Tirosint 200mcg 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 then enters the cell nucleus and binds to thyroid hormone receptors, regulating gene expression and controlling numerous metabolic processes, including protein, carbohydrate, and lipid metabolism, and influencing growth and development.

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 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 or loss of consciousness
+ 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 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 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 essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure continuous 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. 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 risk factors with your doctor, who can help determine if you are at higher risk.

This medication may also affect fertility, potentially leading to difficulties in getting pregnant or fathering a child. If you plan to become pregnant or father a child, consult with your doctor before starting this medication.

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, inform your doctor to discuss the benefits and risks of this medication to you and your baby.

When giving this medication to a child, monitor their weight changes and consult with your doctor, as the dose 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, alters T4 to T3 conversion)
• Certain tyrosine kinase inhibitors (e.g., imatinib, sunitinib, sorafenib - can decrease levothyroxine efficacy)
• Orlistat (can significantly reduce levothyroxine absorption)
• Sodium polystyrene sulfonate (Kayexalate - can bind levothyroxine and reduce absorption)

• Antacids (aluminum, magnesium, calcium carbonate - reduce absorption, separate by 4 hours)
• Iron supplements (ferrous sulfate - reduce absorption, separate by 4 hours)
• Calcium supplements (calcium carbonate, calcium citrate - reduce absorption, separate by 4 hours)
• Bile acid sequestrants (cholestyramine, colestipol, colesevelam - reduce absorption, separate by 4-6 hours)
• Proton pump inhibitors (omeprazole, lansoprazole - may increase gastric pH, potentially reducing absorption)
• Sucralfate (reduces absorption, separate by 4 hours)
• Soy products (can reduce absorption, especially in infants)
• Dietary fiber (high amounts can reduce absorption)
• Rifampin, Carbamazepine, Phenytoin, Phenobarbital (CYP3A4 inducers, increase levothyroxine metabolism, may require dose increase)
• Estrogens (oral contraceptives, hormone replacement therapy - increase TBG, may require dose increase)
• Androgens (decrease TBG, may require dose decrease)
• SSRIs (sertraline - may increase levothyroxine requirements)
• Beta-blockers (propranolol - may inhibit T4 to T3 conversion)
• Corticosteroids (may inhibit T4 to T3 conversion and decrease TBG)
• Warfarin (levothyroxine can enhance anticoagulant effect, monitor INR)

• Coffee (may reduce absorption, separate by 30-60 minutes)
• Grapefruit juice (potential minor effect on absorption, but generally not clinically significant)

• Fatigue
• Weight changes (gain or loss)
• Cold intolerance
• Constipation
• Dry skin
• Hair loss
• Bradycardia or Tachycardia
• Muscle aches and weakness
• Depression or anxiety
• Memory impairment
• Menstrual irregularities
• Goiter (neck swelling)
• Palpitations
• Tremor
• Nervousness
• Heat intolerance
• Diarrhea

Levothyroxine is safe and essential during pregnancy. Thyroid hormone requirements often increase during pregnancy (by 25-50% or more) due to increased TBG, placental deiodination, and fetal thyroid hormone needs. Close monitoring of TSH (every 4-6 weeks) and dose adjustments are crucial to maintain maternal euthyroidism, which is vital for fetal neurodevelopment.

Levothyroxine is considered safe during breastfeeding. Only small amounts are excreted into breast milk, and these amounts are not clinically significant to the infant. It is compatible with breastfeeding and is often continued at pre-pregnancy or adjusted post-partum doses.

Dosing is weight-based and critical for normal growth and neurodevelopment. Untreated congenital hypothyroidism can lead to irreversible intellectual disability and growth retardation. Regular monitoring of TSH and Free T4 is essential, especially in infants and young children. Tirosint capsules may be preferred for children who cannot swallow tablets or for more precise dosing, as they can be opened and mixed with water.

Elderly patients, especially those with underlying cardiovascular disease, should be started on lower doses (e.g., 12.5-25 mcg/day) and titrated slowly to avoid precipitating cardiac events (e.g., angina, arrhythmias). Close monitoring of TSH and clinical symptoms is important.

• Tirosint capsules contain levothyroxine in a liquid gel formulation, which may be beneficial for patients with absorption issues (e.g., gastric bypass, celiac disease, lactose intolerance) or those taking multiple interacting medications, as it may have more consistent absorption than tablet forms.
• Always take levothyroxine on an empty stomach, 30-60 minutes before food or other medications, to maximize absorption. Consistency in timing is key.
• Do not crush or chew Tirosint capsules; they can be swallowed whole or the liquid can be squeezed into water and consumed immediately.
• Patients should be advised that it takes 4-6 weeks for TSH levels to stabilize after a dose change, so patience is required for dose adjustments.
• Symptoms of over-replacement (hyperthyroidism) can be subtle and include anxiety, insomnia, palpitations, and unexplained weight loss. Monitor for these.
• Many medications and supplements can interfere with levothyroxine absorption or metabolism. A thorough medication review is crucial at each visit.
• Tirosint 200mcg is a high dose, typically used for maintenance in patients with significant hypothyroidism or after thyroidectomy for thyroid cancer.

• Other levothyroxine brands (e.g., Synthroid, Levoxyl, Unithroid, generic levothyroxine tablets)
• Liothyronine (T3, Cytomel) - used in specific cases, sometimes in combination with levothyroxine.
• Desiccated thyroid extract (Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from porcine thyroid glands.

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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.