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LEVOXYL®(levothyroxine sodium)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
LEVOXYL® Quick Finder
Highlights
Boxed Warning
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
- Thyroid hormones, including LEVOXYL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.
- ...
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Indications and Usage
1 INDICATIONS AND USAGE
Hypothyroidism
LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal),...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 General Administration Information
Administer LEVOXYL tablets orally as a single daily dose, on an empty stomach, one-half to one hour...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
LEVOXYL tablets are oval, color-coded and, potency marked available as follows:
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Contraindications
4 CONTRAINDICATIONS
Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease
Overtreatment with levothyroxine may...
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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),...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics
Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g., absorption,...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Experience with...
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Overdosage
10 OVERDOSAGE
The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5.4), Adverse Reactions (6)]. In addition,...
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Description
11 DESCRIPTION
LEVOXYL contains the active ingredient, levothyroxine, asynthetic crystalline levothyroxine (T4) in sodium salt form. It is chemically designated as L-3,3',5,5'-tetraiodothyronine monosodium hydrate. Synthetic...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis....
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies have not been performed to evaluate the carcinogenic potential,...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
LEVOXYL (levothyroxine sodium) tablets are oval, color-coded and, potency marked available as follows:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Dosing and...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.