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APO-DEXAMETHASONE is a brand name for Dexamethasone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Corticosteroid therapy is an adjunct to, not a replacement of conventional therapy, which should be instituted as indicated. Dosage must be decreased or therapy discontinued gradually when administration has been continued for more than a few days.
In acute conditions where prompt relief is urgent, large doses are permissible and may be mandatory for a short period. When symptoms have been suppressed adequately, dosage should be maintained at the minimum amount capable of providing sufficient relief without excessive hormonal effects.
Chronic conditions are subject to periods of spontaneous remission. When such periods occur, corticosteroids should be discontinued gradually. Routine laboratory studies such as urinalysis, 2-hourpost-prandial blood sugar, determinations of blood pressure and body weight, and a chest x -ray should be carried out at regular intervals during prolonged therapy.
Periodic de terminations of serum potassium are advisable if large doses are being used. 2 Recommended Dose and Dosage Adjustment Dosage requirements are variable and must be individualized according to the severity of the disease and the response of the patient.
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. The following milligram equivalents facilitate changing to dexamethasone from other glucocorticoids. Milligram for milligram, dexamethasone is approximately equivalent to betamethasone, 4 to 6 times more potent than methylprednisolone and triamcinolone, 6 to 8 times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and about 35 times more potent than cortisone.
At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone. 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. 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.
1 Adverse Reaction Overview Fluid and electrolyte disturbances: sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension. See 7 WARNINGS AND PRECAUTIONS.
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, tendon rupture. See 7 WARNINGS AND PRECAUTIONS.
Gastrointestinal: nausea, vomiting, anorexia which may result in weight loss; increased appetite which may result in weight gain; diarrhea or constipation, abdominal distention, pancreatitis, gastric irritation and ulcerative esophagitis; peptic ulcer with possible perforation and hemorrhage; perforation of the small and large bowel particularly in inflammatory bowel diseases.
See 7 WARNINGS AND PRECAUTIONS. Dermatologic: impaired wound healing; thin fragile skin; petechiae and ecchymoses; facial erythema; striae; hirsutism; acneiform eruptions; suppressed reactions to skin tests; hypersensitivity reactions such as allergic dermatitis, urticaria, angioneurotic edema.
Neurologic: seizures; increased intracranial pressure with papilledema (pseudotumor cerebri) in association with withdrawal of corticosteroid therapy; convulsions; vertigo; headache; psychic disturbances; neuritis; paresthesias. See 7 WARNINGS AND PRECAUTIONS.
Endocrine: decreased carbohydrate tolerance; hyperglycemia; glycosuria; increased requirements for oral hypoglycemics or insulin in diabetes; manifestations of latent diabetes mellitus; 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; hirsutism; increased sweating.
Administration of live virus vaccines in patients receiving immunosuppressive corticosteroid doses. 1 Dosing Considerations Corticosteroid therapy is an adjunct to, not a replacement of conventional therapy, which should be instituted as indicated.
Dosage must be decreased or therapy discontinued gradually when administration has been continued for more than a few days. In acute conditions where prompt relief is urgent, large doses are permissible and may be mandatory for a short period.
When symptoms have been suppressed adequately, dosage should be maintained at the minimum amount capable of providing sufficient relief without excessive hormonal effects. Chronic conditions are subject to periods of spontaneous remission.
When such periods occur, corticosteroids should be discontinued gradually. Routine laboratory studies such as urinalysis, 2-hourpost-prandial blood sugar, determinations of blood pressure and body weight, and a chest x -ray should be carried out at regular intervals during prolonged therapy.
Periodic de terminations of serum potassium are advisable if large doses are being used. 2 Recommended Dose and Dosage Adjustment Dosage requirements are variable and must be individualized according to the severity of the disease and the response of the patient.
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. The following milligram equivalents facilitate changing to dexamethasone from other glucocorticoids. Milligram for milligram, dexamethasone is approximately equivalent to betamethasone, 4 to 6 times more potent than methylprednisolone and triamcinolone, 6 to 8 times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and about 35 times more potent than cortisone.
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. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Patients with systemic fungal infections. See 7 WARNINGS AND PRECAUTIONS. Administration of live virus vaccines in patients receiving immunosuppressive corticosteroid doses.
See Infections:
APO-DEXAMETHASONE (dexamethasone) Page 6 of 30
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Since the course of these conditions is self -limited, prolonged maintenance therapy is not usually necessary. Antiemetic prophylaxis during emetogenic chemotherapy: dexamethasone administered concomitantly with ondansetron has been demonstrated to achieve enhanced efficacy for antiemetic prophylaxis during emetogenic chemotherapy.
Various dosing schedules have been used in clinical studies; however, the following is suggested for this combination: 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.
In general the total treatment duration for this indication should not exceed 5 days beyond chemotherapy. Alternatively, injectable dexamethasone can be infused intravenously in lieu of an oral formulation of dexamethasone using various schedules.
, 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. 5 mg a day; higher doses may be necessary in some patients.
, 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. Epinephrine is the drug of immediate choice in severe allergic reactions.
Dexamethasone is useful either concurrently or as supplementary therapy. In cerebral edema, when maintenance therapy is required. 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. 5 mg may keep children in remission and prevent the recurrence of abnormal excretion of […]
See 7 WARNINGS AND PRECAUTIONS. Ophthalmic: increased intraocular pressure; glaucoma; exophthalmos; posterior subcapsular cataracts. See 7 WARNINGS AND PRECAUTIONS. Metabolic: negative nitrogen balance due to protein catabolism. Psychologic: hallucinations; psychosis; euphoria; mood changes.
5 g given over a period of less than 10 minutes. See 7 WARNINGS AND PRECAUTIONS. Hematologic: leukocytosis, thrombocytopenia, lymphopenia. Others: hypersensitivity; thrombophlebitis; weight gain; increased appetite; nausea; malaise; hiccups; necrotizing angiitis; aggravation or masking of infections; insomnia; anaphylactoid reactions.
See 2 CONTRAINDICATIONS. 5 Post-Market Adverse Reactions Information is not available.
At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone. 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. 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: dexamethasone administered concomitantly with ondansetron has been demonstrated to achieve enhanced efficacy for antiemetic prophylaxis during emetogenic chemotherapy.
Various dosing schedules have been used in clinical studies; however, the following is suggested for this combination: 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.
In general the total treatment duration for this indication should not exceed 5 days beyond chemotherapy. Alternatively, injectable dexamethasone can be infused intravenously in lieu of an oral formulation of dexamethasone using various schedules.
, 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. 5 mg a day; higher doses may be necessary in some patients.
, 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. Epinephrine is the drug of immediate choice in severe allergic reactions.
Dexamethasone is useful either concurrently or as supplementary therapy. In cerebral edema, when maintenance therapy is required. 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 […]