LEVOXYL 200 ug/1
levothyroxine sodium · TABLET · Pfizer Laboratories Div Pfizer Inc
LEVOXYL is a tablet containing levothyroxine sodium at 200 ug/1, taken oral. Manufactured by Pfizer Laboratories Div Pfizer Inc.
Key Facts
- Brand Name
- LEVOXYL
- Generic Name
- levothyroxine sodium
- NDC Code (Product)
60793-860- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Strength
- 200 ug/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA021301
- Marketing Start
- 05/25/2001
Recall History
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Pfizer Inc.
Chemical contamination: emission of strong odor after package was opened.
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Pfizer Inc.
Chemical contamination: emission of strong odor after package was opened.
Pfizer Inc.
Chemical contamination: emission of strong odor after package was opened..
Pfizer Inc.
Superpotent Drug.
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Pfizer Inc.
Chemical contamination: emission of strong odor after package was opened
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 LEVOXYL 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 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 LEVOXYL 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 LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . Limitations of Use : LEVOXYL is not indicated for suppression of benign thyroid nod…
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 LEVOXYL tablets orally as a single daily dose, on an empty stomach, one-half to one hour before breakfast with a full glass of water to avoid choking or gagging [see Adverse Reactions (6) ]. Administer LEVOXYL at least 4 hours before or after dr…
Contraindications
4 CONTRAINDICATIONS Levothyroxine 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 LEVOXYL. ( 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 LEVOXYL (see Tables 2 – 5). Table 2: Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of LEVOXYL 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 LEVOXYL at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and LEVOXYL for changes in thyroid function. Bile Acid Sequestrants -Colesevelam -Cholestyramin…
Adverse Reactions
6 ADVERSE REACTIONS Common adverse reactions with LEVOXYL therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5.4) , 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. Common adverse reactions for LEVOXYL are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increa…
Frequently Asked Questions
What is LEVOXYL used for?
LEVOXYL contains levothyroxine sodium. It is a tablet taken oral. Consult your doctor for specific uses.
Is LEVOXYL a controlled substance?
LEVOXYL is not classified as a controlled substance by the DEA.
What is the generic name for LEVOXYL?
The generic name for LEVOXYL is levothyroxine sodium. There are 12 other brand versions of levothyroxine sodium.
What is the NDC code for LEVOXYL 200 ug/1?
The NDC (National Drug Code) for LEVOXYL 200 ug/1 is 60793-860, listed by Pfizer Laboratories Div Pfizer Inc.
Other Levothyroxine Brands
See all →- Levothyroxine Sodium175 ug/172162-1093
- levothyroxine sodium25 ug/172162-1458
- Levothyroxine Sodium112 ug/172189-605
- Levothyroxine sodium50 ug/10480-8687
- EUTHYROX137 ug/172305-137
- Levothyroxine sodium75 ug/10480-8690
- Levothyroxine sodium200 ug/10480-8722
- Levothyroxine sodium300 ug/10480-8725
- Levothyroxine Sodium88 ug/10527-3283
- Levothyroxine Sodium300 ug/10527-3291
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)