Dexamethasone


Rising Pharmaceuticals, Inc.
Human Prescription Drug
NDC 64980-509
Dexamethasone is a human prescription drug labeled by 'Rising Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Dexamethasone is 64980-509. This drug is available in dosage form of Elixir. The names of the active, medicinal ingredients in Dexamethasone drug includes Dexamethasone - .5 mg/5mL . The currest status of Dexamethasone drug is Active.

Drug Information:

Drug NDC: 64980-509
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Dexamethasone
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Dexamethasone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Rising Pharmaceuticals, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Elixir
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:DEXAMETHASONE - .5 mg/5mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Aug, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 29 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA090891
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Rising Pharmaceuticals, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:309686
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000175576
N0000175450
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:7S5I7G3JQL
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:Corticosteroid Hormone Receptor Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Corticosteroid [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
64980-509-24237 mL in 1 BOTTLE, PLASTIC (64980-509-24)01 Aug, 2011N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Dexamethasone dexamethasone dexamethasone dexamethasone benzoic acid alcohol anhydrous citric acid fd&c red no. 40 sucrose propylene glycol water trisodium citrate dihydrate clear artificial raspberry flavor

Indications and Usage:

Indications and usage 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 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 collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus acute rheumatic carditis de
rmatologic diseases: pemphigus bullous dermatitis herpetiformis severe erythema multiforme (stevens-johnson syndrome) exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis 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 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 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 hematologic disorders: idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired (autoimmune) hemolytic anemia erythroblastopenia (rbc anemia) congenital (erythroid) hypoplastic anemia neoplastic diseases : for palliative management of: leukemia and lymphomas in adults acute leukemia of childhood 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 gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis regional enteritis miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement diagnostic testing of adrenocortical hyperfunction.

Warnings:

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 maybe 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 opticnerves, 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 dexamethasone 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.

Dosage and Administration:

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:

Contraindications systemic fungal infections hypersensitivity to this product

Adverse Reactions:

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 osteoporosis aseptic necrosis of femoral and humeral heads vertebral compression fractures loss of muscle mass pathologic fracture of long bones tendon rupture gastrointestinal: pancreatitis abdominal distention peptic ulcer with possible perforation and hemorrhage ulcerative esophagitis perforation of the small and large bowel, particularly in patients with inflammatory bowel disease dermatologic: impaired wound healing thin fragile skin erythema may suppress reactions to skin tests petechiae and ecchymoses increased sweating other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema neurologic: convulsions vertigo headache psychic disturbances increased intracranial pressure with papilledema (pseudotumor cerebri) usually aft
er treatment endocrine: menstrual irregularities development of cushingoid state manifestations of latent diabetes mellitus secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness decreased carbohydrate tolerance suppression of growth in children 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

Adverse Reactions Table:

Fluid and Electrolyte Disturbances:
Sodium retention Fluid retention Congestive heart failure in susceptible patientsPotassium loss Hypokalemic alkalosis Hypertension
Musculoskeletal:
Muscle weakness Steroid myopathy Osteoporosis Aseptic necrosis of femoral and humeral headsVertebral compression fractures Loss of muscle mass Pathologic fracture of long bones Tendon rupture
Gastrointestinal:
Pancreatitis Abdominal distention Peptic ulcer with possible perforation and hemorrhageUlcerative esophagitis Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease
Dermatologic:
Impaired wound healing Thin fragile skin Erythema May suppress reactions to skin testsPetechiae and ecchymoses Increased sweating Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema
Neurologic:
Convulsions Vertigo Headache Psychic DisturbancesIncreased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
Endocrine:
Menstrual irregularities Development of cushingoid state Manifestations of latent diabetes mellitus Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illnessDecreased carbohydrate tolerance Suppression of growth in children Increased requirements for insulin or oral hypoglycemic agents in diabetes Hirsutism
Ophthalmic:
Posterior subcapsular cataracts Increased intraocular pressureGlaucoma Exophthalmos
Metabolic:
Negative nitrogen balance due to protein catabolism
Cardiovascular:
Myocardial rupture following recent myocardial infarction (See WARNINGS)
Other:
Hypersensitivity Thromboembolism Weight gain Increased appetiteNausea Malaise Hiccups

Overdosage:

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.

Description:

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

Clinical Pharmacology:

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.

How Supplied:

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 pharmaceuticals, inc. saddle brook, nj 07663 manufactured by: lyne laboratories, inc. brockton, ma 02301 r7-12/17

Information for Patients:

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.

Package Label Principal Display Panel:

Rising ® ndc 64980-509-24 dexamethasone elixir, usp 0.5 mg/5 ml contains 5.1% alcohol (% v/v) net: 8 fl oz (237 ml) rx only dexamethasone-elixir-usp-label-8-oz


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