Tirosint-Sol 200mcg/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.
đŸˇī¸
Drug Class
Thyroid hormone replacement
đŸ§Ŧ
Pharmacologic Class
Thyroid hormones
🤰
Pregnancy Category
Category A
✅
FDA Approved
Aug 2016
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

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 work properly, improving symptoms like tiredness, weight gain, and feeling cold.
📋

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 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 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.

Continuing Your Medication

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.
Store 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.
💡

Lifestyle & Tips

  • Take Tirosint-SOL exactly as prescribed by your doctor, usually once a day.
  • Take it on an empty stomach, preferably 15 minutes before breakfast or at bedtime (at least 3 hours after your last meal). This is very important for proper absorption.
  • Do not take it at the same time as other medications, especially antacids, iron, calcium, or cholesterol-lowering drugs. Separate these by at least 4 hours.
  • Do not stop taking this medication without consulting 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, as they can interact with Tirosint-SOL.
  • Regular blood tests (TSH) are necessary to ensure you are on the correct dose.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Highly individualized, based on TSH levels. Typical starting dose for hypothyroidism is 1.6 mcg/kg/day. For Tirosint-SOL, it's administered once daily, preferably 15 minutes before breakfast or at bedtime (3 hours after the last meal).
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

hypothyroidism: Initial: 1.6 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Adjust by 12.5-25 mcg increments every 4-6 weeks based on TSH. Elderly or cardiac patients: Initial 12.5-25 mcg/day, titrate slowly.
thyroid-stimulating hormone (TSH) suppression: Higher doses may be required, individualized based on target TSH level.
đŸ‘ļ

Pediatric Dosing

Neonatal: Initial: 10-15 mcg/kg/day for congenital hypothyroidism. Adjust based on TSH and T4 levels.
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 levels.
Child: 1-5 years: 5-6 mcg/kg/day; 6-12 years: 4-5 mcg/kg/day. Adjust based on TSH and T4 levels.
Adolescent: 12-17 years: 2-3 mcg/kg/day or 1.6 mcg/kg/day (adult dose). Adjust based on TSH and T4 levels.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.
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 closely as metabolism may be altered.

Pharmacology

đŸ”Ŧ

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 then enters the cell nucleus and binds to thyroid hormone receptors, regulating gene expression and controlling numerous metabolic processes, including protein, carbohydrate, and lipid metabolism, and influencing growth and development.
📊

Pharmacokinetics

Absorption:

Bioavailability: 48-79% (variable, influenced by food, gastric pH, and other medications). Tirosint-SOL may have more consistent absorption due to its excipient-free formulation.
Tmax: 2-4 hours
FoodEffect: Food significantly decreases absorption. Tirosint-SOL should be taken on an empty stomach, preferably 15 minutes before breakfast or at bedtime (3 hours after the last meal).

Distribution:

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

Elimination:

HalfLife: 6-7 days (euthyroid); 3-4 days (hyperthyroid); 9-10 days (hypothyroid)
Clearance: Approximately 0.05 L/hr/kg
ExcretionRoute: Primarily renal (approximately 80% as metabolites), with some fecal excretion (approximately 20%)
Unchanged: Less than 1% (renal)
âąī¸

Pharmacodynamics

OnsetOfAction: Gradual, clinical effects typically seen within 3-5 days, but full therapeutic effect may take 4-6 weeks.
PeakEffect: 4-6 weeks (when steady-state TSH levels are achieved)
DurationOfAction: Effects persist for several days after discontinuation due to long half-life.

Safety & Warnings

âš ī¸

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.
âš ī¸

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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Symptoms of too much thyroid hormone (hyperthyroidism): rapid heart rate, palpitations, chest pain, excessive sweating, heat intolerance, nervousness, tremors, insomnia, diarrhea, significant weight loss.
  • Symptoms of too little thyroid hormone (hypothyroidism) if dose is too low: persistent fatigue, weight gain, constipation, dry skin, hair loss, feeling cold, depression.
📋

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
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 medication, consult with your doctor to confirm that it is safe to do so.
âš ī¸

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. Be sure to check your blood sugar levels and have blood work done as directed by your doctor.

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, who can help determine if you are at higher risk.

This medication may also affect fertility, making it more difficult to become pregnant or father a child. If you plan to conceive, consult 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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to 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 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.
🆘

Overdose Information

Overdose Symptoms:

  • Headache
  • Irritability
  • Nervousness
  • Sweating
  • Increased appetite
  • Weight loss
  • Diarrhea
  • Palpitations
  • Tachycardia (rapid heart rate)
  • Arrhythmias (irregular heart rhythm)
  • Tremor
  • Insomnia
  • Fever
  • Heat intolerance
  • Chest pain (angina)
  • Seizures (rare)
  • Heart failure (rare)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment may involve supportive care, beta-blockers for cardiac symptoms, and measures to reduce absorption if recent ingestion.

Drug Interactions

🔴

Major Interactions

  • Amiodarone (can cause hypo- or hyperthyroidism, monitor thyroid function)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib, sorafenib - can decrease levothyroxine absorption, requiring dose increase)
  • Orlistat (can decrease levothyroxine absorption, separate administration by at least 4 hours)
  • Ion exchange resins (e.g., cholestyramine, colestipol, sevelamer, patiromer - decrease absorption, separate administration by 4-6 hours)
  • Sucralfate (decreases absorption, separate administration by 4-6 hours)
  • Proton pump inhibitors (e.g., omeprazole, pantoprazole - increase gastric pH, potentially reducing absorption, monitor TSH)
  • H2 receptor blockers (e.g., ranitidine, cimetidine - increase gastric pH, potentially reducing absorption, monitor TSH)
  • Antacids (aluminum, magnesium, calcium carbonate - decrease absorption, separate administration by 4 hours)
  • Iron supplements (decrease absorption, separate administration by 4 hours)
  • Calcium supplements (decrease absorption, separate administration by 4 hours)
  • Soy products (can decrease absorption, monitor TSH)
🟡

Moderate Interactions

  • Anticoagulants (e.g., warfarin - levothyroxine may increase anticoagulant effect, monitor INR)
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs - may increase cardiac effects of levothyroxine, or alter thyroid hormone levels)
  • Beta-blockers (e.g., propranolol - may reduce conversion of T4 to T3)
  • Digitalis glycosides (e.g., digoxin - levothyroxine may decrease digoxin levels, monitor digoxin levels)
  • Insulin/oral hypoglycemics (levothyroxine may increase blood glucose, requiring dose adjustment of antidiabetic agents)
  • Estrogens/Oral Contraceptives (increase TBG, potentially increasing levothyroxine requirements)
  • Androgens/Anabolic Steroids (decrease TBG, potentially decreasing levothyroxine requirements)
  • Glucocorticoids (can inhibit TSH secretion and T4 to T3 conversion)
  • Phenytoin, Carbamazepine, Rifampin (enzyme inducers, increase levothyroxine metabolism, may require dose increase)
  • Sertraline (may increase levothyroxine requirements)
  • Chloroquine/Proguanil (may impair thyroid function)
đŸŸĸ

Minor Interactions

  • Dietary fiber (may decrease absorption, separate administration)
  • Coffee (may decrease absorption, separate administration)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Thyroid-stimulating hormone (TSH)

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

Timing: Prior to initiation of therapy.

Free Thyroxine (Free T4)

Rationale: To assess baseline thyroid hormone levels, especially in central hypothyroidism or when TSH is unreliable.

Timing: Prior to initiation of therapy.

Clinical symptoms of hypothyroidism

Rationale: To document baseline symptoms for future comparison and assessment of treatment efficacy.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Thyroid-stimulating hormone (TSH)

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

Target: Typically 0.4-4.0 mIU/L (individualized based on patient age, comorbidities, and specific clinical goals).

Action Threshold: If TSH is outside target range, adjust levothyroxine dose.

Free Thyroxine (Free T4)

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

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

Action Threshold: If Free T4 is outside target range, adjust levothyroxine dose.

Clinical symptoms and signs

Frequency: At each visit.

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

Action Threshold: Persistent or worsening symptoms may indicate need for dose adjustment or investigation of other causes.

đŸ‘ī¸

Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold intolerance
  • Constipation
  • Dry skin
  • Hair loss
  • Bradycardia
  • Depression
  • Memory impairment
  • Muscle aches
  • Menstrual irregularities
  • Nervousness
  • Palpitations
  • Tremor
  • Heat intolerance
  • Diarrhea
  • Insomnia

Special Patient Groups

🤰

Pregnancy

Levothyroxine is essential for normal fetal development and is considered safe and necessary during pregnancy. Thyroid hormone requirements often increase during pregnancy, typically by 25-50%. Close monitoring of TSH levels (every 4-6 weeks) and dose adjustments are crucial.

Trimester-Specific Risks:

First Trimester: Untreated maternal hypothyroidism in the first trimester is associated with increased risk of miscarriage, preterm birth, preeclampsia, and impaired neurocognitive development in the offspring.
Second Trimester: Continued need for adequate thyroid hormone for fetal brain development.
Third Trimester: Continued need for adequate thyroid hormone for fetal brain development and growth.
🤱

Lactation

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not considered clinically significant to the infant. It is important for the mother's health and ability to care for the infant.

Infant Risk: L1 (Safest) - No adverse effects expected in breastfed infants. May even be beneficial for infants with congenital hypothyroidism if mother is taking high doses, though this is not a treatment strategy.
đŸ‘ļ

Pediatric Use

Dosing is weight-based and higher per kg in younger children due to higher metabolic rates and rapid growth. Regular monitoring of TSH and Free T4 is critical for proper growth and neurocognitive development. Tirosint-SOL may be particularly useful for infants and young children who cannot swallow pills.

👴

Geriatric Use

Lower starting doses (e.g., 12.5-25 mcg/day) and slower titration are recommended due to increased risk of cardiac side effects (e.g., atrial fibrillation, angina) and potential for underlying cardiovascular disease. Monitor closely for signs of hyperthyroidism.

Clinical Information

💎

Clinical Pearls

  • Tirosint-SOL is an excipient-free formulation, which may be beneficial for patients with allergies or sensitivities to common tablet excipients (e.g., lactose, gluten, dyes).
  • The liquid formulation can be administered directly or mixed with water, making it suitable for patients with dysphagia, feeding tubes, or those who prefer liquid medications.
  • Consistent administration is key: always take on an empty stomach, preferably 15 minutes before breakfast or at bedtime (3 hours after last meal).
  • Emphasize the importance of separating levothyroxine from calcium, iron, antacids, and other interacting medications by at least 4 hours.
  • Patients should be educated on symptoms of both hypo- and hyperthyroidism, as dose adjustments are common.
  • Thyroid hormone replacement is typically a lifelong therapy; adherence is crucial for optimal outcomes.
🔄

Alternative Therapies

  • Levothyroxine tablets (e.g., Synthroid, Levoxyl, Unithroid, Tirosint)
  • Levothyroxine capsules (Tirosint)
  • Liothyronine (T3) (Cytomel, Triostat) - used in specific cases, often in combination with levothyroxine or for short-term TSH suppression.
  • Desiccated thyroid extract (Armour Thyroid, Nature-Throid) - natural thyroid hormone containing both T4 and T3, controversial due to variable potency and lack of standardization.
💰

Cost & Coverage

Average Cost: Not available (highly variable by pharmacy, dose, and quantity) per ml or per bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often preferred brand or generic)
📚

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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.