LIOTHYRONINE SODIUM (Page 2 of 2)

ADVERSE REACTIONS

Adverse reactions, other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period are rare (see OVERDOSAGE).

In rare instances, allergic skin reactions have been reported with liothyronine sodium tablets.

OVERDOSAGE

Signs and Symptoms — Headache, irritability, nervousness, sweating, arrhythmia (including tachycardia), increased bowel motility and menstrual irregularities. Angina pectoris or congestive heart failure may be induced or aggravated. Shock may also develop. Massive overdosage may result in symptoms resembling thyroid storm. Chronic excessive dosage will produce the signs and symptoms of hyperthyroidism.

Treatment Of Overdosage — Dosage should be reduced or therapy temporarily discontinued if signs and symptoms of overdosage appear. Treatment may be reinstituted at a lower dosage. In normal individuals, normal hypothalamic-pituitary-thyroid axis function is restored in 6 to 8 weeks after thyroid suppression.

Treatment of acute massive thyroid hormone overdosage is aimed at reducing gastrointestinal absorption of the drugs and counteracting central and peripheral effects, mainly those of increased sympathetic activity. Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex. Treatment is symptomatic and supportive. Oxygen may be administered and ventilation maintained. Cardiac glycosides may be indicated if congestive heart failure develops. Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed. Antiadrenergic agents, particularly propranolol, have been used advantageously in the treatment of increased sympathetic activity. Propranolol may be administered intravenously at a dosage of 1 to 3 mg over a 10-minute period or orally, 80 to 160 mg/day, especially when no contraindications exist for its use.

DOSAGE & ADMINISTRATION

The dosage of thyroid hormones is determined by the indication and must in every case be individualized according to patient response and laboratory findings.

Liothyronine sodium tablets are intended for oral administration; once-a-day dosage is recommended. Although liothyronine sodium has a rapid cutoff, its metabolic effects persist for a few days following discontinuance.

Mild Hypothyroidism: Recommended starting dosage is 25 mcg daily. Daily dosage then may be increased by up to 25 mcg every 1 or 2 weeks. Usual maintenance dose is 25 to 75 mcg daily.

The rapid onset and dissipation of action of liothyronine sodium (T3), as compared with levothyroxine sodium (T4), has led some clinicians to prefer its use in patients who might be more susceptible to the untoward effects of thyroid medication. However, the wide swings in serum T3 levels that follow its administration and the possibility of more pronounced cardiovascular side effects tend to counterbalance the stated advantages.

Liothyronine sodium tablets may be used in preference to levothyroxine (T4) during radioisotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration. It may also be preferred when impairment of peripheral conversion of T4 to T3 is suspected.

Myxedema: Recommended starting dosage is 5 mcg daily. This may be increased by 5 to 10 mcg daily every 1 or 2 weeks. When 25 mcg daily is reached, dosage may be increased by 5 to 25 mcg every 1 or 2 weeks until a satisfactory therapeutic response is attained. Usual maintenance dose is 50 to 100 mcg daily.

Myxedema Coma: 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.

An intravenous preparation of liothyronine sodium is marketed by JONES PHARMA INCORPORATED, under the trade name Triostat® for use in myxedema coma/precoma.

Congenital Hypothyroidism: Recommended starting dosage is 5 mcg daily, with a 5 mcg increment every 3 to 4 days until the desired response is achieved. Infants a few months old may require only 20 mcg daily for maintenance. At 1 year, 50 mcg daily may be required. Above 3 years, full adult dosage may be necessary (see PRECAUTIONS, Pediatric Use).

Simple (non-toxic) Goiter: Recommended starting dosage is 5 mcg daily. This dosage may be increased by 5 to 10 mcg daily every 1 or 2 weeks. When 25 mcg daily is reached, dosage may be increased every week or two by 12.5 or 25 mcg. Usual maintenance dosage is 75 mcg daily.

In the elderly or in pediatric patients, therapy should be started with 5 mcg daily and increased only by 5 mcg increments at the recommended intervals.

When switching a patient to Liothyronine Sodium tablets from thyroid, L-thyroxine or thyroglobulin, discontinue the other medication, initiate liothyronine sodium at a low dosage, and increase gradually according to the patient’s response. When selecting a starting dosage, bear in mind that this drug has a rapid onset of action, and that residual effects of the other thyroid preparation may persist for the first several weeks of therapy.

Thyroid Suppression Therapy: Administration of thyroid hormone in doses higher than those produced physiologically by the gland results in suppression of the production of endogenous hormone. This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom baseline laboratory tests appear normal or to demonstrate thyroid gland autonomy in patients with Graves’ ophthalmopathy. 131I uptake is determined before and after the administration of the exogenous hormone. A 50% or greater suppression of uptake indicates a normal thyroid-pituitary axis and thus rules out thyroid gland autonomy.

Each 5 mcg tablet contains liothyronine sodium equivalent to 5 mcg of liothyronine. Each 25 mcg tablet contains liothyronine sodium equivalent to 25 mcg of liothyronine. Each 50 mcg tablet contains liothyronine sodium equivalent to 50 mcg of liothyronine.

Liothyronine sodium tablets are given in doses of 75 to 100 mcg/day for 7 days, and radioactive iodine uptake is determined before and after administration of the hormone. If thyroid function is under normal control, the radioiodine uptake will drop significantly after treatment. Liothyronine sodium tablets should be administered cautiously to patients in whom there is a strong suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone effects will be additive to the endogenous source.

PRINCIPAL DISPLAY PANEL

NDC: 51655-122-52

MFG: 42794-020-02

Liothyronine Sodium 50 mcg

30 Tablets

Rx Only

Lot#

Exp. Date:

Each tablet contains liothyroninesodium equivalent to 50 mcg of liothyronine.

Dosage: See prescriber’s instructions.

Store between 59-86 degrees F.

Keep out of reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Mfg by Sigmapharm laboratories, LLC Bensalem, PA 19020 Lot#

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-122-52
(click image for full-size original)
LIOTHYRONINE SODIUM
liothyronine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-122(NDC:42794-020)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIOTHYRONINE SODIUM (LIOTHYRONINE) LIOTHYRONINE 50 ug
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-122-52 30 TABLET in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200295 12/29/2014
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-122)

Revised: 01/2015 Northwind Pharmaceuticals

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