Full Prescribing Info
Dexamethasone sodium phosphate.
Each ampoule contains: Dexamethasone (as sodium phosphate), USP 5 mg.
Pharmacology: Pharmacodynamics: Dexamethasone is a synthetic glucocorticoid with seven (7) times the anti-inflammatory potency of prednisolone and thirty (30) times that of the natural
glucocorticoid, hydrocortisone. Like other glucocorticoids, dexamethasone also has antiallergic, antitoxic, antishock, antipyretic and immunosuppressive properties. It has virtually no water and salt-retaining properties and is, therefore particularly suitable for use in patients with cardiac failure or hypertension.
After administration, Dexamethasone sodium phosphate is rapidly hydrolyzed to dexamethasone. Because of the long biological half-life (36-54 hrs) is especially suitable in conditions where continuous glucocorticoid action is desired. Dexamethasone has plasma half-life of about 190 mins.
Dexamethasone injection may be indicated in the following conditions, especially if oral therapy is not feasible: Immuno-allergology: In some cases, especially in exacerbation of systemic lupus erythematosus, nephrotic syndrome with minimal change lesions, periarteritis nodosa, mixed connective tissue disease, arteritis temporalis; usually in combination with adrenaline in anaphylaxis; hypersensitivity reactions to drugs or chemicals, serum sickness, transfusion reactions, insect stings and bites, angioneurotic edema, severe hay-fever, Steven-Johnson syndrome; to combat acute allograft rejection; Rheumatology: In general as adjunct therapy for short term administration (either systemically or locally) in serious cases of rheumatoid arthritis and rheumatic osteoarthritis, synovitis, ankylosing spondylitis, polymyalgia rheumatica, acute rheumatic carditis; for local administration in cases of acute and subacute bursitis, synovitis, epicondylitis, tendovaginitis; Endocrinology: Primary or secondary adrenocortical insufficiency and adrenogenital syndromes (only if supplemented with mineralocorticoid therapy), polycystic ovary syndrome, non suppurative thyroiditis, thyrotoxic crisis; in surgery, severe stress or trauma in cases of decreased or doubtful adrenocortical function; Dermatology: Severe cases of pemphigus and pemphigoid, exfoliative and other serious cases of dermatitis, mycosis, fungoides, erythema multiforme, locally in keloids and some cases of alopecia aerata; Ophthalmology: Severe acute or chronic allergic inflammatory processes of the eye and its adnexa (subconjunctivally, retrobulbarly or systematically) such as allergic conjunctivitis, iritis, iridocyclitis, choroiditis, optic neuritis, sympathetic ophthalmia, scar-prevention in the eye surgery and eye injuries; Gastro-enterology: To induce remission of ulcerative colitis and regional enteritis; in some cases of chronic hepatitis, especially the aggressive form with hyperimmunity; esophagitis corrosiva, in some cases of coeliac disease, eosinophilic (gastro) enteritis; Cardiology: In some cases of pericarditis (idiopathic, post myocardial infarction and post commissurotomic syndrome); Pulmonology: Asthmatic pulmonary eosinophilia and allergic alveolitis, aspiration pneumonitis, severe bronchial asthma and other chronic nonspecific obstructive lung disease; diffuse interstitial pulmonary processes; as part of the treatment of laryngotracheobronchitis and the respiratory distress syndrome in adults; in combination with tuberculostatic therapy in fulminating tuberculosis; Hematology and Oncology: Idiopathic and secondary thrombocytopenia purpura (IV) only, autoimmune hemolytic anemia, idiopathic immunogranulocytopenia (agranulocytosis), acute and chronic lymphocytic leukemia, acute myelocytic leukemia (blastemic crisis), Hodgkin's disease, other malignancies of the lymphoid and hystocytic tissue, multiple myeloma, advanced myeloma refractory to alkylating agents, macroglobulinemia; as antiemetic in antineoplastic regimens; for palliative treatment in terminal stages of neoplastic disease; Neurology: Cerebral edema particularly those forms resulting from brain tumors, brain abscesses and neurosurgical interventions (in the latter case, also for prevention of brain edema); myoclonic seizures in epilepsy, pseudotumor cerebri, severe myasthenia gravis resistant to anticholinesterase therapy and thymectomy, in some cases of acute multiple sclerosis and peripheral neuritis; acute mountain sickness; Other Indications: In the prevention of inflammatory edema and adhesions in surgery; in most cases of tuberculosis meningitis, pericarditis, peritonitis and pleuritis (in combination with tuberculostatic therapy); antenatal, in the prevention of neonatal respiratory distress syndrome; severe trichinosis, hypercalcemia, e.g. associated with antineoplastic diseases, hypervitaminosis-D, idiopathic infantile hypercalcemia.
Dosage/Direction for Use
In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. Under certain circumstances, for stress and changed clinical picture, extra dosage adjustments maybe necessary. If no favorable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. For Systemic Therapy, daily dosages of 0.05-0.2 mg/kg body weight are usually sufficient. As soon as the symptoms diminish, dosage should be reduced under continuous observation of the clinical picture to the lowest possible level or tapered off completely. This should be done by giving in the early morning, daily or preferably every other day, 1 dose of an oral glucocorticoid with a shorter biological half-life than dexamethasone, e.g. prednisone. For acute life-endangering situations (e.g. anaphylaxis, acute severe asthma), substantial higher dosages maybe needed. Cerebral Edema (adults): Initial dose 10-20 mg IV followed by 6 mg IV or IM every 6 hrs., until a satisfactory result has been obtained. In brain surgery, these dosages may be necessary until several days after the operation. Thereafter, the dosage has to be tapered off gradually. Increase of intracranial pressure associated with brain tumors can be counteracted by continuous treatment.
For Local Therapy, the following dosages can be recommended: Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints; Intrabursally: 2-4 mg; in tendon sheaths: 0.4-1 mg. The frequency of these injections may vary from every 3-5 days to every 2-3 weeks. For Rectal Drip in cases of Ulcerative Colitis: 5 mg diluted in 120 mL saline. Dexamethasone injection can be administered by IV, SC, IM and local injection as well as rectal drip. With IV administration, high plasma levels can be obtained rapidly. IV injection of massive doses should be given slowly, over a period of several minutes. Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease resistance to infection. It has been shown not to lose its potency for at least 24 hrs (at a room temperature and in daylight conditions) when diluted with any of the following infusion fluids: Sodium chloride 0.9%, anhydrous glucose 5%, invert sugar 10%, sorbitol 5%, Ringer's solution, Hatmann's solution (Ringer-lactate), Rheomacrodex, Isodex Haemaccel. Using these infusions fluids, Dexamethasone injection can also be injected directly into the infusion line without causing precipitation of the ingredients. Direct injection into the infusion line is also possible with following infusion fluids but the 24hr stability has not been established: Mannitol 10%. Or as prescribed by the physician.
For Systemic Therapy: Gastric and duodenal ulcers, systemic fungal infections, certain viral infections e.g. varicella and herpes genitalia infections, glaucoma, hypersensitivity to glucocorticoids, sulfites or benzyl alcohol. In general, no contraindications apply in conditions where the use of glucocorticoids may be life-saving.
For Local Therapy: Infection of the affected site e.g. septic arthritis resulting from gonorrhea or tuberculosis, bacterecemia and systemic fungal infections, instability of joint and hypersensitivity to glucocorticoids.
This product contains sodium bisulfite and benzyl alcohol that may cause hypersensitivity reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible persons.
Special Precautions
Patients with any of the following conditions should be monitored: Latent or overt cardiac failure, renal dysfunction, hypertension or migraine since glucocorticoids may induce fluid retention, osteoporosis since glucocorticoids have a negative effect on the calcium balance; a history of psychotic illness; latent tuberculosis, since glucocorticoids may induce reactivation; certain parasitic infestation in particular amoebiasis; incomplete statural growth since glucocorticoids on prolonged administration may accelerate epiphyseal closure. Glucocorticoid therapy is non specific, suppresses the symptoms and signs of disease and decrease resistance to infections. Appropriate antibacterial therapy should accompany glucocorticoid therapy when necessary e.g. tuberculosis and viral and fungal infections of the eye. Patients in long-term glucocorticoid therapy should be regularly examined with respect to their glucose metabolism. Before, during and after stressful situations, dosages may need to be increased in patients currently in glucocorticoids or resumed in patients who have undergone prolonged glucocorticoid treatment in the previous year. Discontinuation of prolonged therapy should be carried out by gradual reduction of dosage and under strict medical supervision, since withdrawal may result in acute exacerbation of the disease and acute adrenocortical insufficiency. Local injection of a glucocorticoid may produce systemic effects. After parenteral administration of glucocorticoids, serious anaphylactoid reactions e.g. glottis edema and bronchospasm, have occasionally occurred, particularly in patients with a history of allergy. If such an anaphylactoid reaction occurs, the following measures are recommended: Immediate slow IV administration of 0.1-0.5 mL of adrenaline 1:1000 (0.1-0.5 mg), IV administration of aminophylline and artificial respiration. The use of corticosteroids may influence the results of certain laboratory tests.
Use in pregnancy and lactation: There are insufficient data on the use of this drug during human pregnancy to assess potential harm to the fetus. However, there are indications for a harmful effect in animal experiments. Infants whose mother received substantial doses of glucocorticoids during pregnancy should be carefully observed for signs of renal insufficiency. Glucocorticoids appear in breast milk in very small quantities, but it is unknown whether this can adversely affect the infant.
Use In Pregnancy & Lactation
Use in pregnancy and lactation: There are insufficient data on the use of this drug during human pregnancy to assess potential harm to the fetus. However, there are indications for a harmful effect in animal experiments. Infants whose mother received substantial doses of glucocorticoids during pregnancy should be carefully observed for signs of renal insufficiency. Glucocorticoids appear in breast milk in very small quantities, but it is unknown whether this can adversely affect the infant.
Adverse Reactions
Adverse reactions associated with prolonged systemic glucocorticoid therapy are unlikely when high doses are administered over a short period of time.
Nevertheless, gastric and duodenal ulceration with possible perforation and hemorrhage, may occasionally occur. Hypersensitivity reactions may occasionally occur. A transient burning or tingling sensation, mainly in the perineal area, may occur following IV injection of large doses of corticosteroid phosphates. The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy: Endocrine and Metabolic Disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.
Fluid and Electrolyte Disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalemic alkalosis.
Musculoskeletal Effects: Myopathy, abdominal dystention, osteoporosis, aseptic necrosis of femoral and humeral heads.
Gastrointestinal Effects: Gastric and duodenal ulceration, perforation and hemorrhage.
Dermatologic Effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.
CNS Effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations, convulsions; in children, pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.
Ophthalmic Effects:
Glaucoma, intraocular pressure, posterior subcapsular cataracts.
Immunosuppressive Effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
Local adverse reactions include post-injection flare and a painless destruction of the joint reminiscent of Charcot's arthropathy, especially with repeated intra-articular injections.
Store at temperatures not exceeding 30°C. Protect from light.
ATC Classification
H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Inj (amp) 5 mg/mL x 10's.
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