Unithroid 150 ug/1

levothyroxine sodium · TABLET · Amneal Pharmaceuticals LLC

No Recall HistoryCurrently in Shortage

Plain English

Unithroid is a tablet containing levothyroxine sodium at 150 ug/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.

Key Facts

Brand Name: Unithroid
Generic Name: levothyroxine sodium
NDC Code (Product): 60846-809
Manufacturer: Amneal Pharmaceuticals LLC
Strength: 150 ug/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA021210
Marketing Start: 07/03/2014

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Hypothyroidism UNITHROID 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 UNITHROID 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: UNITHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with UNITHROID may induce hyperthyroidism [see Warnings and Precautions ( 5.4 )] . UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. UNITHROID 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 …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer once daily, on an empty stomach, one-half to one hour before breakfast with a full glass of water. ( 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 UNITHROID tablets orally as a single daily dose, on an empty stomach, one-half to one hour before breakfast. Administer UNITHROID at least 4 hours before or after drugs that are known to interfere with UNITHROID absorption [see Drug Interactions …

Contraindications

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

Adverse Reactions

6 ADVERSE REACTIONS Common adverse reactions with UNITHROID 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 Seizures have been reported rarely with levothyroxine therapy. Adverse Reactions in Pediatric Patients Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closur…

Frequently Asked Questions

What is Unithroid used for?

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

Is Unithroid a controlled substance?

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

What is the generic name for Unithroid?

The generic name for Unithroid is levothyroxine sodium. There are 12 other brand versions of levothyroxine sodium.

What is the NDC code for Unithroid 150 ug/1?

The NDC (National Drug Code) for Unithroid 150 ug/1 is 60846-809, listed by Amneal Pharmaceuticals LLC.

Product NDC

60846-809

Package NDC

60846-809-01

Other Levothyroxine Brands

See all →

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

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