Tirosint 13mcg 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 and T4 exert their metabolic effects through control of DNA transcription and protein synthesis. They regulate multiple cellular processes, including metabolism of carbohydrates, lipids, and proteins, and are essential for normal growth, development, and maturation of all tissues, particularly the central nervous system and bone.

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 immediately or seek emergency 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 notice 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, 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, please 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, including any medical conditions or allergies

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.

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 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 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 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 difficulty getting pregnant or fathering a child. If you plan to become pregnant or father a child, consult with your doctor before starting treatment.

If you are 65 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, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

When giving this medication to a child, monitor their weight closely and consult with your doctor if it changes, as the dosage may need to be adjusted. Never give your child more than the prescribed dose, 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.

• Amiodarone (can cause hypo- or hyperthyroidism, monitor thyroid function)
• Warfarin (levothyroxine may increase anticoagulant effect, monitor INR)
• Tyrosine kinase inhibitors (e.g., imatinib, sunitinib, can increase levothyroxine requirements)
• Orlistat (may reduce levothyroxine absorption, separate administration by at least 4 hours)

• Antacids (aluminum, magnesium, calcium) - reduce absorption, separate by 4 hours
• Iron supplements - reduce absorption, separate by 4 hours
• Calcium supplements - reduce absorption, separate by 4 hours
• Bile acid sequestrants (cholestyramine, colestipol) - reduce absorption, separate by 4-5 hours
• Sucralfate - reduces absorption, separate by 4 hours
• Proton pump inhibitors (PPIs) and H2 blockers - may reduce absorption due to increased gastric pH, monitor TSH
• Soy products/soy formula - may reduce absorption, monitor TSH
• Dietary fiber - may reduce absorption, monitor TSH
• Rifampin, Carbamazepine, Phenytoin, Phenobarbital (CYP inducers) - may increase levothyroxine metabolism, increase dose
• Sertraline, Chloral hydrate, Furosemide, Heparin, Salicylates (high dose) - may displace levothyroxine from protein binding, monitor free T4
• Estrogens (oral) - increase TBG, may increase levothyroxine requirements
• Androgens, Anabolic steroids - decrease TBG, may decrease levothyroxine requirements
• Beta-blockers - may reduce conversion of T4 to T3

• Coffee - may reduce absorption, separate administration

• Symptoms of hypothyroidism (under-treatment): fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, bradycardia, menstrual irregularities.
• Symptoms of hyperthyroidism (over-treatment): palpitations, tachycardia, nervousness, irritability, tremors, weight loss, heat intolerance, diarrhea, insomnia, excessive sweating.

Levothyroxine requirements often increase during pregnancy. It is essential to continue and often increase levothyroxine dosage to maintain euthyroidism for optimal fetal development. Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Levothyroxine is considered safe during breastfeeding. It is a normal component of human milk, and the amount transferred is minimal and not expected to cause adverse effects in the infant. L1: Safest.

Essential for normal growth and development, especially of the brain and skeletal system. Dosing is weight-based and higher per kg than in adults. Regular monitoring of TSH and T4 is critical to ensure adequate treatment and prevent developmental delays.

Lower starting doses are recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiac disease. Titration should be slow and cautious, with careful monitoring for cardiac symptoms.

• Tirosint is a liquid-filled capsule formulation of levothyroxine, which may be beneficial for patients with malabsorption issues, gastric bypass surgery, or allergies to common excipients (e.g., lactose, gluten, dyes) found in tablet formulations.
• Always take levothyroxine consistently, preferably in the morning on an empty stomach, 30-60 minutes before food or other medications/supplements.
• TSH is the primary laboratory test for monitoring levothyroxine therapy in primary hypothyroidism. Free T4 may be useful in specific situations (e.g., central hypothyroidism, TSH suppression).
• It takes 4-6 weeks for TSH levels to stabilize after a dose change, so do not adjust the dose more frequently than this.
• Educate patients about symptoms of both under- and over-treatment to ensure timely reporting and dose adjustments.
• Patients should be advised against switching between different levothyroxine products (brand to generic, or different generics) without physician consultation, due to potential differences in bioavailability.

• Liothyronine (T3, Cytomel): Synthetic T3, shorter half-life, more rapid onset and offset, typically used in specific cases or in combination with levothyroxine.
• Desiccated Thyroid Extract (Armour Thyroid, NP Thyroid): Natural thyroid hormone derived from porcine thyroid glands, contains both T4 and T3, variable potency, not recommended as first-line by most guidelines.
• Levothyroxine/Liothyronine combination products (e.g., Thyrolar): Fixed-ratio combination of T4 and T3, less commonly used.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.