Cytomel (Page 2 of 2)
Adverse Reactions to Cytomel
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 Cytomel (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-thyroidaxis 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 AND 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.
Cytomel (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 to75 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.
Cytomel (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 Cytomel (liothyronine sodium) Tablets from thyroid, L-thyroxine or thyroglobulin, discontinue the other medication, initiate Cytomel 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 Supression 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. 131 I 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.
Cytomel (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. Cytomel (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.
HOW SUPPLIED
Cytomel (liothyronine sodium) Tablets:
5 mcg
| Bottles of 10 | NDC 54868-5058-3 |
| Bottles of 30 | NDC 54868-5058-1 |
| Bottles of 60 | NDC 54868-5058-2 |
| Bottles of 100 | NDC 54868-5058-0 |
25 mcg
| Bottles of 10 | NDC 54868-1750-2 |
| Bottles of 30 | NDC 54868-1750-1 |
| Bottles of 100 | NDC 54868-1750-0 |
Store between 15° and 30°C (59° and 86°F).
Prescribing Information as of March 2004.
Manufactured by: King Pharmaceuticals, Inc., Bristol, TN 37620
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PRINCIPAL DISPLAY PANEL
Cytomel (liothyronine sodium) Tablets
5 mcg
25 mcg
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| Labeler — Physicians Total Care, Inc. (194123980) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Physicians Total Care, Inc. | 194123980 | relabel, repack | |
Revised: 12/2010 Physicians Total Care, Inc.
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