FOBAN HYDRO OINTMENT

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

SODIUM FUSIDATE; HYDROCORTISONE

Διαθέσιμο από:

HOE PHARMACEUTICALS SDN. BHD.

INN (Διεθνής Όνομα):

SODIUM FUSIDATE; HYDROCORTISONE

Μονάδες σε πακέτο:

15gm mcg/mL; 5gm mcg/mL

Κατασκευάζεται από:

HOE PHARMACEUTICALS SDN. BHD.

Φύλλο οδηγιών χρήσης

Please refer to section E12

Αρχείο Π.Χ.Π.

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