Levothyroxine Sodium Jsp 562 00527 1346 10 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient.
What should I know before taking it?
Levothyroxine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions ( 5.4)] .
What important warnings are listed?
Thyroid hormones, including levothyroxine sodium tablets, 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 . WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. Thyroid hormones, including levothyroxine sodium tablet, should not be used for the.
How is this medication usually taken?
Levothyroxine sodium tablets USP are round, colored, scored and debossed with following debossing details on one side and break-line on other side. They are available as follows (Table 4) Tablet Strength Tablet Color/Shape Debossing Details 25 mcg Peach/Round L15 50 mcg White/Round L16 75 mcg Violet/Round L17 88 mcg Olive/Round L19 100 mcg Yellow/Round L20 112 mcg Rose/Round L21 125 mcg Tan/Round L22 137 mcg Turquoise/Round L23 150 mcg Blue/Round L24 175 mcg Lilac/Round L25 200 mcg Pink/Round L26 300 mcg Green/Round L27
What side effects are listed?
Adverse reactions associated with levothyroxine sodium tablets therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions ( 5) and Overdosage ( 10)] . They include the following: General:fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system:headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal:tremors, muscle weakness, muscle spasm Cardiovascular:palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory:dyspnea Gastrointestinal:diarrhea, vomiting,.
What interactions are listed?
See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to levothyroxine sodium tablets. ( 7)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=50fe00b3-6610-1cac-e063-6294a90af8ac
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.