Levothyroxine Sodium
Generic: LEVOTHYROXINE SODIUM ANHYDROUS
Basic Information
Manufacturer
ENDO USA, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
9d815416-11c9-470e-a82f-89b0bf232e12
Indications & Usage
1 INDICATIONS AND USAGE Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma.
Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established.
Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied.
Levothyroxine Sodium is an L-thyroxine product.
Levothyroxine (T 4 ) Sodium for Injection is indicated for the treatment of myxedema coma.
( 1 ) Important Limitations of Use: The relative bioavailability of this drug has not been established.
Use caution when converting patients from oral to intravenous levothyroxine.
Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established.
Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied.
Levothyroxine Sodium is an L-thyroxine product.
Levothyroxine (T 4 ) Sodium for Injection is indicated for the treatment of myxedema coma.
( 1 ) Important Limitations of Use: The relative bioavailability of this drug has not been established.
Use caution when converting patients from oral to intravenous levothyroxine.
Adverse Reactions
6 ADVERSE REACTIONS ExcessI doses of levothyroxine can predispose to signs and symptoms compatible with hyperthyroidism.
The signs and symptoms of thyrotoxicosis include, but are not limited to: exophthalmic goiter, weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, increased pulse and blood pressure, cardiac arrhythmias, angina pectoris, tremors, insomnia, heat intolerance, fever, and menstrual irregularities.
Excessive doses of L-thyroxine can predispose to signs and symptoms compatible with hyperthyroidism.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The signs and symptoms of thyrotoxicosis include, but are not limited to: exophthalmic goiter, weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, increased pulse and blood pressure, cardiac arrhythmias, angina pectoris, tremors, insomnia, heat intolerance, fever, and menstrual irregularities.
Excessive doses of L-thyroxine can predispose to signs and symptoms compatible with hyperthyroidism.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.