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:

Par Pharmaceutical Inc.

INN (International Name):

LEVOTHYROXINE SODIUM ANHYDROUS

Composition:

LEVOTHYROXINE SODIUM ANHYDROUS 200 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 three 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. The container closure is not made with natural rubber latex. Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 451495 Revised: April 2016 OS201J-01-23-01

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM ANHYDROUS INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
PAR PHARMACEUTICAL INC.
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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
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, 200
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
underlying cardiac cond