Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied.
None.
Thyroid hormones, including Levothyroxine Sodium for Injection, should not be used for the treatment of obesity or for weight loss. ( 5.3 ) Larger doses may produce serious or even life threatening manifestations of toxicity. ( 6 )
None.
Levothyroxine Sodium for Injection is supplied as a lyophilized powder at three strengths in single dose amber-colored vials: 100 mcg, 200 mcg and 500 mcg.
In general, the signs and symptoms of overdosage with levothyroxine are those of hyperthyroidism [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Excessive doses of Levothyroxine Sodium for Injection (greater than 500 mcg) are associated with cardiac complications in patients with underlying cardiac disease. Treatment of Overdosage Levothyroxine Sodium for Injection should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur. To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.
NDC 83270-006-01 Levothyroxine Sodium for Injection 100 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only NDC 83270-006-01 Levothyroxine Sodium for Injection 100 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only OneSource
NDC 83270-007-01 Levothyroxine Sodium for Injection 200 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only NDC 83270-007-01 Levothyroxine Sodium for Injection 200 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only OneSource
NDC 83270-008-01 Levothyroxine Sodium for Injection 500 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only NDC 83270-008-01 Levothyroxine Sodium for Injection 500 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only OneSource
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 97c252d3-9bb8-4530-bb44-9824dc7cf556 | Product name | 6 | 20250729 |
| 6c43b71c-35e6-4db3-ba24-c6ef42ff7003 | Product name | 3 | 20240207 |
| 890fd4bf-1a80-42b7-be1b-2d0259d5f0c8 | Product name | 5 | 20240207 |
| c8ad26bf-af73-460b-b74e-1eff16cc4f9f | Product name | 5 | 20240207 |
| 01383843-4069-43cf-aa76-dc17a6f9f8c4 | Product name | 2 | 20230123 |
| 978cca7d-a938-4791-8322-da48d90a63ef | Product name | 1 | 20230113 |
| 65f86ba3-8816-4e12-899b-18290c8de551 | Product name | 2 | 20210614 |
| f16ab90f-08c2-40be-a543-66d9827cd1f3 | Product name | 1 | 20210601 |
| 6a33ec05-2ae2-45e5-ab82-2d94b3303923 | Product name | 1 | 20190709 |
| 93355a10-1c44-4c92-a11d-7d995e0200d9 | Product name | 1 | 20190219 |
Thyroid hormones, including Levothyroxine Sodium for Injection, should not be used for the treatment of obesity or for weight loss. ( 5.3 ) Larger doses may produce serious or even life threatening manifestations of toxicity. ( 6 )
Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied.
Levothyroxine Sodium for Injection is supplied as a lyophilized powder at three strengths in single dose amber-colored vials: 100 mcg, 200 mcg and 500 mcg.
None.
Excessive doses of levothyroxine can predispose to signs and symptoms compatible with hyperthyroidism. The signs and symptoms of thyrotoxicosis include, but are not limited to: exophthalmic goiter, weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, increased pulse and blood pressure, cardiac arrhythmias, angina pectoris, tremors, insomnia, heat intolerance, fever, and menstrual irregularities.
Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium for Injection. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs (see Section 12.3 ).
In general, the signs and symptoms of overdosage with levothyroxine are those of hyperthyroidism [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Excessive doses of Levothyroxine Sodium for Injection (greater than 500 mcg) are associated with cardiac complications in patients with underlying cardiac disease. Treatment of Overdosage Levothyroxine Sodium for Injection should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur. To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.
Levothyroxine Sodium for Injection contains synthetic crystalline levothyroxine (L-thyroxine) sodium salt. Levothyroxine sodium has an empirical formula of C 15 H 10 I 4 NNaO 4 , a molecular weight of 798.85 g/mol (anhydrous), and the following structural formula: Levothyroxine Sodium for Injection is a sterile, preservative-free lyophilized powder consisting of the active ingredient, levothyroxine sodium, and the excipients dibasic sodium phosphate heptahydrate, USP; mannitol, USP; and sodium hydroxide, NF in single dose amber glass vials. Levothyroxine Sodium for Injection is available at three dosage strengths: 100 mcg per vial, 200 mcg per vial and 500 mcg per vial.
No clinical studies have been conducted with Levothyroxine Sodium for Injection in patients with myxedema coma. However, data from published literature support the intravenous use of levothyroxine sodium for the treatment of myxedema coma.
NDC 83270-006-01 Levothyroxine Sodium for Injection 100 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only NDC 83270-006-01 Levothyroxine Sodium for Injection 100 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only OneSource
NDC 83270-007-01 Levothyroxine Sodium for Injection 200 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only NDC 83270-007-01 Levothyroxine Sodium for Injection 200 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only OneSource
NDC 83270-008-01 Levothyroxine Sodium for Injection 500 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only NDC 83270-008-01 Levothyroxine Sodium for Injection 500 mcg per vial For Intravenous Use Single Dose Vial Discard any unused portion Rx only OneSource
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-05-26 | full-release | 2026-05-31 21:40:18 |