Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEXAMETHASONE SODIUM PHOSPHATE
ATLANTIC LABORATORIES (M) SDN. BHD.
DEXAMETHASONE SODIUM PHOSPHATE
1ml x 50 Ampoules
ATLANTIC LABORATORIES CORPORATION LTD
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Dexamethasone Injection 5mg/ml PRESERVATIVE: Phenol 5 mg/ml. PRODUCT DESCRIPTION Dexasone Injection is a clear colorless sterile solution of Dexamethasone phosphate sodium eq. to Dexamethasone fill in glass ampoule. PHARMACODYNAMICS: The glucocorticoid steroids actions are mainly anti-inflammatory, anti-allergic and anti-rheumatic, in conditions such as asthma and rheumatoid arthritis. It appears that a measure of a corticosteroids potency as glucocorticoid is the degree of inhibition of corticotrophin secretion it produces. Dexamethasone has immunosuppressant properties and can be administered to reduce immune response after organ transplant. PHAMACOKINETICS: Dexasone Injection has rapid onset of action but of short duration. In the circulation, dexamethasone is bound to the plasma protein, but to a lesser extent than for other corticosteroids, mainly to globulin and less to albumin. The corticoid-binding globulin has high affinity low binding capacity, while the albumin had low affinity but large binding capacity. Only unbound dexamethasone has pharmacological effects or is metabolized. Corticosteroids diffuses into tissue fluids and cerebrospinal fluids but Trans placental diffusion in significant amounts had not been demonstrated. Corticosteroids are metabolized in the liver and kidney and excreted in the urine. The slower metabolism and lower protein binding affinity of dexamethasone may account for its increased potency compared with the natural corticosteroids. The biological half-life in plasma of dexamethasone is about 190 minutes. INDICATION: Severe allergic reactions, anaphylactic due to drugs, acute bronchial asthma, transfusion reactions, Steven-Johnson syndrome, acute dermatosis and laryngeal edema. Thyroid crisis and acute thyroiditis. Adrenocortical insufficiency. Management of the symptoms and symptomatic relief of rheumatoid arthritis, rheumatic fever, status asthmaticus, other inflammatory conditions and ulcerative colitis. It is useful in the treatment Prečítajte si celý dokument