DailyMed Label: Baycadron

DailyMed Label: Baycadron

2009

DailyMed Prescription

Baycadron

Dexamethasone

Wockhardt USA, LLC

NDC: 64679-810

NDC: 64679-810

Each 5 mL (teaspoonful) contains: Dexamethasone, USP……….……….…………………………. 0.5 mg Also contains: Benzoic Acid, USP……………………………………………….. 0.1%   (as preservative) Alcohol……………………………………………………………. 5.1% Inactive Ingredients: Artificial Raspberry Flavor; Citric Acid, USP; FD&C Red No. 40; Liquid Sugar; Propylene Glycol, USP and Purified Water, USP. It may also contain Sodium Citrate, USP. 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: Chemical Structure

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   Nonsuppurative thyroiditis   Hypercalcemia associated with cancer 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   Epicondylitis During an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus   Acute rheumatic carditis Pemphigus   Bullous dermatitis herpetiformis   Severe erythema multiforme (Stevens-Johnson syndrome)   Exfoliative dermatitis   Mycosis fungoides   Severe psoriasis   Severe seborrheic dermatitis Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:   Seasonal or perennial allergic rhinitis   Bronchial asthma   Contact dermatitis   Atopic dermatitis   Serum sickness   Drug hypersensitivity reactions 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   Sympathetic ophthalmia Symptomatic sarcoidosis   Loeffler's syndrome not manageable by other means   Berylliosis   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy   Aspiration pneumonitis Idiopathic thrombocytopenic purpura in adults   Secondary thrombocytopenia in adults   Acquired (autoimmune) hemolytic anemia   Erythroblastopenia (RBC anemia)   Congenital (erythroid) hypoplastic anemia For palliative management of:   Leukemia and lymphomas in adults   Acute leukemia of childhood To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus To tide the patient over a critical period of the disease in:   Ulcerative colitis   Regional enteritis Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy   Trichinosis with neurologic or myocardial involvement

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 Baycadron™ 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 Baycadron™ Elixir from other glucocorticoids: BAYCADRON™ ELIXIR METHYLPREDNISOLONE AND TRIAMCINOLONE PREDNISOLONE AND PREDNISONE HYDROCORTISONE CORTISONE 0.75 mg = 4 mg = 5 mg = 20 mg = 25 mg 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. 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.

Systemic fungal infections   Hypersensitivity to this product

Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency. There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis. Fat embolism has been reported as a possible complication of hypercortisonism. When large doses are given, some authorities advise that corticosteroids be taken with meals and antacids taken between meals to help to prevent peptic ulcer. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Steroids may increase or decrease motility and number of spermatozoa in some patients. Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs. False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients. The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies. When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia. Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Baycadron™ Elixir (Dexamethasone Elixir, USP 0.5 mg/5 mL) is supplied as a clear, red, raspberry-flavored liquid in the following size: 8 fl oz (No Dropper) (237 mL) Store at 20° to 25°C (68° to 77°F). [See USP Controlled RoomTemperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight container as defined in the USP.

Naturally occurring glucocorticoids, (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

WOCKHARDT NDC 64679-810-30 BAYCADRON™ ELIXIR (Dexamethasone Elixir, USP 0.5 mg/5 mL) PROFESSIONAL SAMPLE – NOT FOR RESALE Rx Only NET: 1 fl oz (30 mL) PRINCIPAL DISPLAY PANEL - 30 mL Bottle