Each vial contains:
Colistimethate
Sodium (Sterile) IP 30,00,000 IU
Systemic Treatment:
Colistimethate can be given as a 50ml intravenous infusion over a period
of 30 minutes. Patients with a lotally implantable various access device
(TIVAD) in place may tolerate a bolus injection of upto 2 million units
in the 10 ml given over a minimum of 5 minutes. The dose is determined
by the severity and type of infection and the age, weight and renal
function of the patient. Should clinical or bacteriological response be
slow the dose may be increased as indicated by the patient's condition.
Serum level estimations are recommended especially in renal impairment,
neonates and cystic fibrosis patients. Levels of 1015 mg/l (approx. 125
200 units/ml) colistimethate sodium should be adequate for most
infections.
Aminimum of 5 days treatment is generally recommended. For the treatment
of respiratory exacerbations in cystic fibrosis patients treatment
should be continued for up to 12 days.
Children and adults (including the elderly)
Up to 60 kg of body weight
50,000 units/kg/day to a maximum of 75,000 units/kg/day. The total daily
dose should be divided into three doses given at approx. 8 hours
interval. Over 60 kg of body weight
1-2 million units three times a day
The maximum dose is 6-9 million units in 24 hours
Anomalous distribution in patients with cystic fibrosis may require
higher doses in order to maintain therapeutic serum levels.
Aerosol inhalation
For local treatment of lower respiratory tract infections colistimethate
powder is dissolved in 2-4 ml of water for injection, or 0.9 % sodium
chloride intravenous infusion for use in a nebuliser attached to an
air/oxygen supply.
Doses of from 500,000 units twice daily up to 2 million units three
times daily have been found to be safe and effective in patients with
cystic fibrosis The following recommended doses are for guidance only
and should be adjusted according to clinical response:
Children < 2 years:
5,00,000-1 million units twice daily. Children> 2
years and adults: 1-2 million units twice daily
Hypersensitivity to colistimethate sodium (colistin) or to polymyxin
B. Patients with myasthenia gravis.
STORAGE CONDITIONS
Store below 30°C. Protect from light & moisture. Do not freeze.
Keep out of reach of children.