Levothyroxine Sodium 300 ug/1
Levothyroxine Sodium · TABLET · Lannett Company, Inc
Levothyroxine Sodium is a tablet containing levothyroxine sodium at 300 ug/1, taken oral. Manufactured by Lannett Company, Inc.
Key Facts
- Brand Name
- Levothyroxine Sodium
- Generic Name
- Levothyroxine Sodium
- NDC Code (Product)
0527-3291- Manufacturer
- Lannett Company, Inc
- Strength
- 300 ug/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA021342
- Marketing Start
- 08/03/2020
Recall History
Viatris Inc
Superpotent Drug and Subpotent Drug: potency failures obtained
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Alvogen, Inc
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Aidapak Services, LLC
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD60272_70, EXP: 5/22/2014.
IBSA PHARMA INC
Subpotent Drug
ACCORD HEALTHCARE, INC.
Subpotent
IBSA PHARMA INC
Subpotent Drug
King Legacy, a wholly owned subsidiary of Pfizer
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Lloyd Inc. of Iowa
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Lloyd Inc. of Iowa
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
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 Levothyroxine sodium tablets are 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 Levothyroxine sodium tablets are 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 Levothyroxine sodium tablets are 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 levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions (5.1) ]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablets are a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer once daily, preferably 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) 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 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 Important Administration Instructions Administer levothyroxine sodium tablets 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 levothyroxine sodium tablets at least…
Contraindications
4 CONTRAINDICATIONS Levothyroxine sodium tablets are 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 levothyroxine sodium. (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 levothyroxine sodium (Tables 5 to 8). Table 5. Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of levothyroxine sodium 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 levothyroxine sodium tablets at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and levothyroxine sodium for changes in thyroid function. Bi…
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions associated with levothyroxine sodium 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 craniosyno…
Frequently Asked Questions
What is Levothyroxine Sodium used for?
Levothyroxine Sodium contains Levothyroxine Sodium. It is a tablet taken oral. Consult your doctor for specific uses.
Is Levothyroxine Sodium a controlled substance?
Levothyroxine Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Levothyroxine Sodium?
The generic name for Levothyroxine Sodium is Levothyroxine Sodium. There are 6 other brand versions of Levothyroxine Sodium.
What is the NDC code for Levothyroxine Sodium 300 ug/1?
The NDC (National Drug Code) for Levothyroxine Sodium 300 ug/1 is 0527-3291, listed by Lannett Company, Inc.