EUTHYROX 137 ug/1

levothyroxine sodium · TABLET · Provell Pharmaceuticals, LLC

No Recall HistoryCurrently in Shortage

Plain English

EUTHYROX is a tablet containing levothyroxine sodium at 137 ug/1, taken oral. Manufactured by Provell Pharmaceuticals, LLC.

Key Facts

Brand Name: EUTHYROX
Generic Name: levothyroxine sodium
NDC Code (Product): 72305-137
Manufacturer: Provell Pharmaceuticals, LLC
Strength: 137 ug/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA021292
Marketing Start: 10/17/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue9,137 reports

nausea7,796 reports

diarrhoea6,992 reports

headache6,877 reports

dyspnoea6,611 reports

dizziness5,584 reports

drug ineffective5,573 reports

pain5,480 reports

asthenia4,956 reports

vomiting4,888 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE EUTHYROX is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement 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. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) Hypothyroidism EUTHYROX is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression EUTHYROX is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer . Limitations of Use: EUTHYROX is not i…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer once daily, 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, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4 to 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 Administer EUTHYROX tablets orally as a single daily dose, on an empty stomach, one-half to one hour before breakfast. Administer EUTHYROX at least 4 hours before or after drugs known to interfere with EUTHYROX absorption [see Drug Interactions (7.1) ]. Evaluate the need for dose ad…

Contraindications

4 CONTRAINDICATIONS EUTHYROX 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 EUTHYROX. ( 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 EUTHYROX (see Tables 2 – 5). Table 2: Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of EUTHYROX 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 EUTHYROX at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and EUTHYROX for changes in thyroid function. Bile Acid Sequestrants -Colesevelam -Cholestyra…

Adverse Reactions

6 ADVERSE REACTIONS Adverse reactions associated with EUTHYROX 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, muscular 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 and 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 levothyroxine therapy. Adverse reactions associated with EUTHYROX are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakne…

Frequently Asked Questions

What is EUTHYROX used for?

EUTHYROX contains levothyroxine sodium. It is a tablet taken oral. Consult your doctor for specific uses.

Is EUTHYROX a controlled substance?

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

What is the generic name for EUTHYROX?

The generic name for EUTHYROX is levothyroxine sodium. There are 11 other brand versions of levothyroxine sodium.

What is the NDC code for EUTHYROX 137 ug/1?

The NDC (National Drug Code) for EUTHYROX 137 ug/1 is 72305-137, listed by Provell Pharmaceuticals, LLC.

Product NDC

72305-137

Package NDC

72305-137-30

Other Levothyroxine Brands

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

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