LEVOTHYROXINE SODIUM- levothyroxine sodium anhydrous injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

LEVOTHYROXINE SODIUM ANHYDROUS

Composition:

LEVOTHYROXINE SODIUM ANHYDROUS 100 ug in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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. NOVAPLUS is a registered trademark of Vizient, Inc.   Manufactured by: Fresenius Kabi Lake Zurich, IL 60047 www.fresenius-kabi.us 451419A Revised: June 2017

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM ANHYDROUS INJECTION,
POWDER, LYOPHILIZED,
FOR SOLUTION
FRESENIUS KABI USA, LLC
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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 200
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 und