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Unithroid Medication Summary

No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.

This patient-friendly summary is based on FDA/DailyMed prescribing information. It is not a substitute for medical advice. Not every medication has a separate FDA Medication Guide.
This label includes a boxed warning. Review the full prescribing information and talk to a healthcare professional.

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 UNITHROID is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression UNITHROID is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: UNITHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with UNITHROID may induce.

What should I know before taking it?

UNITHROID is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].

What important warnings are listed?

Thyroid hormones, including UNITHROID, 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 UNITHROID, should not be used for the treatment of obesity or for weight loss.

How is this medication usually taken?

UNITHROID tablets are round and color-coded available as follows: Strength (mcg) Color Tablet Markings 25 Peach JSP / 513 50 White JSP / 514 75 Purple JSP / 515 88 Olive JSP / 561 100 Yellow JSP / 516 112 Rose JSP / 562 125 Tan JSP / 519 137 Blue JSP / 564 150 Light Blue JSP / 520 175 Lilac JSP / 563 200 Pink JSP / 522 300 Green JSP / 523

What side effects are listed?

Common adverse reactions with UNITHROID therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5.4) 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 and cramps Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory: dyspnea Gastrointestinal: diarrhea, vomiting, abdominal cramps,.

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 UNITHROID (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=07562e72-7eaa-4ce6-94f0-e08814787e50

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Source: DailyMed prescribing information ↗

⚠️ 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.