Tirosint-Sol 25mcg/ml Oral Sol

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

Overview

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What is this medicine?

Levothyroxine is a medicine that replaces a hormone normally made by your thyroid gland. Your thyroid gland helps control your body's energy and metabolism. When your thyroid doesn't make enough hormone (a condition called hypothyroidism), this medicine helps bring your hormone levels back to normal. Tirosint-SOL is a liquid form that may be easier to absorb for some people.
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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 your medication by placing it directly in your mouth or by mixing 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. Avoid taking 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 them without consulting your doctor.
Continue taking your medication as directed by your doctor or healthcare provider, even if you feel well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light.
Keep your medication in its foil pouch until you are ready to use it.

What to Do If You Miss a Dose

Take a missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and return to your regular schedule.
* Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take this medicine exactly as prescribed by your doctor, usually once a day on an empty stomach.
  • Take it at least 30-60 minutes before breakfast, or at bedtime (3-4 hours after your last meal). Consistency is key.
  • Do not take other medications, especially iron, calcium, antacids, or sucralfate, within 4 hours of taking levothyroxine. Separate from proton pump inhibitors by several hours if possible.
  • Do not stop taking this medicine without talking to your doctor, even if you feel better. This is usually a lifelong treatment.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Report any symptoms of over- or under-treatment to your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized, based on TSH levels. Typical starting dose for primary hypothyroidism: 1.6 mcg/kg/day orally once daily. For Tirosint-SOL, it's often started at the same dose as other levothyroxine formulations, but may require slight adjustment due to potentially improved absorption.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

primaryHypothyroidism: 1.6 mcg/kg/day orally once daily, adjusted in 12.5-25 mcg increments every 4-6 weeks based on TSH.
subclinicalHypothyroidism: Typically 25-75 mcg/day orally once daily, adjusted based on TSH.
thyroidCancerSuppression: Higher doses, often 2.0-2.5 mcg/kg/day, to suppress TSH below 0.1 mIU/L or lower, depending on risk stratification.
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Pediatric Dosing

Neonatal: Congenital Hypothyroidism: 10-15 mcg/kg/day orally once daily. Adjust based on TSH and T4.
Infant: 0-3 months: 10-15 mcg/kg/day; 3-6 months: 8-10 mcg/kg/day; 6-12 months: 6-8 mcg/kg/day. Adjust based on TSH and T4.
Child: 1-5 years: 5-6 mcg/kg/day; 6-12 years: 4-5 mcg/kg/day. Adjust based on TSH and T4.
Adolescent: 12 years and older (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.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: No specific adjustment needed; levothyroxine is highly protein-bound and not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor thyroid function closely as hepatic metabolism may be altered in severe liver disease.

Pharmacology

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Mechanism of Action

Levothyroxine is a synthetic L-isomer of thyroxine (T4), a naturally occurring thyroid hormone. 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. 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: Approximately 48-79% (variable, influenced by food, GI conditions, and other medications). Tirosint-SOL may have more consistent absorption due to its liquid formulation and lack of excipients.
Tmax: Approximately 2-4 hours.
FoodEffect: Food significantly decreases absorption. Should be taken on an empty stomach, at least 30-60 minutes before breakfast, and preferably 3-4 hours after the last meal of the day (e.g., at bedtime).

Distribution:

Vd: Approximately 10-13 L.
ProteinBinding: Greater than 99% (primarily to thyroxine-binding globulin (TBG), transthyretin (TTR), and albumin).
CnssPenetration: Limited

Elimination:

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

OnsetOfAction: Gradual, over several days to weeks.
PeakEffect: Approximately 3-4 weeks (due to long half-life and need to reach steady state).
DurationOfAction: Long, due to long half-life (effects persist for several weeks 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

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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Headache
Feeling tired or weak
Changes in appetite
Unintentional weight changes
Diarrhea, stomach cramps, or vomiting
Mood changes, such as irritability, nervousness, excitability, 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. 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:

* 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, 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 medicine (hyperthyroidism): fast or irregular heartbeat, chest pain, shortness of breath, nervousness, irritability, tremors, sweating, heat intolerance, weight loss, diarrhea, insomnia.
  • Symptoms of too little medicine (hypothyroidism, if dose is too low or missed): extreme tiredness, weight gain, constipation, dry skin, hair loss, feeling cold, depression, slow heart rate.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including 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 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 starting, stopping, or changing the dose of any medication, including this one, 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 allow your supply of this medication to run out. Please note that it may take several weeks to experience the full effects of this medication.

Special Considerations

If you have diabetes (high blood sugar), consult with 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 individual risk factors with your doctor, who can help you determine if you are at higher risk.

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.

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 discuss the benefits and risks of this medication with you, considering both your health and the baby's well-being.

Pediatric Patients

If you are giving this medication to a child and their weight changes, 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 (fast heart rate)
  • Arrhythmias (irregular heart rhythm)
  • Chest pain (angina)
  • Tremors
  • Nervousness
  • Insomnia
  • Diarrhea
  • Weight loss
  • Increased appetite
  • Fever
  • Heat intolerance
  • Sweating

What to Do:

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

Drug Interactions

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Major Interactions

  • Amiodarone (can cause hypo- or hyperthyroidism)
  • Oral anticoagulants (e.g., warfarin - increased anticoagulant effect)
  • Ion exchange resins (e.g., cholestyramine, colestipol - decreased levothyroxine absorption)
  • Sucralfate (decreased levothyroxine absorption)
  • Iron supplements (decreased levothyroxine absorption)
  • Calcium supplements (decreased levothyroxine absorption)
  • Proton pump inhibitors (PPIs) (may decrease levothyroxine absorption, especially with tablet forms; less impact with Tirosint-SOL)
  • Antacids (aluminum, magnesium, calcium - decreased levothyroxine absorption)
  • Orlistat (decreased levothyroxine absorption)
  • Sevelamer (decreased levothyroxine absorption)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib - may increase levothyroxine requirements)
  • Estrogens (oral) / Selective Estrogen Receptor Modulators (SERMs) (e.g., tamoxifen, raloxifene - increase TBG, increasing levothyroxine requirements)
  • Androgens / Anabolic steroids (decrease TBG, decreasing levothyroxine requirements)
  • Glucocorticoids (large doses - may inhibit TSH secretion and T4 to T3 conversion)
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital (increase levothyroxine metabolism)
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Moderate Interactions

  • Beta-blockers (may decrease T4 to T3 conversion)
  • Tricyclic antidepressants (TCAs) (increased sensitivity to TCAs)
  • Digoxin (decreased digoxin levels)
  • Insulin/Oral hypoglycemics (increased requirements for antidiabetic agents)
  • SSRIs (may affect thyroid function tests, usually not clinically significant)
  • Corticosteroids (may alter thyroid hormone levels)
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Minor Interactions

  • Dietary fiber (may slightly decrease absorption)
  • Soy products (may slightly decrease absorption)

Monitoring

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Baseline Monitoring

TSH (Thyroid-Stimulating Hormone)

Rationale: To establish baseline thyroid function and confirm diagnosis of hypothyroidism.

Timing: Prior to initiation of therapy.

Free T4 (Free Thyroxine)

Rationale: To assess baseline thyroid hormone levels and aid in diagnosis.

Timing: Prior to initiation of therapy.

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

Rationale: To document baseline symptoms for comparison during treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

TSH (Thyroid-Stimulating Hormone)

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 often 0.5-2.5 mIU/L for symptomatic relief; for thyroid cancer suppression, target may be <0.1 mIU/L).

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

Free T4 (Free Thyroxine)

Frequency: Often checked with TSH, especially if TSH is abnormal or in central hypothyroidism.

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

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

Clinical symptoms

Frequency: At each follow-up visit.

Target: Resolution or improvement of hypothyroid symptoms.

Action Threshold: Consider dose adjustment or investigation of other causes if symptoms persist despite adequate biochemical control.

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Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia (slow heart rate)
  • Muscle aches or weakness
  • Depression or mood changes
  • Memory impairment
  • Nervousness, irritability, palpitations, tremors (signs of overtreatment/hyperthyroidism)

Special Patient Groups

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Pregnancy

Levothyroxine is Category A and is essential for fetal neurological development. Increased dosage requirements are common during pregnancy (often 25-50% increase) due to increased TBG and fetal thyroid hormone needs. Monitor TSH every 4-6 weeks.

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism can lead to adverse fetal outcomes (e.g., impaired neurocognitive development, increased risk of miscarriage, preterm birth).
Second Trimester: Continued need for increased dose; fetal thyroid gland begins to function, but maternal thyroid hormone remains crucial.
Third Trimester: Dose typically remains elevated; monitor TSH to ensure adequate maternal thyroid status.
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Lactation

Levothyroxine is compatible with breastfeeding. Minimal amounts are excreted into breast milk, and it is not expected to cause adverse effects in breastfed infants. Maternal dose requirements usually return to pre-pregnancy levels postpartum.

Infant Risk: L1 (Safest) - No observed adverse effect on the infant.
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Pediatric Use

Dosing is weight-based and higher per kg than in adults, especially in infants and young children, due to rapid growth and development. Regular monitoring of TSH and Free T4 is crucial to ensure proper growth and neurocognitive development. Tirosint-SOL may be beneficial for infants and children who cannot swallow tablets or require precise dosing.

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Geriatric Use

Lower starting 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. Dose adjustments should be made in smaller increments and less frequently. Monitor for cardiac symptoms.

Clinical Information

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Clinical Pearls

  • Tirosint-SOL is a liquid formulation of levothyroxine, which may offer more consistent absorption compared to tablet forms, especially in patients with malabsorption issues, gastric bypass, or those on medications that interfere with tablet dissolution/absorption (e.g., PPIs, antacids).
  • It is preservative-free, which can be beneficial for patients with sensitivities to excipients found in other levothyroxine formulations.
  • Always administer on an empty stomach, at least 30-60 minutes before breakfast, or at bedtime (3-4 hours after the last meal) to optimize absorption. Consistency in timing relative to meals is more important than the exact time of day.
  • Dose adjustments are highly individualized and guided by TSH levels. It takes 4-6 weeks for TSH to stabilize after a dose change due to levothyroxine's long half-life.
  • Educate patients about potential drug-drug and drug-food interactions that can significantly impact levothyroxine absorption and efficacy.
  • Patients should be advised not to switch between different levothyroxine formulations or brands without consulting their physician, as bioavailability can vary, requiring dose adjustments.
  • Symptoms of over- or under-treatment should be promptly reported to the healthcare provider.
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Alternative Therapies

  • Levothyroxine tablets (e.g., Synthroid, Levoxyl, Unithroid, Tirosint capsules, generic levothyroxine)
  • Liothyronine (T3) (e.g., Cytomel, Triostat) - less commonly used as monotherapy for hypothyroidism due to shorter half-life and fluctuating levels.
  • Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from animal thyroid glands.
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Cost & Coverage

Average Cost: Varies significantly by strength and pharmacy. For 25 mcg/ml, a 30-day supply (e.g., 30ml bottle) can range from $100-$200+. per 30 ml bottle
Generic Available: Yes
Insurance Coverage: Often Tier 2 or 3 for brand, Tier 1 for generic levothyroxine tablets. Tirosint-SOL, being a brand-name liquid, may require prior authorization or be on a higher tier.
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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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.