Hexadrol (Dexamethasone Sodium Phosphate)


Organon Teknika

Dexamethasone Sodium Phosphate


Action And Clinical Pharmacology: After administration of the injection, dexamethasone sodium phosphate is rapidly converted into dexamethasone. This is a synthetic glucocorticoid which has 7 times the anti-inflammatory potency of prednisolone. Like other glucocorticoids, dexamethasone also has antiallergic, antitoxic, antishock, antipyretic and immunosuppressive properties. Dexamethasone has practically no water and salt-retaining properties and is, therefore, particularly suitable for use in patients with cardiac decompensation or hypertension. Because of the long biological half-life (36 to 54 hours), dexamethasone is especially suitable in conditions where a continuous glucocorticoid action is desired.

Indications And Clinical Uses: Dexamethasone sodium phosphate may be given by i.v. or i.m. injection when oral therapy is not feasible in the following conditions:

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.

Rheumatic Disorders: As adjunctive therapy for short-term administration (to support the patient during an acute period of exacerbation) in post traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis.

Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis.

Dermatologic Diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, severe seborrheic dermatitis, severe psoriasis. Allergic states: Initial control of severe allergic conditions: seasonal or perennial allergic rhinitis, bronchial asthma (including status asthmaticus), contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions, urticarial transfusion reactions, acute noninfectious laryngeal edema (epinephrine is the drug of first choice).

Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: herpes zoster ophthalmicus (but not herpes simplex), iritis, iridocylitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis optic neuritis, retrobulbar neuritis, sympathetic ophthalmia.

Gastrointestinal Diseases: To support the patient during a critical period of the disease in ulcerative colitis (systemic therapy), regional enteritis (systemic therapy).

Respiratory Diseases: Sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy, aspiration pneumonitis.

Hematologic Disorders: idiopathic thrombocytopenic purpura in adults (i.v. only; i.m. administration is contraindicated), acquired (autoimmune) hemolytic anemia.

Neoplastic Disorders: For palliative management of leukemias and lymphomas in adults, acute childhood leukemia, hypercalcemia associated with cancer.

Edematous States: To induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia, of the idiopathic type, or that due to lupus erythematosus.

Cerebral Edema: May be used to treat patients with cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management.

Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when concurrently accompanied by appropriate antituberculous chemotherapy.

Diagnostic testing of adrenocortical hyperfunction.

When given intrasynovially or locally into soft tissue sites this product may provide relief of symptoms in: traumatic arthritis, ganglia, bursitis, tendinitis, fibrositis, localized myositis, heloma.

Contra-Indications: Bacteremia and systemic fungal infections, glaucoma, hypersensitivity to any of the product’s components, Cushing’s syndrome, gastric and duodenal ulcers, certain viral infections, i.e. varicella, herpes genitalis.

Manufacturers’ Warnings In Clinical States: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.

While on corticosteroid therapy patients should not be vaccinated against smallpox because of potential complications. Conversely, patients with vaccinia should not receive corticosteroid therapy. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high doses, because of possible hazards of neurological complications and a lack of antibody response. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison’s disease.

Pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the 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.

Lactation: Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacological doses of corticosteroids should be advised not to nurse.

The use of corticosteroids 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.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses or tuberculosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal ulcerations and perforation.

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. If corticosteroids have to be used in the presence of bacterial infections, institute appropriate vigorous anti-infective therapy. Patients with latent or overt cardiac failure, renal dysfunction, hypertension or migraine, certain parasitic infections, particularly amebiasis should be monitored.

Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. The 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.

Because rare instances of serious anaphylactoid reactions such as glottis edema and bronchospasm 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.

Idiopathic thrombocytopenic purpura in adults should be treated by i.v. injection.

Precautions: When large doses are given, some authorities advise that antacids be administered between meals to help prevent peptic ulcer.

Use the lowest possible dose of corticosteroid to control the condition under treatment, and when dosage reduction is possible, the reduction should be gradual.

When corticosteroids are administered concomitantly with potassium depleting diuretics, patients should be observed closely for development of hypokalemia.

The prothrombin time should be checked frequently in patients receiving corticosteroids and coumarin anticoagulants concomitantly because of reports that corticosteroids alter 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.

Use ASA cautiously in conjunction with corticosteroids in hypoprothrombinemia.

If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.

Use corticosteroids with caution in: nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations and convulsions. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Psychological and/or physiological dependency may develop with long term use of corticosteroids. Discontinuance of therapy may lead to the development of withdrawal symptoms, including anorexia, vague pains, weakness and lethargy.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Corticosteroids may increase or decrease motility and number of spermatozoa in some patients.

Phenytoin, phenobarbital, rifampin and ephedrine may enhance the rate of metabolism and clearance of corticosteroids and this may require corticosteroid dosage adjustment. Interpret dexamethasone suppression test results cautiously during concurrent administration of these drugs.

Advise patients to inform subsequent physicians of the prior use of corticosteroids.

Corticosteroids may suppress reactions to skin tests and decrease responsiveness to vaccination.

Intra-articular corticosteroid injection may produce systemic as well as local effects. Frequent intra-articular injection may result in damage to joint tissues. Avoid overdistension of the joint capsule and deposition of steroid along the needle track in intra-articular injection, since this may lead to tissue atrophy.

Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. In intercostal neuritis and neuralgia, guard against entering the pleura.

Appropriate examination of any joint fluid present is necessary to exclude a septic process. Avoid local injection of a corticosteroid into an infected site (septic arthritis).

The slower rate of absorption by i.m. administration must be recognized.

A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, institute appropriate antimicrobial therapy.

Do not inject corticosteroids into unstable joints.

Avoid injection in the deltoid muscle because of high incidence of tissue atrophy.

Patients should be impressed strongly with the importance of not over using joints in which symptomatic benefit has been obtained as long as the inflammatory process remains active.

Patients treated concomitantly with glucocorticoids and 1 of the following drugs should be monitored: diuretics and/or cardiac glucosides, since potassium loss may be enhanced. This is a particular risk in patients using cardiac glucosides, since hypokalemia increases the toxicity of these drugs; antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs; nonsteroidal anti-inflammatory drugs, since the incidence and/or severity of gastrointestinal ulceration may increase.

Adverse Reactions: Fluid and Electrolyte Disturbances: sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension; hypotension or shock like reaction.

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: nausea; gastric and peptic ulcer and possible subsequent perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis.

Dermatologic: impaired wound healing; thin fragile skin; striae; petechiae and ecchymoses; facial erythema; increased sweating; burning or tingling, especially in the perineal area (after large doses of corticosteroid phosphates), acne, other cutaneous reactions.

Neurological: convulsions; increased intracranial pressures with papilledema (pseudotumor cerebri) usually after treatment; vertigo; headache.

Endocrine: menstrual irregularities; development of Cushingoid state; hirsutism 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 diabetes.

Ophthalmic: posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos.

Metabolic: negative nitrogen balance due to protein catabolism.

Other: anaphylactoid or hypersensitivity reactions; thrombo-embolism; malaise; weight gain; increased appetite; psychological or physiological dependence.

The following additional adverse reactions are related to parenteral corticosteroid therapy: rare instances of blindness associated with intralesional therapy around the face and head; hyperpigmentation or hypopigmentation; subcutaneous and cutaneous atrophy; sterile abscess; postinjection flare (following intra-articular use); Charcot like arthropathy.

Compatibility with Infusion Fluids: Stability studies of Hexadrol Phosphate injection diluted in various i.v. solutions such as 5% Dextrose in H2O, 0.9% Sodium Chloride, 5% Dextrose in Saline, and Lactated Ringers, in glass or plastic containers, have demonstrated that potency is maintained up to 4 weeks at room temperature.

Symptoms And Treatment Of Overdose: Symptoms: Hypertension, edema.

Treatment: Anaphylactic and hypersensitivity reactions may be treated with epinephrine, positive pressure artificial respiration, and aminophylline. Keep the patient warm and quiet. Treatment probably is not indicated for reactions due to chronic overdosage.

Dosage And Administration: For general principles governing corticosteroid administration, refer to the introductory paragraphs of the Dosage section of the Hexadrol tablet monograph.

The dose for i.m. or i.v. administration varies from 4 to 20 mg depending on the nature and severity of the disease being treated. Give i.v. doses exceeding 8 mg slowly over a period of several minutes. Repeat the initial dose as necessary until the desired response is noted. Maintenance doses average 2 to 4 mg daily. After achieving satisfactory control, switch the patient to oral therapy as soon as feasible.

In the treatment of unresponsive shock, high pharmacologic doses of glucocorticoids are recommended currently. Various dosage regimens have been suggested in the literature. These include (1) the use of a single i.v. injection of 1 to 6 mg/kg, (2) continuous infusion of 3 mg/kg/24 hours after initial i.v. bolus of 20 mg, and (3) initial i.v. bolus of 40 mg followed by repeat i.v. injections every 2 to 6 hours while the state of shock persists.

Whenever possible use i.v. route for the initial and for as many subsequent doses as are given while the patient is in shock (because of irregular absorption by other routes in such patients). When the blood pressure responds, use the i.m. route until oral therapy can be substituted.

For the treatment of cerebral edema in adults an initial i.v. dose of 10 mg is recommended, followed by 4 mg i.v. or i.m. every 6 hours until maximum response has been noted. This regimen may then be tapered over several days using either parenteral or oral dexamethasone. Non-operative cases of cerebral edema may require continuous therapy to remain free of symptoms of increased intracranial pressure. The smallest effective dose may be used in children, preferably orally. This may approximate 0.2 mg/kg/24 hours in divided doses.

There is a tendency in current medical practice to use high doses of parenteral dexamethasone in the short term therapy of selected cases of lifethreatening cerebral edema. The following dosage regimens have been suggested:

Adults: 48 mg as a single dose then 8 mg every 2 hours on days 1 and 3, 4 mg every 2 hours on days 2 and 4, 4 mg every 4 hours on days 5 through 8. All doses are to be given parenterally.

Alternatively: 100 mg i.v. followed by 100 mg i.m. 6 hours later; then, 4 mg i.m. every 6 hours for 8 days. Thereafter, taper daily by 4 mg.

Children: 10 to 14 years of age: 50% of the adult dose; less than 10 years of age: 25% of the adult dose.

Alternatively: Adults and Children: 1.5 mg/kg as a loading dose followed by 1.5 mg/kg/day for the first 5 days. Then taper slowly over the following 5 days and discontinue. All doses are to be given parenterally.

The dose for intrasynovial administration is usually 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 and helomata. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure.

Employ intrasynovial and soft tissue injections only when affected areas are limited to 1 or 2 sites. Corticosteroids provide palliation only and other conventional or curative methods of therapy should be employed when indicated.

Patients currently being treated with other glucocorticoids may be conveniently transferred to this agent using the following dosage equivalents: dexamethasone 0.75 mg=methylprednisolone and triamcinolone 4.0 mg=prednisone and prednisolone 5 mg=hydrocortisone 20 mg=cortisone 25 mg.

Availability And Storage: 4 mg/mL: Each mL contains: dexamethasone sodium phosphate USP, equivalent to 4 mg of dexamethasone phosphate. Nonmedicinal ingredients: benzyl alcohol NF 10 mg, citric acid USP or sodium hydroxide USP q.s. to adjust pH 7.9, sodium citrate USP (to isotonicity) q.s., sodium sulfite and water for injection USP q.s. to 1 mL. Multiple dose vials of 5 mL.

10 mg/mL: Each mL contains: dexamethasone sodium phosphate USP equivalent to 10 mg dexamethasone phosphate. Nonmedicinal ingredients: benzyl alcohol NF 10 mg, citric acid USP or sodium hydroxide USP q.s. to pH 7.9, sodium citrate USP (to isotonicity) q.s., sodium sulfite and water for injection USP q.s. to 1 mL. Multiple dose vials of 10 mL.

HEXADROL® PHOSPHATE INJECTION Organon Teknika Dexamethasone Sodium Phosphate Corticosteroid

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