Tirosint-Sol 175mcg/ml Oral Sol

Manufacturer IBSA 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 when your thyroid gland doesn't make enough of this hormone, a condition called hypothyroidism. Taking this medicine helps your body function properly, regulating your metabolism, energy, and other important body processes. Tirosint-SOL is a liquid form that can be easier to take, especially for those with swallowing difficulties or certain absorption issues.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely.

Take your medication on an empty stomach, 15 minutes before breakfast.
You can take the medication directly in your mouth or mix it with water. If mixing with water, empty the contents into a cup with water and squeeze the container over the cup at least 5 times until no more medication comes out. Stir well.
After mixing, take your dose immediately. 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 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.
  • Avoid taking with other medications, especially iron, calcium, antacids, or sucralfate, for at least 4 hours.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.
  • Regular blood tests (TSH) are essential to ensure the correct dose.
  • Maintain a consistent diet; avoid sudden changes in dietary fiber or soy intake.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized, based on TSH levels. Typical starting dose for hypothyroidism: 1.6 mcg/kg/day orally once daily. For Tirosint-SOL, it's 175 mcg/mL solution.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial dose 1.6 mcg/kg/day, adjusted by 12.5-25 mcg increments every 4-6 weeks based on TSH. For patients with cardiovascular disease or elderly, start with lower doses (12.5-25 mcg/day).
myxedemaComa: Loading dose 300-500 mcg IV, then 50-100 mcg IV daily until stable.
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Pediatric Dosing

Neonatal: 10-15 mcg/kg/day orally once daily (0-3 months).
Infant: 6-8 mcg/kg/day orally once daily (3-6 months).
Child: 4-6 mcg/kg/day orally once daily (6-12 months); 3-5 mcg/kg/day (1-5 years); 2-3 mcg/kg/day (6-12 years).
Adolescent: 1.6 mcg/kg/day orally once daily (12-17 years, or until growth is complete).
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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; not significantly dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

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 by binding to thyroid hormone receptors in the cell nucleus. Thyroid hormones regulate multiple metabolic processes, including growth and development, carbohydrate, protein, and lipid metabolism, and energy expenditure.
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Pharmacokinetics

Absorption:

Bioavailability: 48-79% (oral solution may have slightly higher or more consistent absorption than tablets, especially in patients with malabsorption issues).
Tmax: 2-4 hours
FoodEffect: Food, certain medications (e.g., iron, calcium, antacids, sucralfate, bile acid sequestrants, proton pump inhibitors), and certain foods (e.g., soybean flour, cottonseed meal, walnuts, dietary fiber) can significantly decrease absorption. Tirosint-SOL is less affected by food and gastric pH than tablet formulations.

Distribution:

Vd: 10-13 L
ProteinBinding: >99% (primarily to thyroxine-binding globulin (TBG), thyroxine-binding prealbumin (TBPA), and albumin).
CnssPenetration: Limited (T4 crosses the blood-brain barrier to a limited extent; T3 crosses more readily).

Elimination:

HalfLife: 6-7 days (euthyroid); 9-10 days (hypothyroid); 3-4 days (hyperthyroid).
Clearance: 0.05-0.06 L/hour
ExcretionRoute: Renal (approximately 80% of metabolites), fecal (approximately 20% of metabolites).
Unchanged: <1% (renal)
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Pharmacodynamics

OnsetOfAction: Gradual, over several days to weeks.
PeakEffect: Clinical effects typically seen within 3-4 weeks, with full effect at 4-6 weeks.
DurationOfAction: Long, due to long half-life; effects persist for several days after discontinuation.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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 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 not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of too much thyroid hormone (hyperthyroidism): rapid heart rate, palpitations, chest pain, excessive sweating, heat intolerance, nervousness, tremor, insomnia, unexplained weight loss, diarrhea.
  • Signs 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.
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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:
+ An overactive thyroid gland
+ A weak adrenal gland

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
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or allergies

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. 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 continuous treatment, do not allow your supply of this medication to run out. You may not experience the full effects of this medication for several weeks.

If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your 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 any 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 developing weak bones (osteoporosis), 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 difficulty 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.

Special Considerations for Children

If your child is taking this medication and experiences any weight changes, consult your doctor, as their dose 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 any concerns.
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Overdose Information

Overdose Symptoms:

  • Palpitations
  • Tachycardia
  • Arrhythmias
  • Chest pain
  • Tremor
  • Nervousness
  • Insomnia
  • Diaphoresis
  • Heat intolerance
  • Weight loss
  • Diarrhea
  • Vomiting
  • Fever
  • Seizures (rare)
  • Heart failure (rare, especially in elderly or those with underlying 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 (alters thyroid hormone metabolism)
  • Oral anticoagulants (may increase anticoagulant effect)
  • Antidiabetic agents (may increase insulin/oral hypoglycemic requirements)
  • Cholestyramine, Colestipol, Sevelamer, Sucralfate, Cation exchange resins (e.g., Kayexalate), Iron supplements, Calcium supplements, Aluminum- and Magnesium-containing antacids (decrease levothyroxine absorption)
  • Proton pump inhibitors (PPIs) and H2 blockers (may decrease levothyroxine absorption by increasing gastric pH, though Tirosint-SOL is less affected)
  • Orlistat (may decrease levothyroxine absorption)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) (may increase levothyroxine requirements)
  • Estrogens (increase TBG, increasing levothyroxine requirements)
  • Androgens, Anabolic steroids, Asparaginase, Glucocorticoids (decrease TBG, decreasing levothyroxine requirements)
  • Phenytoin, Carbamazepine, Rifampin, Phenobarbital (increase levothyroxine metabolism)
  • Sertraline, Chloroquine/Proguanil (may decrease thyroid hormone effectiveness)
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Moderate Interactions

  • Beta-blockers (may decrease conversion of T4 to T3)
  • Digoxin (levothyroxine may decrease digoxin levels)
  • Theophylline (levothyroxine may increase theophylline clearance)
  • SSRIs (may affect thyroid function tests, but clinical significance often minor)
  • Dietary fiber (may 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.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

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 (or individualized target based on patient age, comorbidities, and specific condition).

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

Free T4 (Free Thyroxine)

Frequency: May be checked with TSH, especially if TSH is suppressed or in central hypothyroidism.

Target: 0.8-1.8 ng/dL (or individualized target).

Action Threshold: Adjust dose if Free T4 is outside target range.

Clinical symptoms of hyperthyroidism/hypothyroidism

Frequency: At every visit.

Target: Resolution of hypothyroid symptoms, absence of hyperthyroid symptoms.

Action Threshold: Evaluate for dose adjustment or other causes if symptoms persist or new symptoms appear.

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Symptom Monitoring

  • Fatigue
  • Weight gain
  • Constipation
  • Cold intolerance
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Memory impairment
  • Muscle aches
  • Nervousness
  • Irritability
  • Palpitations
  • Tremor
  • Heat intolerance
  • Weight loss (unintended)
  • Diarrhea
  • Tachycardia
  • Insomnia

Special Patient Groups

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Pregnancy

Levothyroxine is considered safe and essential during pregnancy (Category A). Thyroid hormone requirements often increase during pregnancy, especially in the first trimester. Close monitoring of TSH levels is crucial.

Trimester-Specific Risks:

First Trimester: Increased levothyroxine dose often required due to increased TBG and fetal thyroid development. Untreated maternal hypothyroidism can lead to adverse fetal outcomes (e.g., impaired neurocognitive development, miscarriage, preterm birth).
Second Trimester: Dose adjustments continue based on TSH. Fetal thyroid gland begins to function.
Third Trimester: Dose adjustments continue. Maternal hypothyroidism can lead to preeclampsia, gestational hypertension, and placental abruption.
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Lactation

Levothyroxine is compatible with breastfeeding (L1 - Safest). Only small amounts are excreted into breast milk, which are not clinically significant to the infant. Maternal thyroid hormone replacement is important for maternal health and ability to care for the infant.

Infant Risk: Minimal to none.
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Pediatric Use

Dosing is weight-based and higher per kg than in adults, especially in neonates and infants, due to rapid growth and development. Regular monitoring of TSH and Free T4 is critical to ensure proper neurocognitive development. Tirosint-SOL may be particularly useful for pediatric patients due to ease of administration.

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Geriatric Use

Lower starting doses are recommended due to increased sensitivity to thyroid hormones and higher prevalence of underlying cardiovascular disease. Gradual dose titration is important to avoid cardiac adverse effects. Close monitoring for symptoms of hyperthyroidism is necessary.

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, gastric bypass), swallowing difficulties, or those on tube feeds, as its absorption is less affected by gastric pH and food than tablet formulations.
  • Always take levothyroxine on an empty stomach, 30-60 minutes before breakfast, and separate from other medications (especially calcium, iron, antacids) by at least 4 hours.
  • Consistency is key: take at the same time each day. If a dose is missed, take it as soon as remembered, unless it's almost time for the next dose. Do not double dose.
  • TSH is the primary lab test for monitoring, but Free T4 may be useful in certain situations (e.g., central hypothyroidism, TSH suppression).
  • Patients may require dose adjustments during pregnancy, with changes in weight, or with initiation/discontinuation of interacting medications.
  • Educate patients on symptoms of both hypo- and hyperthyroidism to ensure timely reporting of adverse effects or inadequate dosing.
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Alternative Therapies

  • Liothyronine (T3, Cytomel): Used in specific cases, often in combination with levothyroxine, but not as monotherapy for routine hypothyroidism due to shorter half-life and fluctuating levels.
  • Desiccated thyroid extract (Armour Thyroid, NP Thyroid): Natural thyroid hormone derived from porcine thyroid glands, containing both T4 and T3. Dosing can be less precise due to variable T4/T3 ratios.
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Cost & Coverage

Average Cost: Varies widely by pharmacy and dosage; typically $30-$100+ per 30 mL bottle (175 mcg/mL)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred brand/generic)
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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.