Tirosint 62.5mcg Capsules

Levothyroxine (T4) is a synthetic form of the natural thyroid hormone, L-thyroxine. It is converted to its active metabolite, L-triiodothyronine (T3), in peripheral tissues. T3 enters the cell nucleus and binds to thyroid hormone receptors, which then bind to specific DNA sequences (thyroid hormone response elements) to regulate gene expression, affecting protein synthesis and metabolism across various organ systems.

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, 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 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 is not an exhaustive list of possible side effects. 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 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

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm it is safe to do so.

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 ensure uninterrupted 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 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 directed by your doctor and undergo regular blood tests as recommended.

If you take biotin or any products 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 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 also affect fertility, potentially leading to difficulties in getting pregnant or fathering a child. If you plan to conceive, consult your doctor before starting treatment.

Special Considerations

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

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

Pediatric Patients

If your child is taking this medication and experiences any changes in weight, consult your doctor, as their dose 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 consult your doctor to discuss any concerns.

• Amiodarone (alters thyroid function, monitor closely)
• Antacids (aluminum, magnesium, calcium) - decrease absorption
• Bile acid sequestrants (cholestyramine, colestipol) - decrease absorption
• Cation-containing products (iron, calcium supplements) - decrease absorption
• Sucralfate - decreases absorption
• Proton pump inhibitors (PPIs) - may decrease absorption
• Orlistat - may decrease absorption
• Soy products - may decrease absorption
• Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) - may increase levothyroxine requirements
• Rifampin, Carbamazepine, Phenytoin, Phenobarbital (enzyme inducers) - increase levothyroxine metabolism, may require higher doses
• Warfarin - levothyroxine may enhance anticoagulant effect, monitor INR closely
• Insulin/Oral Hypoglycemics - levothyroxine may increase blood glucose, requiring dose adjustment of antidiabetic agents

• Beta-blockers (e.g., propranolol) - may decrease T4 to T3 conversion
• Corticosteroids - may decrease T4 to T3 conversion
• Estrogens (oral) - increase TBG, may increase levothyroxine requirements
• Androgens - decrease TBG, may decrease levothyroxine requirements
• SSRIs - theoretical interaction, monitor TSH
• Digoxin - levothyroxine may decrease digoxin levels, monitor digoxin levels

• Dietary fiber - may decrease absorption

• Fatigue
• Weight gain or difficulty losing weight
• Cold intolerance
• Constipation
• Dry skin
• Hair loss
• Bradycardia
• Depression
• Muscle aches and weakness
• Puffiness in face and extremities
• Hoarseness

Levothyroxine is essential for normal fetal development and is considered safe and necessary during pregnancy. Hypothyroidism during pregnancy can lead to adverse maternal and fetal outcomes. Dose requirements often increase during pregnancy.

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, and it is not expected to cause adverse effects in breastfed infants.

Dosing is weight-based and adjusted frequently, especially in infants and young children, to ensure normal growth and neurocognitive development. Regular monitoring of TSH and Free T4 is crucial. Tirosint capsules may be opened and mixed with water or breast milk for administration to infants and young children.

Lower initial doses are often recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Dose titration should be slower and more cautious. Monitor for cardiac symptoms.

• Tirosint is a liquid-filled capsule formulation of levothyroxine, which may offer more consistent absorption compared to tablet formulations, especially in patients with gastrointestinal absorption issues or those taking multiple interacting medications.
• Always take levothyroxine on an empty stomach, 30-60 minutes before breakfast, with water. Consistency in timing relative to food and other medications 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.
• Patients should be educated on symptoms of both under- and over-treatment to facilitate timely dose adjustments.
• For patients with cardiac disease, start with a very low dose (e.g., 12.5-25 mcg/day) and titrate slowly to avoid exacerbating angina or arrhythmias.
• Levothyroxine is NOT for weight loss in euthyroid individuals and can cause serious adverse effects if misused for this purpose.

• Liothyronine (T3, Cytomel): Used in specific cases, often in combination with levothyroxine, or for short-term suppression.
• Desiccated thyroid extract (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.

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 facilitate prompt and effective treatment.