Dexamethasone Tablets 4mg 100/Bottle

NDC: 72578-171-01

Dexamethasone Tablets USP, 4 mg, 100 count — Viona Pharmaceuticals

Active ingredient	Dexamethasone 4 mg
Dosage form	Tablet
Route	Oral
Size	100 tablets per bottle
Manufacturer	Viona Pharmaceuticals
NDC	72578-171-01

Indications and Usage

A synthetic corticosteroid indicated for its anti-inflammatory and immunosuppressive effects in a wide range of allergic, dermatologic, endocrine, hematologic, ophthalmic, and rheumatic conditions, as well as cerebral edema and palliative management of certain leukemias and lymphomas.

Dosage and Administration

Initial dosage ranges from 0.75 mg to 9 mg per day depending on the condition being treated, individualized to the disease and the patient's response. After a favorable response, the dose should be tapered gradually to the lowest effective maintenance level; abrupt discontinuation after prolonged use should be avoided.

Warnings and Precautions

• May cause hypothalamic-pituitary-adrenal (HPA) axis suppression; withdraw gradually after prolonged use
• Increases susceptibility to infection and may mask or worsen existing fungal, viral, or bacterial infections
• Prolonged use may cause fluid retention, elevated blood pressure, cataracts, glaucoma, GI perforation, osteoporosis, and psychiatric disturbances

Contraindications

Contraindicated in systemic fungal infections and in patients hypersensitive to any component of this preparation.

Adverse Reactions

Common reactions include fluid retention, hypertension, hyperglycemia, increased appetite, mood changes, and impaired wound healing; prolonged use may lead to osteoporosis, cushingoid features, cataracts, and increased infection risk.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in a tight, light-resistant, child-resistant container.

How Supplied

Off-white to light green, round tablets debossed "1736," supplied in bottles of 100.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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