LEVOTHYROXINE SODIUM injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Piramal Critical Care, Inc.

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. 8.1 Pregnancy 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. 8.2 Labor and Delivery Patients in labor who develop myxedema have not been reported in the literature. However, patients 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. 8.3 Nursing Mothers Adequate replacement doses of thyroid hormones are required to maintain normal lactation. There are no reported cases of Levothyroxine Sodium for Injection used to treat myxedema coma in patients who are lactating. However, such patients 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 nursing patient. 8.4 Pediatric Use Myxedema coma is a disease of the elderly. An approved, oral dosage form of levothyroxine should be used in the pediatric patient population for maintaining a euthyroid state in non-complicated hypothyroidism. 8.5 Geriatric Use and Patients with Underlying Cardiovascular Disease See Section 2, Dosage and Administration, for full prescribing information in the geriatric patient population. Because of the increased prevalence of cardiovascular disease in the elderly, cautious use of Levothyroxine Sodium for Injection in the elderly and in patients with known cardiac risk factors is advised. Atrial fibrillation is a common side effect associated with levothyroxine treatment in the elderly [ See Dosage and Administration ( 2) and Warnings and Precautions ( 5) ].

Product summary:

16.1 How Supplied Levothyroxine Sodium for Injection is available in two dosage strengths. Strength Reconstitution Concentration NDC No. 100 mcg/vial 20 mcg/mL 66794-200-02 500 mcg/vial 100 mcg/mL 66794-201-02 16.2 Storage and Handling 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. Distributed by: Piramal Critical Care, Inc. Bethlehem, PA 18017, USA Issued: 05/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM INJECTION
PIRAMAL CRITICAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
LEVOTHYROXINE SODIUM FOR INJECTION
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.
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