Tirosint 125mcg Capsules

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 binds to thyroid hormone receptors in the cell nucleus, regulating gene expression and controlling numerous metabolic processes, including protein, fat, and carbohydrate metabolism, and influencing 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 feeling irritable, nervous, excitable, anxious, or restless
Shakiness
Trouble sleeping
Sensitivity to heat
Excessive sweating
Fever
Muscle cramps
Muscle weakness
Flushing
Bone pain
Changes in menstrual periods (in women)
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
+ Difficulty swallowing
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, to ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

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 avoid any potential issues, 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 with your doctor, as this medication may affect your 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 taking it at least 2 days before having your thyroid levels checked to ensure accurate test results.

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 of developing osteoporosis.

This medication may affect fertility, making it more difficult to become pregnant or father a child. If you plan to conceive, consult with your doctor before starting this medication.

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 potential benefits and risks of this medication to you and your baby.

Special Considerations for Children

If your child is taking this medication and experiences any changes in weight, consult with your doctor, as their 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. Consult with your doctor to discuss any concerns or questions you may have.

• Amiodarone (can cause hypo- or hyperthyroidism, alters T4/T3 metabolism)
• Oral anticoagulants (e.g., Warfarin - levothyroxine may increase anticoagulant effect)
• Sympathomimetics (e.g., pseudoephedrine, epinephrine - increased risk of cardiac adverse effects)
• Certain antidiabetic agents (levothyroxine may increase blood glucose, requiring dose adjustment of antidiabetic drugs)
• Tyrosine kinase inhibitors (e.g., imatinib, sunitinib - may increase levothyroxine requirements)

• Antacids (aluminum, magnesium, calcium carbonate - decrease levothyroxine absorption)
• Iron supplements (ferrous sulfate - decrease levothyroxine absorption)
• Bile acid sequestrants (cholestyramine, colestipol - decrease levothyroxine absorption)
• Sucralfate (decreases levothyroxine absorption)
• Proton pump inhibitors (PPIs) and H2 blockers (may increase gastric pH, reducing levothyroxine absorption)
• Soy products (may decrease levothyroxine absorption)
• Dietary fiber (may decrease levothyroxine absorption)
• Estrogens (oral - may increase TBG, increasing levothyroxine requirements)
• Androgens (may decrease TBG, decreasing levothyroxine requirements)
• Glucocorticoids (may decrease TBG and inhibit T4 to T3 conversion)
• Phenytoin, Carbamazepine, Rifampin (enzyme inducers - increase levothyroxine metabolism, increasing requirements)
• Beta-blockers (may decrease T4 to T3 conversion)
• SSRIs (may affect thyroid function tests, but clinical significance often low)
• Iodine-containing products (e.g., contrast media - can affect thyroid function)

• Coffee (may decrease absorption if taken concurrently)
• Grapefruit juice (potential minor effect on absorption)

• Fatigue
• Weight changes (gain or loss)
• Cold intolerance
• Constipation
• Dry skin
• Hair loss
• Bradycardia or Tachycardia
• Muscle aches or weakness
• Depression or anxiety
• Irritability
• Nervousness
• Tremor
• Heat intolerance
• Palpitations
• Chest pain

Levothyroxine is considered safe and essential during pregnancy (Category A). Thyroid hormone requirements often increase during pregnancy, typically by 25-50% or more. Close monitoring of TSH levels (every 4-6 weeks) is crucial to ensure adequate dosing and fetal development.

Levothyroxine is compatible with breastfeeding (L1). Only small amounts are excreted into breast milk, which are not considered clinically significant to the infant. Maternal thyroid hormone requirements typically return to pre-pregnancy levels postpartum, requiring dose adjustment.

Dosing is weight-based and higher per kg than in adults, especially in neonates and infants, due to higher metabolic rates and rapid growth. Regular monitoring of TSH and Free T4 is essential to ensure proper growth and neurocognitive development. Treatment is lifelong for congenital hypothyroidism.

Elderly patients, especially those with underlying cardiovascular disease, should be started on lower doses (e.g., 12.5-25 mcg/day) and titrated slowly to avoid precipitating cardiac events. TSH monitoring and clinical assessment are crucial. May have decreased T4 clearance.

• Tirosint capsules contain levothyroxine in a liquid gel formulation, which may offer more consistent absorption compared to tablet formulations, especially in patients with gastrointestinal issues (e.g., malabsorption, gastric bypass) or those taking medications that alter gastric pH (e.g., PPIs).
• Always take levothyroxine on an empty stomach, 30-60 minutes before food or other medications, to optimize absorption. Consistency in timing is key.
• Do not switch between different brands or generic formulations of levothyroxine without consulting a healthcare provider, as bioavailability can vary, potentially requiring dose adjustments and TSH re-monitoring.
• Patients should be advised to report any symptoms of hyperthyroidism (e.g., palpitations, nervousness, weight loss) or persistent hypothyroidism (e.g., fatigue, weight gain) to their doctor.
• For patients unable to swallow capsules, Tirosint can be administered by cutting the capsule and squeezing the liquid contents into a spoon or directly into the mouth, followed by water. Do not mix with food or other liquids.
• Hypothyroidism is a lifelong condition for most patients, requiring continuous therapy and regular monitoring.

• Liothyronine (T3): Used less commonly, typically for short-term TSH suppression or in specific cases of T4 to T3 conversion defects. Has a shorter half-life and more fluctuating levels.
• Desiccated Thyroid Extract (e.g., Armour Thyroid, Nature-Throid): Natural thyroid hormone derived from porcine thyroid glands, containing both T4 and T3. Dosing can be less precise due to variable T4/T3 ratios and potency.

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.