Levothyroxine (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Black Box Warning
WARNING:
See full prescribing information for complete Boxed Warning.
* NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including Levothyroxine Sodium for Injection , should not be used for the treatment of obesity or for weight loss.
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Overview
Levothyroxine (injection) is a {{{drugClass}}} that is FDA approved for the treatment of myxedema coma. There is a Black Box Warning for this drug as shown here. Common adverse reactions include weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, insomnia and fever.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- 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.
Dosage
- An initial intravenous loading dose of Levothyroxine Sodium for Injection between 300 to 500 mcg, followed by once daily intravenous maintenance doses between 50 and 100 mcg, should be administered, as clinically indicated, until the patient can tolerate oral therapy. The age, general physical condition, cardiac risk factors, and clinical severity of myxedema and duration of myxedema symptoms should be considered when determining the starting and maintenance dosages of Levothyroxine Sodium for Injection.
- Levothyroxine Sodium for Injection produces a gradual increase in the circulating concentrations of the hormone with an approximate half-life of 9 to 10 days in hypothyroid patients. Daily administration of Levothyroxine Sodium for Injection should be maintained until the patient is capable of tolerating an oral dose and is clinically stable. For chronic treatment of hypothyroidism, an oral dosage form of levothyroxine should be used to maintain a euthyroid state. Relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Based on medical practice, the relative bioavailability between oral and intravenous administration of Levothyroxine Sodium for Injection is estimated to be from 48 to 74%. Due to differences in absorption characteristics of patients and the oral levothyroxine product formulations, TSH and thyroid hormone levels should be measured a few weeks after initiating oral levothyroxine and dose adjusted accordingly.
Dosing in the Elderly and in Patients with Cardiovascular Disease
- Intravenous levothyroxine may be associated with cardiac toxicity—including arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death—in the elderly and in those with underlying cardiovascular disease. Therefore, cautious use, including doses in the lower end of the recommended range, may be warranted in these populations.
Reconstitution Directions
- Reconstitute the lyophilized Levothyroxine Sodium for Injection by aseptically adding 5 mL of 0.9% Sodium Chloride Injection, USP only. Shake vial to ensure complete mixing. The resultant solution will have a final concentration of approximately 20 mcg per mL, 40 mcg per mL and and 100 mcg per mL for the 100 mcg, 200 mcg and 500 mcg vials, respectively. Reconstituted drug product is preservative free and is stable for 4 hours. Discard any unused portion. DO NOT ADD LEVOTHYROXINE SODIUM FOR INJECTION TO OTHER IV FLUIDS. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Levothyroxine (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Levothyroxine (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Levothyroxine (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Levothyroxine (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Levothyroxine (injection) in pediatric patients.
Contraindications
There is limited information regarding Levothyroxine (injection) Contraindications in the drug label.
Warnings
WARNING:
See full prescribing information for complete Boxed Warning.
* NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including Levothyroxine Sodium for Injection , should not be used for the treatment of obesity or for weight loss.
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There is limited information regarding Levothyroxine (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Levothyroxine (injection) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Levothyroxine (injection) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Levothyroxine (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Levothyroxine (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Levothyroxine (injection) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Levothyroxine (injection) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Levothyroxine (injection) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Levothyroxine (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Levothyroxine (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Levothyroxine (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Levothyroxine (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Levothyroxine (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Levothyroxine (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Levothyroxine (injection) in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Levothyroxine (injection) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Levothyroxine (injection) in the drug label.
Pharmacology
There is limited information regarding Levothyroxine (injection) Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Levothyroxine (injection) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Levothyroxine (injection) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Levothyroxine (injection) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Levothyroxine (injection) in the drug label.
How Supplied
Storage
There is limited information regarding Levothyroxine (injection) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Levothyroxine (injection) in the drug label.
Precautions with Alcohol
- Alcohol-Levothyroxine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- LEVOTHYROXINE SODIUM®[1]
Look-Alike Drug Names
There is limited information regarding Levothyroxine (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.