Cytomel 5 ug/1

liothyronine sodium · TABLET · Pfizer Laboratories Div Pfizer Inc

No Recall History

Plain English

Cytomel is a tablet containing liothyronine sodium at 5 ug/1, taken oral. Manufactured by Pfizer Laboratories Div Pfizer Inc.

Key Facts

Brand Name: Cytomel
Generic Name: liothyronine sodium
NDC Code (Product): 60793-115
Manufacturer: Pfizer Laboratories Div Pfizer Inc
Strength: 5 ug/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA010379
Marketing Start: 05/08/1956

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective948 reports

headache874 reports

fatigue833 reports

nausea576 reports

dyspnoea554 reports

pain476 reports

hypertension464 reports

malaise439 reports

weight increased436 reports

hypothyroidism429 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CYTOMEL is an L-triiodothyronine (T3) indicated for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) • Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) • Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy ( 1.3 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) 1.1 Hypothyroidism CYTOMEL is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pituitary Thyroid-Stimulating Hormone (TSH) Suppression CYTOMEL is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . 1.3 Thyroid Suppression Test…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Administer CYTOMEL orally once daily and individual dosage according to patient response and laboratory findings ( 2.1 ) • See full prescribing information for recommended dosage for hypothyroidism ( 2.2 ) TSH suppression in well-differentiated thyroid cancer ( 2.3 ) and for thyroid suppression test ( 2.4 ) • When switching a patient to CYTOMEL, discontinue levothyroxine therapy and initiate CYTOMEL at a low dosage. Gradually increase the dose according to the patient's response ( 2.5 ) • Adequacy of therapy determined with periodic monitoring of TSH and T3 levels as well as clinical status ( 2.6 ) 2.1 General Principles of Dosing The dose of CYTOMEL for hypothyroidism or pituitary TSH suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated [see Dosage and Administration (2.2 , 2.3 , 2.4) , Warnings and Precautions (5) , and Drug Interactions (7) ] . Dosing must be individualized to account for these factors and dose adjustments made based on peri…

Contraindications

4 CONTRAINDICATIONS CYTOMEL is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ] . Uncorrected adrenal cortical insufficiency ( 4 )

Drug Interactions

7 DRUG INTERACTIONS See full prescribing information for drugs that 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 CYTOMEL ( 7 ) 7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g. absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to CYTOMEL (see Tables 1 – 4). Table 1: Drugs That May Decrease T3 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of CYTOMEL by binding and delaying or preventing absorption, potentially resulting in hypothyroidism. Drug or Drug Class Effect Bile Acid Sequestrants -Colesevelam -Cholestyramine -Colestipol Ion Exchange Resins -Kayexalate -Sevelamer Bile acid sequestrants and ion exchange resins are known to decrease thyroid hormones absorption. Administer CYTOMEL at least 4 hours prior to these drugs or monitor TSH levels. Table 2: Drugs That May Alter Triiodothyronine (T3) Serum Transport Without Affecting Free Thyroxi…

Adverse Reactions

6 ADVERSE REACTIONS Adverse reactions associated with CYTOMEL therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5.4) and Overdosage (10) ] . They include the following: General : fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system : headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal : tremors, muscle weakness and cramps Cardiovascular : palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory : dyspnea Gastrointestinal : diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic : hair loss, flushing Endocrine : decreased bone mineral density Reproductive : menstrual irregularities, impaired fertility Most common adverse reactions for CYTOMEL are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual i…

Frequently Asked Questions

What is Cytomel used for?

Cytomel contains liothyronine sodium. It is a tablet taken oral. Consult your doctor for specific uses.

Is Cytomel a controlled substance?

Cytomel is not classified as a controlled substance by the DEA.

What is the generic name for Cytomel?

The generic name for Cytomel is liothyronine sodium. There are 12 other brand versions of liothyronine sodium.

What is the NDC code for Cytomel 5 ug/1?

The NDC (National Drug Code) for Cytomel 5 ug/1 is 60793-115, listed by Pfizer Laboratories Div Pfizer Inc.

Product NDC

60793-115

Package NDC

60793-115-01

Other Liothyronine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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