LEVO-T 125 ug/1

Levothyroxine Sodium · TABLET · Neolpharma, Inc.

No Recall HistoryCurrently in Shortage

Plain English

LEVO-T is a tablet containing levothyroxine sodium at 125 ug/1, taken oral. Manufactured by Neolpharma, Inc..

Key Facts

Brand Name: LEVO-T
Generic Name: Levothyroxine Sodium
NDC Code (Product): 55466-110
Manufacturer: Neolpharma, Inc.
Strength: 125 ug/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA021342
Marketing Start: 10/29/2015

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue7,990 reports

nausea6,985 reports

diarrhoea6,308 reports

headache6,092 reports

dyspnoea6,052 reports

drug ineffective5,203 reports

pain5,105 reports

dizziness4,855 reports

vomiting4,398 reports

asthenia4,218 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE LEVO-T is L-thyroxine (T 4 ) indicated for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. ( 1 ) Limitations of Use: - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Hypothyroidism LEVO-T is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression LEVO-T is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: LEVO-T is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patient…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer once daily, preferably on an empty stomach, one-half to one hour before breakfast. ( 2.1 ) Administer at least 4 hours before or after drugs that are known to interfere with absorption. ( 2.1 ) Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. ( 2.1 ) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medications. Peak therapeutic effect may not be attained for 4-6 weeks. ( 2.2 ) See full prescribing information for dosing in specific patient populations. ( 2.3 ) Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status. ( 2.4 ) 2.1 General Administration Information Take LEVO-T with a full glass of water as the tablet may rapidly disintegrate . Administer LEVO-T as a single daily dose, on an empty stomach, one-half to one hour before breakfast. Administer LEVO-T at least 4 hours before or after drugs known to interfere with LEVO-T absorption [see Drug Interactions (7.1) ] . Evaluate the need for dose adjustments when regularly administering within one hour of ce…

Contraindications

4 CONTRAINDICATIONS LEVO-T is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ] . Uncorrected adrenal 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 LEVO-T. ( 7 ) 7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to LEVO-T (see Tables 2-5 below). Table 2. Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of LEVO-T by binding and delaying or preventing absorption, potentially resulting in hypothyroidism. Drug or Drug Class Effect Calcium Carbonate Ferrous Sulfate Calcium carbonate may form an insoluble chelate with levothyroxine, and ferrous sulfate likely forms a ferric-thyroxine complex. Administer LEVO-T at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and LEVO-T for changes in thyroid function. Bile Acid Sequestrants -Colesevelam …

Adverse Reactions

6 ADVERSE REACTIONS Adverse reactions associated with LEVO-T therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) , 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, muscle spasm 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, rash Endocrine: decreased bone mineral density Reproductive: menstrual irregularities, impaired fertility Seizures have been reported rarely with the institution of levothyroxine therapy. Adverse reactions associated with LEVO-T therapy are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, …

Frequently Asked Questions

What is LEVO-T used for?

LEVO-T contains Levothyroxine Sodium. It is a tablet taken oral. Consult your doctor for specific uses.

Is LEVO-T a controlled substance?

LEVO-T is not classified as a controlled substance by the DEA.

What is the generic name for LEVO-T?

The generic name for LEVO-T is Levothyroxine Sodium. There are 12 other brand versions of Levothyroxine Sodium.

What is the NDC code for LEVO-T 125 ug/1?

The NDC (National Drug Code) for LEVO-T 125 ug/1 is 55466-110, listed by Neolpharma, Inc..

Product NDC

55466-110

Package NDC

55466-110-11

Other Levothyroxine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)