Tirosint-Sol 50mcg/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 metabolic processes, including protein synthesis, carbohydrate metabolism, lipid metabolism, and cellular respiration. It is essential for normal growth, development, and metabolism.

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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
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. 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.

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, both past and present

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 potential interactions and ensure the safe use of this medication.

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), 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 using 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 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 to you and your baby.

Pediatric Considerations

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, can cause hypo- or hyperthyroidism)
• Orlistat (may reduce levothyroxine absorption)
• Tyrosine kinase inhibitors (e.g., imatinib, sunitinib, sorafenib, pazopanib - may increase levothyroxine requirements)
• Proton pump inhibitors (PPIs) / H2 blockers / Antacids (reduce gastric acidity, potentially impairing levothyroxine absorption, though Tirosint-SOL may be less affected)
• Iron supplements, Calcium supplements, Sucralfate, Bile acid sequestrants (e.g., cholestyramine, colestipol) (form insoluble complexes, reducing absorption)
• Soy products (may reduce absorption)
• Rifampin, Carbamazepine, Phenytoin, Phenobarbital (induce hepatic metabolism of levothyroxine, increasing requirements)
• Warfarin (levothyroxine may enhance anticoagulant effect, requiring dose reduction of warfarin)

• Beta-blockers (may reduce conversion of T4 to T3)
• Tricyclic antidepressants (TCAs) (increased risk of cardiac arrhythmias)
• Digoxin (levothyroxine may decrease digoxin levels)
• Oral contraceptives / Estrogens (increase TBG, increasing levothyroxine requirements)
• Androgens / Anabolic steroids (decrease TBG, decreasing levothyroxine requirements)
• Corticosteroids (may inhibit TSH secretion and T4 to T3 conversion)
• Insulin / Oral hypoglycemics (levothyroxine may increase blood glucose, requiring adjustment of antidiabetic agents)

• Dietary fiber (may slightly reduce absorption)

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

Levothyroxine is essential for normal fetal development and should be continued throughout pregnancy. Thyroid hormone requirements often increase during pregnancy (by 25-50% or more), requiring dose adjustments based on frequent TSH monitoring (e.g., every 4-6 weeks). Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not considered clinically significant to the infant. It is considered L1 (Safest) by Hale's classification.

Dosing is weight-based and higher per kg in younger children due to higher metabolic rates and rapid growth. Crucial for normal physical and mental development. Congenital hypothyroidism requires immediate treatment to prevent irreversible intellectual disability. Tirosint-SOL is particularly useful for pediatric patients due to its liquid formulation, allowing for precise dosing and ease of administration.

Elderly patients may require lower starting doses and slower titration due to increased sensitivity to thyroid hormones and higher prevalence of underlying cardiovascular disease. Monitor for cardiac symptoms. TSH targets may be slightly higher in very elderly patients.

• Tirosint-SOL is an oral solution formulation of levothyroxine, which may offer more consistent absorption compared to tablet formulations, especially in patients with malabsorption issues, gastric acid suppression (e.g., PPIs), or those requiring tube feeding.
• Always take levothyroxine on an empty stomach, 30-60 minutes before food or other medications. For Tirosint-SOL, this is still the recommendation, although its absorption may be less affected by food than tablets.
• The dose is highly individualized and guided by TSH levels. Small dose adjustments can have significant effects.
• Patients should be advised to take the medication at the same time each day for optimal consistency.
• Counsel patients on the importance of separating levothyroxine from calcium, iron, antacids, and other interacting medications by at least 4 hours.
• Symptoms of over- or under-dosing can mimic other conditions; emphasize the importance of regular TSH monitoring.
• Patients switching between different levothyroxine formulations (e.g., tablet to solution, or different brands) should have their TSH re-checked in 4-6 weeks due to potential differences in bioavailability.

• Other levothyroxine oral tablet brands (e.g., Synthroid, Levoxyl, Unithroid, Levothroid)
• Generic levothyroxine oral tablets
• Liothyronine (T3) (e.g., Cytomel, Triostat) - typically used in combination with levothyroxine or for specific conditions like myxedema coma, not as monotherapy for routine hypothyroidism.
• Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from animal thyroid glands.

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 medication, including the amount taken and the time it happened, to ensure you receive the best possible care.