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news.Fresenius Kabi has announced tthe immediate availability in the US of Levothyroxine Sodium Injection Solution in 100mcg per 5mL, 200 mcg per 5mL and 500mcg per 5mL single-dose vials.
Image: Fresenius Kabi Levothyroxine Sodium Injection is the first FDA-approved solution presentation available in the US. Photo: courtesy of Business Wire.
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Fresenius Kabi Levothyroxine Sodium Injection is the first-and-only FDA-approved solution formulation for this medicine available in the U.S.
Fresenius Kabi also sells Levothyroxine Sodium for Injection as a lyophilized powder in 100 mcg, 200 mcg and 500 mcg per 5 mL vial presentations.
“Fresenius Kabi is pleased to continue to increase the number of products we offer to help care for patients with critical illnesses, including life-threatening thyroid conditions,” said John Ducker, president and CEO of Fresenius Kabi USA. “This new liquid formulation of Levothyroxine promotes safe medication practices and operational efficiency by eliminating the need for reconstitution.”
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
Levothyroxine Sodium Injection is L-thyroxine (T4) indicated in adult patients for the treatment of myxedema coma.
Limitations of Use:
Not recommended as a substitute for oral levothyroxine sodium because the relative bioavailability of Levothyroxine Sodium Injection to oral levothyroxine sodium has not been established and there is a risk of inaccurate dose conversion.
Levothyroxine Sodium Injection is contraindicated in uncorrected adrenal insufficiency.
Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease: Overtreatment may cause arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death, particularly in patients with cardiovascular disease and in elderly patients. Start with lower doses in elderly patients and in patients with underlying cardiovascular disease and monitor patients after administration.
Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency: Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment.
Worsening of Diabetic Control: May worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control.
Adverse reactions associated with Levothyroxine Sodium Injection are primarily those of hyperthyroidism due to therapeutic overdosage: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating, headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia, tremors, muscle weakness, muscle spasm, palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest, dyspnea, diarrhea, vomiting, abdominal cramps, elevations in liver function tests, flushing and rash.
Source: Company Press Release
