APO-DEXAMETHASONE 4 MG — DIN 02250055

What is APO-DEXAMETHASONE?

APO-DEXAMETHASONE 4 MG contains DEXAMETHASONE : 4 MG. It is listed in the Health Canada Drug Product Database under DIN 02250055, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 08-Mar-2004. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is APO-DEXAMETHASONE used for?

APO-DEXAMETHASONE (dexamethasone) is indicated for: • Allergic states: Control of severe or incapacitating allergic conditions not responsive to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions. • Rheumatic disorders and collagen diseases: As adjunctive therapy for short-term administration (for acute episode or exacerbation) in: psoriatic and rheumatoid arthritis including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute non-specific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis; for exacerbation or maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis, systemic dermatomyositis, polymyositis, polymyalgia rheumatica, giant cell arteritis. • Dermatologic diseases: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoids, severe psoriasis, severe seborrheic dermatitis. • Ophthalmic diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. • Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; nonsuppurative thyroiditis; hypercalcemia associated with cancer. • Respiratory diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy, aspiration pneumonitis, pulmonary emphysema where bronchospasm or bronchial edema plays a significant role, diffuse interstitial pulmonary fibrosis (Hamman-Rich syndrome). • Hematologic disorders: Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. • Neoplastic diseases: For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. • Edematous states: To induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia, of the idiopathic type or that due to lupus erythematosus. • Nervous system: May be used to treat patients with cerebral edema associated with primary or metastatic brain tumors, neurosurgery, head injury, pseudotumor cerebri and cerebral vascular accident (acute stroke) excluding intracerebral hemorrhage. May also be used in the preoperative preparation of patients with increased intracranial pressure secondary to brain tumors or for palliation of patients with inoperable or recurrent brain neoplasms. • Gastrointestinal diseases: As adjunctive therapy in the treatment of ulcerative colitis and regional enteritis. • Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when concurrently accompanied by appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement; postoperative dental inflammatory reactions. During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis. In combination with ondansetron for the management of nausea and vomiting associated with cisplatin and non-cisplatin emetogenic chemotherapy. APO-DEXAMETHASONE is also used in the diagnostic testing of adrenocortical hyperfunction and antenatal prophylaxis of neonatal respiratory distress.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Dosage requirements are variable and must be individualized according to the severity of the disease and the response of the patient. The usual initial dosage varies from 0.5 to 15 mg per day depending on the disease being treated. For infants and children, the recommended doses usually will have to be reduced, but dosage should be dictated by the severity of the condition rather than by age or body weight. Patients may be transferred to dexamethasone from any other glucocorticoid with the proper adjustment in dosage. In chronic, usually nonfatal diseases including endocrine and chronic rheumatic disorders, edematous states, respiratory and gastrointestinal diseases, some dermatologic diseases and hematologic disorders, start with a low dose (0.5 to 1 mg a day) and gradually increase dosage to the smallest amount that gives the desired degree of symptomatic relief. Dosage may be administered 2, 3 or 4 times a day. In congenital adrenal hyperplasia, the usual daily dose is 0.5 to 1.5 mg. In acute, nonfatal diseases, including allergic states, ophthalmic diseases, acute and subacute rheumatic disorders, dosage ranges between 2 and 3 mg a day, however, higher doses are necessary in some patients. Since the course of these conditions is self-limited, prolonged maintenance therapy is not usually necessary. Antiemetic prophylaxis during emetogenic chemotherapy: 8 to 20 mg of dexamethasone infused over 5 to 15 minutes just prior to chemotherapy, followed by 4 mg of dexamethasone orally every 4 to 6 hours, or by 8 mg orally every 8 hours, and tapered in either strength or frequency of administration over 2 to 3 days. Total treatment duration should not exceed 5 days beyond chemotherapy. Alternatively, injectable dexamethasone can be infused intravenously. In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders (e.g., acute allergic rhinitis, acute attacks of seasonal allergic bronchial asthma, urticaria medicamentosa, and contact dermatoses), the following dosage schedule, combining parenteral and oral therapy, is suggested: 1st day: 1 or 2 mL, intramuscular dexamethasone phosphate injection (4 mg/mL) (4 or 8 mg total daily dosage, 0.5 mg tablets: 4) 2nd day: 2 tablets dexamethasone (0.5 mg) twice a day (2 mg total daily dosage, 0.5 mg tablets: 4) 3rd day: 2 tablets dexamethasone (0.5 mg) twice a day (2 mg total daily dosage, 0.5 mg tablets: 4) 4th day: 1 tablet dexamethasone (0.5 mg) twice a day (1 mg total daily dosage, 0.5 mg tablets: 2) 5th day: 1 tablet dexamethasone (0.5 mg) twice a day (1 mg total daily dosage, 0.5 mg tablets: 2) 6th day: 1 tablet dexamethasone (0.5 mg)/ day (0.5 mg total daily dosage, 0.5 mg tablets: 1) 7th day: 1 tablet dexamethasone (0.5 mg)/ day (0.5 mg total daily dosage, 0.5 mg tablets: 1) 8th day: Follow-up visit In chronic, potentially fatal diseases such as systemic lupus erythematosus, pemphigus, symptomatic sarcoidosis, the recommended initial dosage is 2 to 4.5 mg a day; higher doses may be necessary in some patients. When the disease is acute and life-threatening (e.g., acute rheumatic carditis, crisis of systemic lupus erythematosus, severe allergic reactions, pemphigus, neoplastic diseases), the initial dosage is between 4 and 10 mg a day, administered in at least 4 divided doses. In cerebral edema, for palliative management of patients with recurrent or inoperable brain tumors, a dosage of 2 mg, 2 or 3 times a day may be effective. The smallest dosage necessary to control cerebral edema should be utilized. In the adrenogenital syndrome, daily dosages of 0.5 to 1.5 mg may keep children in remission and prevent the recurrence of abnormal excretion of 17-ketosteroids. As massive therapy in certain conditions, such as acute leukemia, the nephrotic syndrome, and pemphigus, the recommended dosage is from 10 to 15 mg a day. Patients receiving such a high dosage must be observed very closely for the appearance of severe reactions. Dexamethasone Suppression Tests: Give 1 mg orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg dexamethasone orally every 6 hours for 48 hours. Twenty-four-hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. Test to distinguish Cushing's syndrome due to pituitary ACTH excess from Cushing's syndrome due to other causes. Give 2 mg of dexamethasone orally every 6 hours for 48 hours. Twenty-four-hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. Missed Dose: If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

APO-DEXAMETHASONE is contraindicated in: • Patients who are hypersensitive to dexamethasone or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • Patients with systemic fungal infections. • Administration of live virus vaccines in patients receiving immunosuppressive corticosteroid doses.

Warnings and precautions

• Cardiovascular: Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. • Endocrine and Metabolism: Following prolonged therapy, abrupt discontinuation may result in withdrawal syndrome and secondary adrenocortical insufficiency. Symptoms of adrenal insufficiency resulting from rapid withdrawal include: nausea, fatigue, anorexia, dyspnea, hypotension, hypoglycemia, myalgia, fever, malaise, arthralgia, dizziness, desquamation of skin and fainting. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any stressful situation occurring during that period, reinstitute hormone therapy. If the patient is receiving corticosteroids already, the dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid may need to be used. Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstituted or the current dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids in patients with hypothyroidism. Fluid and electrolyte balance: Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention and increased potassium excretion. These 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. • Gastrointestinal: The association between peptic ulceration and corticosteroid therapy remains controversial. However, corticosteroid therapy may mask the symptoms of peptic ulcer. Perforation or hemorrhage may occur without significant pain. Corticosteroids should be used with caution in patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer and in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection. Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea. Steroids should be used 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. 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. There is an enhanced effect of corticosteroids in those with cirrhosis. • Immune: Immunosuppression: Patients being treated with corticosteroids should not be vaccinated against smallpox. Other immunization procedures should generally not be undertaken in these patients, especially those on high doses, because of possible neurological complications and a lack of antibody response. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy. Corticosteroids may suppress reactions to skin tests. Infections: In patients on corticosteroid therapy subjected to unusual stress, increased