Country: Kanada
Tungumál: enska
Heimild: Health Canada
DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
OMEGA LABORATORIES LIMITED
H02AB02
DEXAMETHASONE
10MG
SOLUTION
DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) 10MG
INTRAMUSCULAR
10X1ML
Prescription
ADRENALS
Active ingredient group (AIG) number: 0106305005; AHFS:
MARKETED
2013-05-08
Dexamethasone Omega Unidose 10 mg/1 mL (Dexamethasone Sodium Phosphate Injection USP) Page 1 of 12 PRESCRIBING INFORMATION PR DEXAMETHASONE OMEGA UNIDOSE (DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP) (10 MG/ML) STERILE CORTICOSTEROID Omega Laboratories Limited 11,177 Hamon Montreal, Quebec, Canada H3M 3E4 Date of preparation: June 12, 2012 Control Number: 154533 Dexamethasone Omega Unidose 10 mg/1 mL (Dexamethasone Sodium Phosphate Injection USP) Page 2 of 12 PR D EXAMETHASONE O MEGA U NIDOSE (DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP) 10 MG/ML STERILE CORTICOSTEROID ACTION AND PHARMACOLOGY Dexamethasone is a synthetic glucocorticoid used principally as an anti-inflammatory or immunosuppressant drug. After administration of the injection, dexamethasone sodium phosphate is rapidly converted into dexamethasone. Dexamethasone 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 USE D EXAMETHASONE O MEGA U NIDOSE may be given by IV or IM 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 glucocorticoids may be used in conjunction with a mineralocorticoid 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 glucocorticoids are use Lestu allt skjalið