Synthroid 100 ug/1
Levothyroxine Sodium · TABLET · AbbVie Inc.
Synthroid is a tablet containing levothyroxine sodium at 100 ug/1, taken oral. Manufactured by AbbVie Inc..
Key Facts
- Brand Name
- Synthroid
- Generic Name
- Levothyroxine Sodium
- NDC Code (Product)
0074-6624- Manufacturer
- AbbVie Inc.
- Strength
- 100 ug/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA021402
- Marketing Start
- 07/24/2002
Recall History
Abbott Laboratories
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Abbott Laboratories
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Abbott Laboratories
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
AbbVie Inc.
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Abbott Laboratories
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
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 Hypothyroidism SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid -Stimulating Hormone, TSH) Suppression SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use SYNTHROID 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 SYNTHROID may induce hyperthyroidism [see Warnings and Precautions ( 5.1 )]. SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. SYNTHROID is a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) Pituitary Thyrotropin (…
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 ) Advise patients to stop biotin and biotin-containing supplements at least 2 days before assessing TSH and/or T4 levels. ( 2.2 ) 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 Important Administration Instructions Administer SYNTHROID as a single daily dose, on an empty stomach, one-half to one hour before breakfast. Administer SYNTHROID at least 4 hours before or after drugs known to interfere with SYNTHROID absorption [see Drug Interactions ( 7.1 ) ] . Evaluate the need for dosag…
Contraindications
4 CONTRAINDICATIONS SYNTHROID is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions ( 5.4 ) ] . 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 SYNTHROID. ( 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 SYNTHROID ( Tables 5 to 8 ). Table 5. Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of SYNTHROID by binding and delaying or preventing absorption, potentially resulting in hypothyroidism. Drug or Drug Class Effect Phosphate Binders (e.g., calcium carbonate, ferrous sulfate, sevelamer, lanthanum) Phosphate binders may bind to levothyroxine. Administer SYNTHROID at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and SYNTHROID for changes in thyroid function. Bile Acid Sequestrants (e.g., colesevelam, cholestyramine, co…
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions associated with SYNTHROID therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions ( 5 ) 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, 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 in Pediatric Patients Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Overtreatment may result in craniosynostosis…
Frequently Asked Questions
What is Synthroid used for?
Synthroid contains Levothyroxine Sodium. It is a tablet taken oral. Consult your doctor for specific uses.
Is Synthroid a controlled substance?
Synthroid is not classified as a controlled substance by the DEA.
What is the generic name for Synthroid?
The generic name for Synthroid is Levothyroxine Sodium. There are 12 other brand versions of Levothyroxine Sodium.
What is the NDC code for Synthroid 100 ug/1?
The NDC (National Drug Code) for Synthroid 100 ug/1 is 0074-6624, listed by AbbVie 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)