Tirosint 175mcg Capsules

Levothyroxine (T4) is a synthetic form of the naturally occurring thyroid hormone, L-thyroxine. It is converted to its active metabolite, L-triiodothyronine (T3), in peripheral tissues. Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. They are involved in normal metabolism, growth, and development, and are essential for maintaining metabolic rate, cardiac function, and nervous system development.

Serious 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 within the first few months of treatment)

Reporting Side Effects

This is not a comprehensive list of all 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 symptoms you experienced.
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 prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your overall health status

This information will help your doctor determine whether it is safe for you to take this medication, considering your unique health profile and potential interactions with other substances. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 run out of this medication, as it may take several weeks to experience its full effects.

Special Considerations

If you have diabetes (high blood sugar), consult 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 tests as recommended.

If you take biotin or 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 or address any concerns you may have.

This medication may also affect fertility, potentially leading to difficulty getting pregnant or fathering a child. If you plan to conceive, consult your doctor before starting treatment.

Age-Related Considerations

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

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication for you and your baby.

Pediatric Patients

If you are giving this medication to a child and their weight changes, consult your doctor, 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 teenagers. Regular growth checks may be necessary. Consult your doctor to discuss any concerns or questions you may have.

• Amiodarone (can cause hypo- or hyperthyroidism, and alter levothyroxine metabolism)
• Oral anticoagulants (e.g., Warfarin - increased anticoagulant effect)
• Sympathomimetics (e.g., Epinephrine, Norepinephrine - increased risk of cardiac adverse effects)
• Tyrosine kinase inhibitors (e.g., Sunitinib, Imatinib - can increase TSH and require dose adjustment of levothyroxine)

• Antacids (aluminum, magnesium, calcium carbonate - decreased levothyroxine absorption)
• Iron supplements (decreased levothyroxine absorption)
• Sucralfate (decreased levothyroxine absorption)
• Cholestyramine, Colestipol (decreased levothyroxine absorption)
• Proton pump inhibitors (e.g., Omeprazole - may decrease levothyroxine absorption)
• Soy products/Soy formula (decreased levothyroxine absorption)
• Dietary fiber (decreased levothyroxine absorption)
• Rifampin, Carbamazepine, Phenytoin, Phenobarbital (increased levothyroxine metabolism)
• Estrogens (oral) / Oral contraceptives (increase TBG, may increase levothyroxine requirement)
• Androgens / Anabolic steroids (decrease TBG, may decrease levothyroxine requirement)
• Beta-blockers (may decrease conversion of T4 to T3)
• Antidiabetic agents (levothyroxine may increase blood glucose, requiring increased antidiabetic dose)

• Grapefruit juice (potential for minor decrease in absorption, but clinical significance often low)

• Fatigue
• Weight gain
• Cold intolerance
• Constipation
• Dry skin
• Hair loss
• Bradycardia
• Depression
• Muscle aches
• Palpitations
• Anxiety
• Weight loss
• Heat intolerance
• Diarrhea
• Tremor
• Tachycardia
• Insomnia

Levothyroxine is essential for normal fetal development and is safe to use during pregnancy. Thyroid hormone requirements often increase during pregnancy (by 25-50% or more), especially in the first trimester. 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 is not expected to cause adverse effects in breastfed infants. It is considered safe for use by lactating mothers.

Levothyroxine is crucial for normal growth and development in children. Dosing is weight-based and generally higher per kilogram than in adults. Regular monitoring of TSH and FT4 is essential to ensure proper growth and neurocognitive development. Adherence is critical.

Elderly patients may require lower initial doses and more gradual dose titration due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Monitor for signs of cardiac toxicity (e.g., angina, arrhythmias).

• Tirosint capsules are liquid-filled and may be beneficial for patients with absorption issues, gastric bypass surgery, or sensitivities to excipients found in tablet formulations.
• Consistency is key: Take levothyroxine at the same time every day, preferably in the morning on an empty stomach, separated from food and other medications.
• Do not crush or chew Tirosint capsules; they should be swallowed whole.
• Patients should be advised that it may take several weeks (4-6 weeks) to see the full therapeutic effect and for TSH levels to stabilize after a dose change.
• Educate patients on symptoms of both hypo- and hyperthyroidism to ensure timely reporting of adverse effects or inadequate treatment.
• Inform patients that certain foods (e.g., soy, high-fiber) and supplements (e.g., iron, calcium) can interfere with absorption and should be separated by at least 4 hours.

• Liothyronine (T3 - synthetic triiodothyronine, shorter half-life, more potent)
• Desiccated Thyroid Extract (natural thyroid hormone from animal glands, contains both T4 and T3)
• Combination therapy (Levothyroxine + Liothyronine, used in select cases)

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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.