Tirosint-Sol 100mcg/ml Oral Sol

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 cellular processes, including metabolism, growth, and development.

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 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, 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.

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 concerns

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.

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 continuous 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), 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 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 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 difficult to become pregnant or father a child. If you plan 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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, who will discuss the benefits and risks of this medication to you and your baby.

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.

• Amiodarone (alters thyroid hormone metabolism)
• Oral anticoagulants (e.g., Warfarin - increased anticoagulant effect)
• Antidiabetic agents (e.g., Insulin, Metformin - increased blood glucose, may require dose adjustment of antidiabetic agent)
• Ion exchange resins (e.g., Cholestyramine, Colestipol - significantly reduced levothyroxine absorption)
• Sucralfate (reduced levothyroxine absorption)
• Proton pump inhibitors (e.g., Omeprazole - reduced levothyroxine absorption due to increased gastric pH)
• Iron supplements (reduced levothyroxine absorption)
• Calcium supplements (reduced levothyroxine absorption)
• Aluminum-containing antacids (reduced levothyroxine absorption)
• Orlistat (reduced levothyroxine absorption)

• SSRIs (e.g., Sertraline - may increase levothyroxine requirements)
• Phenytoin, Carbamazepine, Rifampin (increased levothyroxine metabolism)
• Beta-blockers (e.g., Propranolol - may inhibit T4 to T3 conversion)
• Estrogens (e.g., Oral contraceptives, HRT - increased TBG, may increase levothyroxine requirements)
• Androgens (decreased TBG, may decrease levothyroxine requirements)
• Glucocorticoids (may inhibit T4 to T3 conversion)
• Soy products (reduced levothyroxine absorption)
• Dietary fiber (reduced levothyroxine absorption)

• Coffee (may slightly reduce absorption if taken together)

• Hypothyroid symptoms: fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, bradycardia, muscle aches.
• Hyperthyroid symptoms (due to overtreatment): palpitations, tachycardia, nervousness, tremors, weight loss, heat intolerance, diarrhea, insomnia, chest pain.

Levothyroxine is essential for normal fetal development and is safe to use during pregnancy. Thyroid hormone requirements often increase during pregnancy, and doses typically need to be adjusted upwards. Close monitoring of TSH is crucial.

Levothyroxine is compatible with breastfeeding. Minimal amounts are excreted into breast milk, and it does not pose a risk to the nursing infant.

Dosing is weight-based and critical for normal growth and development. Regular monitoring of TSH and clinical status is essential. Tirosint-SOL is particularly useful in pediatric patients due to its liquid formulation, allowing for precise dosing and ease of administration, especially in infants and young children who cannot swallow pills.

Lower initial doses are recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Dose adjustments should be made slowly and cautiously, with careful monitoring for cardiac symptoms.

• Tirosint-SOL is a liquid formulation of levothyroxine, which may be beneficial for patients with malabsorption issues (e.g., celiac disease, gastric bypass), those with difficulty swallowing pills, or those requiring administration via feeding tubes.
• Unlike tablet formulations, Tirosint-SOL is less affected by gastric pH, potentially offering more consistent absorption in patients on PPIs or with achlorhydria, though separation from other medications is still crucial.
• The liquid formulation allows for very precise dose adjustments, which is particularly useful in pediatric patients or those requiring fine-tuning of their thyroid levels.
• Always instruct patients to take Tirosint-SOL on an empty stomach, at least 30-60 minutes before food or other medications, to optimize absorption.
• Patients should be advised to use the provided oral syringe for accurate dosing and not to mix the solution with other liquids or food.

• Other levothyroxine tablet formulations (e.g., Synthroid, Levoxyl, Unithroid, Tirosint capsules)
• Liothyronine (T3) (e.g., Cytomel, Triostat) - typically used in combination with levothyroxine or for specific conditions like myxedema coma.
• Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from porcine thyroid glands.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.