Label: DEXAMETHASONE- dexamethasone tablet 

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

Drug Label Information

Updated 10/12

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone ™ Oral Solution (Concentrate), 1 mg per mL are for oral administration. Intensol

    Each tablet contains:

    Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg

    Each 5 mL of Oral Solution contains:

    Dexamethasone....................................................... 0.5 mg

    Each mL of ™ Oral Solution (Concentrate) contains: Intensol

    Dexamethasone....................................................... 1 mg

    Alcohol 30%

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  • CLINICAL PHARMACOLOGY

    Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems.

    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
  • CONTRAINDICATIONS

    Contraindicated in systemic fungal infections (see : ) and patients with known hypersensitivity to the product and its consituents. WARNINGSFungal Infections

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  • WARNINGS
  • PRECAUTIONS

    Information for Patients

    Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise.

    Persons who are on 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.

    Drug Interactions

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis.

    Steroids may increase or decrease motility and number of spermatozoa in some patients.

    Pregnancy

    Nursing Mothers

    Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

    Pediatric Use

    The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

    The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be to the lowest effective dose. ADVERSE REACTIONStitrated

    Geriatric Use

    Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.

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  • ADVERSE REACTIONS

    (listed alphabetically, under each subsection)

    The following adverse reactions have been reported with dexamethasone or other corticosteroids:

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  • OVERDOSAGE

    Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient's condition, supportive therapy may include gastric lavage or emesis.

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  • Dexamethasone 1.5mg Tablet
  • INGREDIENTS AND APPEARANCE
    DEXAMETHASONE 
    dexamethasone tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-4127(NDC:0054-4182)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 1.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    FD&C RED NO. 3  
    FD&C RED NO. 40  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    STARCH, CORN  
    SUCROSE  
    Product Characteristics
    Color PINK Score 2 pieces
    Shape ROUND Size 6mm
    Flavor Imprint Code 54;943
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-4127-1 35 in 1 BOTTLE
    2 NDC:63629-4127-2 21 in 1 BOTTLE
    3 NDC:63629-4127-3 51 in 1 BOTTLE
    4 NDC:63629-4127-4 90 in 1 BOTTLE
    5 NDC:63629-4127-5 120 in 1 BOTTLE
    6 NDC:63629-4127-6 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA084610 07/07/2006
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-4127), RELABEL(63629-4127)
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