Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4)
Fresenius Kabi USA, LLC
LEVOTHYROXINE SODIUM ANHYDROUS
LEVOTHYROXINE SODIUM ANHYDROUS 100 ug in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
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. None. Pregnancy Category A – There are no reported cases of Levothyroxine Sodium for Injection used to treat myxedema coma in patients who were pregnant or lactating. Studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities. Therefore, pregnant patients who develop myxedema should be treated with Levothyroxine Sodium for Injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. Patients in labor who develop myxedema have
Levothyroxine Sodium for Injection is available in two dosage strengths. Protect from light and store dry product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Reconstituted drug product is preservative free. Discard any unused portion. This container closure is not made with natural rubber latex. PREMIERProRx ® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.
New Drug Application
LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FRESENIUS KABI USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVOTHYROXINE SODIUM FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOTHYROXINE SODIUM FOR INJECTION. LEVOTHYROXINE SODIUM FOR INJECTION, FOR INTRAVENOUS USE. INITIAL U.S. APPROVAL: 1969 WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS THYROID HORMONES, INCLUDING LEVOTHYROXINE SODIUM FOR INJECTION, SHOULD NOT BE USED FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS. ( 5.3) LARGER DOSES MAY PRODUCE SERIOUS OR EVEN LIFE THREATENING MANIFESTATIONS OF TOXICITY. ( 6) INDICATIONS AND USAGE Levothyroxine Sodium is an L-thyroxine product. Levothyroxine (T ) 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. ( 1) DOSAGE AND ADMINISTRATION An initial intravenous loading dose of Levothyroxine Sodium for Injection between 300 to 500 mcg followed by once daily intravenous maintenance doses between 50 and 100 mcg should be administered, as clinically indicated, until the patient can tolerate oral therapy. ( 2.1) Reconstitute the lyophilized Levothyroxine Sodium for Injection by aseptically adding 5 mL of 0.9% Sodium Chloride Injection, USP. Shake vial to ensure complete mixing. Reconstituted drug product is preservative free. Use immediately after reconstitution. Discard any unused portion. ( 2.3) Do not add to other IV fluids. ( 2.3) DOSAGE FORMS AND STRENGTHS Lyophilized powder for injection in single dose vials: 100 mcg and 500 mcg. ( 3) CONTRAINDICATIONS None. ( 4) WARNINGS AND PRECAUTIONS Excessive bolus doses of Levothyroxine Sodium for Injection (> 500 mcg) are associated with cardiac complications, particularly in the elderly and in patients with an unde read_full_document