Liothyronine Sodium 5 ug/1
Liothyronine Sodium · TABLET · Golden State Medical Supply, Inc.
Liothyronine Sodium is a tablet containing liothyronine sodium at 5 ug/1, taken oral. Manufactured by Golden State Medical Supply, Inc..
Key Facts
- Brand Name
- Liothyronine Sodium
- Generic Name
- Liothyronine Sodium
- NDC Code (Product)
51407-384- Manufacturer
- Golden State Medical Supply, Inc.
- Strength
- 5 ug/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090097
- Marketing Start
- 03/20/2009
Recall History
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications
SigmaPharm Laboratories LLC
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications.
Aidapak Services, LLC
Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46414_22, EXP: 5/16/2014; BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD68010_4, EXP: 5/28/2014.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 5 mcg may have potentially been mislabeled as one of the following drugs: LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 00574022201, Pedigree: W003152, EXP: 4/30/2014.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications.
L. Perrigo Co.
Failed Impurities/Degradation Specifications: 3 month stability testing.
Aidapak Services, LLC
Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 5 mcg may be potentially mislabeled as HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 16729018201, Pedigree: AD46414_25, EXP: 5/16/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Liothyronine sodium tablets are an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) Pituitary Thyrotropin (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 Liothyronine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Liothyronine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer liothyronine sodium tablets 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 liothyronine sodium tablets, discontinue levothyroxine therapy and initiate liothyronine sodium tablets 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 liothyronine sodium tablets for hypothyroidism or pituitary Thyroid-Stimulating Hormone (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) …
Contraindications
4 CONTRAINDICATIONS Liothyronine sodium tablets are 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 liothyronine sodium tablets ( 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 liothyronine sodium tablets (see Tables 1 – 4). Table 1: Drugs That May Decrease T3 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of liothyronine sodium tablets 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 liothyronine sodium tablets at least 4 hours prior to these drugs or monitor thyrotropin-stimulating hormon…
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions associated with liothyronine sodium tablets 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 liothyronine sodium tablets are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss,…
Frequently Asked Questions
What is Liothyronine Sodium used for?
Liothyronine Sodium contains Liothyronine Sodium. It is a tablet taken oral. Consult your doctor for specific uses.
Is Liothyronine Sodium a controlled substance?
Liothyronine Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Liothyronine Sodium?
The generic name for Liothyronine Sodium is Liothyronine Sodium. There are 6 other brand versions of Liothyronine Sodium.
What is the NDC code for Liothyronine Sodium 5 ug/1?
The NDC (National Drug Code) for Liothyronine Sodium 5 ug/1 is 51407-384, listed by Golden State Medical Supply, Inc..