Tirosint 75mcg Capsules
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication on an empty stomach, at least 30 to 60 minutes before breakfast.
Swallow the capsule whole - do not chew, break, or crush it.
Avoid taking iron products, antacids containing aluminum or magnesium, or calcium carbonate within 4 hours before or 4 hours after taking your medication.
If you take other medications, they may need to be taken at a different time than your current medication. Consult with your doctor or pharmacist to determine the best schedule.
Certain foods, such as soybean flour (found in infant formula), may interact with your medication. Discuss this with your doctor.
If you regularly consume grapefruit juice or eat grapefruit, talk to your doctor about potential interactions.
Be aware that different brands and forms of this medication are available. Do not switch between them without consulting your doctor.
Continuing Your Medication
Continue taking your medication as directed by your doctor or healthcare provider, even if you feel well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light.
Do not remove your medication from the blister pack until you are ready to take it. Take the medication immediately after opening the blister pack, and do not store it for future use.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take on an empty stomach, at least 30-60 minutes before breakfast, with a full glass of water.
- Avoid taking with other medications, especially calcium, iron, antacids, or sucralfate, for at least 4 hours.
- Take at the same time each day to maintain consistent levels.
- Do not stop taking this medication without consulting your doctor, even if you feel better.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with levothyroxine.
- Regular blood tests (TSH) are essential to ensure the correct dose.
- Maintain a consistent diet; large changes in soy intake or fiber can affect absorption.
Available Forms & Alternatives
Available Strengths:
- Tirosint 13mcg Capsules
- Tirosint 25mcg Capsules
- Tirosint 50mcg Capsules
- Tirosint 75mcg Capsules
- Tirosint 88mcg Capsules
- Tirosint 150mcg Capsules
- Tirosint 137mcg Capsules
- Tirosint 100mcg Capsules
- Tirosint 112mcg Capsules
- Tirosint 125mcg Capsules
- Tirosint 175mcg Capsules
- Tirosint 200mcg Capsules
- Tirosint-Sol 100mcg/ml Oral Sol
- Tirosint-Sol 137mcg/ml Oral Sol
- Tirosint-Sol 150mcg/ml Oral Sol
- Tirosint-Sol 175mcg/ml Oral Sol
- Tirosint-Sol 88mcg/ml Oral Sol
- Tirosint-Sol 200mcg/ml Oral Sol
- Tirosint-Sol 13mcg/ml Oral Sol
- Tirosint-Sol 25mcg/ml Oral Sol
- Tirosint-Sol 50mcg/ml Oral Sol
- Tirosint-Sol 112mcg/ml Oral Sol
- Tirosint-Sol 75mcg/ml Oral Sol
- Tirosint-Sol 125mcg/ml Oral Sol
- Tirosint-Sol 37.5mcg/ml Oral Sol
- Tirosint-Sol 44mcg/ml Oral Sol
- Tirosint-Sol 62.5mcg/ml Oral Sol
- Tirosint 37.5mcg Capsules
- Tirosint 44mcg Capsules
- Tirosint 62.5mcg Capsules
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 immediately or seek 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 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 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, 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.
Seek Immediate Medical Attention If You Experience:
- Symptoms of hyperthyroidism (too much hormone): rapid heart rate, palpitations, chest pain, excessive sweating, heat intolerance, nervousness, tremor, insomnia, weight loss, diarrhea.
- Symptoms of hypothyroidism (too little hormone): extreme fatigue, weight gain, constipation, dry skin, hair loss, feeling cold, depression, slow heart rate.
- Allergic reaction: rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
Before Using This Medicine
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.
Precautions & Cautions
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. Please note that it may take several weeks to experience the full effects of this medication.
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 advised.
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, 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 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
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication to both 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 of this medication than prescribed, as this may 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, so be sure to discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Signs and symptoms of hyperthyroidism: headache, irritability, nervousness, sweating, tachycardia, arrhythmias, increased bowel motility, menstrual irregularities, tremor, insomnia, heat intolerance, fever, weight loss, chest pain, palpitations.
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is symptomatic and supportive, often involving beta-blockers for cardiac symptoms.
Drug Interactions
Major Interactions
- Amiodarone (may alter thyroid function)
- Antacids (aluminum, magnesium, calcium-containing) - decrease absorption
- Bile acid sequestrants (cholestyramine, colestipol) - decrease absorption
- Cation-containing products (iron, calcium supplements) - decrease absorption
- Orlistat - decrease absorption
- Proton pump inhibitors (PPIs) - decrease absorption
- Sucralfate - decrease absorption
- Soy products - decrease absorption
- Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) - may alter thyroid function
- Warfarin (may enhance anticoagulant effect)
Moderate Interactions
- Anticonvulsants (carbamazepine, phenytoin, phenobarbital) - increase metabolism of levothyroxine
- Antidepressants (tricyclics, SSRIs) - may increase cardiac sensitivity to thyroid hormones
- Beta-blockers - may decrease conversion of T4 to T3
- Corticosteroids - may decrease TSH secretion and T4 to T3 conversion
- Estrogens (oral) - increase TBG, requiring higher levothyroxine dose
- Furosemide (>80 mg IV) - may displace T4 from protein binding
- Iodine-containing products (e.g., contrast media) - may alter thyroid function
- Lithium - may cause hypothyroidism
- Metformin - may decrease TSH levels
- Propylthiouracil (PTU) - inhibits T4 to T3 conversion
- Rifampin - increases metabolism of levothyroxine
- Ritonavir - may alter thyroid function
- Statins (e.g., lovastatin, simvastatin) - may increase levothyroxine requirements
- Theophylline - clearance may be altered by thyroid status
Minor Interactions
- Dietary fiber - may decrease absorption
- Grapefruit juice - may decrease absorption (minor effect)
Monitoring
Baseline Monitoring
Rationale: Primary diagnostic and monitoring tool for hypothyroidism. Reflects the body's response to thyroid hormone levels.
Timing: Before initiating therapy.
Rationale: Measures the unbound, active form of T4. Useful in assessing thyroid status, especially in central hypothyroidism or when TSH is unreliable.
Timing: Before initiating therapy.
Rationale: To establish baseline symptom severity and track improvement.
Timing: Before initiating therapy.
Rationale: To assess risk of adverse cardiac events, especially in elderly or those with pre-existing heart conditions, as thyroid hormone replacement can increase cardiac workload.
Timing: Before initiating therapy, particularly in older patients or those with cardiac risk factors.
Routine Monitoring
Frequency: Every 4-6 weeks after initiation or dose change, then every 6-12 months once stable.
Target: 0.4-4.0 mIU/L (for primary hypothyroidism, target often 0.5-2.5 mIU/L); individualized for TSH suppression.
Action Threshold: If TSH is outside target range, adjust levothyroxine dose. If TSH is suppressed (<0.1 mIU/L) in non-cancer patients, consider dose reduction to avoid hyperthyroidism.
Frequency: May be checked with TSH, especially if TSH is abnormal or in central hypothyroidism. Less frequently needed once stable.
Target: 0.8-1.8 ng/dL (or laboratory specific reference range).
Action Threshold: If Free T4 is outside target range, adjust levothyroxine dose.
Frequency: At each visit, especially during dose titration.
Target: Resolution or significant improvement of hypothyroid symptoms.
Action Threshold: Persistent or worsening symptoms may indicate inadequate dosing or other underlying issues.
Frequency: Periodically, especially in postmenopausal women or those on suppressive therapy, if concerns about long-term overtreatment.
Target: Normal bone density for age.
Action Threshold: Evidence of bone loss may warrant re-evaluation of levothyroxine dose to avoid iatrogenic hyperthyroidism.
Symptom Monitoring
- Fatigue
- Weight changes (gain or loss)
- Cold intolerance
- Constipation
- Dry skin
- Hair loss
- Bradycardia or tachycardia
- Palpitations
- Nervousness or irritability
- Tremor
- Heat intolerance
- Diarrhea
- Insomnia
- Chest pain or discomfort
Special Patient Groups
Pregnancy
Levothyroxine is essential for normal fetal development and is considered safe and necessary during pregnancy. Hypothyroidism during pregnancy can lead to adverse maternal and fetal outcomes. Dose requirements often increase during pregnancy.
Trimester-Specific Risks:
Lactation
Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not considered clinically significant to the infant.
Pediatric Use
Dosing is weight-based and higher per kg than in adults, especially in infants, due to rapid growth and development. Regular monitoring of TSH and Free T4 is crucial to ensure proper growth and neurocognitive development. Undermedication can lead to irreversible intellectual disability and growth retardation.
Geriatric Use
Lower initial doses are often recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Gradual dose titration is important to avoid precipitating cardiac events. Monitor for signs of hyperthyroidism and cardiac symptoms.
Clinical Information
Clinical Pearls
- Levothyroxine is a narrow therapeutic index drug; small changes in dose can have significant effects.
- Consistency is key: take at the same time each day, on an empty stomach, and consistently with or without other medications (though empty stomach is preferred).
- Tirosint capsules may be preferred for patients with absorption issues or sensitivities to excipients found in tablet formulations, as they contain fewer inactive ingredients.
- Patients should be advised to avoid switching between different brands or generic formulations without consulting their physician, as bioavailability can vary.
- TSH levels should be monitored 4-6 weeks after any dose adjustment or change in formulation/brand.
- Educate patients on symptoms of both hypo- and hyperthyroidism to recognize when their dose may be too low or too high.
Alternative Therapies
- Liothyronine (T3) - used in specific cases, often in combination with levothyroxine, but not as monotherapy for routine hypothyroidism.
- Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from porcine thyroid glands. Dosing can be less precise and TSH levels may not be a reliable indicator of adequate replacement.