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LEVOXYL®(levothyroxine sodium)

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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 OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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1 INDICATIONS AND USAGE

Hypothyroidism

LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal),...

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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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3 DOSAGE FORMS AND STRENGTHS

LEVOXYL tablets are oval, color-coded and, potency marked available as follows:

...
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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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6 ADVERSE REACTIONS

Common adverse reactions with LEVOXYL therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see

Adverse Reactions in...

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Experience with...

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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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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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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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16 HOW SUPPLIED/STORAGE AND HANDLING

LEVOXYL (levothyroxine sodium) tablets are oval, color-coded and, potency marked available as follows:

...
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Dosing and...

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This product's label may have been updated. For the current prescribing information, please visit www.pfizer.com.

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