Dexamethasone Sodium Phosphate
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-506Dexamethasone Sodium Phosphate is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Dexamethasone Sodium Phosphate is 63323-506. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Dexamethasone Sodium Phosphate drug includes Dexamethasone Sodium Phosphate - 10 mg/mL . The currest status of Dexamethasone Sodium Phosphate drug is Active.
Drug Information:
| Drug NDC: | 63323-506 |
| 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 Sodium Phosphate |
| 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 Sodium Phosphate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fresenius Kabi Usa, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| 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 SODIUM PHOSPHATE - 10 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR INTRAVENOUS
|
| 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: | 29 May, 2003 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ANDA040491 |
| 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: | Fresenius Kabi USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1812079
|
| 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. |
| UPC: | 0363323506414
|
| UPC stands for Universal Product Code. |
| UNII: | AI9376Y64P
|
| 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: | Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63323-506-16 | 25 VIAL in 1 TRAY (63323-506-16) / 1 mL in 1 VIAL (63323-506-41) | 29 May, 2003 | N/A | No |
| 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 sodium phosphate dexamethasone sodium phosphate sodium citrate citric acid monohydrate sodium hydroxide dexamethasone sodium phosphate dexamethasone dexamethasone phosphate
Warnings:
Warnings serious neurologic adverse reactions with epidural administration serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. these serious neurologic events have been reported with and without use of fluoroscopy. the safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. in patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. 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. prolonged use of corticosteroids may produce p
Read more...osterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. children who are on immunosuppressant drugs are more susceptible to infections than healthy children. chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. in such children or in adults who have not had these diseases, particular care should be taken to avoid exposure. if exposed, therapy with varicella zoster immune globulin (vzig) or pooled intravenous immunoglobulin (ivig), as appropriate, may be indicated. if chickenpox develops, treatment with antiviral agents may be considered. similarly, corticosteroids should be used with great care in patients with known or suspected strongyloides (threadworm) infestation. in such patients, corticosteroid-induced immunosuppression may lead to strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. usage in pregnancy since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential 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. average and large doses of cortisone or hydrocortisone 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. patients with a stressed myocardium should be observed carefully and the drug administered slowly since premature ventricular contractions may occur with rapid administration. dietary salt restriction and potassium supplementation may be necessary. all corticosteroids increase calcium excretion. while on corticosteroid therapy patients should not be vaccinated against smallpox. other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response. the use of dexamethasone sodium phosphate injection 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 anti-tuberculosis 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. because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
Dosage and Administration:
Dosage and administration a. intravenous or intramuscular administration the initial dosage of dexamethasone sodium phosphate injection may vary from 0.50 mg/day to 9.0 mg/day depending on the specific disease entity being treated. in situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours. however, in certain overwhelming, acute, life-threatening situations, administration of dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. for the treatment of unresponsive shock high pharmacologic doses of this product are currently recommended. reported regimens range from 1 to 6 mg/kg of body weight as a single intravenous injection to 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists. for the treatment of cerebral edema in adults an i
Read more...nitial intravenous dose of 10 mg is recommended followed by 4 mg intramuscularly every six hours until maximum response has been noted. this regimen may be continued for several days postoperatively in patients requiring brain surgery. oral dexamethasone, 1 to 3 mg t.i.d., should be given as soon as possible and dosage tapered off over a period of five to seven days. nonoperative cases may require continuous therapy to remain free of symptoms of increased intracranial pressure. the smallest effective dose should be used in children, preferably orally. this may approximate 0.2 mg/kg/24 hours in divided doses. in treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4â8 mg dexamethasone every other day for 1 month have been shown to be effective. the initial dosage should be maintained or adjusted until a satisfactory response is noted. if after a reasonable period of time there is a lack of satisfactory clinical response, dexamethasone sodium phosphate injection should be discontinued and the patient transferred to other appropriate therapy. it should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient. after a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. it should be kept in mind that constant monitoring is needed in regard to drug dosage. included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. in this later situation it may be necessary to increase the dosage of dexamethasone sodium phosphate injection for a period of time consistent with the patient's condition. if after a long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. b. intra-articular, soft tissue or intralesional administration. the dose for intrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. for soft tissue and bursal injections a dose of 2 to 4 mg is recommended. ganglia require a dose of 1 to 2 mg. a dose of 0.4 to 1 mg is used for injection into tendon sheaths. injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure. intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites. it should be remembered that corticoids provide palliation only and that other conventional or curative methods of therapy should be employed when indicated. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. frequency of injection usually ranges from once every 3 to 5 days to once every 2 to 3 weeks. frequent intra-articular injection may cause damage to joint tissue.
Contraindications:
Contraindications systemic fungal infections.
Adverse Reactions:
Adverse reactions to report suspected adverse reactions, contact fresenius kabi usa, llc at 1-800-551-7176 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. 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 gastrointestinal: peptic ulcer with possible subsequent perforation and hemorrhage pancreatitis abdominal distention ulcerative esophagitis dermatological: impaired wound healing thin fragile skin facial erythema increased sweating may suppress reactions to skin tests petechiae and ecchymoses neurological: convulsions increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment vertigo headache ophthalmic: posterior subcapsular cataracts incr
Read more...eased intraocular pressure glaucoma 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 diabetics metabolic: negative nitrogen balance due to protein catabolism miscellaneous: hyperpigmentation or hypopigmentation subcutaneous and cutaneous atrophy sterile abscess post-injection flare, following intra-articular use charcot-like arthropathy itching, burning, tingling in the ano-genital region
Use in Pregnancy:
Usage in pregnancy since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential 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. average and large doses of cortisone or hydrocortisone 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. patients with a stressed myocardium should be observed carefully and the drug administered slowly since premature ventricular contractions may occur with rapid administration. dietary salt restriction and potassium supplementation may be necessary. all corticosteroids increa
Read more...se calcium excretion. while on corticosteroid therapy patients should not be vaccinated against smallpox. other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response. the use of dexamethasone sodium phosphate injection 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 anti-tuberculosis 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. because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
Description:
Description dexamethasone sodium phosphate injection, usp, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. dexamethasone sodium phosphate, usp chemically is pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11Ã, 16α). it occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a ph between 7.0 and 8.5. it has the following structural formula: each ml of dexamethasone sodium phosphate injection, usp (preservative free) contains dexamethasone sodium phosphate, usp equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and water for injection, q.s. ph adjusted with citric acid or sodium hydroxide, if necessary. ph: 7.0 to 8.5. structural formula
How Supplied:
How supplied dexamethasone sodium phosphate injection, usp (preservative free) equivalent to 10 mg dexamethasone phosphate, is supplied as follows: product code unit of sale strength each prx500601 ndc 63323-506-16 unit of 25 10 mg per ml ndc 63323-506-41 1 ml single dose vial this container closure is not made with natural rubber latex. storage store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. sensitive to heat. do not autoclave. protect from freezing. protect from light. single dose vialsâstore in container until time of use. discard unused portion.
Package Label Principal Display Panel:
Package label - principal display - dexamethasone 1 ml vial label ndc 63323-506-41 prx500601 dexamethasone sodium phosphate injection, usp 10 mg per ml for im or iv use only. preservative free. discard unused portion. protect from light. 1 ml single dose vial rx only package label - principal display - dexamethasone 1 ml vial label
Package label - principal display - dexamethasone 1 ml vial tray label ndc 63323-506-16 prx500601 dexamethasone sodium phosphate injection, usp 10 mg per ml * for intramuscular or intravenous use only. preservative free. 25 x 1 ml single dose vials rx only package label - principal display - dexamethasone 1 ml vial tray label