Label: BAYCADRON- dexamethasone elixir 

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  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 07/09

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  • DESCRIPTION

    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:

    Chemical Structure
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  • CLINICAL PHARMACOLOGY

    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.

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  • INDICATIONS AND USAGE

    1. 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
     
    Nonsuppurative thyroiditis
     
    Hypercalcemia associated with cancer

    2. 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
     
    Epicondylitis

    3. Collagen Diseases

    During an exacerbation or as maintenance therapy in selected cases of:

     
    Systemic lupus erythematosus
     
    Acute rheumatic carditis

    4. Dermatologic Diseases

     
    Pemphigus
     
    Bullous dermatitis herpetiformis
     
    Severe erythema multiforme (Stevens-Johnson syndrome)
     
    Exfoliative dermatitis
     
    Mycosis fungoides
     
    Severe psoriasis
     
    Severe seborrheic dermatitis

    5. Allergic States

    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

    6. 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
     
    Sympathetic ophthalmia

    7. 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
     
    Aspiration pneumonitis

    8. Hematologic Disorders

     
    Idiopathic thrombocytopenic purpura in adults
     
    Secondary thrombocytopenia in adults
     
    Acquired (autoimmune) hemolytic anemia
     
    Erythroblastopenia (RBC anemia)
     
    Congenital (erythroid) hypoplastic anemia

    9. Neoplastic Diseases

    For palliative management of:

     
    Leukemia and lymphomas in adults
     
    Acute leukemia of childhood

    10. 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

    11. Gastrointestinal Diseases

    To tide the patient over a critical period of the disease in:

     
    Ulcerative colitis
     
    Regional enteritis

    12. Miscellaneous

     
    Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
     
    Trichinosis with neurologic or myocardial involvement

    13. Diagnostic testing of adrenocortical hyperfunction

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  • CONTRAINDICATIONS

     
    Systemic fungal infections
     
    Hypersensitivity to this product
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  • WARNINGS

    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.

    Usage in Pregnancy

    Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

    Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

    Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

    Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.

    Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

    The use of Baycadron™ Elixir in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

    If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

    Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

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  • PRECAUTIONS

    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.

    Information for Patients

    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.

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  • ADVERSE REACTIONS

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

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  • DOSAGE AND 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 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

    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.
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  • HOW SUPPLIED

    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)

    RECOMMENDED STORAGE

    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.

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  • SPL UNCLASSIFIED SECTION

    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

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  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle

    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
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  • INGREDIENTS AND APPEARANCE
    BAYCADRON 
    dexamethasone elixir
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64679-810
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dexamethasone (Dexamethasone) Dexamethasone 0.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    raw sugar  
    propylene glycol  
    benzoic acid  
    alcohol  
    Anhydrous Citric Acid  
    FD&C red no. 40  
    water  
    sodium citrate  
    citric acid monohydrate  
    Product Characteristics
    Color RED (Clear) Score     
    Shape Size
    Flavor RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64679-810-08 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA088254 07/27/1983
    Labeler - Wockhardt USA, LLC (170508365)
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