Tirosint-Sol 44mcg/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 and T4 exert their metabolic effects through control of DNA transcription and protein synthesis. They 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.

Serious 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 medical attention immediately:

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 change
Diarrhea
Stomach cramps
Vomiting
Irritability, nervousness, excitability, anxiety, or other mood changes
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. 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:
+ 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 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 starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.

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 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 advised.

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 individual risk factors with your doctor. Additionally, this medication may affect fertility, potentially leading to difficulties in 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

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

Pediatric Patients

If you are giving this medication to a child and their weight changes, consult your doctor, as the dosage may need to be adjusted. Never give your child more of this medication than prescribed, as this may increase the risk of severe side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult your doctor to discuss any concerns.

• Amiodarone (alters thyroid hormone metabolism)
• Warfarin (enhances anticoagulant effect)
• Tyrosine kinase inhibitors (e.g., imatinib, sunitinib, sorafenib - can affect TSH levels)
• Proton pump inhibitors (e.g., omeprazole - reduce absorption of levothyroxine tablets, less so for solution but still possible)
• Sucralfate (reduces absorption)
• Bile acid sequestrants (e.g., cholestyramine, colestipol - reduce absorption)
• Ion exchange resins (e.g., sodium polystyrene sulfonate - reduce absorption)
• Calcium carbonate/supplements (reduce absorption)
• Iron supplements (reduce absorption)
• Orlistat (reduces absorption)

• Antacids (aluminum, magnesium hydroxide - reduce absorption)
• Soy products (reduce absorption)
• Dietary fiber (reduce absorption)
• Certain anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital - increase metabolism)
• Rifampin (increases metabolism)
• Estrogens (increase TBG, requiring higher levothyroxine dose)
• Androgens (decrease TBG, potentially requiring lower levothyroxine dose)
• Beta-blockers (e.g., propranolol - may inhibit T4 to T3 conversion)
• Corticosteroids (may inhibit T4 to T3 conversion)
• Sertraline (may increase levothyroxine requirements)
• Antidiabetic agents (may alter glucose control, requiring adjustment of antidiabetic dose)

• Grapefruit juice (minor effect on absorption)

• Fatigue
• Weight changes (gain or loss)
• Cold intolerance
• Constipation
• Dry skin
• Hair loss
• Bradycardia
• Depression
• Memory impairment
• Muscle aches/weakness
• Menstrual irregularities
• Nervousness (if over-replacement)
• Palpitations (if over-replacement)
• Heat intolerance (if over-replacement)
• Tremor (if over-replacement)

Levothyroxine is Category A and is essential for fetal neurological development. Pregnant women with hypothyroidism typically require increased doses (often 25-50% higher) during pregnancy due to increased TBG and fetal thyroid hormone requirements. Monitor TSH every 4-6 weeks.

Levothyroxine is considered safe during breastfeeding. Only small amounts are excreted into breast milk, which are not expected to cause adverse effects in the infant. Maternal thyroid hormone requirements usually return to pre-pregnancy levels postpartum.

Dosing is weight-based and higher per kg in younger children due to higher metabolic rates and rapid growth. Essential for normal growth and development, especially neurological. Close monitoring of TSH and T4 is crucial. Tirosint-SOL may be beneficial for children who have difficulty swallowing pills or have absorption issues.

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

• Tirosint-SOL is an alcohol-free, dye-free, and gluten-free liquid formulation, which can be beneficial for patients with allergies, sensitivities, or difficulty swallowing tablets.
• While Tirosint-SOL may have more consistent absorption than tablets, it is still crucial to take it on an empty stomach, at least 30-60 minutes before food or other medications, to ensure consistent absorption.
• Consistency is key: Patients should take levothyroxine at the same time each day, preferably in the morning, to maintain stable hormone levels.
• Do not switch between different levothyroxine brands or formulations (e.g., tablet to solution) without consulting a physician, as bioavailability differences can necessitate dose adjustments.
• Patients should be educated on the symptoms of both hypo- and hyperthyroidism to report any changes to their healthcare provider.
• Many medications and supplements can interfere with levothyroxine absorption or metabolism; a thorough medication review is essential.

• Other levothyroxine oral formulations (tablets, capsules like Tirosint)
• Liothyronine (T3) - used in specific cases, sometimes in combination with levothyroxine, but generally not first-line monotherapy for hypothyroidism.
• Desiccated thyroid extract (e.g., Armour Thyroid) - contains both T4 and T3, but potency can be variable and not recommended by major endocrine societies as first-line.

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.