxine requirements)
  • Orlistat (can reduce levothyroxine absorption)
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Moderate Interactions

  • Calcium carbonate/supplements (reduce absorption, separate by 4 hours)
  • Iron supplements (ferrous sulfate, etc. - reduce absorption, separate by 4 hours)
  • Antacids (aluminum hydroxide, magnesium hydroxide - reduce absorption, separate by 4 hours)
  • Proton pump inhibitors (e.g., omeprazole, lansoprazole - increase gastric pH, potentially reducing absorption, monitor TSH)
  • Sucralfate (reduces absorption, separate by 4 hours)
  • Cholestyramine, colestipol, sevelamer (bile acid sequestrants - reduce absorption, separate by 4-6 hours)
  • Soy products (can reduce absorption, monitor TSH)
  • Dietary fiber (can reduce absorption, monitor TSH)
  • Warfarin (levothyroxine can enhance anticoagulant effect, monitor INR)
  • Beta-blockers (may reduce conversion of T4 to T3)
  • Estrogens (increase TBG, may increase levothyroxine requirements)
  • Androgens (decrease TBG, may decrease levothyroxine requirements)
  • Corticosteroids (can inhibit TSH secretion and T4 to T3 conversion)
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Minor Interactions

  • Certain foods (e.g., grapefruit juice, coffee - may slightly affect absorption, consistency is key)
  • Multivitamins with minerals (separate administration)

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary diagnostic and monitoring tool for hypothyroidism. Reflects the body's response to thyroid hormone levels.

Timing: Before initiation of therapy.

Free Thyroxine (FT4)

Rationale: Measures the unbound, active form of T4. Useful in conjunction with TSH, especially in central hypothyroidism or when TSH is unreliable.

Timing: Before initiation of therapy.

Clinical Symptoms of Hypothyroidism

Rationale: To establish baseline symptoms (e.g., fatigue, weight gain, constipation, cold intolerance) for assessing treatment efficacy.

Timing: Before initiation of therapy.

Cardiac Status (ECG, history of heart disease)

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

Timing: Before initiation of therapy, particularly 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 any dose change, until stable. Once stable, annually or as clinically indicated.

Target: Typically 0.4-4.0 mIU/L (euthyroid range), but target may vary based on patient age, comorbidities, and specific clinical situation (e.g., pregnancy, thyroid cancer).

Action Threshold: If TSH is outside target range, adjust levothyroxine dose. If TSH is high, increase dose; if TSH is low, decrease dose.

Free Thyroxine (FT4)

Frequency: Often checked with TSH, especially if TSH is suppressed or in central hypothyroidism. Less frequently needed once TSH is stable.

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

Action Threshold: Used to guide dose adjustments, particularly when TSH is not a reliable indicator.

Clinical Symptoms of Hypo/Hyperthyroidism

Frequency: At every follow-up visit.

Target: Resolution of hypothyroid symptoms; absence of hyperthyroid symptoms (e.g., palpitations, anxiety, weight loss, heat intolerance).

Action Threshold: Persistent hypothyroid symptoms or emergence of hyperthyroid symptoms indicate need for dose adjustment and/or further investigation.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold or heat intolerance
  • Constipation or diarrhea
  • Dry skin or hair loss
  • Muscle aches or weakness
  • Depression or anxiety
  • Memory impairment
  • Bradycardia or tachycardia
  • Palpitations
  • Tremor
  • Nervousness
  • Insomnia

Special Patient Groups

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Pregnancy

Levothyroxine requirements typically increase during pregnancy. It is crucial to maintain euthyroidism to support fetal neurological development. TSH levels should be monitored closely (e.g., every 4-6 weeks) and dose adjusted as needed.

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism in the first trimester is associated with increased risk of miscarriage, preterm birth, and impaired neurocognitive development in the offspring.
Second Trimester: Continued need for increased dose; fetal thyroid gland begins to function, but maternal thyroid hormone remains important.
Third Trimester: Dose requirements may continue to increase. Adequate maternal thyroid hormone is essential for fetal growth and development.
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Lactation

Levothyroxine is considered safe during breastfeeding. Only small amounts are excreted into breast milk, and it does not adversely affect the nursing infant. Maternal thyroid hormone replacement is important for the mother's health and ability to care for the infant.

Infant Risk: L1 (Safest) - No known risk to the infant; amounts in breast milk are minimal and not expected to cause adverse effects.
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Pediatric Use

Dosing is weight-based and critical for normal growth and neurological development. Regular monitoring of TSH and FT4 is essential. Adherence is crucial, especially in infants and young children, to prevent irreversible developmental delays.

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Geriatric Use

Lower starting doses (e.g., 12.5-25 mcg/day) are often recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Dose titration should be slower and more cautious. Monitor for cardiac symptoms.

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is an oral solution, which may be beneficial for patients with absorption issues (e.g., gastric bypass, celiac disease, lactose intolerance) or those who have difficulty swallowing pills.
  • Always take levothyroxine on an empty stomach, consistently 30-60 minutes before breakfast, and separate from other medications and supplements by at least 4 hours.
  • The 88mcg/ml concentration means 1 ml contains 88 mcg of levothyroxine. Dosing should be precise using the provided oral syringe.
  • Patients should be advised that it takes several weeks for the full therapeutic effect to be seen and for TSH levels to stabilize after a dose change.
  • Educate patients on symptoms of both under- and over-treatment to ensure timely reporting and dose adjustments.
  • Consistency in brand and formulation is generally recommended due to narrow therapeutic index and potential for bioavailability differences between products.
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Alternative Therapies

  • Other levothyroxine formulations (tablets, capsules, softgel capsules, IV injection)
  • Liothyronine (T3) - used in specific cases, often in combination with levothyroxine
  • Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from porcine thyroid glands.
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Cost & Coverage

Average Cost: Varies, typically $30-$100+ per 30ml bottle (88mcg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic levothyroxine; Tirosint-SOL may be Tier 2 or 3 depending on the insurance plan.
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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 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. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.