Trade Name: Dexamethasone Sodium Phosphate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/mL

Storage and handling

DEXAMETHASONE SODIUM PHOSPHATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Dexamethasone Sodium Phosphate (Dexamethasone Sodium Phosphate) which is also known as Dexamethasone Sodium Phosphate and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 10 mg/mL.

Dexamethasone Sodium Phosphate (Dexamethasone Sodium Phosphate) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • 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, (11u00df, 16u03b1).
  • It occurs as a white to practically white powder, is hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5.
  • It has the following structural formula:
  • Each mL of Dexamethasone Sodium Phosphate Injection, USP u00a0 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 monohydrate or sodium hydroxide, if necessary. pH: 7.0 to 8.5.
  • Dexamethasone sodium phosphate injection has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy.
  • 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.
  • 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 oru00a0u00a0 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.
  • u00a0Congenital adrenal hyperplasia
  • u00a0Nonsuppurative thyroiditis
  • u00a0Hypercalcemia associated with cancer
  • 2.
  • Rheumatic
  • Disorders
  • As adjunctive therapy for short-term administration (to tide the patient over an acute episodeu00a0 or exacerbation) in:
  • Post-traumatic osteoarthritis
  • Synovitis of osteoarthritis
  • Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
  • Acute and subacute bursitis
  • Epicondylitis
  • Acute nonspecific tenosynovitis
  • Acute gouty arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • 3. u00a0n
  • During an exacerbation or as maintenance therapy in selected cases of:
  • Systemic lupus erythematosus
  • Acute rheumatic carditis
  • 4. u00a0u00a0
  • Pemphigus
  • Severe erythema multiforme (Stevens-Johnson syndrome)
  • Exfoliative dermatitis
  • Bullous dermatitis herpetiformis
  • Severe seborrheic dermatitis
  • Severe psoriasis
  • Mycosis fungoides
  • 5. u00a0n
  • Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:
  • Bronchial asthma
  • Contact dermatitis
  • Atopic dermatitis
  • Serum sickness
  • Seasonal or perennial allergic rhinitis
  • Drug hypersensitivity reactions
  • Urticarial transfusion reactions
  • Acute noninfectious laryngeal edema (epinephrine is the drug of first choice).
  • 6. u00a0n
  • Severe acute and chronic allergic and inflammatory processes involving the eye, such as:
  • Herpes zoster ophthalmicus
  • Iritis, iridocyclitis
  • Chorioretinitis
  • Diffuse posterior uveitis and choroiditis
  • Optic neuritis
  • Sympathetic ophthalmia
  • Anterior segment inflammation
  • Allergic conjunctivitis
  • Keratitis
  • Allergic corneal marginal ulcers
  • 7. u00a0n
  • To tide the patient over a critical period of the disease in:
  • Ulcerative colitis (systemic therapy)u00a0
  • Regional enteritis (systemic therapy)
  • 8. u00a0u00a0
  • Symptomatic sarcoidosisu00a0
  • Berylliosis
  • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.
  • Loeffler's syndrome not manageable by other means.
  • Aspiration pneumonitis
  • 9. u00a0n
  • Acquired (autoimmune) hemolytic anemia.u00a0
  • Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated).u00a0
  • Secondary thrombocytopenia in adultsu00a0
  • Erythroblastopenia (RBC anemia)u00a0
  • Congenital (erythroid) hypoplastic anemia
  • 10. u00a0n
  • For palliative management of:u00a0
  • Leukemias and lymphomas in adults
  • Acute leukemia of childhood
  • 11. u00a0n
  • To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of f the idiopathic type or that due to lupus erythematosus.
  • 12. n
  • Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
  • Trichinosis with neurologic or myocardial involvement.
  • 13 u00a0u00a0u00a0u00a0n
  • 14 u00a0 associated with primary or metastatic brain tumor, craniotomy, or head injury.u00a0
  • Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitiveu00a0
  • management such as neurosurgery or other specific therapy.
  • Systemic fungal infections (see regarding amphotericin B).
  • Hypersensitivity to any component of this product (see )n
  • No data
  • This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial.
  • 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 for fear of 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 must 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 within caution 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, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism.
  • When large doses are given, some authorities advise that antacids be administered between meals to help prevent peptic ulcer.
  • 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.
  • The slower rate of absorption by intramuscular administration should be recognized.
  • Fluid and electrolyte disturbances:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Sodium retention
  • u00a0u00a0u00a0u00a0u00a0u00a0 Fluid retention
  • u00a0u00a0u00a0u00a0u00a0u00a0 Congestive heart failure in susceptible patients
  • u00a0u00a0u00a0u00a0u00a0u00a0 Potassium loss
  • u00a0u00a0u00a0u00a0u00a0u00a0 Hypokalemic alkalosis
  • u00a0u00a0u00a0u00a0u00a0u00a0 Hypertension
  • Musculoskeletal:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Muscle weakness
  • u00a0u00a0u00a0u00a0 u00a0u00a0Steroid myopathy
  • u00a0u00a0u00a0u00a0u00a0u00a0 Loss of muscle mass
  • u00a0u00a0u00a0u00a0u00a0u00a0 Osteoporosis
  • u00a0u00a0u00a0u00a0u00a0u00a0 Vertebral compression fractures
  • u00a0u00a0u00a0u00a0u00a0u00a0 Aseptic necrosis of femoral and humeral heads
  • u00a0u00a0u00a0u00a0u00a0u00a0 Tendon rupture
  • u00a0u00a0u00a0u00a0u00a0u00a0 Pathologic fracture of long bones
  • Gastrointestinal:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Peptic ulcer with possible subsequent perforation and hemorrhage
  • u00a0u00a0u00a0u00a0u00a0u00a0 Perforation of the small and large bowel; particularly in patients with inflammatory bowel disease
  • u00a0u00a0u00a0u00a0u00a0u00a0 Pancreatitis
  • u00a0u00a0u00a0u00a0u00a0u00a0 Abdominal distention
  • u00a0u00a0u00a0u00a0u00a0u00a0 Ulcerative esophagitis
  • Dermatologic:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Impaired wound healing
  • u00a0u00a0u00a0u00a0u00a0u00a0 Thin fragile skin
  • u00a0u00a0u00a0u00a0u00a0u00a0 Petechiae and ecchymoses
  • u00a0u00a0u00a0u00a0u00a0u00a0 Erythema
  • u00a0u00a0u00a0u00a0u00a0u00a0 Increased sweating
  • u00a0u00a0u00a0u00a0u00a0u00a0 May suppress reactions to skin tests
  • u00a0u00a0u00a0u00a0u00a0u00a0 Burning or tingling, especially in the perineal area (after IV injection)
  • u00a0u00a0u00a0u00a0u00a0u00a0 Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema
  • Neurologic:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Convulsions
  • u00a0u00a0u00a0u00a0u00a0u00a0 Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
  • u00a0u00a0u00a0u00a0u00a0u00a0 Vertigo
  • u00a0u00a0u00a0u00a0u00a0u00a0 Headache
  • u00a0u00a0u00a0u00a0u00a0u00a0 Psychic disturbances
  • Endocrine:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Menstrual irregularities
  • u00a0u00a0u00a0u00a0u00a0u00a0 Development of cushingoid state
  • u00a0u00a0u00a0u00a0u00a0u00a0 Suppression of growth in pediatric patients
  • u00a0u00a0u00a0u00a0u00a0u00a0 Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness
  • u00a0u00a0u00a0u00a0u00a0u00a0 Decreased carbohydrate tolerance
  • u00a0u00a0u00a0u00a0u00a0u00a0 Manifestations of latent diabetes mellitus
  • u00a0u00a0u00a0u00a0u00a0u00a0 Increased requirements for insulin or oral hypoglycemic agents in diabetics
  • u00a0u00a0u00a0u00a0u00a0u00a0 Hirsutism
  • Ophthalmic:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Posterioru00a0 subcapsularu00a0 cataracts
  • u00a0u00a0u00a0u00a0u00a0u00a0 Increased intraocular pressure
  • u00a0u00a0u00a0u00a0u00a0u00a0 Glaucoma
  • u00a0u00a0u00a0u00a0u00a0u00a0 Exophthalmos
  • u00a0u00a0u00a0u00a0u00a0u00a0 Retinopathy of prematurity
  • Metabolic:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Negative nitrogen balance due to protein catabolism
  • Cardiovascular:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Myocardial rupture following recent myocardial infarction (see )
  • u00a0u00a0u00a0u00a0u00a0u00a0 Hypertrophic cardiomyopathy in low birth weight infants
  • Other:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Anaphylactoid or hypersensitivity reactions
  • u00a0u00a0u00a0u00a0u00a0u00a0 Thromboembolism
  • u00a0u00a0u00a0u00a0u00a0u00a0 Weight gain
  • u00a0u00a0u00a0u00a0u00a0u00a0 Increased appetite
  • u00a0u00a0u00a0u00a0u00a0u00a0 Nausea
  • u00a0 u00a0u00a0u00a0u00a0u00a0Malaise
  • u00a0u00a0u00a0u00a0u00a0u00a0 Hiccups
  • The following adverse reactions are related to parenteral corticosteroid therapy:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Hyperpigmentation or hypopigmentationu00a0
  • u00a0u00a0u00a0u00a0u00a0u00a0 Subcutaneous and cutaneous atrophy
  • u00a0u00a0u00a0u00a0u00a0u00a0 Sterile abscessu00a0
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Charcot-like arthropathy
  • 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 of dexamethasone in female mice was 6.5 g/kg. The intravenous LD of dexamethasone sodium phosphate in female mice was 794 mg/kg.
  • Dexamethasone sodium phosphate injection, 10 mg/mLu2013 u00a0u00a0u00a0u00a0u00a0n
  • Dexamethasone sodium phosphate injection can be given directly from the vial, or it can be added to Sodium Chloride Injection or Dextrose Injection and administered by intravenous drip.
  • Solutions used for intravenous administration or further dilution of this product should be preservative free when used in the neonate, especially the premature infant.
  • When it is mixed with an infusion solution, sterile precautions should be observed. Since infusion solutions generally do not contain preservatives, mixtures should be used within 24 hours.
  • DOSAGEn- REQUIREMENTSn- AREn- VARIABLEn- ANDn- MUSTn- BEn- INDIVIDUALIZEDn- ONn- THEn- BASISn- OFn- THEn- DISEASEn- ANDn- THEn- RESPONSEn- OFn- THEn- PATIENT.
  • Dexamethasone Sodium Phosphate Injection, USP u00a0 equivalent to 10 mg dexamethasone phosphate, is supplied in a single dose vial as follows:
  • NDCn- Non- Strengthn- Vialn- Size
  • 70069--25u00a0u00a0u00a0u00a0u00a0u00a0 10 mg/mLu00a0u00a0u00a0u00a0u00a0u00a0u00a0 1 mL Vial Packaged in twenty-fives.
  • The vial stopper closure is not made with natural rubber latex.
  • Arrayn- Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Sensitive to heat.
  • Do not autoclave.
  • Protect from freezing.
  • Protectn- fromn- light.
  • Singlen- dosen- vialsn- u2013Storen- inn- containern- untiln- timen- ofn- use.n- Discardn- unusedn- portion.
  • For Product Inquiry call 1-800-417-9175.
  • Manufactured by:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Manufactured for:u00a0
  • Wintac Limitedu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Somerset Therapeutics, LLC
  • Bangalore-562 123u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Somerset, NJ 08873
  • India.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0ST-DEX21/P/01
  • Code No.: KR/DRUGS/KTK/28/289/97
  • Revised: 06/2018
  • Container Label (Vial)
  • Carton Label

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