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Triostat (Liothyronine Sodium Injection) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Triostat (liothyronine sodium injection) (T3) is indicated in the treatment of myxedema coma/precoma.

Triostat can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.

DOSAGE AND ADMINISTRATION

Adults

Myxedema coma is usually precipitated in the hypothyroid patient of long standing by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency. Therapy should be directed at the correction of electrolyte disturbances, possible infection, or other intercurrent illness in addition to the administration of intravenous liothyronine (T3). Simultaneous glucocorticosteroids are required.

Triostat (liothyronine sodium injection) (T3) is for intravenous administration only. It should not be given intramuscularly or subcutaneously.

  • Prompt administration of an adequate dose of intravenous liothyronine (T3) is important in determining clinical outcome.

  • Initial and subsequent doses of Triostat should be based on continuous monitoring of the patient's clinical status and response to therapy.

  • Triostat doses should normally be administered at least four hours–and not more than 12 hours–apart.

  • Administration of at least 65 mcg/day of intravenous liothyronine (T3) in the initial days of therapy was associated with lower mortality.

  • There is limited clinical experience with intravenous liothyronine (T3) at total daily doses exceeding 100 mcg/day.

No controlled clinical studies have been done with Triostat. The following dosing guidelines have been derived from data analysis of myxedema coma/precoma case reports collected by SmithKline Beecham Pharmaceuticals since 1963 and from scientific literature since 1956.

An initial intravenous Triostat dose ranging from 25 mcg to 50 mcg is recommended in the emergency treatment of myxedema coma/precoma in adults. In patients with known or suspected cardiovascular disease, an initial dose of 10 mcg to 20 mcg is suggested (see WARNINGS). However, both the initial dose and subsequent doses should be determined on the basis of continuous monitoring of the patient's clinical condition and response to Triostat therapy. Normally at least four hours should be allowed between doses to adequately assess therapeutic response and no more than 12 hours should elapse between doses to avoid fluctuations in hormone levels. Caution should be exercised in adjusting the dose due to the potential of large changes to precipitate adverse cardiovascular events. Review of the myxedema case reports indicates decreased mortality in patients receiving at least 65 mcg/day in the initial days of treatment. However, there is limited clinical experience at total daily doses above 100 mcg. See PRECAUTIONS–Drug Interactions for potential interactions between thyroid hormones and digitalis and vasopressors.

Pediatric Use

There is limited experience with Triostat in the pediatric population. Safety and effectiveness in pediatric patients have not been established.

Switching to Oral Therapy

Oral therapy should be resumed as soon as the clinical situation has been stabilized and the patient is able to take oral medication. When switching a patient to liothyronine sodium tablets from Triostat, discontinue Triostat, initiate oral therapy at a low dosage, and increase gradually according to the patient's response.

If L-thyroxine rather than liothyronine sodium is used in initiating oral therapy, the physician should bear in mind that there is a delay of several days in the onset of L-thyroxine activity and that intravenous therapy should be discontinued gradually.

HOW SUPPLIED

The 1 mL vial at a concentration of 10 mcg/mL is available as follow:

NDC 42023-120-01-Single-Use Vial- Pack of 1

NDC 42023-120-06-Single-Use Vials- Pack of 6

Store between 2° and 8°C (36° and 46°F).

Rx Only.

Prescribing Information as of August 2012.

Manufactured and Distributed by:
JHP Pharmaceuticals, LLC
Rochester, MI 48307

3000813D

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