Dexamethasone

INDICATIONS AND USAGE Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Atopic dermatitis, Bronchial asthma, Contact dermatitis, Drug hypersensitivity reactions, Seasonal or perennial allergic rhinitis, and Serum sickness. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus, and Acute rheumatic carditis. Dermatologic Diseases Bullous dermatitis herpetiformis, Exfoliative dermatitis, Mycosis fungoides, Pemphigus, Severe erythema multiforme (Stevens-Johnson syndrome), Severe psoriasis, and Severe seborrheic dermatitis. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, and Nonsuppurative thyroiditis. Gastrointestinal diseases To tide the patient over a critical period of the disease in: Ulcerative colitis, and Regional enteritis. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia in adults, Acquired (autoimmune) hemolytic anemia, Erythroblastopenia (RBC anemia), and Congenital (erythroid) hypoplastic anemia. Miscellaneous Diagnostic testing of adrenocortical hyperfunction, Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, and Trichinosis with neurologic or myocardial involvement. Neoplastic Diseases For palliative management of: Leukemia and lymphomas in adults, and Acute leukemia of childhood. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: Allergic conjunctivitis, Keratitis, Allergic corneal marginal ulcers, Herpes zoster ophthalmicus, Iritis and iridocyclitis, Chorioretinitis, Anterior segment inflammation, Diffuse posterior uveitis and choroiditis, Optic neuritis, and Sympathetic ophthalmia. Respiratory Diseases Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, Berylliosis, Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, and Aspiration pneumonitis. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis, Acute and subacute bursitis, Acute nonspecific tenosynovitis, Acute gouty arthritis, Post-traumatic osteoarthritis, Synovitis of osteoarthritis, and Epicondylitis.

DOSAGE & ADMINISTRATION For oral administration: DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT. The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.75 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient’s response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue Dexamethasone Elixir and transfer the patient to other therapy. After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily. If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually. The following milligram equivalents facilitate changing to Dexamethasone Elixir from other glucocorticoids: Dexamethasone Elixir Methylprednisolone and Triamcinolone Prednisolone and Prednisone Hydrocortisone Cortisone 0.75 mg = 4 mg = 5 mg = 20 mg = 25 mg Dexamethasone suppression tests 1. Tests for Cushing’s syndrome. Give 1 mg of Dexamethasone orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. 2. Test to distinguish Cushing’s syndrome due to pituitary ACTH excess from Cushing’s syndrome due to other causes. Give 2 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

CONTRAINDICATIONS Contraindicated in patients with known systemic fungal infections (See WARNINGS : Infections: Fungal Infections ) and patients with a known sensitivity to this drug.

ADVERSE REACTIONS Fluid and Electrolyte Disturbances: Sodium retention, Fluid retention, Congestive heart failure in susceptible patients, Potassium loss, Hypokalemic alkalosis, and Hypertension. Musculoskeletal: Muscle weakness, Steroid myopathy, Loss of muscle mass, Osteoporosis, Vertebral compression fractures, Aseptic necrosis of femoral and humeral heads, Pathologic fracture of long bones, Tendon rupture. Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease, Pancreatitis, Abdominal distention, and Ulcerative esophagitis. Dermatologic: Impaired wound healing, Thin fragile skin, Petechiae and ecchymoses, Erythema, Increased sweating, May suppress reactions to skin tests, Other cutaneous reactions, such as allergic dermatitis, urticaria, and angioneurotic edema. Neurologic: Convulsions, Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, Vertigo, Headache, and Psychic disturbances. Endocrine: Menstrual irregularities, Development of cushingoid state, Suppression of growth in children, Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness, Decreased carbohydrate tolerance, Manifestations of latent diabetes mellitus, Increased requirements for insulin or oral hypoglycemic agents in diabetics, and Hirsutism. Ophthalmic: Posterior subcapsular cataracts, Increased intraocular pressure, Glaucoma, and Exophthalmos. Metabolic: Negative nitrogen balance due to protein catabolism Cardiovascular: Myocardial rupture following recent myocardial infarction (see WARNINGS ) Other: Hypersensitivity, Thromboembolism, Weight gain, Increased appetite, Nausea, Malaise, and Hiccups. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION Each 5 mL (teaspoonful) contains: Dexamethasone, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg Also contains: Benzoic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.1% (as preservative) Alcohol (% v/v) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1% Inactive Ingredients: artificial raspberry flavor; citric acid; FD&C red no. 40; sucrose; propylene glycol and purified water. It may also contain sodium citrate dihydrate. 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. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C 22 H 29 FO 5 and the structural formula is: structure

OVERDOSAGE Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic. The oral LD 50 of dexamethasone in female mice was 6 . 5 g/kg.

HOW SUPPLIED Dexamethasone Elixir, USP 0.5 mg/5 mL is supplied as a clear, red, raspberry-flavored liquid in the following size: 8 fl oz (237 mL) bottle (NDC 64980-509-24) RECOMMENDED STORAGE Store at 20 ̊-25 ̊C (68 ̊-77 ̊F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight container as defined in the USP. Rx Only Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 Revised : 08/2025 PIR50924-00 Each 5 mL (teaspoonful) contains: Dexamethaosne, USP....................................................................................................0.5 mg Also contains: Benzoic Acid, USP (as preservative)................................................................................0.1% Alcohol (%v/v)............................................................................................................5.1% USUAL ADULT DOSAGE: See accompanying package insert. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Store at 20o – 25oC (68o – 77oF) [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight container as defined in the USP. Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 Revised: 08/2025 LR50924-00