Tirosint 112mcg 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 and T4 bind to thyroid hormone receptors in the cell nucleus and exert their metabolic effects through gene expression modulation, regulating metabolism, 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, or anxious
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 persist, 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, 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, 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 crucial that you 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 drug.

Diabetes Considerations

If you have high blood sugar (diabetes), consult with 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 work as advised.

Thyroid Level Checks

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.

Osteoporosis Risk

High doses of this medication may increase the risk of weak bones (osteoporosis), particularly after menopause. Discuss your risk factors with your doctor, who can help determine if you are at higher risk and address any concerns you may have.

Fertility and Pregnancy Considerations

This medication may affect fertility, potentially leading to difficulties in getting pregnant or fathering a child. If you plan to conceive, consult with your doctor before starting this medication. Additionally, if you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks to you and your baby.

Special Considerations for Older Adults

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

Pediatric Considerations

When giving this medication to a child, consult with your doctor if your child's weight changes, 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 with your doctor to discuss any concerns.

• Acute myocardial infarction
• Uncorrected adrenal insufficiency
• Untreated thyrotoxicosis

• Oral anticoagulants (e.g., warfarin) - may increase anticoagulant effect
• Antidiabetic agents (insulin, oral hypoglycemics) - may increase antidiabetic agent requirements
• Amiodarone - may alter thyroid function
• Cholestyramine, Colestipol, Sevelamer, Kayexalate - decrease levothyroxine absorption
• Iron supplements, Calcium carbonate, Aluminum-containing antacids, Sucralfate - decrease levothyroxine absorption
• Proton pump inhibitors (e.g., omeprazole) - may decrease levothyroxine absorption
• Orlistat - may decrease levothyroxine absorption
• Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) - may increase levothyroxine requirements
• Estrogens (oral) - may increase TBG, increasing levothyroxine requirements
• Androgens, Anabolic steroids, Asparaginase, Glucocorticoids - may decrease TBG, decreasing levothyroxine requirements

• Sertraline - may increase levothyroxine requirements
• Rifampin, Carbamazepine, Phenytoin, Phenobarbital - may increase levothyroxine metabolism
• Beta-blockers - may decrease conversion of T4 to T3
• Iodine-containing agents (e.g., radiographic contrast media) - may alter thyroid function
• Soy products, dietary fiber - may decrease levothyroxine absorption

• Not available

• Fatigue
• Weight changes (gain or loss)
• Cold intolerance
• Constipation
• Dry skin
• Hair loss
• Bradycardia (slow heart rate)
• Depression
• Memory impairment
• Muscle aches
• Palpitations
• Nervousness
• Tremor
• Heat intolerance
• Diarrhea
• Insomnia
• Excessive sweating

Levothyroxine requirements typically increase during pregnancy. It is crucial to continue levothyroxine therapy and monitor TSH levels closely (every 4-6 weeks) to ensure adequate thyroid hormone levels for fetal development. Untreated maternal hypothyroidism can lead to adverse pregnancy outcomes and impaired neurocognitive development in the child. Levothyroxine is Category A.

Levothyroxine is compatible with breastfeeding. Minimal amounts are excreted into breast milk, and it is not expected to cause adverse effects in breastfed infants. Maternal thyroid hormone levels should be maintained within the normal range.

Dosing is weight-based and critical for normal growth and development. Under-treatment can lead to impaired intellectual development and growth retardation. Over-treatment can lead to craniosynostosis in infants and accelerated bone maturation. Close monitoring of TSH and Free T4 is essential.

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). Initial doses should be lower (e.g., 12.5-25 mcg/day) and titrated slowly with careful monitoring of TSH and cardiac status.

• Tirosint is a liquid-filled capsule, which may be beneficial for patients with absorption issues (e.g., gastric bypass, celiac disease, lactose intolerance) or those taking multiple medications that interfere with tablet absorption.
• Always take levothyroxine on an empty stomach, 30-60 minutes before food or other medications, to ensure consistent absorption.
• Consistency is key: take the medication at the same time every day.
• Patients should be advised that it may take several weeks for symptoms to improve and for TSH levels to normalize.
• Regular monitoring of TSH (and sometimes Free T4) is essential to ensure the correct dose and prevent over- or under-treatment.
• Educate patients on symptoms of both hypo- and hyperthyroidism to report any changes to their healthcare provider.

• Other levothyroxine sodium brands (e.g., Synthroid, Levoxyl, Unithroid, Tirosint-SOL liquid solution)
• Liothyronine (synthetic T3, e.g., Cytomel, Triostat) - typically used for short-term TSH suppression or in specific cases of T4 to T3 conversion issues.
• Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - natural thyroid hormone containing both T4 and T3.

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 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.