Tirosint 137mcg Capsules

Manufacturer IBSA PHARMA Active Ingredient Levothyroxine Capsules(lee voe thye ROKS een) Pronunciation lee voe thye ROKS een
WARNING: Do not use this drug for weight loss. Severe and sometimes deadly side effects may happen with this drug if it is taken in large doses or with other drugs for weight loss. If you have questions, talk with the doctor. @ COMMON USES: It is used to add thyroid hormone to the body.It is used to manage thyroid cancer.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Thyroid hormone replacement
đŸ§Ŧ
Pharmacologic Class
Thyroid hormones
🤰
Pregnancy Category
Category A
✅
FDA Approved
Jan 1949
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Levothyroxine is a medicine that replaces a hormone normally made by your thyroid gland. It's used when your thyroid gland doesn't make enough of this hormone (a condition called hypothyroidism). Taking this medicine helps your body's metabolism work properly, affecting your energy, weight, and many other body functions.
📋

How to Use This Medicine

Taking Your Medication Correctly

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.

Important Notes

There are different brands and forms of this medication. Do not switch between them without consulting your doctor.
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 the removed medication for future use.

Missing a Dose

If you miss a dose, take it as soon as you remember.
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, or at bedtime (at least 3 hours after your last meal). Consistency in timing is crucial.
  • Avoid taking with other medications or supplements (especially iron, calcium, antacids) within 4 hours, as they can interfere with absorption.
  • Inform your doctor about all other medications, supplements, and dietary changes, as they can affect your levothyroxine dose.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.
  • Regular blood tests (TSH) are necessary to ensure you are on the correct dose.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Initial dose typically 1.6 mcg/kg/day orally once daily for primary hypothyroidism. Adjust by 12.5-25 mcg increments every 4-6 weeks based on TSH levels.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

primaryHypothyroidism: Initial: 1.6 mcg/kg/day orally once daily. Maintenance: 100-200 mcg/day (average 125 mcg/day).
subclinicalHypothyroidism: Initial: 25-75 mcg/day orally once daily. Titrate to normalize TSH.
thyroidCancerSuppression: Higher doses, typically 2-2.5 mcg/kg/day, to suppress TSH below 0.1 mIU/L or to undetectable levels, depending on risk stratification.
đŸ‘ļ

Pediatric Dosing

Neonatal: Congenital Hypothyroidism: Initial 10-15 mcg/kg/day orally once daily. Adjust based on TSH and T4/FT4.
Infant: 0-3 months: 10-15 mcg/kg/day; 3-6 months: 8-10 mcg/kg/day; 6-12 months: 6-8 mcg/kg/day.
Child: 1-5 years: 5-6 mcg/kg/day; 6-12 years: 4-5 mcg/kg/day.
Adolescent: 12-17 years (growth and puberty complete): 2-3 mcg/kg/day or adult dose (1.6 mcg/kg/day).
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: No specific adjustment needed; not significantly dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

đŸ”Ŧ

Mechanism of Action

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.
📊

Pharmacokinetics

Absorption:

Bioavailability: 48-79% (average 60-80%), highly variable and affected by food, other medications, and gastrointestinal conditions.
Tmax: Approximately 2-4 hours.
FoodEffect: Food significantly decreases absorption. Should be taken on an empty stomach, at least 30-60 minutes before breakfast, or at bedtime (at least 3 hours after the last meal).

Distribution:

Vd: Approximately 10-13 L.
ProteinBinding: >99% (primarily to thyroxine-binding globulin (TBG), thyroxine-binding prealbumin (TBPA), and albumin).
CnssPenetration: Limited, but active transport mechanisms allow some entry.

Elimination:

HalfLife: Approximately 6-7 days (euthyroid); 9-10 days (hypothyroid); 3-4 days (hyperthyroid).
Clearance: Approximately 0.05 L/hr/kg.
ExcretionRoute: Primarily renal (approximately 80% as metabolites), with some fecal excretion (approximately 20%).
Unchanged: Less than 1% of the dose is excreted unchanged in urine.
âąī¸

Pharmacodynamics

OnsetOfAction: Gradual, clinical effects typically seen within 3-5 days, but full therapeutic effect may take 4-6 weeks due to long half-life and need for TSH stabilization.
PeakEffect: TSH suppression/normalization typically achieved within 4-6 weeks.
DurationOfAction: Long, due to long half-life, allowing once-daily dosing.

Safety & Warnings

âš ī¸

BLACK BOX WARNING

Thyroid hormones, including Tirosint, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
âš ī¸

Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

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 change
Diarrhea, stomach cramps, or vomiting
Mood changes, such as feeling irritable, nervous, excitable, anxious, or restless
Shakiness
Trouble sleeping
Sensitivity to heat
Excessive sweating
Fever
Muscle cramps
Muscle weakness
Flushing
Bone pain
Changes in menstrual period (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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Symptoms of too much thyroid hormone (overdose/hyperthyroidism): Chest pain, rapid or irregular heartbeat, palpitations, excessive sweating, heat intolerance, nervousness, tremors, insomnia, diarrhea, significant weight loss.
  • Symptoms of too little thyroid hormone (underdose/hypothyroidism): Persistent fatigue, weight gain, cold intolerance, constipation, dry skin, hair loss, depression.
📋

Before Using This Medicine

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, 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.
âš ī¸

Precautions & Cautions

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. 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 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 osteoporosis (weak bones), 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 with 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 potential benefits and risks to you and your baby.

Pediatric Patients

If you are giving this medication to a child and their weight changes, consult with 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, so be sure to discuss this with your doctor.
🆘

Overdose Information

Overdose Symptoms:

  • Chest pain (angina)
  • Rapid or irregular heartbeat (tachycardia, arrhythmias)
  • Palpitations
  • Excessive sweating
  • Heat intolerance
  • Nervousness
  • Tremors
  • Insomnia
  • Diarrhea
  • Weight loss
  • Fever
  • Seizures (rare)
  • Heart failure (in susceptible individuals)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For non-emergencies, call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, often involving beta-blockers for cardiac symptoms and measures to reduce absorption if recent ingestion.

Drug Interactions

🔴

Major Interactions

  • Amiodarone (can cause hypo- or hyperthyroidism)
  • Antacids (aluminum, magnesium, calcium) - decrease absorption
  • Bile acid sequestrants (cholestyramine, colestipol) - decrease absorption
  • Cation exchange resins (sevelamer, patiromer, sodium polystyrene sulfonate) - decrease absorption
  • Iron supplements - decrease absorption
  • Sucralfate - decrease absorption
  • Orlistat - decrease absorption
  • Proton pump inhibitors (e.g., omeprazole) - may decrease absorption
  • Soy products - decrease absorption
  • Grapefruit juice - may decrease absorption
  • Warfarin (levothyroxine may enhance anticoagulant effect)
  • Antidiabetic agents (levothyroxine may increase blood glucose, requiring dose adjustment of antidiabetics)
  • Digoxin (levothyroxine may decrease digoxin levels)
  • Sympathomimetics (increased risk of cardiac adverse effects)
🟡

Moderate Interactions

  • Estrogens (increase TBG, potentially increasing levothyroxine requirement)
  • Androgens (decrease TBG, potentially decreasing levothyroxine requirement)
  • Glucocorticoids (may alter thyroid hormone metabolism)
  • Beta-blockers (may decrease T4 to T3 conversion)
  • Phenytoin, Carbamazepine, Rifampin (induce metabolism of thyroid hormones)
  • Sertraline (may increase levothyroxine requirement)
  • Imatinib, Sunitinib (may increase levothyroxine requirement)
  • Tyrosine kinase inhibitors (e.g., imatinib, sunitinib, sorafenib) - may increase levothyroxine requirement
đŸŸĸ

Minor Interactions

  • Dietary fiber (may decrease absorption)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Thyroid Stimulating Hormone (TSH)

Rationale: To establish baseline thyroid function and confirm diagnosis of hypothyroidism.

Timing: Prior to initiation of therapy.

Free Thyroxine (FT4)

Rationale: To assess baseline thyroid hormone levels.

Timing: Prior to initiation of therapy.

Cardiac status (ECG, history of cardiovascular disease)

Rationale: To assess for underlying cardiac conditions that may be exacerbated by thyroid hormone replacement.

Timing: Prior to initiation, especially in elderly or those with known cardiac disease.

📊

Routine Monitoring

Thyroid Stimulating Hormone (TSH)

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 may be individualized, often 0.5-2.5 mIU/L). For thyroid cancer suppression, target is often <0.1 mIU/L.

Action Threshold: Adjust dose if TSH is outside target range.

Free Thyroxine (FT4)

Frequency: May be checked with TSH, especially if TSH is suppressed or in central hypothyroidism.

Target: 0.8-1.8 ng/dL (or laboratory specific reference range).

Action Threshold: Adjust dose if FT4 is outside target range, particularly if TSH is not reliable.

Clinical symptoms (e.g., fatigue, weight changes, cold intolerance, heart rate)

Frequency: At each visit.

Target: Resolution of hypothyroid symptoms.

Action Threshold: Evaluate for under- or overtreatment if symptoms persist or new symptoms develop.

đŸ‘ī¸

Symptom Monitoring

  • Fatigue
  • Weight changes (gain or loss)
  • Cold or heat intolerance
  • Constipation or diarrhea
  • Dry skin or hair loss
  • Muscle aches or weakness
  • Changes in mood (depression, anxiety)
  • Heart palpitations or rapid heart rate (signs of overtreatment)
  • Chest pain (signs of overtreatment)

Special Patient Groups

🤰

Pregnancy

Levothyroxine is considered safe and essential during pregnancy. Thyroid hormone requirements often increase during pregnancy, especially in the first trimester. Close monitoring of TSH levels (every 4-6 weeks) and dose adjustments are crucial to maintain maternal euthyroidism, which is vital for fetal neurological development.

Trimester-Specific Risks:

First Trimester: Increased levothyroxine dose often required due to increased TBG and fetal thyroid hormone demand. Inadequate maternal thyroid hormone can lead to adverse fetal neurodevelopmental outcomes.
Second Trimester: Continued monitoring and dose adjustment as needed.
Third Trimester: Continued monitoring and dose adjustment as needed. Dose may decrease postpartum.
🤱

Lactation

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not considered clinically significant to the infant. It is often necessary for the mother to continue therapy postpartum.

Infant Risk: L1 (Safest) - No adverse effects reported in infants. Considered safe.
đŸ‘ļ

Pediatric Use

Dosing is weight-based and higher per kg in younger children due to higher metabolic rates and rapid growth. Close monitoring of TSH and FT4 is essential, especially in infants with congenital hypothyroidism, to ensure proper neurodevelopment. Adherence is critical.

👴

Geriatric Use

Lower initial doses are often recommended in elderly patients, especially those with underlying cardiovascular disease, due to increased sensitivity to thyroid hormones and a higher risk of cardiac adverse effects. Gradual dose titration is preferred.

Clinical Information

💎

Clinical Pearls

  • Consistency is key: Take levothyroxine at the same time each day, preferably in the morning on an empty stomach, 30-60 minutes before food or other medications.
  • Avoid taking with calcium, iron, antacids, or bile acid sequestrants within 4 hours, as they significantly impair absorption.
  • Tirosint capsules may be beneficial for patients with absorption issues or sensitivities to excipients found in tablet formulations, as they contain fewer inactive ingredients.
  • Full therapeutic effect may take 4-6 weeks, and TSH levels should not be rechecked sooner than 4-6 weeks after a dose change.
  • Patients should be educated on symptoms of both under- and overtreatment.
  • Pregnancy significantly increases levothyroxine requirements; close monitoring and dose adjustments are critical.
  • Do not use for weight loss in euthyroid individuals due to serious cardiac risks.
🔄

Alternative Therapies

  • Liothyronine (T3) - used in specific cases, often for short-term TSH suppression or in combination with levothyroxine.
💰

Cost & Coverage

Average Cost: Varies widely by pharmacy and dosage strength. Tirosint (capsules) tends to be more expensive than generic levothyroxine tablets. per 30 capsules
Generic Available: Yes
Insurance Coverage: Most insurance plans cover generic levothyroxine as a Tier 1 or Tier 2 medication. Brand-name formulations like Tirosint may be Tier 2 or Tier 3, requiring higher co-pays or prior authorization.
📚

General Drug Facts

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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 seeking help, be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it was taken.