Each vial contains :
Polymyxin-B Sulphate (Sterile) USP
Eq. To Polymyxin-b 500000 units
(A Sterile Lyophilized Powder)
Polymyxin B for Injection (polymyxin B (polymyxin b Sulphate)
Sulphate)
is one of a group of basic polypeptide antibiotics derived from B
polymyxa (B aerosporous). Polymyxin B (polymyxin B Sulphate)
Sulphate is
the Sulphate salt of Polymyxins B1 and B2, which are produced by the
growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea).It
has
a potency of not less than 6000 polymyxin B (polymyxin b Sulphate)
units
per mg, calculated on the anhydrous basis.
Each vial contains 500,000 polymyxin B (polymyxin b Sulphate) units
for
parenteral or ophthalmic administration.
Polymyxin B (polymyxin B Sulphate) forInjection is in powder form
suitable for preparation of sterile solutions for intramuscular,
intravenous drip, intrathecal, or ophthalmic use.
In the medical literature, dosages have frequently been given in
terms
of equivalent weights of pure polymyxin B (polymyxin b Sulphate)
base.Each milligram of pure polymyxin B (polymyxin b Sulphate) base
is
equivalent to 10,000 units of polymyxin B (polymyxin b Sulphate) and
each microgram of pure polymyxin B (polymyxin B Sulphate) base is
equivalent to 10 units of polymyxin B.
Aqueous solutions of polymyxin B (polymyxin b Sulphate) Sulphate may
be
stored up to 12 months without significant loss of potency if kept
under
refrigeration. In the interest of safety, solutions for parenteral
use
should be stored under refrigeration and any unused portion should
be
discarded after 72 hours. Polymyxin B (polymyxin B Sulphate)
Sulphate
should not be stored in alkaline solutions since they are less
stable.
To reduce the development of drug-resistant bacteria and maintain
the
effectiveness of polymyxin B (polymyxin B Sulphate) and other
antibacterial drugs, polymyxin B (polymyxin b Sulphate) should be
used
only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
Parenteral :
Intravenous: Dissolve 500,000 polymyxin B (polymyxin b Sulphate)
units in 300 to 500 ml solutions for parenteral dextrose injection
5% for continuous drip.
Adults and children: 15,000 to 25,000 units/kg body weight/day in
individuals with normal kidney function.This amount should be
reduced from 15,000 units/kg downward for individuals with kidney
impairment. Infusions may be given every 12 hours; however, the
total daily dose must not exceed 25,000 units/kg/day.
Infants: Infants with normal kidney function may receive up to
40,000 units/kg/day without adverse effects.
Intramuscular:Not recommended routinely because of severe pain at
injection sites, particularly in infants and children. Dissolve
500,000 polymyxin B units in 2 ml sterile water for injection or
sodium chloride injection or procaine hydrochloride injection 1%.
Adults and children: 25,000 to 30,000 units/kg/day.This should be
reduced in the presence of renal impairment.The dosage may be
divided and given at either 4 or 6 hour intervals.
Infants: Infants with normal kidney function may receive up to
40,000 units/kg/day without adverse effects.
Storage: Store below 25ºC, Protected from direct sun
light.
