Dexamethasone Tablet
FDA Label NDC 81279-117

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pangea Pharmaceuticals, Llc for the product Dexamethasone (NDC 81279-117). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, clinical pharmacology, contraindications, adverse reactions (listed alphabetically, under each subsection), overdosage, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.

Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione.

The structural formula is represented below:

Image (0b2ad1c2 Aa4a 4741 Ae0b 645a3943dd77 01)

Image (0b2ad1c2 Aa4a 4741 Ae0b 645a3943dd77 01)

C 22H 29FO 5 MW 392.47

DEXLYT TM, for oral administration, contains 0.25 mgof dexamethasone.

Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6.

Clinical Pharmacology

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems.

At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

Contraindications

Systemic fungal infections (see WARNINGS, Fungal Infections).

Dexamethasone Tablets are contraindicated in patients who are hypersensitive to any components of these products.

Adverse Reactions (Listed Alphabetically, Under Each Subsection)

The following adverse reactions have been reported with Dexamethasone or other corticosteroids:

Overdosage

Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient's condition, supportive therapy may include gastric lavage or emesis.

How Supplied

DEXLYT TM (dexamethasone) tablets, USP are available as:

0.25 mg tablets scored (orange), debossed "083" and supplied bottles of 60 (NDC 81279-117-60).

Dispense in a tight, light-resistant, child-resistant container as defined in USP.

Store at 20 - 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP controlled Room Temperature].

Manufactured for:
Pangea Pharmaceuticals, LLC
Brielle, NJ 08730

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