Tirosint 44mcg 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 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. This leads to increased metabolic rate, protein synthesis, and effects on growth, development, and metabolism of carbohydrates, lipids, and proteins.

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 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
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. 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 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 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. 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. 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.

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, making it more difficult to become pregnant or father a child. If you plan to start a family, consult your doctor before taking this medication.

Special Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women should consult their doctor to discuss the potential benefits and risks of taking this medication.

Pediatric Patients

If your child is taking this medication and experiences a change in weight, consult 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 teens, so regular growth checks may be necessary. Consult your doctor to discuss any concerns.

• Amiodarone (can cause hypo- or hyperthyroidism, requiring dose adjustment)
• Oral Anticoagulants (e.g., Warfarin - increased anticoagulant effect, monitor INR)
• Ion Exchange Resins (e.g., Cholestyramine, Colestipol, Sevelamer, Patiromer - significantly decrease absorption of levothyroxine, separate administration by 4 hours)
• Proton Pump Inhibitors (e.g., Omeprazole, Lansoprazole - may reduce levothyroxine absorption, monitor TSH)
• Sucralfate (reduces absorption, separate administration by 4 hours)
• Iron supplements (reduces absorption, separate administration by 4 hours)
• Calcium carbonate (reduces absorption, separate administration by 4 hours)
• Soy products (may decrease absorption, monitor TSH)

• Antacids (aluminum and magnesium containing - reduce absorption, separate administration by 4 hours)
• Certain Anticonvulsants (e.g., Phenytoin, Carbamazepine, Phenobarbital - increase levothyroxine metabolism, may require higher dose)
• Rifampin (increases levothyroxine metabolism, may require higher dose)
• Beta-blockers (may reduce conversion of T4 to T3)
• Estrogens (increase TBG, may increase levothyroxine requirement)
• Androgens (decrease TBG, may decrease levothyroxine requirement)
• SSRIs (may affect thyroid function tests, monitor TSH)
• Orlistat (may decrease absorption, monitor TSH)

• Dietary fiber (may slightly decrease absorption)

• Fatigue
• Weight gain or loss
• Cold or heat intolerance
• Constipation or diarrhea
• Dry skin
• Hair loss
• Muscle aches or weakness
• Depression or anxiety
• Memory problems
• Bradycardia or tachycardia
• Palpitations
• Tremors
• Nervousness
• Insomnia

Levothyroxine is considered safe and essential during pregnancy. Thyroid hormone requirements often increase during pregnancy (by 25-50% or more), especially in the first trimester. Adequate thyroid hormone levels are crucial for fetal neurological development. TSH should be monitored frequently (e.g., every 4-6 weeks) and dose adjusted to maintain TSH within trimester-specific target ranges.

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, and it does not pose a risk to the nursing infant. It is considered safe for use by lactating mothers.

Levothyroxine is critical for normal growth and development in children with hypothyroidism. Dosing is weight-based and higher per kg in younger children due to higher metabolic rates. Regular monitoring of TSH and FT4 is essential to ensure proper growth and neurocognitive development. Under-treatment can lead to irreversible intellectual disability and growth retardation.

Elderly patients may require lower starting doses and smaller, more gradual dose adjustments due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Careful monitoring for cardiac symptoms (e.g., angina, arrhythmias) is crucial. TSH target ranges may be slightly higher for very elderly patients.

• Tirosint is a liquid gel capsule formulation of levothyroxine, which may offer more consistent absorption compared to tablet forms, especially in patients with malabsorption issues or those taking multiple interacting medications (though separation of doses is still recommended).
• Always take levothyroxine on an empty stomach, 30-60 minutes before food or other medications, to maximize absorption and ensure consistent blood levels.
• Consistency is key: take it at the same time every day. If a dose is missed, take it as soon as remembered, but do not double dose.
• Patients should be advised that it takes several weeks for the full therapeutic effect to be seen and for TSH levels to stabilize after a dose change.
• Symptoms of over-treatment (hyperthyroidism) or under-treatment (hypothyroidism) should be reviewed with patients, and they should be instructed to report these to their healthcare provider.
• Tirosint is available in a wide range of strengths, allowing for precise dose titration.

• Other levothyroxine sodium tablet brands (e.g., Synthroid, Levoxyl, Unithroid, Levothroid)
• Levothyroxine oral solution (e.g., Tirosint-SOL)
• Liothyronine (synthetic T3, generally used in specific cases or in combination with levothyroxine)
• Desiccated thyroid extract (natural thyroid hormones, contains T4 and T3, e.g., Armour Thyroid, NP Thyroid)

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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.