DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL
DEXAMETHASONE SODIUM PHOSPHATE · INJECTION, SOLUTION · Eugia US LLC
DEXAMETHASONE SODIUM PHOSPHATE is a injection, solution containing dexamethasone sodium phosphate at 4 mg/mL, taken intra-articular. Manufactured by Eugia US LLC.
Key Facts
- Brand Name
- DEXAMETHASONE SODIUM PHOSPHATE
- Generic Name
- DEXAMETHASONE SODIUM PHOSPHATE
- NDC Code (Product)
55150-237- Manufacturer
- Eugia US LLC
- Strength
- 4 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
- Marketing Status
- Application #
- ANDA206781
- Marketing Start
- 12/01/2015
Recall History
West-Ward Pharmaceuticals Corp.
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Eugia US LLC
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
US Compounding Inc
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Edge Pharma, LLC
Lack of Assurance of Sterility
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Martin Avenue Pharmacy, Inc.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Pharmedium Services, LLC
Lack of sterility assurance.
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. Endocrine disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance) Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used) Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic disorders As adjunctive therapy for short-term admini…
Dosage & 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 initial 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 i…
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. Immunosuppression and Increased Risk of Infection Corticosteroids, including Dexamethasone Sodium Phosphate, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation o…
Contraindications
CONTRAINDICATIONS Systemic fungal infections.
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 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 Increased 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 I…
Frequently Asked Questions
What is DEXAMETHASONE SODIUM PHOSPHATE used for?
DEXAMETHASONE SODIUM PHOSPHATE contains DEXAMETHASONE SODIUM PHOSPHATE. It is a injection, solution taken intra-articular. Consult your doctor for specific uses.
Is DEXAMETHASONE SODIUM PHOSPHATE a controlled substance?
DEXAMETHASONE SODIUM PHOSPHATE is not classified as a controlled substance by the DEA.
What is the generic name for DEXAMETHASONE SODIUM PHOSPHATE?
The generic name for DEXAMETHASONE SODIUM PHOSPHATE is DEXAMETHASONE SODIUM PHOSPHATE. There are 11 other brand versions of DEXAMETHASONE SODIUM PHOSPHATE.
What is the NDC code for DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL?
The NDC (National Drug Code) for DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL is 55150-237, listed by Eugia US LLC.
Other DEXAMETHASONE SODIUM PHOSPHATE Dosages
Other Dexamethasone Brands
See all →- Dexamethasone Sodium Phosphate10 mg/mL72485-118
- Dexamethasone Sodium Phosphate4 mg/mL76420-398
- Dexamethasone Sodium Phosphate10 mg/mL76420-399
- Mardex 25 Kit76420-810
- Dexamethasone Sodium Phosphate10 mg/mL0641-0367
- Dexamethasone Sodium Phosphate10 mg/mL55154-5118
- Dexamethasone Sodium Phosphate10 mg/mL63323-516
- Dexamethasone Sodium Phosphate4 mg/mL67457-421
- Dexamethasone Sodium Phosphate4 mg/mL67457-484
- Dexamethasone Sodium Phosphate10 mg/mL68083-607
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)