Country: United States
Language: English
Source: NLM (National Library of Medicine)
Levothyroxine Sodium Anhydrous (UNII: 054I36CPMN) (Levothyroxine - UNII:Q51BO43MG4)
Par Pharmaceutical Companies, Inc.
Levothyroxine Sodium Anhydrous
Levothyroxine Sodium Anhydrous 200 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 non-treatment 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 n
Levothyroxine Sodium for Injection is available in three dosage strengths. NDC 42023-161-01: 200 mcg in a single use vial individually packaged. Reconstituted concentration is 40 mcg/mL. Protect from light and store unreconstituted product between 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.
Abbreviated New Drug Application
LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PAR PHARMACEUTICAL COMPANIES, INC. ---------- 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 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. DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Lyophilized powder for injection in single use vial: 200 mcg. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS EXCESSIVE DOSES OF L-THYROXINE CAN PREDISPOSE TO SIGNS AND SYMPTOMS COMPATIBLE WITH HYPERTHYROIDISM. (6)FOR MEDICAL ADVICE ABOUT ADVERSE REACTIONS CONTACT YOUR MEDICAL PROFESSIONAL. TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PAR PHARMACEUTICAL, INC. AT 1-800-828-9393 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.G O V/MEDWATCH. DRUG INTERACTIONS Many drugs 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 Levothyroxine Sodium for Injection. (7, 12.3) USE IN SPECIFIC POPULATIONS • 4 An initial intravenous loading dose of Levothyroxine Sodium for Injection between 300 to 500 mcg followed by once daily intravenous maintena Read the complete document