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Euthyrox Prescribing Information
- Thyroid hormones, including EUTHYROX, 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[see Adverse Reactions (6), Drug Interactions (7.7), and Overdosage (10)].
EUTHYROX is L-thyroxine (T4) indicated in pediatric and adult patients for:
- Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
- Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
- Administer once daily, on an empty stomach, one-half to one hour before breakfast.
- Administer at least 4 hours before or after drugs that are known to interfere with absorption.
- Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption.
- Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4 to 6 weeks.
- See full prescribing information for dosing in specific patient populations.
- Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status.
EUTHYROX tablets are uncoated, off-white, round and flat on both sides with a beveled edge, and a dividing score on both sides available as:
| Tablet Strength | Tablet Markings |
|---|---|
| 25 mcg | "EM" and "25" |
| 50 mcg | "EM" and "50" |
| 75 mcg | "EM" and "75" |
| 88 mcg | "EM" and "88" |
| 100 mcg | "EM" and "100" |
| 112 mcg | "EM" and "112" |
| 125 mcg | "EM" and "125" |
| 137 mcg | "EM" and "137" |
| 150 mcg | "EM" and "150" |
| 175 mcg | "EM" and "175" |
| 200 mcg | "EM" and "200" |
- Pregnancy may require the use of higher doses of EUTHYROX.
EUTHYROX is contraindicated in patients with uncorrected adrenal insufficiency [
see Warnings and Precautions (5.3)].
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available