Levothyroxine 0.088mg (88mcg) Caps

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.

Serious Side Effects: Seek Medical Help Right Away

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 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 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 periods

Additional Side Effects in Children and Infants

Children: Hip or knee pain, or a limp
Infants: Changes in the shape of the head and face

Other Possible Side Effects

Not everyone will experience side effects, and many people may only have mild symptoms. However, 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

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, 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 concerns

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.

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 avoid any potential issues, 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 individual risk factors with your doctor, who can help determine if you are at a higher risk of osteoporosis.

This medication may also affect fertility, potentially making it more difficult to become pregnant or father a child. If you plan to conceive, 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 and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, who will discuss the benefits and risks of this medication with you and help you make an informed decision.

Special Considerations for Children

If your child is taking this medication and experiences any changes in weight, consult with your doctor, as their dosage may need to be adjusted. Never give your child more of this medication than prescribed, 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 to monitor any potential effects. Consult with your doctor to discuss any concerns.

• Amiodarone (can cause hypo- or hyperthyroidism, monitor thyroid function)
• Anticoagulants (e.g., Warfarin - increased anticoagulant effect, monitor INR)
• Cholestyramine, Colestipol, Sevelamer (decreased levothyroxine absorption, separate administration by 4-6 hours)
• Sucralfate (decreased levothyroxine absorption, separate administration by 4-6 hours)
• Iron supplements, Calcium supplements (decreased levothyroxine absorption, separate administration by 4 hours)
• Proton Pump Inhibitors (PPIs) (e.g., Omeprazole - decreased levothyroxine absorption, monitor TSH)
• H2 Blockers (e.g., Ranitidine - decreased levothyroxine absorption, monitor TSH)
• Orlistat (decreased levothyroxine absorption, separate administration by 4 hours)
• Tyrosine Kinase Inhibitors (e.g., Sunitinib, Imatinib - can alter thyroid function, monitor TSH)
• Estrogens (e.g., Oral contraceptives, HRT - increase TBG, may require higher levothyroxine dose)
• Androgens (decrease TBG, may require lower levothyroxine dose)
• Phenytoin, Carbamazepine, Rifampin, Phenobarbital (increase levothyroxine metabolism, may require higher dose)
• Sertraline (may decrease levothyroxine absorption, monitor TSH)
• Beta-blockers (may decrease peripheral conversion of T4 to T3)
• Insulin, Oral Hypoglycemics (levothyroxine may increase blood glucose, adjust antidiabetic dose)

• Antacids (aluminum, magnesium, simethicone - decreased absorption, separate administration by 4 hours)
• Dietary fiber (decreased absorption, separate administration)
• Soy products (decreased absorption, separate administration)
• Grapefruit juice (may affect absorption, avoid consistent intake)
• Corticosteroids (can inhibit TSH secretion and T4 to T3 conversion)
• Salicylates (>2g/day - can inhibit T4 binding to TBG)
• Lithium (can cause hypothyroidism)

• Not available

• Fatigue
• Weight changes (gain or loss)
• Cold intolerance
• Constipation
• Dry skin
• Hair loss
• Bradycardia
• Depression
• Muscle aches/weakness
• Memory impairment
• Nervousness
• Irritability
• Heat intolerance
• Palpitations
• Tremor
• Diarrhea
• Insomnia
• Weight loss (unexplained)

Levothyroxine is essential for normal fetal development and is safe to use during pregnancy. Thyroid hormone requirements typically increase during pregnancy, often requiring a dose increase of 25-50% to maintain TSH within the target range (lower than non-pregnant range).

Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not considered clinically significant to the infant.

Dosing is weight-based and higher per kg in younger children due to higher metabolic rates. Regular monitoring of TSH and Free T4 is crucial to ensure proper growth and neurocognitive development. Adherence is critical for congenital hypothyroidism to prevent irreversible intellectual disability.

Lower initial doses (e.g., 12.5-25 mcg/day) are recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiac disease. Dose adjustments should be made cautiously and gradually. TSH monitoring remains the primary guide.

• Always take levothyroxine on an empty stomach, 30-60 minutes before breakfast, with water, and separate from other medications and supplements (especially calcium, iron, antacids) by at least 4 hours.
• Consistency is key: take at the same time each day. If a dose is missed, take it as soon as remembered, unless it's almost time for the next dose. Do not double dose.
• TSH is the primary lab test for monitoring, but Free T4 may be useful in certain situations (e.g., central hypothyroidism, TSH suppression therapy).
• Patients may feel worse before feeling better as the body adjusts to the correct hormone levels. Full therapeutic effect can take 4-6 weeks.
• Capsule formulations (e.g., Tirosint) may have more consistent absorption and be less affected by food or gastric pH compared to tablet forms, which can be beneficial for patients with absorption issues.
• Educate patients about symptoms of both hypo- and hyperthyroidism to recognize when a dose adjustment might be needed.
• Avoid using levothyroxine for weight loss in euthyroid individuals due to the risk of serious adverse cardiac events.

• Liothyronine (T3) - used in specific cases like myxedema coma or for short-term TSH suppression before thyroid cancer scans, but not typically for chronic hypothyroidism due to shorter half-life and fluctuating levels.

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 consult with your pharmacist. If you have any questions or concerns about this 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.