Levothyroxine Sodium Tablets | Oral Thyroid Hormone Therapy
Important Safety Information: Levothyroxine Sodium Tablets | Oral Thyroid Hormone Therapy
Levothyroxine is a synthetic form of thyroxine, also known as T4, a hormone naturally produced by the thyroid gland. It is prescribed for individuals diagnosed with hypothyroidism, a condition in which the thyroid does not produce enough hormone to regulate metabolism. Low thyroid levels may contribute to symptoms such as fatigue, weight gain, dry skin, hair thinning, constipation, cold sensitivity, and low mood.
Levothyroxine works by restoring normal thyroid hormone levels in the body, helping regulate metabolism, support energy production, and maintain healthy organ function. Treatment is individualized based on laboratory testing and clinical presentation. Your Superior provider will determine the appropriate starting dose and adjust therapy based on TSH and free T4 monitoring to ensure safe and appropriate hormone replacement.
This product may be dispensed as either an FDA-approved commercial medication or a compounded formulation prepared by a licensed compounding pharmacy. Compounded medications have not been reviewed by the FDA for safety or efficacy. Review important medication safety information.
What is this?
This Important Safety Information summarizes key warnings and precautions for Levothyroxine Sodium Tablets, a synthetic form of thyroxine (T4), a hormone normally produced by the thyroid gland. Levothyroxine is used as replacement therapy in adults and pediatric patients with primary, secondary, or tertiary hypothyroidism and may be used for TSH suppression in certain thyroid cancer patients. This medication should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions.
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including levothyroxine sodium, should not be used for the treatment of obesity or for weight loss. Doses beyond daily hormonal requirements may cause serious or life-threatening toxicity.
Most Serious Warnings
Product can cause:
Severe heart-related complications, including chest pain, irregular heartbeat, atrial fibrillation, heart attack, or heart failure
Worsening of underlying cardiovascular disease
Acute adrenal crisis in patients with untreated adrenal insufficiency
Decreased bone mineral density and increased fracture risk with over-treatment
Severe allergic reactions, including rash, swelling, or breathing difficulty
Who Should NOT Take Levothyroxine
Do not take this medication if you:
Have uncorrected adrenal insufficiency
Have been advised by your provider that thyroid hormone therapy is not appropriate for you
Before Taking Levothyroxine, Tell Your Healthcare Provider if You:
Have heart disease, coronary artery disease, or arrhythmias
Are elderly or at risk for atrial fibrillation
Have adrenal or pituitary disorders
Have diabetes
Have osteoporosis or are at increased risk for bone loss
Take blood thinners (anticoagulants)
Take insulin or other diabetes medications
Take iron, calcium, antacids, bile acid binders, or proton pump inhibitors
Take antidepressants, beta blockers, amiodarone, or seizure medications
Take biotin or biotin-containing supplements
Are pregnant, planning pregnancy, or breastfeeding
Possible Side Effects
Adverse reactions are generally due to over-treatment and may resemble symptoms of hyperthyroidism.
Common (may indicate dose too high):
Rapid or irregular heartbeat
Chest pain
Nervousness or anxiety
Irritability
Insomnia
Tremors
Increased sweating
Heat intolerance
Weight loss
Diarrhea
Menstrual irregularities
Headache
Serious (seek medical care immediately):
Severe chest pain
Shortness of breath
Fainting
Seizures
Signs of allergic reaction including rash, swelling, or difficulty breathing
While Taking Levothyroxine
Take levothyroxine exactly as prescribed. It should be taken once daily on an empty stomach, one-half to one hour before breakfast with a full glass of water.
Do not take within 4 hours of iron, calcium, or antacids.
Stop biotin supplements at least 2 days before thyroid lab testing.
It may take several weeks before symptom improvement occurs.
Therapy is typically lifelong for hypothyroidism.
Pregnancy and Lactation
Levothyroxine is generally safe and necessary during pregnancy for patients with hypothyroidism. Untreated hypothyroidism during pregnancy may increase risks to both mother and baby. Dosage adjustments are often required during pregnancy. Do not stop taking levothyroxine without provider guidance.
Overdose
Symptoms of overdose may include:
Confusion or disorientation
Severe chest pain
Irregular heartbeat
Seizures
Shock or coma
If overdose is suspected, seek emergency medical attention or contact Poison Control at 1-800-222-1222 immediately.
Missed Dosage
If you miss a dose:
Take it as soon as you remember unless it is close to your next dose
Do not double your dose
Contact your provider if multiple doses are missed
Storage
Store at room temperature
Protect from light and moisture
Keep out of reach of children
Medication Disposal
Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication. Contact your pharmacy for disposal instructions.
Provider Oversight and Order Review
Levothyroxine therapy requires ongoing provider supervision and periodic laboratory monitoring of TSH and/or free T4 levels to ensure appropriate dosing. Dose adjustments may be required based on age, cardiovascular status, pregnancy status, and lab results.
Telemedicine Disclosure
This prescription may be issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.
Disclaimer
This summary does not include all information about levothyroxine sodium and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations.
Superior Health & Wellness
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
