Tirosint 50mcg Capsules

Levothyroxine sodium is a synthetic L-thyroxine (T4) which is converted to L-triiodothyronine (T3) in peripheral tissues. T3 then binds to thyroid hormone receptors in the cell nucleus, regulating gene expression and metabolic processes involved in growth, development, and metabolism.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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, anxiety, or other emotional 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. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Hair loss (usually temporary and resolves on its own)
Other side effects not listed 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
+ Difficulty swallowing
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins

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 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 continuous treatment, 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. Monitor your blood sugar levels as instructed by your doctor and undergo regular blood tests as recommended.

When taking biotin or products containing biotin, discontinue use 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 making it difficult to conceive or father a child. If you plan to become pregnant or father a child, consult with your doctor before starting treatment.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy, Breastfeeding, and Pediatric Use

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.

When administering this medication to children, monitor their weight changes and consult with your doctor, as the dosage may need to be adjusted. Never exceed the recommended dose, as this may increase the risk of severe side effects. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks. Consult with your doctor to discuss any concerns.

• Oral anticoagulants (e.g., warfarin): May increase anticoagulant effect, requiring dose reduction of anticoagulant.
• Sympathomimetics (e.g., pseudoephedrine, epinephrine): Increased risk of cardiac adverse effects.
• Tyrosine kinase inhibitors (e.g., imatinib, sunitinib): May decrease levothyroxine efficacy, requiring dose increase.

• Antacids (aluminum, magnesium), iron supplements, calcium supplements, sucralfate, bile acid sequestrants (cholestyramine, colestipol), polystyrene sulfonate, sevelamer, lanthanum: Decrease levothyroxine absorption. Separate administration by at least 4 hours.
• Proton pump inhibitors (PPIs), H2 blockers: May reduce levothyroxine absorption due to altered gastric pH.
• Soy products, dietary fiber: Can decrease levothyroxine absorption.
• Estrogens (oral), tamoxifen, clofibrate, furosemide, heparin, methadone: May increase TBG, increasing levothyroxine requirements.
• Carbamazepine, phenytoin, phenobarbital, rifampin, sertraline: May increase levothyroxine metabolism, increasing requirements.
• Amiodarone: Can cause hypo- or hyperthyroidism and alter T4 to T3 conversion.
• Beta-blockers, glucocorticoids, propylthiouracil (PTU), methimazole: Can inhibit T4 to T3 conversion.
• Insulin, oral hypoglycemics: Levothyroxine may increase blood glucose, requiring adjustment of antidiabetic agents.

• Fatigue
• Weight changes (gain or loss)
• Cold or heat intolerance
• Constipation or diarrhea
• Dry skin or excessive sweating
• Hair loss
• Mood changes (depression, anxiety, irritability)
• Palpitations or rapid heart rate
• Tremor
• Muscle weakness or aches
• Changes in menstrual cycle

Levothyroxine is essential for normal fetal neurological development. Hypothyroidism during pregnancy can lead to adverse maternal and fetal outcomes. Dose requirements often increase by 25-50% during pregnancy due to increased TBG and fetal demand. TSH should be monitored frequently (e.g., every 4-6 weeks) and dose adjusted to maintain TSH within the trimester-specific target range.

Levothyroxine is considered safe during breastfeeding. Minimal amounts are excreted into breast milk and are not expected to cause adverse effects in the breastfed infant. It is compatible with breastfeeding.

Levothyroxine is crucial for normal growth and development in children. Untreated congenital hypothyroidism can lead to irreversible intellectual disability and growth retardation. Dosing is weight-based and higher per kg than in adults, especially in infants. Regular monitoring of TSH and Free T4 is essential to ensure proper development.

Elderly patients may be more sensitive to the effects of levothyroxine and are at increased risk of cardiac adverse events (e.g., atrial fibrillation, angina, myocardial infarction). Lower starting doses (e.g., 12.5-25 mcg/day) and slower titration increments are recommended. Close monitoring for cardiac symptoms is important.

• Tirosint capsules may be particularly beneficial for patients with malabsorption issues (e.g., celiac disease, gastric bypass), gastric pH abnormalities (e.g., on PPIs), or allergies/sensitivities to excipients found in tablet formulations.
• Consistency is paramount: Advise patients to take Tirosint at the same time each day, on an empty stomach, and consistently separate from interacting medications and supplements.
• TSH is the primary laboratory parameter for monitoring, but clinical symptoms are equally important. Treat the patient, not just the numbers.
• Patients should be educated on symptoms of both under- and over-treatment to facilitate timely dose adjustments.
• Do not use levothyroxine for weight loss in euthyroid patients; it is ineffective and potentially dangerous.

• Other levothyroxine sodium tablet formulations (e.g., Synthroid, Levoxyl, Unithroid, generic levothyroxine tablets)
• Levothyroxine sodium oral solution (Tirosint-SOL)
• Liothyronine (T3) (e.g., Cytomel) - typically used in specific cases, not as monotherapy for routine hypothyroidism.
• Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3.

If your symptoms or health issues persist or worsen, it is 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 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.