Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM FUSIDATE; HYDROCORTISONE
HOE PHARMACEUTICALS SDN. BHD.
SODIUM FUSIDATE; HYDROCORTISONE
15gm mcg/mL; 5gm mcg/mL
HOE PHARMACEUTICALS SDN. BHD.
Please refer to section E12 Baca dokumen lengkap
NAME AND STRENGTH OF ACTIVE SUBSTANCES: CREAM: Fusidic Acid 2.0% w/w and Hydrocortisone 1.0% w/w. OINTMENT: Sodium Fusidate 2.0% w/w and Hydrocortisone 1.0% w/w. PRODUCT DESCRIPTION: CREAM: A white cream. Other ingredients: Propylparaben, Methylparaben, White Soft Paraffin, Cetostearyl Alcohol, Cetomacrogol 1000, Propylene Glycol, Liquid Paraffin and Purified Water. OINTMENT: A colourless ointment. Other ingredients: Liquid Paraffin and White Soft Paraffin. PHARMACODYNAMICS: The antibacterial action of fusidic acid and its salt results from inhibition of bacterial protein synthesis. The drug interferes with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes. The spectrum of antibacterial activity of Fusidic acid is primarily toward Gram-positive organisms, demonstrating particularly high activity against _Staphylococcus aureus._ Hydrocortisone has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of topical corticosteroids is generally unclear. However, corticosteroids are thought to induce phospholipase A2 inhibitor proteins, preventing arachidonic acid release and the biosynthesis of potent mediators of inflammation. PHARMACOKINETICS Fusidic acid and its salt are widely distributed in tissues and body fluids, including bone, synovial fluid and pus. They penetrate into cerebral abscesses but do not enter cerebrospinal fluid in appreciable amounts. They have been found in foetal circulation and in breast milk. About 95% or more of Fusidic acid or Sodium fusidate in the circulation is bound to plasma protein. Fusidic acid or Sodium fusidate is excreted in the bile, almost entirely as metabolites, some of which have weak antimicrobial activity. About 2% appears unchanged in the faeces. Little is excreted in the urine or removed by haemodialysis. Corticosteroids are rapidly distributed to all body tissues. They cross the placenta to varying degrees and may be distributed in small amounts into breast milk. Most corticosteroids in the circ Baca dokumen lengkap