Tirosint-Sol 62.5mcg/ml Oral Sol

Manufacturer IBSA PHARMA Active Ingredient Levothyroxine Oral Solution (Tirosint-SOL)(lee voe thye ROKS een) Pronunciation lee voe thye ROKS een
WARNING: Do not use this drug for weight loss. Severe and sometimes deadly side effects may happen with this drug if it is taken in large doses or with other drugs for weight loss. If you have questions, talk with the doctor. @ COMMON USES: It is used to add thyroid hormone to the body.It is used to manage thyroid cancer.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Thyroid hormone replacement
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Pharmacologic Class
Thyroid hormones
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Pregnancy Category
Category A
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FDA Approved
Aug 2016
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tirosint-SOL is a liquid medicine that replaces a hormone your body normally makes, called thyroid hormone. 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, improving symptoms like tiredness, weight gain, and feeling cold.
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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. 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 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 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 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

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 on an empty stomach, typically 30-60 minutes before breakfast, with a full glass of water. For Tirosint-SOL, it can be taken directly or mixed with water.
  • Do not take with food, coffee, or other medications/supplements (especially iron, calcium, antacids) within 4 hours of your dose, as they can interfere with absorption.
  • Take at the same time each day for best results.
  • 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 essential to ensure you are on the correct dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's TSH levels, clinical response, and underlying condition. Typical initial dose for primary hypothyroidism: 1.6 mcg/kg/day orally once daily. For Tirosint-SOL, it can be taken directly or diluted in water.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

Primary Hypothyroidism (initial): 1.6 mcg/kg/day orally once daily. Adjust by 12.5-25 mcg increments every 4-6 weeks based on TSH.
Subclinical Hypothyroidism: Often 25-75 mcg/day, individualized based on TSH and symptoms.
Myxedema Coma: IV formulation used, not oral solution.
Cardiac Disease (initial): 12.5-25 mcg/day orally once daily. Titrate slowly with 12.5-25 mcg increments every 4-6 weeks.
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Pediatric Dosing

Neonatal: Congenital Hypothyroidism (0-3 months): 10-15 mcg/kg/day orally once daily. Adjust based on TSH and T4.
Infant: Congenital Hypothyroidism (3-6 months): 8-10 mcg/kg/day; (6-12 months): 6-8 mcg/kg/day. Adjust based on TSH and T4.
Child: Hypothyroidism (1-5 years): 5-6 mcg/kg/day; (6-12 years): 4-5 mcg/kg/day. Adjust based on TSH and T4.
Adolescent: Hypothyroidism (>12 years, growth and puberty complete): 2-3 mcg/kg/day or adult dose (1.6 mcg/kg/day). Adjust based on TSH and T4.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed; monitor TSH and adjust dose as clinically indicated.
Moderate: No specific adjustment needed; monitor TSH and adjust dose as clinically indicated.
Severe: No specific adjustment needed; monitor TSH and adjust dose as clinically indicated.
Dialysis: No specific adjustment needed; monitor TSH and adjust dose as clinically indicated. Levothyroxine is highly protein-bound and not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed; monitor TSH and adjust dose as clinically indicated.
Moderate: No specific adjustment needed; monitor TSH and adjust dose as clinically indicated.
Severe: No specific adjustment needed; monitor TSH and adjust dose as clinically indicated.

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 and T4 exert their metabolic effects through control of DNA transcription and protein synthesis. Thyroid hormones regulate multiple metabolic processes, including carbohydrate, lipid, and protein metabolism, and are essential for normal growth and development, especially of the central nervous system and bone.
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Pharmacokinetics

Absorption:

Bioavailability: 48-79% (highly variable, influenced by food, gastric pH, and other medications). Tirosint-SOL may have more consistent absorption due to its formulation.
Tmax: 2-4 hours
FoodEffect: Food significantly decreases absorption. 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: 10-13 L
ProteinBinding: >99% (primarily to thyroxine-binding globulin (TBG), thyroxine-binding prealbumin (TBPA), and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 6-7 days (euthyroid); 9-10 days (hypothyroid); 3-4 days (hyperthyroid)
Clearance: Not available
ExcretionRoute: Renal (approximately 80% of conjugated T4 is excreted in urine), fecal (approximately 20% of conjugated T4 is excreted in feces via biliary elimination).
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Gradual, over several days to weeks
PeakEffect: Clinical effects typically seen within 3-4 weeks, full effect may take 4-6 weeks (due to long half-life and need for TSH stabilization)
DurationOfAction: Effects persist for several days after discontinuation due to long half-life

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Headache
Feeling tired or weak
Changes in appetite
Unintentional weight changes
Diarrhea, stomach cramps, or vomiting
Mood changes, such as feeling irritable, nervous, excitable, or anxious
Shakiness
Trouble sleeping
Sensitivity to heat
Excessive sweating
Fever
Muscle cramps
Muscle weakness
Flushing
Bone pain
Changes in menstrual periods
In children: hip or knee pain, or a limp
In infants: changes in the shape of the head and face

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people 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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, chest pain, shortness of breath, excessive sweating, heat intolerance, nervousness, 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.
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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 crucial that you inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure uninterrupted treatment, do not allow your supply of this medication to run out. Please note that it may take several weeks to experience the full effects of this drug.

Special Considerations

If you have diabetes (high blood sugar), it is essential to discuss this 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 developing weak bones (osteoporosis), particularly after menopause. Discuss your individual 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 making it more difficult to become pregnant or father a child. If you are planning to conceive, consult with your doctor before starting this medication.

Age-Related Considerations

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

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of this medication for both you and your baby.

Pediatric Patients

If you are giving this medication to a child and notice any changes in their 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, so be sure to discuss this with your doctor.
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Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia
  • Arrhythmias
  • Chest pain
  • Tremors
  • Nervousness
  • Insomnia
  • Diaphoresis
  • Heat intolerance
  • Weight loss
  • Diarrhea
  • Fever
  • Seizures (rare)
  • Heart failure (rare, especially in elderly or those with cardiac disease)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment 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)
  • Antacids (aluminum, magnesium, calcium carbonate - decrease absorption)
  • Bile acid sequestrants (cholestyramine, colestipol - decrease absorption)
  • Cation-containing products (iron, calcium supplements - decrease absorption)
  • Proton pump inhibitors (PPIs - decrease absorption by increasing gastric pH)
  • Sucralfate (decreases absorption)
  • Orlistat (decreases absorption)
  • Soy products (large amounts can decrease absorption)
  • Phenytoin, Carbamazepine, Rifampin (increase levothyroxine metabolism)
  • Warfarin (levothyroxine may enhance anticoagulant effect)
  • Insulin/Oral Hypoglycemics (levothyroxine may increase insulin requirements)
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Moderate Interactions

  • SSRIs (sertraline - may increase levothyroxine requirements)
  • Estrogens (increase TBG, may increase levothyroxine requirements)
  • Androgens (decrease TBG, may decrease levothyroxine requirements)
  • Beta-blockers (may decrease conversion of T4 to T3)
  • Corticosteroids (may decrease conversion of T4 to T3)
  • Digoxin (levothyroxine may decrease digoxin levels)
  • Theophylline (levothyroxine may increase theophylline clearance)
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Minor Interactions

  • Dietary fiber (may decrease absorption if taken concurrently)

Monitoring

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Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: Primary diagnostic and monitoring tool for hypothyroidism.

Timing: Before initiating therapy.

Free Thyroxine (Free T4)

Rationale: Assesses thyroid hormone levels directly, useful in central hypothyroidism or when TSH is unreliable.

Timing: Before initiating therapy.

Clinical Symptoms of Hypothyroidism

Rationale: To establish baseline and track improvement.

Timing: Before initiating therapy.

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Routine Monitoring

Thyroid Stimulating Hormone (TSH)

Frequency: Every 4-6 weeks after initiation or dose change, then every 6-12 months once stable.

Target: 0.4-4.0 mIU/L (individualized based on patient factors, e.g., age, pregnancy, cardiac disease).

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 if TSH is suppressed.

Target: 0.8-1.8 ng/dL (or laboratory specific range).

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

Clinical Symptoms

Frequency: At each visit.

Target: Resolution or improvement of hypothyroid symptoms (e.g., fatigue, weight gain, constipation, cold intolerance).

Action Threshold: Consider dose adjustment if symptoms persist despite normal TSH.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or difficulty losing weight)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Memory impairment
  • Muscle aches and weakness
  • Puffiness in face/eyes
  • Hoarseness
  • Menstrual irregularities

Special Patient Groups

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Pregnancy

Levothyroxine is the drug of choice for hypothyroidism during pregnancy. Thyroid hormone requirements often increase during pregnancy, typically by 25-50% or more. Close monitoring of TSH (every 4-6 weeks) is crucial to ensure adequate dosing and fetal neurological development.

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; inadequate thyroid hormone can affect fetal brain development.
Third Trimester: Continued need for increased dose; inadequate thyroid hormone can affect fetal brain development.
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Lactation

Levothyroxine is considered compatible with breastfeeding (L1). Minimal amounts are excreted into breast milk, and it does not adversely affect the infant. Maternal thyroid hormone requirements typically return to pre-pregnancy levels postpartum, but monitoring is still needed.

Infant Risk: Low risk; not expected to cause adverse effects in breastfed infants.
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Pediatric Use

Dosing is weight-based and higher per kg in younger children due to higher metabolic rates and rapid growth. Crucial for normal growth, bone maturation, and central nervous system development. Regular monitoring of TSH and T4 is essential. Tirosint-SOL may be beneficial for infants and young children who cannot swallow pills or have feeding tubes.

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Geriatric Use

Lower initial doses (e.g., 12.5-25 mcg/day) are often recommended, especially in patients with underlying cardiac disease, due to increased sensitivity to thyroid hormones and potential for cardiac adverse effects. Dose titration should be slower. Monitor for signs of cardiac toxicity.

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is a liquid formulation that may be beneficial for patients with malabsorption issues (e.g., celiac disease, bariatric surgery), allergies to excipients in tablet formulations, or difficulty swallowing pills.
  • Always take levothyroxine on an empty stomach, consistently 30-60 minutes before breakfast, to optimize absorption. Consistency in timing relative to meals is more important than the exact time of day.
  • Educate patients about common drug and food interactions that can impair absorption (e.g., calcium, iron, antacids, PPIs, soy, coffee). Advise separating administration by at least 4 hours.
  • TSH is the primary lab test for monitoring, but Free T4 may be useful in specific situations (e.g., central hypothyroidism, TSH suppression).
  • Dose adjustments should be made gradually, typically every 4-6 weeks, allowing TSH levels to stabilize.
  • Symptoms of hypothyroidism can overlap with other conditions; ensure TSH is adequately controlled before attributing persistent symptoms solely to hypothyroidism.
  • Patients with cardiac disease should start with very low doses and titrate slowly to avoid exacerbating cardiac symptoms.
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Alternative Therapies

  • Levothyroxine tablets (Synthroid, Levoxyl, Unithroid, Tirosint)
  • Liothyronine (Cytomel, Triostat) - T3 hormone, shorter half-life, more potent, generally not first-line for chronic replacement.
  • Desiccated Thyroid Extract (Armour Thyroid, Nature-Throid) - Natural thyroid hormones (T4 and T3) from porcine thyroid glands.
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Cost & Coverage

Average Cost: Varies widely by dose and pharmacy, typically $30-$100+ per 30 mL bottle (62.5 mcg/mL)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic levothyroxine; brand-name Tirosint-SOL may be Tier 2 or 3, sometimes requiring prior authorization.
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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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.