LEVOXYL® How Supplied/Storage and Handling (levothyroxine sodium) | Pfizer Medical Information - US

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16 HOW SUPPLIED/STORAGE AND HANDLING

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

Strength (mcg)	Color	Tablet Markings	NDC - bottles of 100	NDC - bottles of 1000
25	Orange	25	60793-850-01	60793-850-10
50	White	50	60793-851-01	60793-851-10
75	Purple	75	60793-852-01	60793-852-10
88	Olive	88	60793-853-01	60793-853-10
100	Yellow	100	60793-854-01	60793-854-10
112	Rose	112	60793-855-01	60793-855-10

125	Light Brown	125	60793-856-01	60793-856-10
137	Dark Blue	137	60793-857-01	60793-857-10
150	Blue	150	60793-858-01	60793-858-10
175	Turquoise	175	60793-859-01	60793-859-10
200	Pink	200	60793-860-01	60793-860-10

STORAGE CONDITIONS

Store between 68°F–77°F (20°C–25°C) with excursions permitted between 59°F–86°F (15°C–30°C). Store LEVOXYL away from heat, moisture, and light.

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.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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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4 CONTRAINDICATIONS

Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].

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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 Warnings and Precautions (5.4),...

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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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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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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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To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

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.