Baycadron

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 C₂₂H₂₉FO₅ and the structural formula is:

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.

• Systemic fungal infections
• Hypersensitivity to this product

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false-negative results.

In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding.

Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

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.

Fluid and Electrolyte Disturbances:

• Sodium retention
• Fluid retention
• Congestive heart failure in susceptible patients
• Potassium loss
• Hypokalemic alkalosis
• 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
• 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, angioneurotic edema

Neurologic:

• Convulsions
• Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
• Vertigo
• Headache
• 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 diabetes
• Hirsutism

Ophthalmic:

• Posterior subcapsular cataracts
• Increased intraocular pressure
• Glaucoma
• 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
• Hiccups

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 LD₅₀ of dexamethasone in female mice was 6.5 g/kg.

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)

Rx Only

Product No.: 8810

Manufactured For:
Wockhardt USA, LLC
Parsippany, NJ 07054

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

28810
ISS. 12-08

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)