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 Companies, 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 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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM ANHYDROUS INJECTION,
POWDER, LYOPHILIZED,
FOR SOLUTION
PAR PHARMACEUTICAL COMPANIES, 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
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•
•
DOSAGE FORMS AND STRENGTHS
Lyophilized powder for injection in single use vial: 200 mcg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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•
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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